Dextrose side effects: what 13,086 FDA adverse event reports show

Dextrose · 1,092 reaction terms · 61,251 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Who reports

13,086 reports · 92% serious · 2,055 with death outcome · 53% 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 40 strongest signals

Labeled (related wording) 2Reporting / coding artifact 7Lab value / disease marker 7Not in label — unassessed 24

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.
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. 1,052 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
Normal labour	123	12,142.9 7,214.8–20,437.2ROR 12,258.0 · χ² 170,499 / p <1e-300	1,146.8 EB05 986.5 · IC025 +7.4 3/3 methods agree	Not in label — unassessed	serious n=123 · ♀ 100% (drug 53%) · 90% clinician	no trial arm names this drug
Sleep disorder therapy	121	3,033.8 2,238.4–4,111.7ROR 3,062.0 · χ² 124,568 / p <1e-300	891.6 EB05 766.0 · IC025 +7.3 3/3 methods agree	Reporting / coding artifact	serious n=121 · ♀ 6% (drug 53%) · 98% clinician	no trial arm names this drug
Appendicolith	244	2,942.1 2,381.0–3,635.4ROR 2,997.9 · χ² 249,582 / p <1e-300	951.0 EB05 855.0 · IC025 +8.2 3/3 methods agree	Not in label — unassessed	serious n=244 · ♀ 3% (drug 53%) · 98% clinician	no trial arm names this drug
Antacid therapy	71	2,336.4 1,620.6–3,368.5ROR 2,349.2 · χ² 65,916 / p <1e-300	750.8 EB05 615.3 · IC025 +6.6 3/3 methods agree	Reporting / coding artifact	serious n=71 · ♀ 10% (drug 53%) · 97% clinician	no trial arm names this drug
Analgesic therapy	116	979.8 777.7–1,234.5ROR 988.6 · χ² 69,402 / p <1e-300	549.9 EB05 470.9 · IC025 +7.1 3/3 methods agree	Reporting / coding artifact	serious n=116 · ♀ 6% (drug 53%) · 96% clinician	no trial arm names this drug
Vitamin b1 increased	15	911.3 482.8–1,720.1ROR 912.3 · χ² 8,081 / p <1e-300	332.7 EB05 214.0 · IC025 +4.0 3/3 methods agree	Lab value / disease marker	serious n=15	no trial arm names this drug
Drug therapy	111	855.3 679.3–1,076.8ROR 862.6 · χ² 60,892 / p <1e-300	506.5 EB05 432.2 · IC025 +7.0 3/3 methods agree	Reporting / coding artifact	serious n=111 · ♀ 6% (drug 53%) · 95% clinician	no trial arm names this drug
Congenital hiatus hernia	58	569.0 421.7–767.9ROR 571.6 · χ² 23,762 / p <1e-300	367.7 EB05 294.9 · IC025 +6.1 3/3 methods agree	Not in label — unassessed	serious n=58 · ♀ 0% (drug 53%) · 100% clinician	no trial arm names this drug
Anticoagulant therapy	71	552.5 421.9–723.5ROR 555.5 · χ² 28,548 / p <1e-300	368.8 EB05 302.2 · IC025 +6.3 3/3 methods agree	Reporting / coding artifact	serious n=71 · ♀ 10% (drug 53%) · 96% clinician	no trial arm names this drug
Malignant melanoma stage 0	45	530.4 378.6–743.2ROR 532.3 · χ² 17,408 / p <1e-300	339.8 EB05 264.4 · IC025 +5.7 3/3 methods agree	Not in label — unassessed	serious n=45 · ♀ 0% (drug 53%) · 100% clinician	no trial arm names this drug
