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)
Dysphoria19.04.02.0040.000104%Not Available
Dyspnoea22.02.01.004; 02.01.03.0020.003334%
Dysuria20.02.02.002--
Ear infection11.01.05.001; 04.03.01.0060.000243%Not Available
Ear pain04.03.01.0030.000174%
Ecchymosis01.01.03.001; 24.07.06.002; 23.06.01.0010.000139%Not Available
Eczema23.03.04.0060.000104%
Electrocardiogram QT prolonged13.14.05.004--
Emotional disorder19.04.02.0050.000695%Not Available
Enuresis20.02.02.003; 19.07.04.0010.000313%Not Available
Eosinophilia01.02.04.0010.000452%
Eosinophilic pneumonia22.01.01.004; 01.02.04.0030.000174%Not Available
Epilepsy17.12.03.0020.000521%Not Available
Episcleritis10.02.01.024; 06.04.07.0010.000174%Not Available
Epistaxis24.07.01.005; 22.04.03.0010.000417%
Erythema23.03.06.0010.000521%Not Available
Erythema multiforme23.03.01.003; 10.01.03.0150.000069%
Erythema nodosum23.07.02.001; 10.02.01.020--Not Available
Eye pain06.08.03.002--
Eye swelling06.08.03.003--Not Available
Eyelid oedema06.04.04.004; 23.04.01.003; 10.01.05.0010.000208%Not Available
Eyelid ptosis17.17.02.004; 06.05.01.0020.000069%Not Available
Face oedema23.04.01.004; 10.01.05.002; 08.01.07.0030.000104%
Faeces discoloured07.01.03.0020.000104%Not Available
Fatigue08.01.01.002--
Fear19.06.03.0010.000764%Not Available
Febrile convulsion17.12.03.004; 08.05.02.0090.000069%Not Available
Feeling abnormal08.01.09.0140.000799%Not Available
Feeling hot08.01.09.0090.000104%Not Available
Femur fracture15.08.03.003; 12.04.01.003--Not Available
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