Drug · FAERS side-effect profile with label screen

Monobasic and Dibasic side effects: what 352 FDA adverse event reports show

Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic · 5 reaction terms · 53 drug–reaction co-reports · data 2026-09-14

Drug class

Phosphorus replacement product

FDA label, Indications wording of the closest related product

Label matched

Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic (Potassium Phosphates)

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

Who reports

352 reports · 84% serious · 63 with death outcome · 47% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Potassium Phosphates Injection is indicated as a source of phosphorus: • in intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacement is not possible, insufficient or contraindicated. • for parenteral nutrition in adults and pediatric patients when oral or enteral nutrition is not possible, insufficient or contraindicated.

FDA label, Indications and Usage

What it is

Potassium Phosphates Injection, USP, a phosphorus replacement product containing phosphorus 3 mmol/mL and potassium 4.4 mEq/mL. It is a sterile, non-pyrogenic, concentrated solution containing a mixture of monobasic potassium phosphate and dibasic potassium phosphate in water for injection.

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 4 strongest signals

Not in label — unassessed 4

What the badges mean

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. 1 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
Cytokine release syndrome	20	62.6 40.9–95.8ROR 66.3 · χ² 1,151 / p 1e-252	59.2 EB05 40.4 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious PRR 43.3 · 95% clinician	no trial data cached
Toxic epidermal necrolysis (severe skin peeling reaction)	13	51.4 30.1–87.6ROR 53.3 · χ² 593 / p 3e-131	48.0 EB05 29.8 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 35.2	no trial data cached
Sinus tachycardia	9	37.8 19.9–72.2ROR 38.8 · χ² 287 / p 1e-64	35.2 EB05 19.8 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 26.4	no trial data cached
Neurotoxicity	8	27.4 13.8–54.4ROR 28.1 · χ² 178 / p 6e-41	25.6 EB05 13.3 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 19.0	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
Cytokine release syndrome	20	62.6 40.9–95.8ROR 66.3 · χ² 1,151 / p 1e-252	59.2 EB05 40.4 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious PRR 43.3 · 95% clinician	no trial data cached
Toxic epidermal necrolysis (severe skin peeling reaction)	13	51.4 30.1–87.6ROR 53.3 · χ² 593 / p 3e-131	48.0 EB05 29.8 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 35.2	no trial data cached
Sinus tachycardia	9	37.8 19.9–72.2ROR 38.8 · χ² 287 / p 1e-64	35.2 EB05 19.8 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 26.4	no trial data cached
Neurotoxicity	8	27.4 13.8–54.4ROR 28.1 · χ² 178 / p 6e-41	25.6 EB05 13.3 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 19.0	no trial data cached
Product preparation error	3	8.6 2.8–26.6ROR 8.7 · χ² 13 / p 1e-4	4.5 EB05 1.7 · IC025 -0.0 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	–	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.

Cytokine release syndrome — n=20, PRR 62.6

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 Monobasic and Dibasic?

In FDA FAERS, the most frequently co-reported reaction terms for Monobasic and Dibasic are cytokine release syndrome, toxic epidermal necrolysis, sinus tachycardia, neurotoxicity. 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 Monobasic and Dibasic have an FDA boxed warning?

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

Do FAERS signals prove that Monobasic and 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 475f5cd7-45bd-412a-b419-9962585d6cda, effective 20250228; matched on openfda.generic_name.exact:"POTASSIUM PHOSPHATE, MONOBASIC 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, 5 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.