Adverse Drug Reaction Classification System

         

Pharmaceutical Information
Drug Name Etelcalcetide
Drug ID BADD_D02514
Description Etelcalcetide is a calcimimetic drug for the treatment of secondary hyperparathyroidism in patients undergoing hemodialysis. Etelcalcetide was approved (trade name Parsabiv) for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis in February, 2017.
Indications and Usage Etelcalcetide is a calcium-sensing receptor agonist indicated for: Secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.
Marketing Status approved; investigational
ATC Code H05BX04
DrugBank ID DB12865
KEGG ID D10676
MeSH ID C583569
PubChem ID 71511839
TTD Drug ID D07RYI
NDC Product Code 55463-0030; 55513-741; 55513-740; 52076-6227; 55513-742
UNII 60ME133FJB
Synonyms etelcalcetide hydrochloride | velcalcetide | etelcalcetide | KAI-4169 | Parsabiv | AMG-416 | AMG 416
Chemical Information
Molecular Formula C38H73N21O10S2
CAS Registry Number 1262780-97-1
SMILES CC(C(=O)NC(CCCN=C(N)N)C(=O)N)NC(=O)C(CCCN=C(N)N)NC(=O)C(CCCN=C(N)N)NC(=O)C(CCCN= C(N)N)NC(=O)C(C)NC(=O)C(CSSCC(C(=O)O)N)NC(=O)C
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)
Pruritus23.03.12.0010.068395%
Rash pruritic23.03.13.0300.013040%Not Available
Respiratory disorder22.02.07.0020.001918%Not Available
Retinal haemorrhage24.07.05.003; 06.10.01.0010.001278%Not Available
Seizure17.12.03.0010.008310%
Sexual dysfunction19.08.05.002; 21.03.02.0030.004347%Not Available
Skin exfoliation23.03.07.0030.004986%Not Available
Skin ulcer24.04.03.007; 23.07.03.0030.002813%
Therapeutic response unexpected08.06.01.0010.004986%Not Available
Throat irritation22.12.03.029; 07.05.05.0370.004347%Not Available
Upper gastrointestinal haemorrhage24.07.02.024; 07.12.02.0060.001278%
Ventricular fibrillation02.03.04.0080.001278%
Vertigo17.02.12.002; 04.04.01.0030.005625%
Vomiting07.01.07.0030.083608%
Calciphylaxis14.04.01.0120.002557%Not Available
Hypoaesthesia oral17.02.06.021; 07.05.05.0030.011506%Not Available
Paraesthesia oral07.05.05.035; 17.02.06.0080.013040%Not Available
Hot flush24.03.01.005; 21.02.02.001; 08.01.03.0270.008693%
Adverse event08.06.01.0100.017131%Not Available
Cardiac disorder02.11.01.0030.003196%Not Available
Ill-defined disorder08.01.03.0490.001918%Not Available
Drug intolerance08.06.01.0130.030171%Not Available
Unevaluable event08.01.03.0510.006009%Not Available
Peripheral arterial occlusive disease24.04.03.0100.005753%Not Available
Adverse reaction08.06.01.0180.004347%Not Available
Stenosis08.01.03.0600.001278%Not Available
Hungry bone syndrome05.04.03.004; 15.02.03.015; 14.04.04.0140.001918%Not Available
Sleep disorder due to a general medical condition19.02.04.0030.006520%Not Available
Taste disorder17.02.07.029; 07.14.03.0040.004347%Not Available
Therapeutic product effect decreased08.06.01.0500.006520%Not Available
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