Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Degarelix acetate
Drug ID BADD_D00600
Description Degarelix is used for the treatment of advanced prostate cancer. Degarelix is a synthetic peptide derivative drug which binds to gonadotropin-releasing hormone (GnRH) receptors in the pituitary gland and blocks interaction with GnRH. This antagonism reduces luteinising hormone (LH) and follicle-stimulating hormone (FSH) which ultimately causes testosterone suppression. Reduction in testosterone is important in treating men with advanced prostate cancer. Chemically, it is a synthetic linear decapeptide amide with seven unnatural amino acids, five of which are D-amino acids. FDA approved on December 24, 2008.
Indications and Usage Degaralix is used for the management of advanced prostate cancer.
Marketing Status approved
ATC Code L02BX02
DrugBank ID DB06699
KEGG ID D08635; D09400
MeSH ID C431566
PubChem ID 16186010
TTD Drug ID D0Y7KH
NDC Product Code 14799-3003; 66529-0017; 66558-0194; 70155-022; 61662-0015
UNII I18S89P20R
Synonyms acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide | uglypeptide1 | Ac-2Nal-4Cpa-3Pal-Ser-4Aph(hydroorotyl)-4Aph(carbamoyl)-Leu-ILys-pro-Ala-NH2 | Firmagon | degarelix | degarelix acetate | Gonax | FE 200486 | FE200486 | FE-200486
Chemical Information
Molecular Formula C84H107ClN18O18
CAS Registry Number 934016-19-0
SMILES CC(C)CC(C(=O)NC(CCCCNC(C)C)C(=O)N1CCCC1C(=O)NC(C)C(=O)N)NC(=O)C(CC2=CC=C(C=C2)NC (=O)N)NC(=O)C(CC3=CC=C(C=C3)NC(=O)C4CC(=O)NC(=O)N4)NC(=O)C(CO)NC(=O)C(CC5=CN=CC= C5)NC(=O)C(CC6=CC=C(C=C6)Cl)NC(=O)C(CC7=CC8=CC=CC=C8C=C7)NC(=O)C.CC(=O)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)
Arthralgia15.01.02.001--
Asthenia08.01.01.001--Not Available
Back pain15.03.04.005--
Chills15.05.03.016; 08.01.09.001--
Constipation07.02.02.001--
Diarrhoea07.02.01.001--
Dizziness02.11.04.006; 24.06.02.007; 17.02.05.003--
Drug specific antibody present13.17.01.001--Not Available
Dyspepsia07.01.02.001--
Fatigue08.01.01.002--
Gamma-glutamyltransferase increased13.03.04.024--
Gynaecomastia21.05.04.003; 05.05.02.003--
Headache17.14.01.001--
Hyperhidrosis23.02.03.004; 08.01.03.028--
Hypertension24.08.02.001--
Injection site erythema08.02.03.001; 23.03.06.015; 12.07.03.001--Not Available
Injection site induration12.07.03.007; 08.02.03.007--Not Available
Injection site pain12.07.03.011; 08.02.03.010--Not Available
Injection site reaction12.07.03.015; 08.02.03.014--
Insomnia19.02.01.002; 17.15.03.002--
Laboratory test abnormal13.18.01.001--Not Available
Nausea07.01.07.001--
Nervous system disorder17.02.10.001--Not Available
Night sweats23.02.03.006; 08.01.03.031--Not Available
Pyrexia08.05.02.003--
Testicular atrophy21.13.01.001; 05.05.02.004--Not Available
Urinary tract infection20.08.02.001; 11.01.14.004--
Weight increased13.15.01.006--
Bone density decreased13.16.01.001--Not Available
Injection site swelling12.07.03.018; 08.02.03.017--Not Available
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