Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Enzalutamide
Drug ID BADD_D00775
Description Enzalutamide is an androgen receptor inhibitor for the treatment of castration-resistant prostate cancer. FDA approved on August 31, 2012.
Indications and Usage Enzalutamide is indicated for the treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel.
Marketing Status approved
ATC Code L02BB04
DrugBank ID DB08899
KEGG ID D10218
MeSH ID C540278
PubChem ID 15951529
TTD Drug ID D0QK5X
NDC Product Code 16812-010; 11014-0003; 42385-733; 65392-2209; 0469-0725; 59285-018; 65015-876; 15308-1121; 0469-1725; 65129-1376; 0469-0625; 54893-0044; 55111-976; 0469-1125; 62128-0388; 68554-0106; 77382-0150; 0469-0125; 70277-001; 76302-019
UNII 93T0T9GKNU
Synonyms enzalutamide | 4-(3-(4-cyano-3-(trifluoromethyl)phenyl)-5,5-dimethyl-4-oxo-2-thioxo-1-imidazolidinyl)-2-fluoro-N-methyl-benzamide | enzalutamide D3 | HC-1119 | HC 1119 | 4-(3-(4-cyano-3-(trifluoromethyl)phenyl)-5,5-dimethyl-4-oxo-2-thioxo-1-imidazolidinyl)-2-fluoro-N-(methyl-d3)benzamide | Xtandi | MDV 3100 | MDV3100 | MDV-3100
Chemical Information
Molecular Formula C21H16F4N4O2S
CAS Registry Number 915087-33-1
SMILES CC1(C(=O)N(C(=S)N1C2=CC(=C(C=C2)C(=O)NC)F)C3=CC(=C(C=C3)C#N)C(F)(F)F)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)
Intervertebral disc degeneration15.10.01.0020.000334%Not Available
Jaw disorder15.02.04.0090.000734%Not Available
Malnutrition14.03.02.0040.000667%Not Available
Meningeal disorder17.02.10.0030.000334%Not Available
Mental disorder19.07.01.002--Not Available
Metastatic neoplasm16.16.01.0070.000834%Not Available
Motor dysfunction15.05.06.006; 17.01.02.0310.001335%Not Available
Oesophageal disorder07.11.02.0010.001135%Not Available
Optic nerve disorder17.04.05.004; 06.02.08.0010.000334%
Partial seizures17.12.03.0100.000334%Not Available
Cardiac valve disease02.07.02.0010.000501%Not Available
Decreased appetite14.03.01.005; 08.01.09.0280.104708%
Feeling of body temperature change08.01.09.0120.000734%Not Available
Ill-defined disorder08.01.03.049--Not Available
Parkinson's disease17.01.05.0100.002336%Not Available
Urinary tract obstruction20.08.01.0040.001168%
Blood disorder01.05.01.004--Not Available
Bone lesion15.02.04.0160.001168%Not Available
Disease progression08.01.03.0380.015783%
Drug intolerance08.06.01.0130.024492%Not Available
Metastasis16.22.01.0010.001168%Not Available
Sinus disorder22.04.06.0020.002035%
Unevaluable event08.01.03.051--Not Available
Bowel movement irregularity07.02.03.0030.001869%Not Available
Osteonecrosis of jaw24.04.05.005; 15.02.04.0100.003070%
Urethral stenosis20.07.03.0030.000334%Not Available
Treatment failure08.06.01.017--Not Available
Regurgitation07.01.07.0040.000334%Not Available
Head and neck cancer16.16.01.0030.000667%Not Available
Skin mass23.07.04.0140.000334%Not Available
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