Drug · FAERS side-effect profile with label screen

Potassium Chloride Oral side effects: what 277,538 FDA adverse event reports show

Potassium Chloride Oral · Potassium Chloride · 1,197 reaction terms · 413,256 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Brand names

Potassium Chloride

openFDA label

Who reports

277,538 reports · 70% serious · 33,789 with death outcome · 62% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Potassium chloride oral solution is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction are insufficient. Potassium.

FDA label, Indications and Usage

What it is

Potassium chloride is a metal chloride salt with a K(+) counterion. It has a role as a NMR chemical shift reference compound and a fertilizer.

PubChem CID 4873 (ChEBI)

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

Reporting / coding artifact 5Lab value / disease marker 6No label text to screen 29

What the badges mean

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.
No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.

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, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,157 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
Vaginal flatulence	183	344.0 273.1–433.3ROR 344.7 · calibrated p 5e-12 ✓	134.3 EB05 118.7 · IC025 +6.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Appendicolith	206	272.7 222.5–334.2ROR 273.3 · calibrated p 4e-11 ✓	122.1 EB05 108.7 · IC025 +6.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Sleep disorder therapy	97	249.4 186.7–333.1ROR 249.7 · calibrated p 1e-10 ✓	115.8 EB05 97.7 · IC025 +5.9 3/3 methods agree	Reporting / coding artifact	–	no trial arm names this drug
Analgesic therapy	92	97.5 76.4–124.6ROR 97.6 · calibrated p 2e-7 ✓	67.3 EB05 56.5 · IC025 +5.3 3/3 methods agree	Reporting / coding artifact	–	no trial arm names this drug
Drug therapy	85	82.3 64.2–105.5ROR 82.4 · calibrated p 7e-7 ✓	59.7 EB05 49.8 · IC025 +5.1 3/3 methods agree	Reporting / coding artifact	–	no trial arm names this drug
Device maintenance issue	84	39.7 31.5–50.1ROR 39.8 · calibrated p 7e-5 ✓	33.7 EB05 28.0 · IC025 +4.5 3/3 methods agree	Reporting / coding artifact	–	no trial arm names this drug
Female genital tract fistula	199	29.7 25.6–34.4ROR 29.7 · calibrated p 3e-4 ✓	26.3 EB05 23.3 · IC025 +4.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Radiculopathy	241	22.8 20.0–26.1ROR 22.9 · calibrated p 0.001 ✓	20.8 EB05 18.7 · IC025 +4.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Hyperphosphataemia	171	19.9 17.0–23.3ROR 19.9 · calibrated p 0.002 ✓	18.3 EB05 16.1 · IC025 +3.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Infusion site discharge	126	18.0 15.1–21.6ROR 18.1 · calibrated p 0.003 ✓	16.7 EB05 14.4 · IC025 +3.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Chronic kidney disease-mineral and bone disorder	79	18.0 14.3–22.6ROR 18.0 · calibrated p 0.004 ✓	16.6 EB05 13.8 · IC025 +3.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Proctitis	198	17.2 14.9–19.9ROR 17.3 · calibrated p 0.004 ✓	16.0 EB05 14.2 · IC025 +3.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Chronic sinusitis	261	17.0 15.0–19.3ROR 17.0 · calibrated p 0.004 ✓	15.8 EB05 14.3 · IC025 +3.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Cardioactive drug level increased	92	16.9 13.7–20.9ROR 16.9 · calibrated p 0.005 ✓	15.7 EB05 13.2 · IC025 +3.5 3/3 methods agree	Lab value / disease marker	–	no trial arm names this drug
Left atrial dilatation	83	15.7 12.5–19.6ROR 15.7 · calibrated p 0.006 ✓	14.6 EB05 12.1 · IC025 +3.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Oesophageal spasm	118	15.5 12.9–18.7ROR 15.5 · calibrated p 0.006 ✓	14.5 EB05 12.4 · IC025 +3.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Blood phosphorus increased	171	15.2 13.0–17.7ROR 15.2 · calibrated p 0.007 ✓	14.2 EB05 12.5 · IC025 +3.5 3/3 methods agree	Lab value / disease marker	–	no trial arm names this drug
