Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Zafirlukast
Drug ID BADD_D02377
Description Zafirlukast is an oral leukotriene receptor antagonist (LTRA) for the maintenance treatment of asthma, often used in conjunction with an inhaled steroid and/or long-acting bronchodilator. It is available as a tablet and is usually dosed twice daily. Another leukotriene receptor antagonist is montelukast (Singulair), which is usually taken just once daily. Zafirlukast blocks the action of the cysteinyl leukotrienes on the CysLT1 receptors, thus reducing constriction of the airways, build-up of mucus in the lungs and inflammation of the breathing passages.
Indications and Usage For the prophylaxis and chronic treatment of asthma.
Marketing Status approved; investigational
ATC Code R03DC01
DrugBank ID DB00549
KEGG ID D00411
MeSH ID C062735
PubChem ID 5717
TTD Drug ID D05DVP
NDC Product Code 16571-654; 49884-589; 64380-187; 68084-059; 55111-625; 65977-0113; 64380-178; 31722-008; 49884-554; 49884-590; 63629-2102; 64380-188; 42291-970; 52562-800; 55111-886; 55111-626; 52562-801; 31722-007; 64380-177; 50370-0008; 42291-971; 49884-549
UNII XZ629S5L50
Synonyms zafirlukast | 4-(5-cyclopentyloxycarbonylamino-2-methylindol-3-yl-methyl)-3-methoxy-N-O-tolylsulfonylbenzamide | Olmoran | ICI 204,219 | ICI-204219 | ICI 204219 | Accolate | Aeronix
Chemical Information
Molecular Formula C31H33N3O6S
CAS Registry Number 107753-78-6
SMILES CC1=CC=CC=C1S(=O)(=O)NC(=O)C2=CC(=C(C=C2)CC3=CN(C4=C3C=C(C=C4)NC(=O)OC5CCCC5)C)O C
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice.
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Hepatic function abnormal09.01.02.001---
Hepatitis09.01.07.004---
Hepatitis fulminant09.01.07.007; 11.07.01.003---
Hepatotoxicity09.01.07.009; 12.03.01.008---
Hyperbilirubinaemia01.06.04.003; 09.01.01.003; 14.11.01.010---
Hypersensitivity10.01.03.003--
Hypersensitivity vasculitis01.01.04.008; 10.02.02.017; 23.06.02.005; 24.12.04.013---
Hypoaesthesia17.02.06.023; 23.03.03.081---
Increased tendency to bruise01.01.03.005; 23.06.01.009; 24.07.06.012---
Infection11.01.08.002---
Influenza like illness08.01.03.010--
Injury12.01.08.004---
Insomnia17.15.03.002; 19.02.01.002--
Jaundice01.06.04.004; 09.01.01.004; 23.03.03.030---
Liver function test abnormal13.03.04.030---
Liver transplant25.09.02.001---
Malaise08.01.01.003--
Myalgia15.05.02.001--
Nausea07.01.07.001--
Neuropathy peripheral17.09.03.003---
Neutropenia01.02.03.004---
Oedema08.01.07.006; 14.05.06.010---
Pain08.01.08.004--
Pruritus23.03.12.001--
Pyrexia08.05.02.003--
Rash23.03.13.001---
Rectal haemorrhage07.12.03.001; 24.07.02.018--
Sensory loss17.02.07.007---
Sinusitis11.01.13.005; 22.07.03.007--
Swelling08.01.03.015---
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ADReCS-Target
Drug Name ADR Term Target
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