Drug · FAERS side-effect profile with label screen

Dibasic side effects: what 300 FDA adverse event reports show

Potassium Phosphate, Dibasic · 17 reaction terms · 906 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Label matched

Potassium Phosphate, Dibasic (Kali Phos 6X)

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

Who reports

300 reports · 98% serious · 48 with death outcome · 69% female

openFDA FAERS counts, all years, deduplication not applied

Used for

■ Temporarily relieves: ■ stress ■ simple nervous tension ■ headaches

FDA label, Indications and Usage

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 17 strongest signals

Reporting / coding artifact 4No label text to screen 13

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.
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 flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 0 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
Contraindicated product administered	67	156.1 126.4–192.8ROR 200.9 · χ² 10,163 / p <1e-300	149.2 EB05 121.6 · IC025 +5.8 3/3 methods agree	Reporting / coding artifact	serious PRR 113.2 · ♀ 100% (drug 69%)	no trial data cached
Toxic epidermal necrolysis (severe skin peeling reaction)	30	139.8 99.5–196.3ROR 155.3 · χ² 3,991 / p <1e-300	128.3 EB05 94.2 · IC025 +4.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 81.5 · ♀ 11% (drug 69%)	no trial data cached
Sleep disorder	137	137.6 121.6–155.7ROR 253.1 · χ² 18,464 / p <1e-300	134.8 EB05 116.9 · IC025 +6.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 132.2 · ♀ 100% (drug 69%)	no trial data cached
Treatment failure	116	99.2 86.1–114.5ROR 161.5 · χ² 11,212 / p <1e-300	97.6 EB05 83.5 · IC025 +5.8 3/3 methods agree	Reporting / coding artifact	serious PRR 111.2 · ♀ 100% (drug 69%)	no trial data cached
Synovitis	25	97.3 66.8–141.6ROR 106.1 · χ² 2,285 / p <1e-300	90.6 EB05 64.5 · IC025 +4.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 59.4 · ♀ 100% (drug 69%)	no trial data cached
Infection	138	67.2 59.4–75.9ROR 123.9 · χ² 8,985 / p <1e-300	66.5 EB05 57.7 · IC025 +5.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 49.3 · ♀ 100% (drug 69%)	no trial data cached
Joint stiffness	25	66.9 45.9–97.3ROR 72.9 · χ² 1,557 / p <1e-300	63.7 EB05 45.4 · IC025 +4.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 70.9 · ♀ 100% (drug 69%)	no trial data cached
Rheumatoid arthritis	106	65.8 56.5–76.7ROR 101.4 · χ² 6,730 / p <1e-300	65.0 EB05 55.3 · IC025 +5.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 46.9 · ♀ 100% (drug 69%)	no trial data cached
Brain injury	9	62.9 33.1–119.8ROR 64.9 · χ² 488 / p 2e-108	55.9 EB05 31.5 · IC025 +2.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 37.2	no trial data cached
Skin lesion	22	56.7 37.9–84.8ROR 61.1 · χ² 1,150 / p 3e-252	54.2 EB05 37.7 · IC025 +3.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 46.4	no trial data cached
Drug eruption	13	51.8 30.4–88.1ROR 54.1 · χ² 597 / p 3e-132	48.3 EB05 30.0 · IC025 +3.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 34.7	no trial data cached
Ventricular fibrillation	8	50.4 25.4–99.9ROR 51.8 · χ² 339 / p 4e-76	45.3 EB05 24.6 · IC025 +2.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 29.4	no trial data cached
Product use issue	127	47.7 41.8–54.4ROR 82.1 · χ² 5,804 / p <1e-300	47.3 EB05 40.8 · IC025 +5.0 3/3 methods agree	Reporting / coding artifact	serious PRR 62.3 · ♀ 100% (drug 69%)	no trial data cached
Cytokine release syndrome	12	44.2 25.4–76.9ROR 46.0 · χ² 464 / p 3e-103	41.5 EB05 25.3 · IC025 +3.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 26.1	no trial data cached
Malignant neoplasm progression	44	30.3 23.1–39.8ROR 35.4 · χ² 1,223 / p 3e-268	29.9 EB05 23.2 · IC025 +4.0 3/3 methods agree	Reporting / coding artifact	serious PRR 18.0 · ♀ 97% (drug 69%)	no trial data cached
Herpes zoster (shingles)	22	26.8 17.9–40.1ROR 28.9 · χ² 522 / p 6e-116	26.3 EB05 18.3 · IC025 +3.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 24.9	no trial data cached