Hyperparathyroidism secondary	151	14.4 12.2–17.0ROR 14.4 · calibrated p 0.009 ✓	13.5 EB05 11.8 · IC025 +3.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Infusion site infection	132	14.0 11.8–16.7ROR 14.0 · calibrated p 0.010 ✓	13.2 EB05 11.4 · IC025 +3.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Metabolic alkalosis	92	13.9 11.3–17.1ROR 13.9 · calibrated p 0.010 ✓	13.0 EB05 10.9 · IC025 +3.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Nephrogenic anaemia	262	13.5 11.9–15.3ROR 13.5 · calibrated p 0.011 ✓	12.7 EB05 11.5 · IC025 +3.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Orthopnoea	169	12.7 10.9–14.8ROR 12.7 · calibrated p 0.014 ✓	12.0 EB05 10.5 · IC025 +3.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Hypervolaemia	245	12.2 10.7–13.9ROR 12.2 · calibrated p 0.016 ✓	11.6 EB05 10.4 · IC025 +3.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Infusion site haemorrhage	163	12.0 10.3–14.1ROR 12.0 · calibrated p 0.017 ✓	11.4 EB05 9.9 · IC025 +3.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Aortic stenosis	173	11.9 10.2–13.8ROR 11.9 · calibrated p 0.018 ✓	11.2 EB05 9.9 · IC025 +3.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Device infusion issue	121	11.8 9.8–14.1ROR 11.8 · calibrated p 0.019 ✓	11.1 EB05 9.5 · IC025 +3.1 3/3 methods agree	Reporting / coding artifact	–	no trial arm names this drug
Colitis microscopic	212	10.7 9.3–12.3ROR 10.8 · calibrated p 0.026 ✓	10.2 EB05 9.1 · IC025 +3.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Therapeutic agent toxicity	149	10.5 8.9–12.3ROR 10.5 · calibrated p 0.028 ✓	9.9 EB05 8.6 · IC025 +3.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Hypokalaemia (low potassium)	2,016	10.4 10.0–10.9ROR 10.6 · calibrated p 0.026 ✓	10.0 EB05 9.6 · IC025 +3.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Oxygen consumption increased	103	10.3 8.5–12.6ROR 10.4 · calibrated p 0.030 ✓	9.7 EB05 8.2 · IC025 +2.9 3/3 methods agree	Lab value / disease marker	–	no trial arm names this drug
Right ventricular failure	304	10.2 9.1–11.4ROR 10.2 · calibrated p 0.030 ✓	9.7 EB05 8.8 · IC025 +3.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Blood chloride decreased	111	10.1 8.4–12.2ROR 10.1 · calibrated p 0.032 ✓	9.5 EB05 8.1 · IC025 +2.9 3/3 methods agree	Lab value / disease marker	–	no trial arm names this drug
Vascular device infection	190	10.0 8.6–11.5ROR 10.0 · calibrated p 0.033 ✓	9.5 EB05 8.4 · IC025 +3.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Ischaemic cardiomyopathy	129	9.9 8.3–11.8ROR 9.9 · calibrated p 0.035 ✓	9.3 EB05 8.0 · IC025 +2.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Activated partial thromboplastin time prolonged	209	9.7 8.5–11.2ROR 9.7 · calibrated p 0.036 ✓	9.3 EB05 8.2 · IC025 +3.0 3/3 methods agree	Lab value / disease marker	–	no trial arm names this drug
Lymphoedema	283	9.7 8.6–10.9ROR 9.7 · calibrated p 0.036 ✓	9.3 EB05 8.4 · IC025 +3.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Brain natriuretic peptide increased	124	9.5 7.9–11.4ROR 9.5 · calibrated p 0.040 ✓	9.0 EB05 7.7 · IC025 +2.9 3/3 methods agree	Lab value / disease marker	–	no trial arm names this drug
Infusion site pain	512	9.5 8.7–10.3ROR 9.5 · calibrated p 0.038 ✓	9.1 EB05 8.4 · IC025 +3.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Haemorrhagic anaemia	175	9.3 8.0–10.8ROR 9.3 · calibrated p 0.043 ✓	8.8 EB05 7.8 · IC025 +2.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Breath sounds abnormal	190	9.1 7.9–10.5ROR 9.1 · calibrated p 0.045 ✓	8.7 EB05 7.7 · IC025 +2.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug

Trial evidence (ClinicalTrials.gov)

ClinicalTrials.gov returned results-bearing trials mentioning Potassium Chloride Oral only as a background or rescue medication (NCT00090259, NCT00094302); no trial listing it as the tested intervention was cached, so no trial cross-check is shown.

