Zirconium Cyclosilicate side effects: what 3,691 FDA adverse event reports show
Drug class
Potassium binder
Label matched
Sodium Zirconium Cyclosilicate (Lokelma)
Who reports
3,691 reports · 81% serious · 1,340 with death outcome · 37% female
Used for
LOKELMA is indicated for the treatment of hyperkalemia in adults. Limitation of Use LOKELMA should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action . LOKELMA is a potassium binder indicated for the treatment of hyperkalemia in adults.
What it is
LOKELMA is a powder for oral suspension. The active ingredient in LOKELMA is sodium zirconium cyclosilicate, a potassium binder. Sodium zirconium cyclosilicate is a non-absorbed zirconium silicate that preferentially exchanges potassium for hydrogen and sodium.
Boxed warning
None in the current label
Causality screen of the 31 strongest signals
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.
- Outcome field, not a reaction Death is a report outcome, not a reaction term. It is dominated by the underlying illness; see the seriousness profile and the boxed warning instead.
- 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. 21 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Blood potassium increased | 191 | 67.6 58.8–77.7ROR 71.2 · χ² 12,325 / p <1e-300 | 66.4 EB05 58.8 · IC025 +5.6 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 40.5 | no trial data cached |
| Hyperkalaemia (high potassium) | 150 | 24.5 20.9–28.7ROR 25.5 · χ² 3,347 / p <1e-300 | 24.3 EB05 21.2 · IC025 +4.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 16.5 | no trial data cached |
| End stage renal disease | 55 | 17.0 13.1–22.1ROR 17.2 · χ² 810 / p 2e-178 | 16.8 EB05 13.4 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 12.0 | no trial data cached |
| Glomerular filtration rate decreased | 23 | 10.8 7.2–16.2ROR 10.9 · χ² 194 / p 2e-44 | 9.9 EB05 6.7 · IC025 +2.5 3/3 methods agree | Lab value / disease marker | serious PRR 7.8 | no trial data cached |
| Hypokalaemia (low potassium) | 71 | 8.8 7.0–11.1ROR 8.9 · χ² 483 / p 3e-107 | 8.5 EB05 6.9 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.2 · 94% clinician | no trial data cached |
| Blood potassium decreased | 44 | 8.3 6.2–11.1ROR 8.4 · χ² 276 / p 3e-62 | 7.8 EB05 6.0 · IC025 +2.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 5.5 | no trial data cached |
| Death | 1,088 | 7.2 6.8–7.5ROR 9.8 · χ² 6,018 / p <1e-300 | 7.2 EB05 6.8 · IC025 +2.7 3/3 methods agree | Outcome field, not a reaction | serious PRR 5.1 | no trial data cached |
| Oedema | 68 | 7.1 5.6–9.0ROR 7.3 · χ² 353 / p 4e-79 | 6.8 EB05 5.6 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.3 | no trial data cached |
| Ileus | 15 | 6.9 4.2–11.5ROR 6.9 · χ² 70 / p 3e-17 | 5.9 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Cardiac failure (heart failure) | 90 | 6.4 5.2–7.8ROR 6.5 · χ² 403 / p 8e-90 | 6.2 EB05 5.2 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.5 | no trial data cached |
| Dialysis | 14 | 5.6 3.3–9.4ROR 5.6 · χ² 48 / p 2e-12 | 4.8 EB05 3.0 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.6 | no trial data cached |
| Chronic kidney disease | 72 | 5.3 4.2–6.7ROR 5.4 · χ² 250 / p 1e-56 | 5.2 EB05 4.2 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.8 | no trial data cached |
| Toxic epidermal necrolysis (severe skin peeling reaction) | 14 | 5.3 3.1–8.9ROR 5.3 · χ² 44 / p 1e-11 | 4.5 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 | no trial data cached |
