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)
Incoherent17.02.08.002; 19.10.03.0060.000334%-
Incontinence07.01.06.011; 17.05.01.006; 20.02.02.0040.002703%-
Infection11.01.08.002---
Injection site mass08.02.03.009; 12.07.03.010---
Injection site pain08.02.03.010; 12.07.03.011---
Injury12.01.08.004---
Insomnia17.15.03.002; 19.02.01.0020.034402%
Interstitial lung disease10.02.01.033; 22.01.02.0030.004671%-
Jaundice cholestatic09.01.01.0050.000334%-
Joint swelling15.01.02.0040.010277%-
Lacrimation increased06.08.02.0040.003036%
Laryngitis11.01.13.001; 22.07.03.001--
Left ventricular failure02.05.02.0010.000334%-
Lethargy08.01.01.008; 17.02.04.003; 19.04.04.0040.013614%
Leukoencephalopathy17.13.02.0030.000334%
Leukopenia01.02.02.001---
Lip swelling07.05.04.005; 10.01.05.005; 23.04.01.0070.005439%-
Listless08.01.01.012; 19.04.04.0030.001068%-
Loss of control of legs08.01.02.0030.000334%-
Lower respiratory tract infection11.01.09.002; 22.07.01.002---
Lung disorder22.02.07.001---
Lymph node pain01.09.01.0070.000334%
Lymphadenopathy01.09.01.0020.001835%-
Lymphoedema01.09.01.006; 24.09.01.0010.000667%
Macular degeneration06.09.03.0010.000334%-
Malaise08.01.01.0030.051286%
Marasmus14.03.02.0130.001335%-
Mass08.03.05.0030.000501%-
Memory impairment17.03.02.003; 19.20.01.0030.022957%
Meningioma16.30.01.005; 17.20.01.0050.000501%-
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