Dextrose and Sodium Chloride side effects: what 165 FDA adverse event reports show

Dextrose And Sodium Chloride · 11 reaction terms · 167 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Who reports

165 reports · 94% serious · 56 with death outcome · 45% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Dextrose Injection (5%) is indicated as a source of water and calories in adult and pediatric patients, and may also be used as a diluent for reconstitution of a powder or liquid drug product. Dextrose Injection (5%) is indicated as a source of water and calories in adult and pediatric patients, and may also be used as a diluent for reconstitution of a powder or liquid drug product. ( 1 )

FDA label, Indications and Usage

What it is

Dextrose Injection USP (5%) is a sterile, nonpyrogenic, and isotonic solution and contains no bacteriostatic or antimicrobial agents. This product is intended for intravenous administration. The formula of the active ingredient is: Ingredient Molecular Formula Molecular Weight Hydrous Dextrose USP 198.17

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 10 strongest signals

Reporting / coding artifact 1Not in label — unassessed 9

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.

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
Appendicitis	23	315.2 215.6–460.8ROR 366.1 · χ² 6,879 / p <1e-300	249.4 EB05 175.0 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious PRR 195.4 · ♀ 0% (drug 45%) · 96% clinician	no trial data cached
Ventricular fibrillation	23	263.0 179.9–384.4ROR 305.4 · χ² 5,734 / p <1e-300	215.6 EB05 151.3 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious PRR 161.1 · ♀ 0% (drug 45%) · 96% clinician	no trial data cached
Cardiogenic shock	23	205.2 140.4–299.8ROR 238.2 · χ² 4,466 / p <1e-300	175.2 EB05 123.0 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious PRR 125.4 · ♀ 5% (drug 45%) · 91% clinician	no trial data cached
Incorrect route of product administration	15	113.5 70.1–184.0ROR 124.8 · χ² 1,562 / p <1e-300	99.4 EB05 64.0 · IC025 +3.7 3/3 methods agree	Reporting / coding artifact	serious PRR 138.9	no trial data cached
Ascites	26	112.4 79.0–160.0ROR 133.3 · χ² 2,762 / p <1e-300	103.9 EB05 74.5 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious PRR 69.8 · ♀ 8% (drug 45%) · 96% clinician	no trial data cached
Bacterial infection	14	95.9 58.1–158.3ROR 104.7 · χ² 1,221 / p 7e-268	85.0 EB05 53.8 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious PRR 67.8	no trial data cached
Multiple organ dysfunction syndrome	21	95.7 64.2–142.7ROR 109.5 · χ² 1,876 / p <1e-300	88.2 EB05 60.9 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious PRR 58.5 · ♀ 0% (drug 45%) · 95% clinician	no trial data cached
Cytopenia	5	53.2 22.4–126.1ROR 54.8 · χ² 207 / p 4e-47	44.4 EB05 20.0 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 33.7	no trial data cached
Cytokine release syndrome	7	46.7 22.6–96.4ROR 48.7 · χ² 269 / p 9e-61	41.7 EB05 21.6 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 28.9	no trial data cached
Neurotoxicity	6	43.9 20.0–96.3ROR 45.5 · χ² 211 / p 5e-48	38.7 EB05 18.8 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 27.2	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
Ascites	26	112.4 79.0–160.0ROR 133.3 · χ² 2,762 / p <1e-300	103.9 EB05 74.5 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious PRR 69.8 · ♀ 8% (drug 45%) · 96% clinician	no trial data cached
Cardiogenic shock	23	205.2 140.4–299.8ROR 238.2 · χ² 4,466 / p <1e-300	175.2 EB05 123.0 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious PRR 125.4 · ♀ 5% (drug 45%) · 91% clinician	no trial data cached
Ventricular fibrillation	23	263.0 179.9–384.4ROR 305.4 · χ² 5,734 / p <1e-300	215.6 EB05 151.3 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious PRR 161.1 · ♀ 0% (drug 45%) · 96% clinician	no trial data cached
Appendicitis	23	315.2 215.6–460.8ROR 366.1 · χ² 6,879 / p <1e-300	249.4 EB05 175.0 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious PRR 195.4 · ♀ 0% (drug 45%) · 96% clinician	no trial data cached
Multiple organ dysfunction syndrome	21	95.7 64.2–142.7ROR 109.5 · χ² 1,876 / p <1e-300	88.2 EB05 60.9 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious PRR 58.5 · ♀ 0% (drug 45%) · 95% clinician	no trial data cached
Incorrect route of product administration	15	113.5 70.1–184.0ROR 124.8 · χ² 1,562 / p <1e-300	99.4 EB05 64.0 · IC025 +3.7 3/3 methods agree	Reporting / coding artifact	serious PRR 138.9	no trial data cached
Bacterial infection	14	95.9 58.1–158.3ROR 104.7 · χ² 1,221 / p 7e-268	85.0 EB05 53.8 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious PRR 67.8	no trial data cached
Cytokine release syndrome	7	46.7 22.6–96.4ROR 48.7 · χ² 269 / p 9e-61	41.7 EB05 21.6 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 28.9	no trial data cached
Neurotoxicity	6	43.9 20.0–96.3ROR 45.5 · χ² 211 / p 5e-48	38.7 EB05 18.8 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 27.2	no trial data cached
Cytopenia	5	53.2 22.4–126.1ROR 54.8 · χ² 207 / p 4e-47	44.4 EB05 20.0 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 33.7	no trial data cached
Mydriasis	4	39.7 15.1–104.4ROR 40.6 · χ² 115 / p 5e-27	31.9 EB05 10.6 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious PRR 31.4	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.

Appendicitis — n=23, PRR 315.2
Ventricular fibrillation — n=23, PRR 263.0
Cardiogenic shock — n=23, PRR 205.2
Ascites — n=26, PRR 112.4
Multiple organ dysfunction syndrome — n=21, PRR 95.7

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 Dextrose?

In FDA FAERS, the most frequently co-reported reaction terms for Dextrose are ascites, cardiogenic shock, ventricular fibrillation, appendicitis, multiple organ dysfunction syndrome, bacterial infection. 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 Dextrose have an FDA boxed warning?

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

Do FAERS signals prove that Dextrose 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 60b6d7c3-0164-46c9-aa38-b5aa1c31a5d5, effective 20260512; matched on openfda.generic_name.exact:"DEXTROSE")
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, 11 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.