Drug · FAERS side-effect profile with label screen
Patiromer side effects: what 13,760 FDA adverse event reports show
Drug class
Potassium Binder
FDA label (Established Pharmacologic Class)
Brand names
Veltassa
openFDA label
Who reports
13,760 reports · 49% serious · 2,117 with death outcome · 43% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Veltassa is indicated for the treatment of hyperkalemia in adults and pediatric patients ages 12 years and older. Limitation of Use: Veltassa should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action .
FDA label, Indications and Usage
What it is
Veltassa is a powder for suspension in water for oral administration. The active ingredient is patiromer sorbitex calcium which consists of the active moiety, patiromer, a non-absorbed potassium-binding polymer, and a calcium-sorbitol counterion.
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 40 strongest signals
Labeled adverse reaction 2Likely indication confounding 3Reporting / coding artifact 16Lab value / disease marker 4Not in label — unassessed 15
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.
- 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. 760 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Dialysis device insertion | 15 | 250.5 145.0–432.5ROR 250.7 · χ² 2,984 / p <1e-300 | 169.0 EB05 108.7 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Arteriovenous fistula operation | 16 | 95.8 57.8–158.7ROR 95.9 · χ² 1,323 / p 5e-290 | 81.6 EB05 53.3 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | serious n=15 | no trial data cached |
| Blood potassium increased | 801 | 79.1 73.8–84.8ROR 84.0 · χ² 58,669 / p <1e-300 | 75.1 EB05 70.8 · IC025 +6.1 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 52.0 · 74% consumer | no trial data cached |
| Blood potassium abnormal | 81 | 47.9 38.4–59.7ROR 48.1 · χ² 3,557 / p <1e-300 | 45.9 EB05 38.1 · IC025 +4.8 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=38 · 74% consumer | no trial data cached |
| Loss of employment | 70 | 35.8 28.3–45.4ROR 36.0 · χ² 2,280 / p <1e-300 | 34.7 EB05 28.4 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=70 · ♀ 100% (drug 43%) | no trial data cached |
| Dialysis | 322 | 35.3 31.6–39.4ROR 36.1 · χ² 10,453 / p <1e-300 | 34.4 EB05 31.4 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 40.9 | no trial data cached |
| Product solubility abnormal | 107 | 33.4 27.6–40.4ROR 33.6 · χ² 3,254 / p <1e-300 | 32.5 EB05 27.6 · IC025 +4.5 3/3 methods agree | Reporting / coding artifact | serious n=18 · 74% consumer | no trial data cached |
| Product colour issue | 102 | 31.3 25.7–38.0ROR 31.5 · χ² 2,901 / p <1e-300 | 30.5 EB05 25.9 · IC025 +4.4 3/3 methods agree | Reporting / coding artifact | serious n=11 | no trial data cached |
| Faeces hard | 71 | 28.4 22.4–35.8ROR 28.5 · χ² 1,813 / p <1e-300 | 27.7 EB05 22.7 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=25 · 77% consumer | no trial data cached |
| Renal transplant | 56 | 24.0 18.4–31.2ROR 24.1 · χ² 1,192 / p 1e-261 | 23.5 EB05 18.7 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=56 · 71% consumer | no trial data cached |
| Product taste abnormal | 185 | 21.2 18.4–24.5ROR 21.5 · χ² 3,501 / p <1e-300 | 20.9 EB05 18.5 · IC025 +4.1 3/3 methods agree | Reporting / coding artifact | serious n=49 | no trial data cached |
| Product difficult to swallow | 14 | 21.0 12.4–35.6ROR 21.0 · χ² 244 / p 3e-55 | 20.0 EB05 12.4 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Constipation | 2,143 | 15.2 14.6–15.8ROR 17.9 · χ² 28,492 / p <1e-300 | 15.1 EB05 14.6 · IC025 +3.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.6 · 80% consumer | no trial data cached |
| Rehabilitation therapy | 33 | 13.1 9.3–18.5ROR 13.2 · χ² 355 / p 2e-79 | 12.7 EB05 9.2 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious n=26 · 76% consumer | no trial data cached |
| Inhibitory drug interaction | 13 | 12.5 7.3–21.7ROR 12.6 · χ² 126 / p 2e-29 | 11.0 EB05 6.2 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=3 | no trial data cached |
| Product physical consistency issue | 43 | 12.1 8.9–16.3ROR 12.1 · χ² 422 / p 4e-94 | 11.6 EB05 8.8 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious n=8 · 84% consumer | no trial data cached |