Neuroglycopenia	20	363.1 223.4–590.2ROR 363.7 · χ² 5,582 / p <1e-300	230.5 EB05 157.6 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious n=20 · 100% clinician	no trial arm names this drug
Delivery	122	362.2 297.8–440.7ROR 365.6 · χ² 35,458 / p <1e-300	281.8 EB05 242.3 · IC025 +6.8 3/3 methods agree	Not in label — unassessed	serious n=122 · ♀ 100% (drug 53%)	no trial arm names this drug
Blood lactic acid decreased	31	349.8 237.1–515.9ROR 350.6 · χ² 8,543 / p <1e-300	243.6 EB05 179.8 · IC025 +5.1 3/3 methods agree	Lab value / disease marker	serious n=31 · ♀ 100% (drug 53%) · 90% clinician	no trial arm names this drug
Cardiac output increased	30	340.9 229.8–505.6ROR 341.7 · χ² 8,085 / p <1e-300	238.1 EB05 174.8 · IC025 +5.0 3/3 methods agree	Lab value / disease marker	serious n=30 · ♀ 100% (drug 53%) · 90% clinician	no trial arm names this drug
Burkholderia test positive	19	288.6 177.0–470.4ROR 289.0 · χ² 4,364 / p <1e-300	196.2 EB05 132.8 · IC025 +4.3 3/3 methods agree	Lab value / disease marker	serious n=19	no trial arm names this drug
Bacteroides infection	38	275.3 195.2–388.4ROR 276.1 · χ² 8,613 / p <1e-300	210.0 EB05 159.7 · IC025 +5.3 3/3 methods agree	Not in label — unassessed	serious n=38 · ♀ 0% (drug 53%) · 100% clinician	no trial arm names this drug
Vitamin b1 decreased	36	269.5 189.3–383.6ROR 270.2 · χ² 7,999 / p <1e-300	205.4 EB05 155.0 · IC025 +5.2 3/3 methods agree	Lab value / disease marker	serious n=36 · ♀ 100% (drug 53%)	no trial arm names this drug
Soft tissue mass	34	127.3 89.8–180.4ROR 127.6 · χ² 3,826 / p <1e-300	110.7 EB05 82.8 · IC025 +4.9 3/3 methods agree	Not in label — unassessed	serious n=34 · ♀ 0% (drug 53%) · 100% clinician	no trial arm names this drug
Hyperphosphataemia	155	126.4 107.4–148.7ROR 127.9 · χ² 17,740 / p <1e-300	115.5 EB05 101.0 · IC025 +6.1 3/3 methods agree	Not in label — unassessed	serious n=155 · ♀ 6% (drug 53%) · 96% clinician	no trial arm names this drug
Blood phosphorus increased	194	122.8 106.2–141.9ROR 124.6 · χ² 21,631 / p <1e-300	112.7 EB05 100.0 · IC025 +6.2 3/3 methods agree	Lab value / disease marker	serious n=193 · ♀ 6% (drug 53%) · 95% clinician	no trial arm names this drug
Dehiscence	13	118.0 67.2–207.3ROR 118.1 · χ² 1,297 / p 3e-284	95.0 EB05 59.1 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=13	no trial arm names this drug
Spinal muscular atrophy	17	107.8 66.0–176.2ROR 108.0 · χ² 1,586 / p <1e-300	91.0 EB05 60.2 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=17	no trial arm names this drug
Granulocyte count decreased	112	107.4 88.8–130.0ROR 108.3 · χ² 10,957 / p <1e-300	99.0 EB05 84.5 · IC025 +5.8 3/3 methods agree	Lab value / disease marker	serious n=112	no trial arm names this drug
Genital erosion	17	99.1 60.7–161.7ROR 99.2 · χ² 1,462 / p <1e-300	84.7 EB05 56.0 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=17	no trial arm names this drug
Bronchopulmonary aspergillosis allergic	52	96.3 72.8–127.3ROR 96.7 · χ² 4,533 / p <1e-300	88.0 EB05 69.7 · IC025 +5.2 3/3 methods agree	Not in label — unassessed	serious n=52 · ♀ 0% (drug 53%) · 100% clinician	no trial arm names this drug
