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---
Benign prostatic hyperplasia21.04.02.0010.001406%-
Bile duct cancer09.04.02.001; 16.07.01.0010.001406%-
Bladder stenosis12.02.10.011; 20.03.01.011---
Blood bilirubin increased13.03.04.018--
Blood creatinine increased13.13.01.004--
Blood glucose abnormal13.02.02.008---
Blood urea increased13.13.01.006---
Body temperature increased13.15.01.001---
Bone disorder15.02.04.004---
Bone pain15.02.01.0010.003515%
Bradycardia02.03.02.002---
Breast pain21.05.05.003--
Breast swelling21.05.05.0080.001406%-
Breast tenderness21.05.05.004---
Bronchitis11.01.09.001; 22.07.01.001--
Cachexia08.01.01.009; 14.03.02.001; 16.32.03.0110.001406%-
Cardiac arrest02.03.04.001--
Cardiac failure02.05.01.0010.018560%
Cardiac failure congestive02.05.01.0020.004218%-
Cardio-respiratory arrest02.03.04.002; 22.02.06.0070.002109%-
Cardiomegaly02.04.02.0010.002109%-
Cardiomyopathy02.04.01.0010.001406%-
Cataract06.06.01.001--
Cerebral haemorrhage17.08.01.003; 24.07.04.0010.003515%-
Cerebral infarction17.08.01.004; 24.04.06.0020.012655%-
Cerebral ischaemia17.08.01.005; 24.04.06.0030.002109%
Cerebral thrombosis17.08.01.006; 24.01.04.0030.001406%-
Cerebrovascular accident17.08.01.007; 24.03.05.001--
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