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)
Prostatic disorder21.04.01.001--Not Available
Pruritus23.03.12.001--
Pulmonary embolism24.01.06.001; 22.06.02.0010.011952%Not Available
Pulmonary fibrosis22.01.02.0060.007733%
Pyrexia08.05.02.0030.019966%
Rash23.03.13.001--Not Available
Rash erythematous23.03.13.0290.002109%Not Available
Rectal haemorrhage07.12.03.001; 24.07.02.0180.003796%
Respiratory disorder22.02.07.0020.001406%Not Available
Respiratory failure22.02.06.002; 14.01.04.0030.007733%
Rhabdomyolysis15.05.05.0020.007030%
Rhinitis22.07.03.006; 11.01.13.004--
Sciatica15.10.01.001; 17.10.03.0010.002109%Not Available
Sepsis11.01.11.003--
Sexual dysfunction21.03.02.003; 19.08.05.0020.004218%Not Available
Shock24.06.02.0020.002109%Not Available
Sinusitis22.07.03.007; 11.01.13.005--
Skin cancer16.03.02.002; 23.08.02.002--Not Available
Skin disorder23.03.03.007--Not Available
Skin hyperpigmentation23.05.01.0030.001406%
Skin hypertrophy23.01.04.002--Not Available
Skin ulcer24.04.03.007; 23.07.03.003--
Somnolence17.02.04.006; 19.02.05.003--
Spinal cord compression17.10.01.0060.004218%
Squamous cell carcinoma16.16.01.0020.001406%Not Available
Stevens-Johnson syndrome10.01.01.045; 12.03.01.014; 23.03.01.007; 11.07.01.0050.001406%
Sudden death08.04.01.003; 02.03.04.0130.001406%
Suicide attempt19.12.01.0040.004218%
Supraventricular tachycardia02.03.03.0120.002109%
Swelling08.01.03.0150.008718%Not Available
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