Potassium Acetate side effects: what 1,437 FDA adverse event reports show

Potassium Acetate · 53 reaction terms · 564 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Who reports

1,437 reports · 73% serious · 155 with death outcome · 67% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Potassium Acetate Injection (2 mEq/mL) is indicated as a source of potassium, for the addition to large volume intravenous fluids, to prevent or correct hypokalemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific intravenous fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions.

FDA label, Indications and Usage

What it is

DESCRIPTION Potassium Acetate Injection, USP (2 mEq/mL) is a sterile, nonpyrogenic, concentrated solution of potassium acetate in water for injection. The solution is administered after dilution by the intravenous route as an electrolyte replenisher. It must not be administered undiluted.

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 21 strongest signals

Labeled (related wording) 1Likely indication confounding 2Reporting / coding artifact 1Lab value / disease marker 3Not in label — unassessed 14

What the badges mean

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. 32 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
Atelectasis	14	21.1 12.5–35.5ROR 21.3 · χ² 248 / p 3e-56	20.4 EB05 12.6 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 15.7	no trial data cached
Mitral valve incompetence	14	18.1 10.7–30.4ROR 18.2 · χ² 209 / p 1e-47	17.3 EB05 10.4 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 14.4	no trial data cached
Pharmaceutical product complaint	25	13.9 9.4–20.4ROR 14.1 · χ² 286 / p 2e-64	13.4 EB05 9.2 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 10.0 · 100% consumer	no trial data cached
Anorexia	12	13.4 7.6–23.6ROR 13.5 · χ² 126 / p 2e-29	11.9 EB05 6.4 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 8.2	no trial data cached
Pulmonary congestion	12	13.2 7.5–23.3ROR 13.3 · χ² 124 / p 5e-29	11.7 EB05 6.3 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 12.2	no trial data cached
Blood potassium decreased	27	13.1 9.0–19.0ROR 13.3 · χ² 290 / p 2e-65	12.6 EB05 8.8 · IC025 +2.8 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 9.7	no trial data cached
Economic problem	13	12.3 7.2–21.2ROR 12.4 · χ² 124 / p 4e-29	10.8 EB05 6.1 · IC025 +2.2 3/3 methods agree	Reporting / coding artifact	serious PRR 10.7	no trial data cached
Blood potassium increased	13	11.7 6.8–20.1ROR 11.8 · χ² 117 / p 2e-27	10.2 EB05 5.7 · IC025 +2.1 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 10.2	no trial data cached
Hypoaesthesia oral	11	10.7 5.9–19.2ROR 10.7 · χ² 87 / p 6e-21	8.8 EB05 4.8 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 15.5	no trial data cached
Coronary artery occlusion	10	10.6 5.7–19.6ROR 10.7 · χ² 78 / p 7e-19	8.5 EB05 4.5 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 8.4	no trial data cached
Restless legs syndrome	13	10.4 6.1–17.9ROR 10.5 · χ² 102 / p 3e-24	8.8 EB05 5.1 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 11.4	no trial data cached
Pulmonary hypertension	14	9.8 5.8–16.5ROR 9.9 · χ² 102 / p 3e-24	8.3 EB05 4.9 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 7.8	no trial data cached
Blood sodium decreased	12	9.3 5.3–16.4ROR 9.4 · χ² 81 / p 1e-19	7.6 EB05 4.4 · IC025 +1.8 3/3 methods agree	Lab value / disease marker	serious PRR 8.4	no trial data cached
Spinal fracture	10	7.3 3.9–13.6ROR 7.4 · χ² 48 / p 2e-12	5.7 EB05 3.3 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 6.1	no trial data cached
Coronary artery disease	14	6.7 4.0–11.3ROR 6.8 · χ² 62 / p 1e-15	5.6 EB05 3.5 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 5.4	no trial data cached
Blood glucose decreased	22	6.7 4.4–10.1ROR 6.8 · χ² 100 / p 6e-24	5.9 EB05 4.1 · IC025 +1.9 3/3 methods agree	Lab value / disease marker	serious PRR 7.4	no trial data cached
Cardiac failure congestive	34	6.1 4.4–8.5ROR 6.2 · χ² 141 / p 8e-33	5.7 EB05 4.2 · IC025 +1.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 5.0	no trial data cached
Fluid retention	20	5.7 3.7–8.9ROR 5.8 · χ² 74 / p 4e-18	5.1 EB05 3.5 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 5.1	no trial data cached