| Renal disorder | 43 | 5.2 3.9–7.0ROR 5.3 · χ² 143 / p 3e-33 | 5.0 EB05 3.8 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.0 · 72% consumer | no trial data cached |
| Renal impairment | 69 | 4.7 3.7–5.9ROR 4.8 · χ² 197 / p 5e-45 | 4.5 EB05 3.7 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 | no trial data cached |
| Incorrect route of product administration | 13 | 4.4 2.6–7.6ROR 4.4 · χ² 31 / p 1e-8 | 3.9 EB05 2.4 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious PRR 5.3 | no trial data cached |
| Blood creatinine increased | 47 | 4.1 3.1–5.4ROR 4.1 · χ² 106 / p 3e-25 | 3.9 EB05 3.1 · IC025 +1.5 3/3 methods agree | Lab value / disease marker | serious PRR 2.8 | no trial data cached |
| Stevens-johnson syndrome (severe blistering skin reaction) | 16 | 4.1 2.5–6.6ROR 4.1 · χ² 34 / p 3e-9 | 3.7 EB05 2.4 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 2.9 | no trial data cached |
| Blood urea increased | 12 | 4.0 2.3–7.1ROR 4.1 · χ² 25 / p 4e-7 | 3.6 EB05 2.2 · IC025 +0.9 3/3 methods agree | Lab value / disease marker | serious PRR 2.4 | no trial data cached |
| Proteinuria | 12 | 3.6 2.1–6.4ROR 3.6 · χ² 20 / p 4e-6 | 3.2 EB05 2.0 · IC025 +0.7 3/3 methods agree | Not in label — unassessed | serious PRR 2.4 | no trial data cached |
| Choking | 12 | 3.5 2.0–6.2ROR 3.5 · χ² 19 / p 6e-6 | 3.2 EB05 2.0 · IC025 +0.7 | Not in label — unassessed | serious PRR 2.9 | no trial data cached |
| Renal failure (kidney failure) | 79 | 3.4 2.7–4.2ROR 3.4 · χ² 129 / p 4e-30 | 3.3 EB05 2.7 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.3 | no trial data cached |
| Blindness | 23 | 3.2 2.1–4.8ROR 3.2 · χ² 33 / p 5e-9 | 3.0 EB05 2.2 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 2.3 | no trial data cached |
| Cardiac failure congestive | 45 | 3.2 2.4–4.2ROR 3.2 · χ² 64 / p 6e-16 | 3.1 EB05 2.4 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 2.2 · 95% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 14 | 2.8 1.7–4.8ROR 2.9 · χ² 15 / p 5e-5 | 2.7 EB05 1.7 · IC025 +0.5 | Not in label — unassessed | serious PRR 2.0 | no trial data cached |
| Mouth ulceration | 10 | 2.7 1.5–5.0ROR 2.7 · χ² 9 / p 0.001 | 2.5 EB05 1.5 · IC025 +0.2 | Not in label — unassessed | serious PRR 2.5 | no trial data cached |
| Metabolic acidosis | 15 | 2.7 1.6–4.5ROR 2.7 · χ² 14 / p 8e-5 | 2.5 EB05 1.7 · IC025 +0.5 | Not in label — unassessed | serious PRR 1.9 | no trial data cached |
| Dementia | 13 | 2.6 1.5–4.6ROR 2.7 · χ² 12 / p 3e-4 | 2.5 EB05 1.6 · IC025 +0.4 | Not in label — unassessed | serious PRR 2.0 | no trial data cached |
| Rash papular | 10 | 2.5 1.4–4.7ROR 2.5 · χ² 8 / p 0.003 | 2.4 EB05 1.4 · IC025 +0.2 | Not in label — unassessed | serious PRR 4.5 | no trial data cached |
| Cerebral infarction | 10 | 2.3 1.2–4.3ROR 2.3 · χ² 6 / p 0.006 | 2.2 EB05 1.3 · IC025 +0.0 | Not in label — unassessed | serious PRR 1.6 | no trial data cached |
| Cerebral haemorrhage | 13 | 2.1 1.2–3.6ROR 2.1 · χ² 6 / p 0.007 | 2.0 EB05 1.3 · IC025 +0.1 | Not in label — unassessed | serious PRR 1.4 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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 |
|---|---|---|---|---|---|---|
| Death | 1,088 | 7.2 6.8–7.5ROR 9.8 · χ² 6,018 / p <1e-300 | 7.2 EB05 6.8 · IC025 +2.7 3/3 methods agree | Outcome field, not a reaction | serious PRR 5.1 | no trial data cached |
