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)
Urinary tract disorder20.08.01.001--Not Available
Urine flow decreased20.02.02.0120.000734%Not Available
Vertigo17.02.12.002; 04.04.01.003--
Vertigo positional04.04.01.005; 17.02.12.0040.000734%Not Available
Vestibular disorder17.02.02.008; 04.04.02.0010.000501%
Vision blurred17.17.01.010; 06.02.06.0070.023891%
Visual impairment06.02.10.0130.013547%Not Available
Mobility decreased17.02.05.018; 08.01.03.030; 15.03.05.0230.003203%Not Available
Musculoskeletal disorder15.03.05.0250.000834%Not Available
Deafness unilateral04.02.01.011--Not Available
Hypoacusis04.02.01.0060.003771%
Performance status decreased08.01.03.0420.001969%Not Available
Peripheral swelling08.01.03.053; 02.05.04.0150.038873%Not Available
Osteopenia14.04.04.004; 15.02.03.0030.000501%Not Available
General physical health deterioration08.01.03.0180.018219%Not Available
Balance disorder08.01.03.081; 17.02.02.0070.014682%Not Available
Dysstasia15.03.05.011; 08.01.03.089; 17.02.02.0120.002069%Not Available
Musculoskeletal chest pain22.09.01.001; 15.03.04.0120.003837%
Lower gastrointestinal haemorrhage07.12.03.011; 24.07.02.0300.000667%
Cardiopulmonary failure22.02.06.004; 02.05.01.0040.000334%Not Available
Malignant neoplasm progression16.16.01.0050.221695%Not Available
Prostatomegaly21.04.01.0020.000501%Not Available
Metabolic syndrome14.06.02.007; 05.06.02.007; 24.08.02.0140.000334%Not Available
Eyelid margin crusting23.03.03.029; 06.04.04.0050.001135%Not Available
Ear discomfort04.03.01.0050.000334%Not Available
Lymphatic disorder01.09.01.003--Not Available
Large intestinal haemorrhage24.07.02.026; 07.12.03.0030.000334%
Cardiac flutter02.03.02.0120.000334%Not Available
Musculoskeletal stiffness15.03.05.0270.007841%Not Available
Musculoskeletal discomfort15.03.04.0010.001635%Not Available
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