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)
Abnormal dreams19.02.03.001; 17.15.02.0010.005039%Not Available
Acute myocardial infarction24.04.04.001; 02.02.02.001--Not Available
Acute promyelocytic leukaemia16.01.05.003; 01.10.05.0030.000501%Not Available
Adrenal insufficiency05.01.02.001; 14.11.01.0040.000667%
Ageusia17.02.07.001; 07.14.03.0030.007174%Not Available
Alanine aminotransferase increased13.03.04.005--
Amnesia19.20.01.001; 17.03.02.0010.011645%
Anorectal disorder07.03.01.0010.000334%Not Available
Anosmia22.04.03.006; 17.04.04.0010.000734%
Anxiety19.06.02.002--
Aortic aneurysm24.02.03.0010.000334%Not Available
Aortic dissection24.02.03.0020.000834%Not Available
Aortic stenosis24.04.01.0010.000334%Not Available
Aphonia22.12.03.001; 19.19.01.002; 17.02.08.0090.002369%
Arrhythmia02.03.02.001--Not Available
Arthralgia15.01.02.0010.050152%
Asphyxia12.01.08.011; 22.02.02.0010.000667%Not Available
Aspiration22.02.07.0070.002069%
Asthenia08.01.01.0010.104641%Not Available
Atrial fibrillation02.03.03.002--
Atrial flutter02.03.03.0030.000501%
B-cell lymphoma16.28.01.001; 01.15.01.0010.000501%Not Available
Back pain15.03.04.0050.053956%
Bladder neoplasm20.03.04.002; 16.08.03.0020.000334%Not Available
Blindness unilateral06.02.10.007; 17.17.01.0160.000667%Not Available
Blood bilirubin increased13.03.04.018--
Blood pressure fluctuation24.06.01.0020.001401%Not Available
Bone disorder15.02.04.004--Not Available
Bone neoplasm16.29.01.001; 15.09.02.0010.000501%Not Available
Bone pain15.02.01.0010.025460%
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