Peripheral circulatory failure	22	91.0 59.2–139.8ROR 91.1 · χ² 1,767 / p <1e-300	80.3 EB05 55.9 · IC025 +4.2 3/3 methods agree	Labeled (related wording) related wording	serious n=22 · ♀ 100% (drug 53%) · 100% clinician	no trial arm names this drug
Myelosuppression	1,678	83.1 79.4–87.0ROR 95.2 · χ² 129,433 / p <1e-300	78.9 EB05 75.8 · IC025 +6.2 3/3 methods agree	Not in label — unassessed	serious PRR 49.2 · 95% clinician	no trial arm names this drug
Positive airway pressure therapy	11	79.0 43.1–144.7ROR 79.0 · χ² 734 / p 6e-162	66.9 EB05 39.9 · IC025 +3.1 3/3 methods agree	Reporting / coding artifact	serious n=11	no trial arm names this drug
Stoma closure	14	77.9 45.5–133.1ROR 77.9 · χ² 940 / p 8e-207	67.7 EB05 42.9 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=14	no trial arm names this drug
Hyperdynamic left ventricle	10	67.5 35.9–127.1ROR 67.6 · χ² 566 / p 2e-125	58.0 EB05 33.7 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious n=10	no trial arm names this drug
Oesophageal perforation	31	62.0 43.3–88.7ROR 62.1 · χ² 1,732 / p <1e-300	57.7 EB05 42.6 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious n=31 · ♀ 0% (drug 53%) · 100% clinician	no trial arm names this drug
Motor neurone disease	18	60.9 38.0–97.5ROR 61.0 · χ² 964 / p 6e-212	55.4 EB05 37.1 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious n=18	no trial arm names this drug
Renal ischaemia	19	58.0 36.7–91.7ROR 58.1 · χ² 973 / p 6e-214	53.2 EB05 36.0 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious n=19	no trial arm names this drug
Scrotal abscess	13	57.0 32.8–99.2ROR 57.1 · χ² 638 / p 5e-141	51.2 EB05 31.8 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious n=13	no trial arm names this drug
Respiratory tract infection bacterial	16	52.9 32.1–87.0ROR 52.9 · χ² 738 / p 6e-163	48.4 EB05 31.6 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=16	no trial arm names this drug
Neonatal infection	11	52.5 28.8–95.7ROR 52.5 · χ² 489 / p 1e-108	47.0 EB05 28.0 · IC025 +3.0 3/3 methods agree	Labeled (related wording) related wording	serious n=11	no trial arm names this drug
Po2 increased	16	51.7 31.4–85.0ROR 51.7 · χ² 722 / p 3e-159	47.4 EB05 31.0 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=16	no trial arm names this drug
Total lung capacity decreased	50	51.6 38.9–68.3ROR 51.8 · χ² 2,353 / p <1e-300	49.1 EB05 38.7 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious n=50 · ♀ 14% (drug 53%) · 96% clinician	no trial arm names this drug
Vitamin b1 deficiency	13	51.1 29.4–88.7ROR 51.1 · χ² 571 / p 2e-126	46.4 EB05 28.8 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=13	no trial arm names this drug
Multiple drug therapy	21	49.7 32.2–76.6ROR 49.7 · χ² 924 / p 3e-203	46.3 EB05 31.9 · IC025 +3.8 3/3 methods agree	Reporting / coding artifact	serious n=21 · 100% clinician	no trial arm names this drug

