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)
Incoherent19.10.03.006; 17.02.08.0020.000334%Not Available
Incontinence07.01.06.011; 20.02.02.004; 17.05.01.0060.002703%Not Available
Infection11.01.08.002--Not Available
Injection site mass12.07.03.010; 08.02.03.009--Not Available
Injection site pain12.07.03.011; 08.02.03.010--Not Available
Injury12.01.08.004--Not Available
Insomnia17.15.03.002; 19.02.01.0020.034402%
Interstitial lung disease22.01.02.003; 10.02.01.0330.004671%Not Available
Jaundice cholestatic09.01.01.0050.000334%Not Available
Joint swelling15.01.02.0040.010277%Not Available
Lacrimation increased06.08.02.0040.003036%
Laryngitis22.07.03.001; 11.01.13.001--
Left ventricular failure02.05.02.0010.000334%Not Available
Lethargy19.04.04.004; 17.02.04.003; 08.01.01.0080.013614%
Leukoencephalopathy17.13.02.0030.000334%
Leukopenia01.02.02.001--Not Available
Lip swelling23.04.01.007; 10.01.05.005; 07.05.04.0050.005439%Not Available
Listless19.04.04.003; 08.01.01.0120.001068%Not Available
Loss of control of legs08.01.02.0030.000334%Not Available
Lower respiratory tract infection22.07.01.002; 11.01.09.002--Not Available
Lung disorder22.02.07.001--Not Available
Lymph node pain01.09.01.0070.000334%
Lymphadenopathy01.09.01.0020.001835%Not Available
Lymphoedema24.09.01.001; 01.09.01.0060.000667%
Macular degeneration06.09.03.0010.000334%Not Available
Malaise08.01.01.0030.051286%
Marasmus14.03.02.0130.001335%Not Available
Mass08.03.05.0030.000501%Not Available
Memory impairment19.20.01.003; 17.03.02.0030.022957%
Meningioma17.20.01.005; 16.30.01.0050.000501%Not Available
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