Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Sodium zirconium cyclosilicate
Drug ID BADD_D02521
Description Sodium zirconium cyclosilicate is approved as the trade product Lokelma developed by AstraZeneca - an insoluble, non-absorbed sodium zirconium silicate, formulated as a powder for oral suspension that acts as a highly selective potassium removing agent.[L2933] It is administered orally and is odorless, tasteless, and stable at room temperature.[L2933] Approval of the medication is supported by data from three double-blind, placebo-controlled trials and two open-label trials which showed that the onset of action was approximately 1.0 hour and the median time to achieving normal potassium levels in the blood was 2.2 hours, with 92% of patients achieving normal potassium levels within 48 hours following administration.[L2933] The treatment effect was maintained for up to 12 months.[L2933]
Indications and Usage Sodium zirconium cyclosilicate is a potassium binder indicated for the treatment of hyperkalemia in adult patients [FDA Label, F130].
Marketing Status Not Available
ATC Code V03AE10
DrugBank ID DB14048
KEGG ID D10727
MeSH ID C000597310
PubChem ID 92042806
TTD Drug ID D03AZK
NDC Product Code 65977-0132; 0310-1110; 0310-2111; 0310-1105
Synonyms sodium zirconium cyclosilicate | ZS-9 compound | Lokelma
Chemical Information
Molecular Formula H26Na2O20Si3Zr
CAS Registry Number 17141-74-1
SMILES O.O.O.O.O.O.[OH-].[OH-].O[Si](O)(O)O.O[Si](O)(O)O.O[Si](O)(O)O.[Na+].[Na+].[Zr]
Chemical Structure
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal discomfort07.01.06.0010.017494%Not Available
Blood potassium abnormal13.11.01.0240.008747%Not Available
Blood potassium increased13.11.01.0110.008747%Not Available
Blood pressure increased13.14.03.0050.011662%Not Available
Cardiac failure02.05.01.0010.001521%
Cardiac failure congestive02.05.01.0020.008747%Not Available
Constipation07.02.02.0010.032071%
Death08.04.01.001--
Diarrhoea07.02.01.0010.029156%
Dizziness02.01.02.004; 17.02.05.003; 24.06.02.0070.005831%
Fluid overload02.05.04.004; 14.05.06.0010.005831%Not Available
Fluid retention14.05.06.002; 20.01.02.0030.005831%Not Available
Heart rate increased13.14.04.0020.005831%Not Available
Hyperkalaemia14.05.03.0010.005831%
Hypertension24.08.02.0010.011662%
Hypokalaemia14.05.03.0020.008747%
Joint swelling15.01.02.0040.005831%Not Available
Nausea07.01.07.001--
Oedema08.01.07.006; 14.05.06.0100.020409%Not Available
Oedema peripheral02.05.04.007; 08.01.07.007; 14.05.06.0110.005831%
Rash23.03.13.0010.005831%Not Available
Rash pruritic23.03.12.0020.005831%Not Available
Swelling08.01.03.0150.005831%Not Available
Urticaria10.01.06.001; 23.04.02.0010.005831%
Weight increased13.15.01.0060.017494%
Peripheral swelling02.05.04.015; 08.01.03.0530.005831%Not Available
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