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)
Back pain15.03.04.0050.007030%
Balanoposthitis21.09.03.001--Not Available
Benign prostatic hyperplasia21.04.02.0010.001406%Not Available
Bile duct cancer16.07.01.001; 09.04.02.0010.001406%Not Available
Bladder stenosis12.02.10.011; 20.03.01.011--Not Available
Blood bilirubin increased13.03.04.018--
Blood creatinine increased13.13.01.004--
Blood glucose abnormal13.02.02.008--Not Available
Blood urea increased13.13.01.006--Not Available
Body temperature increased13.15.01.001--Not Available
Bone disorder15.02.04.004--Not Available
Bone pain15.02.01.0010.003515%
Bradycardia02.03.02.002--Not Available
Breast pain21.05.05.003--
Breast swelling21.05.05.0080.001406%Not Available
Breast tenderness21.05.05.004--Not Available
Bronchitis22.07.01.001; 11.01.09.001--
Cachexia16.32.03.011; 14.03.02.001; 08.01.01.0090.001406%Not Available
Cardiac arrest02.03.04.001--
Cardiac failure02.05.01.0010.018560%
Cardiac failure congestive02.05.01.0020.004218%Not Available
Cardio-respiratory arrest02.03.04.002; 22.02.06.0070.002109%Not Available
Cardiomegaly02.04.02.0010.002109%Not Available
Cardiomyopathy02.04.01.0010.001406%Not Available
Cataract06.06.01.001--
Cerebral haemorrhage24.07.04.001; 17.08.01.0030.003515%Not Available
Cerebral infarction24.04.06.002; 17.08.01.0040.012655%Not Available
Cerebral ischaemia24.04.06.003; 17.08.01.0050.002109%
Cerebral thrombosis24.01.04.003; 17.08.01.0060.001406%Not Available
Cerebrovascular accident24.03.05.001; 17.08.01.007--
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