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 The immediate release tablet of Zileuton has been withdrawn from the US market.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Marketing Status approved; investigational; withdrawn
ATC Code Not Available
DrugBank ID DB00744
KEGG ID D00414
MeSH ID C063449
PubChem ID 60490
TTD Drug ID D09JUG
NDC Product Code 10122-901; 50384-5000; 76055-0002; 64980-206; 49706-2115; 59285-035; 72643-022; 64380-189; 42973-156; 14501-0056; 49884-723; 51407-741; 31722-044; 69339-130; 13672-010
UNII V1L22WVE2S
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
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)
Muscle rigidity15.05.04.001; 17.05.02.005---
Myalgia15.05.02.001--
Nausea07.01.07.001--
Neck pain15.03.04.009--
Nervousness19.06.02.003---
Pain08.01.08.004--
Pruritus23.03.12.001--
Pyrexia08.05.02.003--
Rash23.03.13.001---
Sinusitis11.01.13.005; 22.07.03.007--
Sleep disorder19.02.04.001---
Somnolence17.02.04.006; 19.02.05.003--
Tension19.06.02.005---
Upper respiratory tract infection11.01.13.009; 22.07.03.011--
Urinary tract infection11.01.14.004; 20.08.02.001--
Urticaria10.01.06.001; 23.04.02.001--
Vaginal infection11.01.10.002; 21.14.02.002--
Vomiting07.01.07.003--
White blood cell count decreased13.01.06.012--
Musculoskeletal discomfort15.03.04.001---
Nuchal rigidity15.05.04.005; 17.05.02.006---
Abnormal behaviour19.01.01.001---
Ill-defined disorder08.01.03.049---
Liver injury09.01.07.022; 12.01.17.012---
Traumatic liver injury09.01.08.010; 12.01.17.027---
Vulvovaginal inflammation21.14.02.014---
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