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)
Restlessness19.11.02.002; 17.02.05.021--
Retching07.01.07.0020.003504%Not Available
Rhinitis22.07.03.006; 11.01.13.004--
Rotator cuff syndrome12.01.07.018; 15.01.08.0020.000334%
Saliva altered07.06.01.0040.001135%Not Available
Seizure17.12.03.0010.017652%
Sepsis11.01.11.003--
Sinus congestion22.04.06.0010.001702%Not Available
Sinusitis11.01.13.005; 22.07.03.007--
Skin disorder23.03.03.007--Not Available
Skin odour abnormal23.03.03.0120.001301%
Skin ulcer24.04.03.007; 23.07.03.003--
Sleep apnoea syndrome22.02.01.013; 19.02.05.002; 17.15.05.0010.001401%
Sleep terror17.15.02.006; 19.02.03.0080.001301%Not Available
Sluggishness08.01.01.0040.001401%Not Available
Small cell lung cancer22.08.01.013; 16.19.08.0030.000334%Not Available
Speech disorder19.19.02.002; 17.02.08.003; 22.12.03.0270.003470%Not Available
Spinal cord compression17.10.01.0060.001668%
Sudden death08.04.01.003; 02.03.04.0130.001168%
Testicular pain21.13.01.0050.001869%
Throat irritation22.12.03.029; 07.05.05.0370.011378%Not Available
Thrombocytopenia01.08.01.002--Not Available
Tongue disorder07.14.01.0020.000334%Not Available
Tongue neoplasm malignant stage unspecified16.13.07.003; 07.21.07.0030.000334%Not Available
Toothache07.09.06.0010.002603%
Transient ischaemic attack24.04.06.005; 17.08.04.0010.002669%
Upper respiratory tract infection22.07.03.011; 11.01.13.009--
Urethral disorder20.07.01.002--Not Available
Urinary incontinence20.02.02.010; 17.05.01.0080.003103%
Urinary retention20.02.02.0110.003303%
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