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What the label lists and what reports show

Sodium polystyrene sulfonate side effects

Sodium polystyrene sulfonate's FDA label lists its adverse reactions in its own words. FAERS holds 1,586 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 hyperkalaemia (110 reports).

  • Generic listed

Check it at the source: the sodium polystyrene sulfonate FDA label on DailyMed (effective November 29, 2023, Epic Pharma, LLC); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

The following adverse reactions are discussed elsewhere in the labeling: • Intestinal Necrosis [ see Warnings and Precautions (5.1) ] • Electrolyte Disturbances [see Warnings and Precautions (5.2, 5.3) ] • Aspiration [ see Warnings and Precautions (5.4) ] The following adverse reactions have been identified during post-approval use of Sodium Polystyrene Sulfonate Powder, for Suspension. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or establish a causal relationship to drug exposure. …

Source: FDA drug label, Epic Pharma, LLC, effective November 29, 2023 (SPL set 61cc890b-eb3d-494c-ae45-629a27e721ce), via openFDA; the full label on DailyMed

What do FAERS reports show?

1,586 reports list sodium polystyrene sulfonate among the medicines taken, each a report of something that happened, not proof the medicine caused it; 220 are coded as a death and 749 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 20 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

  • Hyperkalaemia110
  • Diarrhoea (named in the label)108
  • Acute Kidney Injury100
  • Constipation (named in the label)97
  • Renal Failure95
  • Chronic Kidney Disease91
  • Death (an outcome recorded in the report)82
  • Nausea (named in the label)78
  • Fatigue70
  • Vomiting (named in the label)70
  • End Stage Renal Disease65
  • Pneumonia60
  • Off Label Use (a use or a product term, not a reaction)59
  • Drug Interaction (a use or a product term, not a reaction)56
  • Dyspnoea55
  • Pain54
  • Pyrexia52
  • Anaemia51
  • Asthenia51
  • Drug Ineffective (a use or a product term, not a reaction)49
  • Blood Potassium Increased47
  • Malaise44
  • Dizziness41
  • Hospitalisation (an outcome recorded in the report)40
  • Hypotension40

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

What next?

Sodium polystyrene sulfonate: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions