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.[L12822,F130]
Marketing Status approved; investigational
ATC Code V03AE10
DrugBank ID DB14048
KEGG ID D10727
MeSH ID C000597310
PubChem ID 92042806
TTD Drug ID D03AZK
NDC Product Code 65977-0132; 0310-1105; 50090-6502; 0310-1110; 50090-6501; 0310-2111
UNII D652ZWF066
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
*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 discomfort07.01.06.0010.021065%-
Abdominal distension07.01.04.0010.011152%
Abdominal pain upper07.01.05.0030.006319%
Ageusia07.14.03.003; 17.02.07.0010.004213%-
Angioedema10.01.05.009; 22.04.02.008; 23.04.01.0010.001859%-
Bezoar07.11.01.0080.004213%-
Cardiac arrest02.03.04.0010.002478%
Cardiac failure02.05.01.0010.005576%
Cardiac failure congestive02.05.01.0020.004585%-
Cerebral haemorrhage17.08.01.003; 24.07.04.0010.001859%-
Cerebrovascular accident17.08.01.007; 24.03.05.0010.002478%
Cerebrovascular disorder17.08.02.002; 24.03.05.0020.001239%-
Colon cancer07.21.01.001; 16.13.01.0010.001239%-
Constipation07.02.02.0010.035934%
Deafness04.02.01.0010.001239%-
Death08.04.01.0010.071745%
Diarrhoea07.02.01.0010.042750%
Dyspepsia07.01.02.0010.004213%
Fluid retention14.05.06.002; 20.01.02.0030.004833%-
Hyperkalaemia14.05.03.0010.010904%
Hypernatraemia14.05.04.0010.001239%
Hypertension24.08.02.0010.010532%
Hypokalaemia14.05.03.0020.008302%
Ileus07.13.01.0010.002478%
Intestinal obstruction07.13.01.0020.001239%-
Intestinal perforation07.04.06.0020.001859%-
Joint swelling15.01.02.0040.006319%-
Lip swelling07.05.04.005; 10.01.05.005; 23.04.01.0070.003346%-
Metabolic acidosis14.01.01.0030.003717%-
Muscle spasms15.05.03.0040.006319%
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