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%Not Available
Abdominal distension07.01.04.0010.011152%
Abdominal pain upper07.01.05.0030.006319%
Ageusia17.02.07.001; 07.14.03.0030.004213%Not Available
Angioedema22.04.02.008; 23.04.01.001; 10.01.05.0090.001859%Not Available
Bezoar07.11.01.0080.004213%Not Available
Cardiac arrest02.03.04.0010.002478%
Cardiac failure02.05.01.0010.005576%
Cardiac failure congestive02.05.01.0020.004585%Not Available
Cerebral haemorrhage17.08.01.003; 24.07.04.0010.001859%Not Available
Cerebrovascular accident24.03.05.001; 17.08.01.0070.002478%
Cerebrovascular disorder24.03.05.002; 17.08.02.0020.001239%Not Available
Colon cancer16.13.01.001; 07.21.01.0010.001239%Not Available
Constipation07.02.02.0010.035934%
Deafness04.02.01.0010.001239%Not Available
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%Not Available
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%Not Available
Intestinal perforation07.04.06.0020.001859%Not Available
Joint swelling15.01.02.0040.006319%Not Available
Lip swelling23.04.01.007; 10.01.05.005; 07.05.04.0050.003346%Not Available
Metabolic acidosis14.01.01.0030.003717%Not Available
Muscle spasms15.05.03.0040.006319%
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