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 Prescription
ATC Code L02BB04
DrugBank ID DB08899
KEGG ID D10218
MeSH ID C540278
PubChem ID 15951529
TTD Drug ID D0QK5X
NDC Product Code 54893-0044; 55111-976; 0469-0625; 65392-2209; 68554-0106; 65015-876; 62128-0388; 65129-1376; 59285-018; 42385-733; 0469-0725; 11014-0003; 15308-1121; 0469-0125
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
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Flank pain20.02.03.006; 15.03.04.003; 08.01.08.0070.002942%
Flatulence07.01.04.0020.012503%
Fluid overload14.05.06.001; 02.05.04.004--Not Available
Fluid retention20.01.02.003; 14.05.06.002--Not Available
Flushing23.06.05.003; 24.03.01.002; 08.01.03.025--
Foreign body aspiration22.02.07.008; 12.01.03.0010.001471%Not Available
Formication19.10.02.010; 17.02.06.0180.003677%Not Available
Fracture15.08.02.001; 12.04.02.001--
Frequent bowel movements07.02.04.002--Not Available
Gait disturbance17.02.05.016; 08.01.02.0020.039716%
Gallbladder disorder09.03.02.001--Not Available
Gamma-glutamyltransferase increased13.03.01.011--
Gastritis07.08.02.001--
Gastrooesophageal reflux disease07.02.02.003--
Gastrointestinal disorder07.11.01.001--Not Available
Gastrointestinal haemorrhage24.07.02.009; 07.12.02.001--Not Available
Generalised oedema14.05.06.007; 08.01.07.0040.003677%
Gout15.01.06.001; 14.09.01.0010.005884%Not Available
Groin pain15.03.02.0040.002942%Not Available
Guillain-Barre syndrome17.09.01.001; 11.07.01.001; 10.04.10.0050.001471%
Gynaecomastia21.05.04.003; 05.05.02.0030.006619%
Haemangioma16.02.01.002; 24.03.06.0040.001471%Not Available
Haematemesis24.07.02.011; 07.12.02.002--Not Available
Haematochezia24.07.02.012; 07.12.02.003--Not Available
Haematocrit decreased13.01.05.001--Not Available
Haematoma24.07.01.001--
Haematuria24.07.01.047; 20.02.01.0060.018387%
Blood urine present13.13.02.0020.016916%Not Available
Haemoglobin decreased13.01.05.003--Not Available
Haemorrhage intracranial24.07.04.003; 17.08.01.008--
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