Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Denosumab
Drug ID BADD_D00608
Description Denosumab is a novel, fully human IgG2 monoclonal antibody specific to receptor activator of nuclear factor kappa-B ligand (RANKL), suppresses bone resorption markers in patients with a variety of metastatic tumors and is being investigated in multiple clinical trials for the prevention and treatment of bone metastases. Chemically, it consists of 2 heavy and 2 light chains. Each light chain consists of 215 amino acids. Each heavy chain consists of 448 amino acids with 4 intramolecular disulfides. FDA approved on June 1, 2010.
Indications and Usage Prolia is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture. It reduces the incidence of vertebral, nonvertebral, and hip fractures. Prolia is also indicated as a treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer. It can also be used in men with osteoporosis at high risk for fracture or in men receiving androgen deprivation therapy for nonmetastatic prostate cancer to increase bone mass. Xgeva is indicated for the prevention of skeletal-related events in patients with bone metastases from solid tumors.
Marketing Status approved
ATC Code M05BX04
DrugBank ID DB06643
KEGG ID D03684
MeSH ID D000069448
PubChem ID Not Available
TTD Drug ID D08WSY
NDC Product Code 55513-730; 55513-710
UNII 4EQZ6YO2HI
Synonyms Denosumab | Xgeva | AMG 162 | Prolia
Chemical Information
Molecular Formula Not Available
CAS Registry Number 615258-40-7
SMILES Not Available
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)
Abdominal pain upper07.01.05.003--
Anaemia01.03.02.001--
Angina pectoris02.02.02.002; 24.04.04.002--
Arthralgia15.01.02.001--
Asthenia08.01.01.001---
Atrial fibrillation02.03.03.002--
Back pain15.03.04.005--
Bone pain15.02.01.001--
Cataract06.06.01.001--
Cellulitis11.02.01.001; 23.11.02.004---
Cystitis11.01.14.001; 20.03.02.002--
Dermatitis23.03.04.002---
Eczema23.03.04.006--
Erysipelas11.02.06.001; 23.11.02.007---
Flatulence07.01.04.002--
Gastrooesophageal reflux disease07.02.02.003--
Herpes zoster11.05.02.003; 17.09.03.026; 23.11.05.005--
Hypercholesterolaemia14.08.01.001---
Hypocalcaemia14.04.01.004--
Infection11.01.08.002---
Insomnia17.15.03.002; 19.02.01.002--
Musculoskeletal pain15.03.04.007--
Myalgia15.05.02.001--
Neoplasm malignant16.16.01.001---
Oedema peripheral02.05.04.007; 08.01.07.007; 14.05.06.011--
Pain in extremity15.03.04.010--
Pancreatitis07.18.01.001--
Pharyngitis07.05.07.004; 11.01.13.003; 22.07.03.004--
Pneumonia11.01.09.003; 22.07.01.003---
Pruritus23.03.12.001--
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