Drug · FAERS side-effect profile with label screen

Polystyrene Sulfonate side effects: what 1,586 FDA adverse event reports show

Sodium Polystyrene Sulfonate · 41 reaction terms · 934 drug–reaction co-reports · data 2026-09-14

Drug class

Potassium Binder

FDA label (Established Pharmacologic Class) of the closest related product

Label matched

Sodium Polystyrene Sulfonate (Sodium Polystyrene Sulfonate)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

1,586 reports · 77% serious · 220 with death outcome · 42% female

openFDA FAERS counts, all years, deduplication not applied

Used for

SPS ® Suspension is indicated for the treatment of hyperkalemia.

FDA label, Indications and Usage

What it is

DESCRIPTION Sodium Polystyrene Sulfonate Suspension USP (SPS ® Suspension) can be administered orally or in an enema. It is a cherry-flavored suspension containing 15 grams of cation-exchange .

FDA label, Description section

Boxed warning

None in the current label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 23 strongest signals

Labeled adverse reaction 2Labeled (related wording) 4Likely indication confounding 1Reporting / coding artifact 4Lab value / disease marker 1Not in label — unassessed 11

What the badges mean

Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 18 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
End stage renal disease	65	46.8 36.9–59.5ROR 48.8 · χ² 2,863 / p <1e-300	46.1 EB05 37.4 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious PRR 34.6	no trial data cached
Hyperkalaemia (high potassium)	110	41.8 34.9–50.1ROR 44.9 · χ² 4,336 / p <1e-300	41.4 EB05 35.3 · IC025 +4.8 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 31.4 · 95% clinician	no trial data cached
Blood potassium increased	47	38.4 29.0–51.0ROR 39.6 · χ² 1,673 / p <1e-300	37.8 EB05 29.6 · IC025 +4.3 3/3 methods agree	Labeled (related wording) related wording	serious PRR 24.4	no trial data cached
Toxic epidermal necrolysis (severe skin peeling reaction)	18	15.8 10.0–25.0ROR 16.0 · χ² 235 / p 2e-53	15.2 EB05 9.7 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 11.7	no trial data cached
Chronic kidney disease	91	15.7 12.9–19.2ROR 16.6 · χ² 1,243 / p 1e-272	15.6 EB05 13.1 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 11.8	no trial data cached
Dialysis	14	13.0 7.7–22.0ROR 13.1 · χ² 144 / p 2e-33	11.8 EB05 6.8 · IC025 +2.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 10.1	no trial data cached
Economic problem	14	12.0 7.1–20.3ROR 12.1 · χ² 131 / p 1e-30	10.7 EB05 6.1 · IC025 +2.2 3/3 methods agree	Reporting / coding artifact	serious PRR 9.7	no trial data cached
Disseminated intravascular coagulation	12	11.3 6.4–19.8ROR 11.3 · χ² 102 / p 3e-24	9.5 EB05 5.3 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 8.4	no trial data cached
Renal failure acute	32	9.8 7.0–13.9ROR 10.0 · χ² 246 / p 1e-55	9.2 EB05 6.6 · IC025 +2.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 7.4 · 92% clinician	no trial data cached
Renal failure (kidney failure)	95	9.4 7.7–11.4ROR 9.9 · χ² 709 / p 2e-156	9.2 EB05 7.7 · IC025 +2.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 7.0	no trial data cached
Renal injury	21	9.3 6.1–14.2ROR 9.4 · χ² 147 / p 5e-34	8.3 EB05 5.5 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 6.9	no trial data cached
Lactic acidosis	22	9.1 6.0–13.7ROR 9.2 · χ² 150 / p 8e-35	8.1 EB05 5.5 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 6.7 · 91% clinician	no trial data cached
Acute kidney injury (sudden kidney damage)	100	8.7 7.2–10.5ROR 9.2 · χ² 677 / p 1e-149	8.5 EB05 7.1 · IC025 +2.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 6.5	no trial data cached
Metabolic acidosis	18	7.5 4.8–11.9ROR 7.6 · χ² 96 / p 7e-23	6.5 EB05 4.3 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 5.6	no trial data cached
Renal disorder	26	7.4 5.0–10.8ROR 7.5 · χ² 137 / p 6e-32	6.7 EB05 4.7 · IC025 +2.1 3/3 methods agree	Labeled (related wording) related wording	serious PRR 6.4	no trial data cached
Conjunctivitis	10	7.2 3.9–13.4ROR 7.2 · χ² 47 / p 3e-12	5.7 EB05 3.2 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 9.9	no trial data cached
Anhedonia	14	7.0 4.2–11.8ROR 7.0 · χ² 66 / p 2e-16	5.9 EB05 3.7 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 5.7	no trial data cached
Bradycardia (slow heart rate)	25	6.2 4.2–9.2ROR 6.3 · χ² 105 / p 7e-25	5.6 EB05 4.0 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 4.8	no trial data cached
Rhabdomyolysis (muscle breakdown)	19	6.0 3.9–9.4ROR 6.1 · χ² 75 / p 2e-18	5.3 EB05 3.6 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 4.3	no trial data cached
