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)
Oropharyngeal discomfort22.12.03.015; 07.05.05.008--Not Available
Posterior reversible encephalopathy syndrome17.13.02.0070.002002%
Functional gastrointestinal disorder07.11.01.0160.000334%Not Available
Slow speech19.19.02.004; 17.02.08.0160.001001%Not Available
Mouth swelling23.04.01.020; 10.01.05.020; 07.05.04.0070.000734%Not Available
Anal incontinence17.05.01.021; 07.01.06.0290.001802%
Cerebellar haemorrhage17.08.01.046; 24.07.04.0230.000334%Not Available
Lymphadenopathy mediastinal22.09.03.006; 01.09.01.0250.000334%Not Available
Malignant pleural effusion16.32.03.014; 22.05.04.0010.000334%Not Available
Metastases to bone16.22.02.005; 15.09.03.0060.009209%Not Available
Metastases to lymph nodes16.22.02.006; 01.09.01.0150.000834%Not Available
Normal pressure hydrocephalus17.07.01.0020.000334%Not Available
Prostatic haemorrhage21.04.01.009; 24.07.03.0280.000334%
Throat cancer22.08.02.008; 16.19.02.0070.000334%Not Available
Urinary bladder haemorrhage20.03.01.023; 24.07.01.0860.000667%Not Available
Terminal state08.01.03.0790.001001%Not Available
Fear of falling19.06.03.0080.001135%Not Available
Metastases to bone marrow16.22.02.013; 01.05.01.0220.000334%Not Available
Metastases to meninges16.22.02.003; 17.02.10.0120.000501%Not Available
Foaming at mouth08.01.03.070; 17.02.05.056; 07.05.05.0190.000734%Not Available
Bladder tamponade24.07.01.064; 20.02.02.0240.000334%Not Available
Hormone-refractory prostate cancer21.04.02.007; 16.25.01.0040.003570%Not Available
Oncologic complication16.32.03.0250.000501%Not Available
Seizure like phenomena17.12.03.0300.000667%Not Available
Spinal pain08.01.08.030; 17.10.01.020; 15.02.01.0080.001702%Not Available
Abdominal lymphadenopathy07.11.01.018; 01.09.01.0200.000334%Not Available
Tongue discomfort07.14.02.0190.001135%Not Available
Biliary obstruction09.02.02.0050.000501%Not Available
Cardiac dysfunction02.11.01.0040.000334%Not Available
Drug effect less than expected08.06.01.036--Not Available
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