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---
Pruritus23.03.12.001--
Pulmonary embolism22.06.02.001; 24.01.06.0010.011952%-
Pulmonary fibrosis22.01.02.0060.007733%
Pyrexia08.05.02.0030.019966%
Rash23.03.13.001---
Rash erythematous23.03.13.0290.002109%-
Rectal haemorrhage07.12.03.001; 24.07.02.0180.003796%
Respiratory disorder22.02.07.0020.001406%-
Respiratory failure14.01.04.003; 22.02.06.0020.007733%
Rhabdomyolysis15.05.05.0020.007030%
Rhinitis11.01.13.004; 22.07.03.006--
Sciatica15.10.01.001; 17.10.03.0010.002109%-
Sepsis11.01.11.003--
Sexual dysfunction19.08.05.002; 21.03.02.0030.004218%-
Shock24.06.02.0020.002109%-
Sinusitis11.01.13.005; 22.07.03.007--
Skin cancer16.03.02.002; 23.08.02.002---
Skin disorder23.03.03.007---
Skin hyperpigmentation23.05.01.0030.001406%
Skin hypertrophy23.01.04.002---
Skin ulcer23.07.03.003; 24.04.03.007--
Somnolence17.02.04.006; 19.02.05.003--
Spinal cord compression17.10.01.0060.004218%
Squamous cell carcinoma16.16.01.0020.001406%-
Stevens-Johnson syndrome10.01.01.045; 11.07.01.005; 12.03.01.014; 23.03.01.0070.001406%
Sudden death02.03.04.013; 08.04.01.0030.001406%
Suicide attempt19.12.01.0040.004218%
Supraventricular tachycardia02.03.03.0120.002109%
Swelling08.01.03.0150.008718%-
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