Myelodysplastic syndrome	5	24.2 10.2–57.8ROR 24.6 · χ² 89 / p 2e-21	20.1 EB05 6.5 · IC025 +1.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 14.3	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
Infection	138	67.2 59.4–75.9ROR 123.9 · χ² 8,985 / p <1e-300	66.5 EB05 57.7 · IC025 +5.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 49.3 · ♀ 100% (drug 69%)	no trial data cached
Sleep disorder	137	137.6 121.6–155.7ROR 253.1 · χ² 18,464 / p <1e-300	134.8 EB05 116.9 · IC025 +6.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 132.2 · ♀ 100% (drug 69%)	no trial data cached
Product use issue	127	47.7 41.8–54.4ROR 82.1 · χ² 5,804 / p <1e-300	47.3 EB05 40.8 · IC025 +5.0 3/3 methods agree	Reporting / coding artifact	serious PRR 62.3 · ♀ 100% (drug 69%)	no trial data cached
Treatment failure	116	99.2 86.1–114.5ROR 161.5 · χ² 11,212 / p <1e-300	97.6 EB05 83.5 · IC025 +5.8 3/3 methods agree	Reporting / coding artifact	serious PRR 111.2 · ♀ 100% (drug 69%)	no trial data cached
Rheumatoid arthritis	106	65.8 56.5–76.7ROR 101.4 · χ² 6,730 / p <1e-300	65.0 EB05 55.3 · IC025 +5.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 46.9 · ♀ 100% (drug 69%)	no trial data cached
Contraindicated product administered	67	156.1 126.4–192.8ROR 200.9 · χ² 10,163 / p <1e-300	149.2 EB05 121.6 · IC025 +5.8 3/3 methods agree	Reporting / coding artifact	serious PRR 113.2 · ♀ 100% (drug 69%)	no trial data cached
Malignant neoplasm progression	44	30.3 23.1–39.8ROR 35.4 · χ² 1,223 / p 3e-268	29.9 EB05 23.2 · IC025 +4.0 3/3 methods agree	Reporting / coding artifact	serious PRR 18.0 · ♀ 97% (drug 69%)	no trial data cached
Toxic epidermal necrolysis (severe skin peeling reaction)	30	139.8 99.5–196.3ROR 155.3 · χ² 3,991 / p <1e-300	128.3 EB05 94.2 · IC025 +4.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 81.5 · ♀ 11% (drug 69%)	no trial data cached
Joint stiffness	25	66.9 45.9–97.3ROR 72.9 · χ² 1,557 / p <1e-300	63.7 EB05 45.4 · IC025 +4.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 70.9 · ♀ 100% (drug 69%)	no trial data cached
Synovitis	25	97.3 66.8–141.6ROR 106.1 · χ² 2,285 / p <1e-300	90.6 EB05 64.5 · IC025 +4.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 59.4 · ♀ 100% (drug 69%)	no trial data cached
Herpes zoster (shingles)	22	26.8 17.9–40.1ROR 28.9 · χ² 522 / p 6e-116	26.3 EB05 18.3 · IC025 +3.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 24.9	no trial data cached
Skin lesion	22	56.7 37.9–84.8ROR 61.1 · χ² 1,150 / p 3e-252	54.2 EB05 37.7 · IC025 +3.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 46.4	no trial data cached
Drug eruption	13	51.8 30.4–88.1ROR 54.1 · χ² 597 / p 3e-132	48.3 EB05 30.0 · IC025 +3.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 34.7	no trial data cached
Cytokine release syndrome	12	44.2 25.4–76.9ROR 46.0 · χ² 464 / p 3e-103	41.5 EB05 25.3 · IC025 +3.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 26.1	no trial data cached
Brain injury	9	62.9 33.1–119.8ROR 64.9 · χ² 488 / p 2e-108	55.9 EB05 31.5 · IC025 +2.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 37.2	no trial data cached

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.

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 Dibasic?

In FDA FAERS, the most frequently co-reported reaction terms for Dibasic are infection, sleep disorder, rheumatoid arthritis, toxic epidermal necrolysis, joint stiffness, synovitis. 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 Dibasic have an FDA boxed warning?

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

Do FAERS signals prove that Dibasic 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 dbfe86e8-c06f-2a84-e053-2a95a90a1f3d, effective 20250430; matched on openfda.generic_name.exact:"POTASSIUM PHOSPHATE, DIBASIC")
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, 17 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.