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)
Menopausal symptoms21.02.02.002--Not Available
Mental impairment19.21.02.003; 17.03.03.002--Not Available
Metastases to liver16.22.02.001; 09.04.02.0040.003670%Not Available
Metastases to lung22.08.01.005; 16.22.02.0020.001835%Not Available
Metastases to spine16.22.02.007; 15.09.03.0070.000667%Not Available
Micturition urgency20.02.02.0060.000834%
Monoparesis17.01.04.0110.000334%Not Available
Monoplegia17.01.04.0030.000501%Not Available
Motor neurone disease17.05.05.0020.000334%Not Available
Multiple fractures15.08.02.005; 12.04.02.009--Not Available
Muscle atrophy15.05.03.003; 17.05.03.0040.001635%Not Available
Muscle disorder15.05.03.0140.001135%Not Available
Muscular weakness17.05.03.005; 15.05.06.0010.028529%
Musculoskeletal pain15.03.04.0070.007841%
Myalgia15.05.02.0010.028663%
Nail discolouration23.02.05.0010.000901%
Nail disorder23.02.05.0020.001301%
Nasopharyngitis22.07.03.002; 11.01.13.002--Not Available
Necrosis24.04.02.006; 08.03.03.0010.000334%Not Available
Neoplasm16.16.02.0010.002402%Not Available
Neoplasm malignant16.16.01.001--Not Available
Nephrolithiasis20.04.01.002--
Nerve compression17.09.02.002; 12.01.12.0010.000734%Not Available
Nervous system disorder17.02.10.0010.003370%Not Available
Nervousness19.06.02.0030.003270%Not Available
Neutropenia01.02.03.004--Not Available
Night sweats23.02.03.006; 08.01.03.0310.003103%Not Available
Nightmare19.02.03.0030.006840%Not Available
Nipple pain21.05.05.0090.000734%Not Available
Nocturia20.02.03.0010.002936%Not Available
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