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)
Flank pain20.02.03.006; 15.03.04.003; 08.01.08.0070.000667%
Flatulence07.01.04.0020.005706%
Formication19.10.04.002; 17.02.06.0180.000901%Not Available
Fracture15.08.02.001; 12.04.02.001--
Gait disturbance15.03.05.013; 17.02.05.016; 08.01.02.0020.016384%
Gastrointestinal disorder07.11.01.001--Not Available
Generalised oedema14.05.06.007; 08.01.07.0040.000834%
Gout15.01.06.001; 14.09.01.0010.001735%Not Available
Groin pain15.03.02.0040.001068%Not Available
Haematoma24.07.01.001--
Haematuria20.02.01.006; 21.10.01.018; 24.07.01.0470.006607%
Haemorrhagic stroke24.07.04.014; 17.08.01.0110.000834%Not Available
Hallucination19.10.04.0030.009310%
Hallucination, tactile19.10.04.006--Not Available
Hallucination, visual19.10.04.007--Not Available
Head discomfort17.02.05.0270.003170%Not Available
Headache17.14.01.001--
Hepatitis cholestatic09.01.01.0020.000501%Not Available
Hepatomegaly09.01.05.001--Not Available
Hydronephrosis20.01.05.0010.002002%Not Available
Hypercalcaemia14.04.01.003; 05.04.01.0020.001001%
Hypersomnia19.02.05.001; 17.15.01.0010.007675%
Hypertension24.08.02.0010.017518%
Hypertensive crisis24.08.01.0010.001168%Not Available
Hypertensive encephalopathy24.08.05.001; 17.13.02.0020.000334%Not Available
Hypertonic bladder20.03.03.003; 17.10.01.0030.000734%Not Available
Hypoaesthesia23.03.03.081; 17.02.06.0230.019854%Not Available
Hypogeusia17.02.07.004; 07.14.03.0020.000334%Not Available
Hypokinesia17.01.02.0090.002603%Not Available
Ileus07.13.01.0010.001335%
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