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
Diarrhoea (diarrhea)	6,755	2.4 2.4–2.5ROR 2.5 · calibrated p 0.806	2.4 EB05 2.3 · IC025 +1.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Dyspnoea (shortness of breath)	6,669	2.7 2.6–2.8ROR 2.8 · calibrated p 0.681	2.7 EB05 2.6 · IC025 +1.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Nausea	6,485	1.9 1.8–1.9ROR 1.9 · calibrated p 0.914	1.9 EB05 1.8 · IC025 +0.9	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Fatigue (tiredness)	6,276	1.8 1.8–1.9ROR 1.9 · calibrated p 0.893	1.8 EB05 1.8 · IC025 +0.8	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Death	4,579	1.2 1.2–1.2ROR 1.2 · calibrated p 0.456	1.2 EB05 1.2 · IC025 +0.2	Outcome field, not a reaction	–	no trial arm names this drug
Pneumonia (lung infection)	4,486	3.2 3.1–3.3ROR 3.3 · calibrated p 0.536	3.2 EB05 3.1 · IC025 +1.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Headache	4,146	1.5 1.5–1.6ROR 1.5 · calibrated p 0.665	1.5 EB05 1.5 · IC025 +0.5	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Vomiting	4,137	2.0 2.0–2.1ROR 2.1 · calibrated p 0.980	2.0 EB05 2.0 · IC025 +1.0	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Asthenia (weakness)	4,137	2.5 2.4–2.6ROR 2.6 · calibrated p 0.774	2.5 EB05 2.4 · IC025 +1.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Off label use (used outside approved label)	4,036	1.1 1.0–1.1ROR 1.1 · calibrated p 0.347	1.1 EB05 1.0 · IC025 +0.0	Reporting / coding artifact	–	no trial arm names this drug
Dizziness	3,964	1.8 1.8–1.9ROR 1.9 · calibrated p 0.863	1.8 EB05 1.8 · IC025 +0.8	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Pain	3,851	1.4 1.4–1.5ROR 1.4 · calibrated p 0.606	1.4 EB05 1.4 · IC025 +0.5	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Fall	3,611	2.5 2.4–2.6ROR 2.6 · calibrated p 0.792	2.5 EB05 2.4 · IC025 +1.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug
Drug ineffective (drug did not work)	3,566	0.6 0.6–0.6ROR 0.6 · calibrated p 0.085	0.6 EB05 0.6 · IC025 -0.8 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	–	no trial arm names this drug
Anaemia (low red blood cells)	3,138	3.8 3.7–3.9ROR 3.9 · calibrated p 0.399	3.7 EB05 3.6 · IC025 +1.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial arm names this drug

Unlabeled candidate signals

Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.

✓ A hand-written Bradford Hill causality assessment exists for this drug: Minoxidil (oral) ↔ Pericardial effusion.

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 Chloride Oral?

In FDA FAERS, the most frequently co-reported reaction terms for Potassium Chloride Oral are diarrhoea, dyspnoea, nausea, fatigue, pneumonia, headache. 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 Chloride Oral have an FDA boxed warning?

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

Do FAERS signals prove that Potassium Chloride Oral 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 fea3ae21-3395-437e-b773-b180e1c98801, effective 20260824; matched on openfda.generic_name.exact:"POTASSIUM CHLORIDE ORAL" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG")
PubChem CID 4873 description (ChEBI)
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, 1,197 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
ClinicalTrials.gov API v2 (query POTASSIUM CHLORIDE ORAL, results-bearing studies sorted by enrollment)

Page generated 2026-10-14. 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.