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)
Syncope02.11.04.015; 24.06.02.012; 17.02.04.0080.004218%
Systemic lupus erythematosus23.03.02.006; 15.06.02.003; 10.04.03.0040.002812%Not Available
Tachypnoea22.02.01.0140.001406%Not Available
Tenderness08.01.08.005--Not Available
Tension19.06.02.005--Not Available
Testicular atrophy21.13.01.001; 05.05.02.0040.001406%Not Available
Thrombocytopenia01.08.01.0020.013358%Not Available
Thrombophlebitis24.01.02.001--Not Available
Tooth abscess11.01.04.003; 07.09.01.003--Not Available
Tooth loss12.01.17.026; 07.09.09.0010.001406%Not Available
Torsade de pointes02.03.04.0050.004921%Not Available
Transient ischaemic attack24.04.06.005; 17.08.04.0010.007030%
Tumour lysis syndrome16.32.03.002; 14.05.01.0040.001406%
Urethral disorder20.07.01.002--Not Available
Urinary incontinence20.02.02.010; 17.05.01.008--
Urinary retention20.02.02.0110.004921%
Urinary tract disorder20.08.01.001--Not Available
Urinary tract infection20.08.02.001; 11.01.14.004--
Urticaria23.04.02.001; 10.01.06.001--
Ventricular extrasystoles02.03.04.0070.001406%Not Available
Ventricular fibrillation02.03.04.0080.002812%
Ventricular tachycardia02.03.04.0100.001406%
Visual impairment06.02.10.013--Not Available
Vomiting07.01.07.003--
Weight decreased13.15.01.005--
Weight increased13.15.01.006--
White blood cell count decreased13.01.06.012--
Yellow skin23.03.03.042; 09.01.01.009; 08.01.03.046--Not Available
Tubulointerstitial nephritis20.05.02.0020.004921%Not Available
General physical health deterioration08.01.03.0180.003515%Not Available
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