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)
Odynophagia07.01.06.0360.000734%Not Available
Oedema peripheral14.05.06.011; 08.01.07.007; 02.05.04.0070.024592%
Oesophageal pain07.01.05.0120.001235%
Oesophageal stenosis07.13.02.0010.001068%
Pain in extremity15.03.04.0100.027161%
Panic attack19.06.04.0010.003504%Not Available
Paraesthesia23.03.03.094; 17.02.06.005--
Paralysis17.01.04.0040.001001%Not Available
Parkinsonism17.01.05.0030.001001%Not Available
Parosmia22.04.03.007; 17.04.04.0020.002369%Not Available
Pathological fracture16.32.03.007; 15.08.02.008; 12.04.02.0060.000334%Not Available
Penile pain21.12.01.0080.000734%
Peripheral coldness23.06.04.008; 24.04.03.006; 08.01.09.0100.002603%Not Available
Personality change19.05.01.006; 17.02.05.0190.000667%
Petit mal epilepsy17.12.04.0010.000334%Not Available
Pharyngitis22.07.03.004; 11.01.13.003; 07.05.07.004--
Photopsia17.17.01.006; 06.02.06.0040.001135%
Pleural effusion22.05.02.002--
Pneumonia11.01.09.003; 22.07.01.003--Not Available
Pneumothorax22.05.02.003--
Pollakiuria20.02.02.0070.006206%
Polyarthritis15.01.01.0050.000334%Not Available
Proctalgia07.03.02.0010.000334%
Prostate cancer metastatic16.25.01.002; 21.04.02.0040.001835%Not Available
Prostatitis21.09.01.0010.000734%Not Available
Pruritus23.03.12.001--
Pulmonary oedema22.01.03.003; 02.05.02.003--
Rectal cancer16.13.01.003; 07.21.05.0020.000501%Not Available
Renal pain20.02.03.0030.001301%Not Available
Respiratory disorder22.02.07.0020.001902%Not Available
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