Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Bicalutamide
Drug ID BADD_D00271
Description Bicalutamide is an oral non-steroidal anti-androgen for prostate cancer. It is comprised of a racemic mixture that is a 50:50 composition of the (R)-bicalutamide and (S)-bicalutamide enantionmers. Bicalutamide binds to the androgen receptor.
Indications and Usage For treatment (together with surgery or LHRH analogue) of advanced prostatic cancer.
Marketing Status approved
ATC Code L02BB03
DrugBank ID DB01128
KEGG ID D00961
MeSH ID C053541
PubChem ID 2375
TTD Drug ID D0V9BD
NDC Product Code 49711-1504; 49711-1509; 51846-1028; 62559-890; 71205-577; 0904-6019; 53104-7664; 16714-816; 60429-177; 62559-680; 43265-7195; 46014-1111; 82920-004; 54893-0001; 16729-023; 58623-0068; 63629-8308; 15308-0360; 47335-485
UNII A0Z3NAU9DP
Synonyms bicalutamide | 4'-cyano-3-(4-fluorophenylsulfonyl)-2-hydroxy-2-methyl-3'-(trifluoromethyl)propionanilide | Casodex | Cosudex | ICI-176334 | ICI 176334
Chemical Information
Molecular Formula C18H14F4N2O4S
CAS Registry Number 90357-06-5
SMILES CC(CS(=O)(=O)C1=CC=C(C=C1)F)(C(=O)NC2=CC(=C(C=C2)C#N)C(F)(F)F)O
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)
Small cell carcinoma16.16.01.0170.002109%Not Available
Urinary bladder haemorrhage24.07.01.086; 20.03.01.0230.001406%Not Available
Bone marrow oedema15.02.01.005; 01.05.01.0190.002109%Not Available
Neuroendocrine carcinoma16.24.01.007; 05.08.01.0110.001406%Not Available
Hormone-refractory prostate cancer21.04.02.007; 16.25.01.0040.001406%Not Available
Exposed bone in jaw15.02.04.0340.003515%Not Available
Phyllodes tumour21.05.01.026; 16.10.02.0020.002812%Not Available
Allergic reaction to excipient10.01.01.0350.001406%Not Available
Bone sequestrum15.02.04.0420.001406%Not Available
Gait inability17.02.05.069; 08.01.02.0110.001406%Not Available
Male reproductive tract disorder21.10.05.0240.001406%Not Available
Microscopic enteritis07.08.03.0270.001406%Not Available
Myelosuppression01.03.03.0150.001406%Not Available
Neuroendocrine carcinoma of prostate05.08.01.020; 21.04.02.013; 16.25.01.0090.001406%Not Available
Therapy non-responder08.06.01.0630.004921%Not Available
Ureteric rupture20.06.01.012; 12.01.05.0090.002812%Not Available
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