Trial evidence (ClinicalTrials.gov)

ClinicalTrials.gov returned results-bearing trials mentioning Dextrose only as a background or rescue medication (NCT07465926, NCT05214573); 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
Myelosuppression	1,678	83.1 79.4–87.0ROR 95.2 · χ² 129,433 / p <1e-300	78.9 EB05 75.8 · IC025 +6.2 3/3 methods agree	Not in label — unassessed	serious PRR 49.2 · 95% clinician	no trial arm names this drug
Off label use (used outside approved label)	1,037	1.9 1.8–2.0ROR 2.0 · χ² 471 / p 8e-105	1.9 EB05 1.8 · IC025 +0.8	Reporting / coding artifact	serious PRR 2.1	no trial arm names this drug
Nausea	994	2.0 1.9–2.1ROR 2.1 · χ² 530 / p 2e-117	2.0 EB05 1.9 · IC025 +0.9	Labeled adverse reaction exact term	serious PRR 2.3	no trial arm names this drug
Drug ineffective (drug did not work)	939	1.1 1.1–1.2ROR 1.2 · χ² 18 / p 1e-5	1.1 EB05 1.1 · IC025 +0.1	Reporting / coding artifact	serious PRR 1.9 · 94% clinician	no trial arm names this drug
Vomiting	922	3.2 3.0–3.4ROR 3.3 · χ² 1,382 / p <1e-300	3.1 EB05 3.0 · IC025 +1.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 2.9	no trial arm names this drug
Acute kidney injury (sudden kidney damage)	790	8.3 7.8–8.9ROR 8.8 · χ² 5,111 / p <1e-300	8.3 EB05 7.8 · IC025 +2.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 5.2 · 95% clinician	no trial arm names this drug
Pyrexia (fever)	689	3.2 3.0–3.4ROR 3.3 · χ² 1,050 / p 1e-230	3.2 EB05 3.0 · IC025 +1.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 2.4	no trial arm names this drug
White blood cell count decreased	677	10.1 9.3–10.8ROR 10.5 · χ² 5,502 / p <1e-300	10.0 EB05 9.3 · IC025 +3.2 3/3 methods agree	Lab value / disease marker	serious PRR 8.7	no trial arm names this drug
Dyspnoea (shortness of breath)	660	1.9 1.7–2.0ROR 1.9 · χ² 273 / p 1e-61	1.9 EB05 1.8 · IC025 +0.8	Not in label — unassessed	serious PRR 1.6	no trial arm names this drug
Sepsis (blood infection)	573	8.3 7.6–9.0ROR 8.6 · χ² 3,650 / p <1e-300	8.2 EB05 7.6 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 5.2 · ♀ 24% (drug 53%) · 95% clinician	no trial arm names this drug
Abdominal pain	528	3.6 3.4–4.0ROR 3.8 · χ² 1,019 / p 6e-224	3.6 EB05 3.4 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 3.0	no trial arm names this drug
Hypotension (low blood pressure)	515	4.1 3.8–4.5ROR 4.3 · χ² 1,225 / p 9e-269	4.1 EB05 3.8 · IC025 +1.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 3.0	no trial arm names this drug
Neutrophil count decreased	471	18.8 17.2–20.6ROR 19.5 · χ² 7,856 / p <1e-300	18.6 EB05 17.2 · IC025 +4.0 3/3 methods agree	Lab value / disease marker	serious PRR 13.5	no trial arm names this drug
Condition aggravated	466	2.5 2.3–2.7ROR 2.5 · χ² 413 / p 4e-92	2.5 EB05 2.3 · IC025 +1.2 3/3 methods agree	Reporting / coding artifact	serious PRR 2.2 · ♀ 25% (drug 53%) · 91% clinician	no trial arm names this drug
Anaemia (low red blood cells)	463	3.9 3.6–4.3ROR 4.0 · χ² 999 / p 1e-219	3.9 EB05 3.6 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 2.6 · 93% clinician	no trial arm names this drug

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.

Normal labour — n=123, PRR 12,142.9
Appendicolith — n=244, PRR 2,942.1
Congenital hiatus hernia — n=58, PRR 569.0
Malignant melanoma stage 0 — n=45, PRR 530.4
Neuroglycopenia — n=20, PRR 363.1
Delivery — n=122, PRR 362.2
Bacteroides infection — n=38, PRR 275.3
Soft tissue mass — n=34, PRR 127.3
Hyperphosphataemia — n=155, PRR 126.4
Bronchopulmonary aspergillosis allergic — n=52, PRR 96.3

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 myelosuppression, nausea, vomiting, acute kidney injury, pyrexia, white blood cell count decreased. 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, 1,092 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 DEXTROSE, results-bearing studies sorted by enrollment)

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.