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What the label lists and what reports show

Sodium zirconium cyclosilicate side effects

Sodium zirconium cyclosilicate's FDA label: “Most common adverse reactions with LOKELMA: mild to moderate edema.” FAERS holds 3,695 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is blood potassium increased (191 reports).

  • No generic listed

Check it at the source: the sodium zirconium cyclosilicate FDA label on DailyMed (effective February 8, 2024, AstraZeneca Pharmaceuticals LP); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

Most common adverse reactions with LOKELMA: mild to moderate edema.

From the label: adverse reactions, continued

The following adverse reactions are discussed in greater detail elsewhere in the label: • Edema [see Warnings and Precautions (5.2) ]. Most common adverse reactions with LOKELMA: mild to moderate edema. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. The total exposure to LOKELMA in the safety and efficacy clinical trials of patients not on dialysis with hyperkalemia was 1,760 patients with 652 patients exposed to LOKELMA for at least 6 months and 507 patients exposed for at least one year. The population (n=1,009) in the placebo-controlled trials included patients aged 22 to 96 years, females (n=454), Caucasians (n=859) and Blacks (n=130). Patients had hyperkalemia in association with comorbid diseases such as chronic kidney disease, heart failure, and diabetes mellitus. …

Source: FDA drug label, AstraZeneca Pharmaceuticals LP, effective February 8, 2024 (SPL set 90bf8e28-748d-4e4b-a19f-9cf483370eff), via openFDA; the full label on DailyMed

What do FAERS reports show?

3,695 reports list sodium zirconium cyclosilicate among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,340 are coded as a death and 979 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 21 reactions below, 4 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

  • Death (an outcome recorded in the report)1,088
  • Blood Potassium Increased191
  • Diarrhoea (named in the label)168
  • Hyperkalaemia150
  • Constipation (named in the label)118
  • Off Label Use (a use or a product term, not a reaction)117
  • Cardiac Failure90
  • Nausea89
  • Renal Failure79
  • Vomiting78
  • Acute Kidney Injury77
  • Drug Ineffective (a use or a product term, not a reaction)77
  • Chronic Kidney Disease72
  • Hypokalaemia (named in the label)71
  • Pneumonia70
  • Dyspnoea69
  • Renal Impairment69
  • Oedema (named in the label)68
  • Fall66
  • Asthenia61
  • Fatigue60
  • Product Dose Omission Issue (a use or a product term, not a reaction)59
  • Dizziness58
  • Hypertension56
  • End Stage Renal Disease55

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Sodium zirconium cyclosilicate: the full record
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Side effects hub
the most reported medicines and reactions