International normalised ratio increased	13	6.0 3.5–10.3ROR 6.0 · χ² 49 / p 1e-12	5.0 EB05 3.1 · IC025 +1.4 3/3 methods agree	Lab value / disease marker	serious PRR 4.9	no trial data cached
Product dose omission	17	3.4 2.1–5.5ROR 3.4 · χ² 26 / p 1e-7	3.2 EB05 2.1 · IC025 +0.9 3/3 methods agree	Reporting / coding artifact	serious PRR 7.9	no trial data cached
Drug dose omission	30	2.4 1.7–3.4ROR 2.4 · χ² 23 / p 1e-6	2.3 EB05 1.7 · IC025 +0.6	Reporting / coding artifact	serious PRR 3.3	no trial data cached
Foetal exposure during pregnancy	13	2.1 1.2–3.6ROR 2.1 · χ² 7 / p 0.005	2.0 EB05 1.3 · IC025 +0.1	Reporting / coding artifact	serious PRR 1.6	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Hyperkalaemia (high potassium)	110	41.8 34.9–50.1ROR 44.9 · χ² 4,336 / p <1e-300	41.4 EB05 35.3 · IC025 +4.8 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 31.4 · 95% clinician	no trial data cached
Acute kidney injury (sudden kidney damage)	100	8.7 7.2–10.5ROR 9.2 · χ² 677 / p 1e-149	8.5 EB05 7.1 · IC025 +2.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 6.5	no trial data cached
Renal failure (kidney failure)	95	9.4 7.7–11.4ROR 9.9 · χ² 709 / p 2e-156	9.2 EB05 7.7 · IC025 +2.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 7.0	no trial data cached
Chronic kidney disease	91	15.7 12.9–19.2ROR 16.6 · χ² 1,243 / p 1e-272	15.6 EB05 13.1 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 11.8	no trial data cached
End stage renal disease	65	46.8 36.9–59.5ROR 48.8 · χ² 2,863 / p <1e-300	46.1 EB05 37.4 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious PRR 34.6	no trial data cached
Blood potassium increased	47	38.4 29.0–51.0ROR 39.6 · χ² 1,673 / p <1e-300	37.8 EB05 29.6 · IC025 +4.3 3/3 methods agree	Labeled (related wording) related wording	serious PRR 24.4	no trial data cached
Renal failure acute	32	9.8 7.0–13.9ROR 10.0 · χ² 246 / p 1e-55	9.2 EB05 6.6 · IC025 +2.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 7.4 · 92% clinician	no trial data cached
Drug dose omission	30	2.4 1.7–3.4ROR 2.4 · χ² 23 / p 1e-6	2.3 EB05 1.7 · IC025 +0.6	Reporting / coding artifact	serious PRR 3.3	no trial data cached
Renal disorder	26	7.4 5.0–10.8ROR 7.5 · χ² 137 / p 6e-32	6.7 EB05 4.7 · IC025 +2.1 3/3 methods agree	Labeled (related wording) related wording	serious PRR 6.4	no trial data cached
Bradycardia (slow heart rate)	25	6.2 4.2–9.2ROR 6.3 · χ² 105 / p 7e-25	5.6 EB05 4.0 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 4.8	no trial data cached
Lactic acidosis	22	9.1 6.0–13.7ROR 9.2 · χ² 150 / p 8e-35	8.1 EB05 5.5 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 6.7 · 91% clinician	no trial data cached
Renal injury	21	9.3 6.1–14.2ROR 9.4 · χ² 147 / p 5e-34	8.3 EB05 5.5 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 6.9	no trial data cached
Rhabdomyolysis (muscle breakdown)	19	6.0 3.9–9.4ROR 6.1 · χ² 75 / p 2e-18	5.3 EB05 3.6 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 4.3	no trial data cached
Metabolic acidosis	18	7.5 4.8–11.9ROR 7.6 · χ² 96 / p 7e-23	6.5 EB05 4.3 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 5.6	no trial data cached
Toxic epidermal necrolysis (severe skin peeling reaction)	18	15.8 10.0–25.0ROR 16.0 · χ² 235 / p 2e-53	15.2 EB05 9.7 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 11.7	no trial data cached

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

End stage renal disease — n=65, PRR 46.8
Chronic kidney disease — n=91, PRR 15.7
Renal injury — n=21, PRR 9.3
Lactic acidosis — n=22, PRR 9.1
Bradycardia — n=25, PRR 6.2

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Polystyrene Sulfonate?

In FDA FAERS, the most frequently co-reported reaction terms for Polystyrene Sulfonate are hyperkalaemia, acute kidney injury, renal failure, chronic kidney disease, end stage renal disease, blood potassium increased. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Polystyrene Sulfonate have an FDA boxed warning?

No. The FDA label retrieved for Polystyrene Sulfonate has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Polystyrene Sulfonate causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

FDA label via openFDA (set ID 3c3b02a3-9a75-40a5-889d-97318faf881f, effective 20251029; matched on openfda.generic_name.exact:"SODIUM POLYSTYRENE SULFONATE")
Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA count= aggregation, field patient.drug.openfda.generic_name.exact, 41 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath

Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.