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)
Pituitary haemorrhage24.07.04.009; 05.03.04.005; 17.08.01.0190.001406%Not Available
Malignant neoplasm progression16.16.01.0050.024606%Not Available
Prostatomegaly21.04.01.0020.001406%Not Available
Acute coronary syndrome24.04.04.011; 02.02.02.0150.007030%Not Available
Conjunctival hyperaemia06.04.01.0040.003515%Not Available
Musculoskeletal stiffness15.03.05.027--Not Available
Musculoskeletal discomfort15.03.04.001--Not Available
Injection site swelling12.07.03.018; 08.02.03.0170.002109%Not Available
Depressive symptom19.15.02.0030.001406%Not Available
Haemorrhage24.07.01.002--Not Available
Pulmonary mass22.02.07.0040.002109%Not Available
Intra-abdominal haematoma24.07.02.034; 07.12.02.0050.001406%Not Available
Colitis microscopic07.08.01.0110.001406%Not Available
Lung neoplasm malignant22.08.01.001; 16.19.02.0010.007733%Not Available
Nuchal rigidity17.05.02.006; 15.05.04.005--Not Available
Disturbance in sexual arousal19.08.04.003--Not Available
Intestinal mass07.11.01.0100.001406%Not Available
Gastrointestinal toxicity12.03.01.019; 07.08.03.0060.001406%Not Available
Angiopathy24.03.02.007--Not Available
Blood alkaline phosphatase increased13.04.02.004--
Hepatic enzyme increased13.03.04.028--Not Available
Hot flush24.03.01.005; 21.02.02.001; 08.01.03.0270.029809%
Prostate cancer21.04.02.002; 16.25.01.0010.025309%Not Available
Breast cancer male21.05.01.008; 16.10.01.0020.004218%Not Available
Breast disorder21.05.04.004--Not Available
Cardiac disorder02.11.01.003--Not Available
Feeding disorder19.09.01.003; 14.03.02.0030.003093%Not Available
Malnutrition14.03.02.0040.001406%Not Available
Mediastinal disorder22.09.03.001--Not Available
Mental disorder19.07.01.002--Not Available
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