| Hospice care | 72 | 11.2 8.9–14.1ROR 11.3 · χ² 655 / p 9e-145 | 10.9 EB05 8.9 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 11.6 | no trial data cached |
| Bowel movement irregularity | 55 | 11.1 8.5–14.4ROR 11.1 · χ² 490 / p 6e-109 | 10.7 EB05 8.4 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=13 · 78% consumer | no trial data cached |
| Catheter placement | 13 | 10.7 6.2–18.5ROR 10.7 · χ² 104 / p 9e-25 | 9.0 EB05 5.2 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Blood magnesium decreased | 60 | 10.7 8.3–13.7ROR 10.7 · χ² 512 / p 1e-113 | 10.3 EB05 8.2 · IC025 +2.9 3/3 methods agree | Lab value / disease marker | serious PRR 6.0 · 80% consumer | no trial data cached |
| Blood potassium decreased | 208 | 10.6 9.3–12.1ROR 10.7 · χ² 1,789 / p <1e-300 | 10.5 EB05 9.3 · IC025 +3.1 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 7.8 · 78% consumer | no trial data cached |
| Living in residential institution | 13 | 10.6 6.1–18.3ROR 10.6 · χ² 103 / p 2e-24 | 8.9 EB05 5.1 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious n=3 | no trial data cached |
| Blood phosphorus increased | 18 | 10.1 6.4–16.1ROR 10.1 · χ² 138 / p 3e-32 | 8.9 EB05 5.7 · IC025 +2.2 3/3 methods agree | Lab value / disease marker | serious n=7 | no trial data cached |
| Flatulence (gas) | 366 | 9.9 9.0–11.0ROR 10.2 · χ² 2,912 / p <1e-300 | 9.8 EB05 9.0 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.1 · 77% consumer | no trial data cached |
| Hospitalisation | 974 | 9.8 9.2–10.4ROR 10.5 · χ² 7,691 / p <1e-300 | 9.7 EB05 9.2 · IC025 +3.2 3/3 methods agree | Reporting / coding artifact | serious PRR 11.7 | no trial data cached |
| Inappropriate schedule of drug administration | 461 | 9.8 8.9–10.7ROR 10.1 · χ² 3,619 / p <1e-300 | 9.7 EB05 9.0 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious PRR 11.8 · 79% consumer | no trial data cached |
| Faecaloma | 30 | 8.4 5.9–12.1ROR 8.5 · χ² 189 / p 3e-43 | 7.7 EB05 5.6 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=30 · ♀ 17% (drug 43%) | no trial data cached |
| Dyschezia | 15 | 7.6 4.6–12.6ROR 7.6 · χ² 79 / p 3e-19 | 6.4 EB05 4.0 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious n=7 | no trial data cached |
| Product physical issue | 99 | 7.6 6.2–9.3ROR 7.6 · χ² 559 / p 8e-124 | 7.4 EB05 6.2 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious n=28 | no trial data cached |
| Cardiac operation | 42 | 7.6 5.6–10.2ROR 7.6 · χ² 232 / p 1e-52 | 7.1 EB05 5.4 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 9.3 · 76% consumer | no trial data cached |
| Product dose omission | 321 | 7.4 6.7–8.3ROR 7.6 · χ² 1,773 / p <1e-300 | 7.3 EB05 6.7 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 15.4 · 75% consumer | no trial data cached |
| Hepatic steatosis | 90 | 7.4 6.0–9.1ROR 7.4 · χ² 490 / p 7e-109 | 7.2 EB05 6.0 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 9.9 · ♀ 100% (drug 43%) | no trial data cached |
| Leg amputation | 19 | 7.0 4.5–11.0ROR 7.0 · χ² 92 / p 5e-22 | 6.1 EB05 4.1 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious n=19 | no trial data cached |
| Toe amputation | 23 | 6.9 4.6–10.4ROR 6.9 · χ² 109 / p 6e-26 | 6.1 EB05 4.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious n=23 · ♀ 13% (drug 43%) · 87% consumer | no trial data cached |
| Blood calcium increased | 38 | 6.6 4.8–9.1ROR 6.6 · χ² 175 / p 3e-40 | 6.2 EB05 4.7 · IC025 +2.1 3/3 methods agree | Lab value / disease marker | serious n=13 | no trial data cached |
| Drug dose omission | 672 | 6.1 5.7–6.6ROR 6.4 · χ² 2,890 / p <1e-300 | 6.1 EB05 5.7 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 9.1 | no trial data cached |
| Hyperparathyroidism secondary | 10 | 6.0 3.2–11.2ROR 6.0 · χ² 37 / p 6e-10 | 4.8 EB05 2.8 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious n=8 | no trial data cached |
| Blood creatinine decreased | 11 | 5.4 3.0–9.7ROR 5.4 · χ² 35 / p 2e-9 | 4.5 EB05 2.7 · IC025 +1.1 3/3 methods agree | Lab value / disease marker | serious n=2 | no trial data cached |
