Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Zileuton
Drug ID BADD_D02384
Description Leukotrienes are substances that induce numerous biological effects including augmentation of neutrophil and eosinophil migration, neutrophil and monocyte aggregation, leukocyte adhesion, increased capillary permeability, and smooth muscle contraction. These effects contribute to inflammation, edema, mucus secretion, and bronchoconstriction in the airways of asthmatic patients. Zileuton relieves such symptoms through its selective inhibition of 5-lipoxygenase, the enzyme that catalyzes the formation of leukotrienes from arachidonic acid. Specifically, it inhibits leukotriene LTB4, LTC4, LTD4, and LTE4 formation. Both the R(+) and S(-) enantiomers are pharmacologically active as 5-lipoxygenase inhibitors in in vitro systems. The immediate release tablet of Zileuton has been withdrawn from the US market.
Indications and Usage For the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older.
Marketing Status Prescription; Discontinued
ATC Code Not Available
DrugBank ID DB00744
KEGG ID D00414
MeSH ID C063449
PubChem ID 60490
TTD Drug ID D09JUG
NDC Product Code 50384-5000; 72643-022; 68180-169; 76055-0002; 59285-035; 49706-2115; 14501-0056; 49884-723; 69339-130; 64980-206; 13672-010; 66993-485; 42973-156; 10122-901
Synonyms zileuton | N-(1-benzo(b)thien-2-ylethyl)-N-hydroxyurea | A 64077 | Abbot 64077 | A-64077 | Zyflo
Chemical Information
Molecular Formula C11H12N2O2S
CAS Registry Number 111406-87-2
SMILES CC(C1=CC2=CC=CC=C2S1)N(C(=O)N)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)
Abdominal pain07.01.05.002--
Abdominal pain upper07.01.05.003--
Alanine aminotransferase increased13.03.01.003--
Arthralgia15.01.02.001--
Asthenia08.01.01.001--Not Available
Body temperature increased13.15.01.001--Not Available
Chest pain22.02.08.003; 08.01.08.002; 02.02.02.011--Not Available
Conjunctivitis11.01.06.012; 06.04.01.002--
Constipation07.02.02.001--
Dermatitis23.03.04.002--Not Available
Diarrhoea07.02.01.001--
Discomfort08.01.08.003--Not Available
Dizziness24.06.02.007; 17.02.05.003; 02.01.02.004--
Dyspepsia07.01.02.001--
Feeling abnormal08.01.09.014--Not Available
Flatulence07.01.04.002--
Gastrointestinal disorder07.11.01.001--Not Available
Headache17.14.01.001--
Hepatitis09.01.07.004--Not Available
Hepatotoxicity12.03.01.008; 09.01.07.009--Not Available
Hyperbilirubinaemia14.11.01.010; 09.01.01.003; 01.06.04.003--Not Available
Hypersensitivity10.01.03.003--
Hypertonia17.05.02.001; 15.05.04.007--Not Available
Injury12.01.08.004--Not Available
Insomnia19.02.01.002; 17.15.03.002--
Jaundice01.06.04.004; 23.03.03.030; 09.01.01.004--Not Available
Laryngeal pain22.02.05.036--
Liver disorder09.01.08.001--Not Available
Lymphadenopathy01.09.01.002--Not Available
Malaise08.01.01.003--
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