Emotional disorder	10	4.7 2.5–8.7ROR 4.7 · χ² 26 / p 2e-7	3.9 EB05 2.3 · IC025 +0.9 3/3 methods agree	Not in label — unassessed	serious PRR 6.9	no trial data cached
Convulsion (seizure)	18	4.5 2.9–7.2ROR 4.6 · χ² 46 / p 5e-12	4.1 EB05 2.8 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	serious PRR 3.7	no trial data cached
Blood glucose increased	50	3.9 2.9–5.1ROR 4.0 · χ² 104 / p 1e-24	3.7 EB05 3.0 · IC025 +1.4 3/3 methods agree	Lab value / disease marker	serious PRR 4.8	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
Blood glucose increased	50	3.9 2.9–5.1ROR 4.0 · χ² 104 / p 1e-24	3.7 EB05 3.0 · IC025 +1.4 3/3 methods agree	Lab value / disease marker	serious PRR 4.8	no trial data cached
Cardiac failure congestive	34	6.1 4.4–8.5ROR 6.2 · χ² 141 / p 8e-33	5.7 EB05 4.2 · IC025 +1.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 5.0	no trial data cached
Blood potassium decreased	27	13.1 9.0–19.0ROR 13.3 · χ² 290 / p 2e-65	12.6 EB05 8.8 · IC025 +2.8 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 9.7	no trial data cached
Pharmaceutical product complaint	25	13.9 9.4–20.4ROR 14.1 · χ² 286 / p 2e-64	13.4 EB05 9.2 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 10.0 · 100% consumer	no trial data cached
Blood glucose decreased	22	6.7 4.4–10.1ROR 6.8 · χ² 100 / p 6e-24	5.9 EB05 4.1 · IC025 +1.9 3/3 methods agree	Lab value / disease marker	serious PRR 7.4	no trial data cached
Fluid retention	20	5.7 3.7–8.9ROR 5.8 · χ² 74 / p 4e-18	5.1 EB05 3.5 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 5.1	no trial data cached
Convulsion (seizure)	18	4.5 2.9–7.2ROR 4.6 · χ² 46 / p 5e-12	4.1 EB05 2.8 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	serious PRR 3.7	no trial data cached
Coronary artery disease	14	6.7 4.0–11.3ROR 6.8 · χ² 62 / p 1e-15	5.6 EB05 3.5 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 5.4	no trial data cached
Pulmonary hypertension	14	9.8 5.8–16.5ROR 9.9 · χ² 102 / p 3e-24	8.3 EB05 4.9 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 7.8	no trial data cached
Mitral valve incompetence	14	18.1 10.7–30.4ROR 18.2 · χ² 209 / p 1e-47	17.3 EB05 10.4 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 14.4	no trial data cached
Atelectasis	14	21.1 12.5–35.5ROR 21.3 · χ² 248 / p 3e-56	20.4 EB05 12.6 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 15.7	no trial data cached
Restless legs syndrome	13	10.4 6.1–17.9ROR 10.5 · χ² 102 / p 3e-24	8.8 EB05 5.1 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 11.4	no trial data cached
Blood potassium increased	13	11.7 6.8–20.1ROR 11.8 · χ² 117 / p 2e-27	10.2 EB05 5.7 · IC025 +2.1 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 10.2	no trial data cached
Economic problem	13	12.3 7.2–21.2ROR 12.4 · χ² 124 / p 4e-29	10.8 EB05 6.1 · IC025 +2.2 3/3 methods agree	Reporting / coding artifact	serious PRR 10.7	no trial data cached
Blood sodium decreased	12	9.3 5.3–16.4ROR 9.4 · χ² 81 / p 1e-19	7.6 EB05 4.4 · IC025 +1.8 3/3 methods agree	Lab value / disease marker	serious PRR 8.4	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.

Pharmaceutical product complaint — n=25, PRR 13.9
Fluid retention — n=20, PRR 5.7

✓ A hand-written Bradford Hill causality assessment exists for this drug: Medroxyprogesterone acetate ↔ Meningioma.

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 Potassium Acetate?

In FDA FAERS, the most frequently co-reported reaction terms for Potassium Acetate are blood glucose increased, cardiac failure congestive, blood potassium decreased, pharmaceutical product complaint, blood glucose decreased, fluid retention. 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 Potassium Acetate have an FDA boxed warning?

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

Do FAERS signals prove that Potassium Acetate 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 2f069f41-903a-4a57-b566-eda5c44367d8, effective 20241206; matched on openfda.generic_name.exact:"POTASSIUM ACETATE")
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, 53 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.