| Treatment noncompliance | 181 | 5.1 4.4–5.9ROR 5.1 · χ² 590 / p 1e-130 | 5.0 EB05 4.4 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 3.5 | no trial data cached |
| Drug administration error | 103 | 5.1 4.2–6.1ROR 5.1 · χ² 330 / p 4e-74 | 4.9 EB05 4.2 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 2.0 · 89% consumer | 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 |
|---|---|---|---|---|---|---|
| Constipation | 2,143 | 15.2 14.6–15.8ROR 17.9 · χ² 28,492 / p <1e-300 | 15.1 EB05 14.6 · IC025 +3.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.6 · 80% consumer | no trial data cached |
| Death | 1,823 | 3.2 3.1–3.4ROR 3.6 · χ² 2,919 / p <1e-300 | 3.2 EB05 3.1 · IC025 +1.6 3/3 methods agree | Outcome field, not a reaction | serious PRR 3.8 | no trial data cached |
| Diarrhoea (diarrhea) | 1,294 | 3.1 2.9–3.2ROR 3.3 · χ² 1,857 / p <1e-300 | 3.1 EB05 2.9 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.8 · 70% consumer | no trial data cached |
| Hospitalisation | 974 | 9.8 9.2–10.4ROR 10.5 · χ² 7,691 / p <1e-300 | 9.7 EB05 9.2 · IC025 +3.2 3/3 methods agree | Reporting / coding artifact | serious PRR 11.7 | no trial data cached |
| Off label use (used outside approved label) | 930 | 1.6 1.5–1.7ROR 1.7 · χ² 238 / p 7e-54 | 1.6 EB05 1.5 · IC025 +0.6 | Reporting / coding artifact | serious PRR 2.1 | no trial data cached |
| Blood potassium increased | 801 | 79.1 73.8–84.8ROR 84.0 · χ² 58,669 / p <1e-300 | 75.1 EB05 70.8 · IC025 +6.1 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 52.0 · 74% consumer | no trial data cached |
| Nausea | 709 | 1.4 1.3–1.5ROR 1.4 · χ² 73 / p 6e-18 | 1.4 EB05 1.3 · IC025 +0.3 | Labeled adverse reaction exact term | serious PRR 1.1 · ♀ 64% (drug 43%) | no trial data cached |
| Drug dose omission | 672 | 6.1 5.7–6.6ROR 6.4 · χ² 2,890 / p <1e-300 | 6.1 EB05 5.7 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 9.1 | no trial data cached |
| Malaise (feeling unwell) | 582 | 2.0 1.9–2.2ROR 2.1 · χ² 304 / p 2e-68 | 2.0 EB05 1.9 · IC025 +0.9 | Not in label — unassessed | serious PRR 2.1 | no trial data cached |
| Abdominal discomfort | 541 | 4.9 4.6–5.4ROR 5.1 · χ² 1,707 / p <1e-300 | 4.9 EB05 4.6 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.3 | no trial data cached |
| Inappropriate schedule of drug administration | 461 | 9.8 8.9–10.7ROR 10.1 · χ² 3,619 / p <1e-300 | 9.7 EB05 9.0 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious PRR 11.8 · 79% consumer | no trial data cached |
| Vomiting | 447 | 1.5 1.3–1.6ROR 1.5 · χ² 64 / p 6e-16 | 1.5 EB05 1.3 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 0.8 · 71% consumer | no trial data cached |
| Abdominal pain upper | 426 | 3.2 2.9–3.5ROR 3.2 · χ² 633 / p 5e-140 | 3.2 EB05 2.9 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.7 | no trial data cached |
| No adverse event | 377 | 3.2 2.9–3.6ROR 3.3 · χ² 587 / p 7e-130 | 3.2 EB05 3.0 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | 75% consumer | no trial data cached |
| Dyspnoea (shortness of breath) | 373 | 1.0 0.9–1.1ROR 1.0 · χ² 0 / p 0.472 | 1.0 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious PRR 1.3 | 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.
- Loss of employment — n=70, PRR 35.8
- Dialysis — n=322, PRR 35.3
- Faeces hard — n=71, PRR 28.4
- Renal transplant — n=56, PRR 24.0
- Hospice care — n=72, PRR 11.2
- Bowel movement irregularity — n=55, PRR 11.1
- Faecaloma — n=30, PRR 8.4
- Hepatic steatosis — n=90, PRR 7.4
- Toe amputation — n=23, PRR 6.9
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 Patiromer?
In FDA FAERS, the most frequently co-reported reaction terms for Patiromer are constipation, diarrhoea, blood potassium increased, nausea, malaise, abdominal discomfort. 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 Patiromer have an FDA boxed warning?
No. The FDA label retrieved for Patiromer has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Patiromer 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 bf002984-d6c9-46df-aecb-a07733f763c1, effective 20250131; matched on
openfda.generic_name.exact:"PATIROMER") - 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, 800 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.