| Blood potassium increased | 191 | 67.6 58.8–77.7ROR 71.2 · χ² 12,325 / p <1e-300 | 66.4 EB05 58.8 · IC025 +5.6 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 40.5 | no trial data cached |
| Hyperkalaemia (high potassium) | 150 | 24.5 20.9–28.7ROR 25.5 · χ² 3,347 / p <1e-300 | 24.3 EB05 21.2 · IC025 +4.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 16.5 | no trial data cached |
| Cardiac failure (heart failure) | 90 | 6.4 5.2–7.8ROR 6.5 · χ² 403 / p 8e-90 | 6.2 EB05 5.2 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.5 | no trial data cached |
| Renal failure (kidney failure) | 79 | 3.4 2.7–4.2ROR 3.4 · χ² 129 / p 4e-30 | 3.3 EB05 2.7 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.3 | no trial data cached |
| Chronic kidney disease | 72 | 5.3 4.2–6.7ROR 5.4 · χ² 250 / p 1e-56 | 5.2 EB05 4.2 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.8 | no trial data cached |
| Hypokalaemia (low potassium) | 71 | 8.8 7.0–11.1ROR 8.9 · χ² 483 / p 3e-107 | 8.5 EB05 6.9 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.2 · 94% clinician | no trial data cached |
| Renal impairment | 69 | 4.7 3.7–5.9ROR 4.8 · χ² 197 / p 5e-45 | 4.5 EB05 3.7 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 | no trial data cached |
| Oedema | 68 | 7.1 5.6–9.0ROR 7.3 · χ² 353 / p 4e-79 | 6.8 EB05 5.6 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.3 | no trial data cached |
| End stage renal disease | 55 | 17.0 13.1–22.1ROR 17.2 · χ² 810 / p 2e-178 | 16.8 EB05 13.4 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 12.0 | no trial data cached |
| Blood creatinine increased | 47 | 4.1 3.1–5.4ROR 4.1 · χ² 106 / p 3e-25 | 3.9 EB05 3.1 · IC025 +1.5 3/3 methods agree | Lab value / disease marker | serious PRR 2.8 | no trial data cached |
| Cardiac failure congestive | 45 | 3.2 2.4–4.2ROR 3.2 · χ² 64 / p 6e-16 | 3.1 EB05 2.4 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 2.2 · 95% clinician | no trial data cached |
| Blood potassium decreased | 44 | 8.3 6.2–11.1ROR 8.4 · χ² 276 / p 3e-62 | 7.8 EB05 6.0 · IC025 +2.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 5.5 | no trial data cached |
| Renal disorder | 43 | 5.2 3.9–7.0ROR 5.3 · χ² 143 / p 3e-33 | 5.0 EB05 3.8 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.0 · 72% consumer | no trial data cached |
| Blindness | 23 | 3.2 2.1–4.8ROR 3.2 · χ² 33 / p 5e-9 | 3.0 EB05 2.2 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 2.3 | 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=55, PRR 17.0
- Renal impairment — n=69, PRR 4.7
- Blindness — n=23, PRR 3.2
- Cardiac failure congestive — n=45, PRR 3.2
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 Zirconium Cyclosilicate?
In FDA FAERS, the most frequently co-reported reaction terms for Zirconium Cyclosilicate are blood potassium increased, hyperkalaemia, cardiac failure, renal failure, chronic kidney disease, hypokalaemia. 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 Zirconium Cyclosilicate have an FDA boxed warning?
No. The FDA label retrieved for Zirconium Cyclosilicate has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Zirconium Cyclosilicate 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 8833d6e6-33ab-4ea9-b78f-3ec30a904ef8, effective 20260326; matched on
openfda.generic_name.exact:"SODIUM ZIRCONIUM CYCLOSILICATE") - 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, fieldpatient.drug.openfda.generic_name.exact, 52 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.