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)
Organ failure08.01.03.0410.000334%Not Available
Secretion discharge08.01.03.0190.000334%Not Available
Cerebral haematoma24.07.04.006; 17.08.01.0140.000334%Not Available
Haemorrhoidal haemorrhage24.10.02.001; 07.15.03.0020.000334%
Cerebral disorder17.02.10.0170.000501%Not Available
Haemorrhage urinary tract24.07.01.007; 20.02.03.0050.000334%Not Available
Fluid intake reduced14.05.10.0010.000334%Not Available
Faecaloma07.01.03.0040.000334%Not Available
Urine odour abnormal20.02.01.0200.001135%Not Available
Cognitive disorder19.21.02.001; 17.03.03.0030.010511%
Cancer pain16.32.03.0040.002169%Not Available
Lung neoplasm malignant22.08.01.001; 16.19.02.0010.003837%Not Available
Restless legs syndrome17.02.07.008; 15.05.03.0120.008342%Not Available
Angiopathy24.03.02.0070.000334%Not Available
Metastases to central nervous system17.02.10.013; 16.22.02.0040.001502%Not Available
Drug resistance08.06.01.005--Not Available
Hot flush24.03.01.005; 21.02.02.001; 08.01.03.0270.061196%
Joint injury15.01.08.019; 12.04.03.005--Not Available
Neurological symptom17.02.05.0100.000734%Not Available
Prostate cancer21.04.02.002; 16.25.01.0010.020821%Not Available
Ventricular failure02.05.01.0070.000334%Not Available
Appetite disorder19.09.01.002; 14.03.01.0040.001301%Not Available
Bladder disorder20.03.01.0020.000501%Not Available
Brain neoplasm17.20.01.003; 16.30.01.0030.000901%Not Available
Cardiac disorder02.11.01.003--Not Available
Connective tissue disorder10.04.04.026; 15.06.01.006--Not Available
Feeding disorder19.09.01.003; 14.03.02.0030.003370%Not Available
Embolism24.01.01.0090.000667%
Gastrointestinal motility disorder07.02.03.0010.000334%Not Available
Infestation23.11.01.002; 11.09.01.001--Not Available
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