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)
Decreased appetite14.03.01.005; 08.01.09.0280.011530%
Erectile dysfunction19.08.04.001; 21.03.01.0070.007733%
Urinary tract obstruction20.08.01.0040.002109%
Blood disorder01.05.01.004--Not Available
Bone lesion15.02.04.0160.002109%Not Available
Disease progression08.01.03.0380.017013%
Pulmonary toxicity22.01.02.007; 12.03.01.0130.001406%Not Available
Hepatic lesion09.01.08.0050.001406%Not Available
Hepatobiliary disease09.01.08.003--Not Available
Metastasis16.22.01.0010.007733%Not Available
Renal impairment20.01.03.0100.004218%Not Available
Peripheral arterial occlusive disease24.04.03.0100.001406%Not Available
Osteonecrosis of jaw15.02.04.010; 24.04.05.0050.023200%
Bone marrow failure01.03.03.0050.002812%
Treatment failure08.06.01.0170.010967%Not Available
Organising pneumonia22.01.02.0080.001406%Not Available
Hypertransaminasaemia09.01.02.005--Not Available
Acute kidney injury20.01.03.0160.012655%
Drug-induced liver injury12.03.01.044; 09.01.07.0230.005202%Not Available
Hepatic cancer16.07.02.004; 09.04.02.0080.002109%Not Available
Hepatocellular carcinoma16.07.02.005; 09.04.02.0100.002109%Not Available
Multiple organ dysfunction syndrome08.01.03.0570.007030%
Anal incontinence17.05.01.021; 07.01.06.0290.002812%
Immune-mediated adverse reaction10.02.01.0440.001406%Not Available
Adenocarcinoma of colon16.13.01.010; 07.21.01.0080.001406%Not Available
Metastases to bone16.22.02.005; 15.09.03.0060.010545%Not Available
Metastases to breast21.05.01.024; 16.22.02.0140.002109%Not Available
Metastases to lymph nodes16.22.02.006; 01.09.01.0150.004218%Not Available
Prostate cancer recurrent21.04.02.008; 16.25.01.0050.002109%Not Available
Prostatic haemorrhage24.07.03.028; 21.04.01.0090.002109%
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