Dextrose Monohydrate side effects: what 13,281 FDA adverse event reports show

Dextrose Monohydrate · 1,089 reaction terms · 61,684 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Who reports

13,281 reports · 93% serious · 2,064 with death outcome · 54% 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. 1,049 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	11,964.5 7,108.8–20,137.1ROR 12,076.3 · χ² 167,995 / p <1e-300	1,132.9 EB05 974.6 · IC025 +7.4 3/3 methods agree	Not in label — unassessed	serious n=123 · ♀ 100% (drug 54%) · 90% clinician	no trial arm names this drug
Sleep disorder therapy	121	2,989.2 2,205.5–4,051.3ROR 3,016.7 · χ² 122,737 / p <1e-300	880.4 EB05 756.4 · IC025 +7.3 3/3 methods agree	Reporting / coding artifact	serious n=121 · ♀ 6% (drug 54%) · 98% clinician	no trial arm names this drug
Appendicolith	244	2,898.9 2,346.0–3,582.1ROR 2,953.1 · χ² 245,915 / p <1e-300	938.1 EB05 843.4 · IC025 +8.2 3/3 methods agree	Not in label — unassessed	serious n=244 · ♀ 3% (drug 54%) · 98% clinician	no trial arm names this drug
Antacid therapy	71	2,302.1 1,596.8–3,319.1ROR 2,314.5 · χ² 64,947 / p <1e-300	742.0 EB05 608.1 · IC025 +6.6 3/3 methods agree	Reporting / coding artifact	serious n=71 · ♀ 10% (drug 54%) · 97% clinician	no trial arm names this drug
Analgesic therapy	116	965.4 766.3–1,216.4ROR 973.9 · χ² 68,381 / p <1e-300	542.6 EB05 464.6 · IC025 +7.1 3/3 methods agree	Reporting / coding artifact	serious n=116 · ♀ 6% (drug 54%) · 96% clinician	no trial arm names this drug
Vitamin b1 increased	15	897.9 475.7–1,694.8ROR 898.9 · χ² 7,962 / p <1e-300	329.8 EB05 212.2 · IC025 +4.0 3/3 methods agree	Lab value / disease marker	serious n=15	no trial arm names this drug
Drug therapy	111	842.7 669.3–1,061.0ROR 849.8 · χ² 59,995 / p <1e-300	499.7 EB05 426.4 · IC025 +7.0 3/3 methods agree	Reporting / coding artifact	serious n=111 · ♀ 6% (drug 54%) · 95% clinician	no trial arm names this drug
Congenital hiatus hernia	58	560.7 415.5–756.6ROR 563.1 · χ² 23,412 / p <1e-300	363.0 EB05 291.1 · IC025 +6.1 3/3 methods agree	Not in label — unassessed	serious n=58 · ♀ 0% (drug 54%) · 100% clinician	no trial arm names this drug
Anticoagulant therapy	71	544.3 415.7–712.9ROR 547.3 · χ² 28,128 / p <1e-300	363.9 EB05 298.2 · IC025 +6.3 3/3 methods agree	Reporting / coding artifact	serious n=71 · ♀ 10% (drug 54%) · 96% clinician	no trial arm names this drug
Malignant melanoma stage 0	45	522.7 373.0–732.3ROR 524.4 · χ² 17,151 / p <1e-300	335.6 EB05 261.1 · IC025 +5.7 3/3 methods agree	Not in label — unassessed	serious n=45 · ♀ 0% (drug 54%) · 100% clinician	no trial arm names this drug
Burkholderia test positive	28	458.7 301.1–698.9ROR 459.7 · χ² 9,527 / p <1e-300	285.4 EB05 207.2 · IC025 +5.0 3/3 methods agree	Lab value / disease marker	serious n=28 · ♀ 25% (drug 54%) · 100% clinician	no trial arm names this drug
Neuroglycopenia	20	357.8 220.1–581.5ROR 358.3 · χ² 5,499 / p <1e-300	227.9 EB05 155.8 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious n=20 · 100% clinician	no trial arm names this drug
Delivery	122	356.9 293.4–434.2ROR 360.2 · χ² 34,934 / p <1e-300	277.9 EB05 238.9 · IC025 +6.8 3/3 methods agree	Not in label — unassessed	serious n=122 · ♀ 100% (drug 54%)	no trial arm names this drug
Blood lactic acid decreased	31	344.6 233.6–508.3ROR 345.4 · χ² 8,417 / p <1e-300	240.6 EB05 177.5 · IC025 +5.1 3/3 methods agree	Lab value / disease marker	serious n=31 · ♀ 100% (drug 54%) · 90% clinician	no trial arm names this drug
Cardiac output increased	30	335.9 226.5–498.2ROR 336.7 · χ² 7,966 / p <1e-300	235.1 EB05 172.6 · IC025 +5.0 3/3 methods agree	Lab value / disease marker	serious n=30 · ♀ 100% (drug 54%) · 90% clinician	no trial arm names this drug
Bacteroides infection	38	271.3 192.3–382.7ROR 272.1 · χ² 8,486 / p <1e-300	207.2 EB05 157.6 · IC025 +5.3 3/3 methods agree	Not in label — unassessed	serious n=38 · ♀ 0% (drug 54%) · 100% clinician	no trial arm names this drug
Vitamin b1 decreased	36	265.5 186.6–378.0ROR 266.3 · χ² 7,880 / p <1e-300	202.7 EB05 153.0 · IC025 +5.2 3/3 methods agree	Lab value / disease marker	serious n=36 · ♀ 100% (drug 54%)	no trial arm names this drug
Soft tissue mass	34	125.4 88.5–177.8ROR 125.7 · χ² 3,769 / p <1e-300	109.1 EB05 81.7 · IC025 +4.9 3/3 methods agree	Not in label — unassessed	serious n=34 · ♀ 0% (drug 54%) · 100% clinician	no trial arm names this drug
Hyperphosphataemia	155	124.5 105.8–146.5ROR 126.0 · χ² 17,475 / p <1e-300	113.8 EB05 99.5 · IC025 +6.1 3/3 methods agree	Not in label — unassessed	serious n=155 · ♀ 6% (drug 54%) · 96% clinician	no trial arm names this drug
Blood phosphorus increased	194	121.0 104.6–139.9ROR 122.7 · χ² 21,308 / p <1e-300	111.1 EB05 98.6 · IC025 +6.2 3/3 methods agree	Lab value / disease marker	serious n=193 · ♀ 6% (drug 54%) · 95% clinician	no trial arm names this drug
Dehiscence	13	116.3 66.2–204.2ROR 116.4 · χ² 1,277 / p 5e-280	93.8 EB05 58.3 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=13	no trial arm names this drug
Granulocyte count decreased	116	109.9 91.1–132.5ROR 110.8 · χ² 11,590 / p <1e-300	101.0 EB05 86.5 · IC025 +5.9 3/3 methods agree	Lab value / disease marker	serious n=116	no trial arm names this drug
Spinal muscular atrophy	17	106.3 65.0–173.6ROR 106.4 · χ² 1,562 / p <1e-300	89.8 EB05 59.4 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=17	no trial arm names this drug
Genital erosion	17	97.6 59.8–159.3ROR 97.8 · χ² 1,440 / p <1e-300	83.6 EB05 55.3 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=17	no trial arm names this drug
Bronchopulmonary aspergillosis allergic	52	94.9 71.7–125.5ROR 95.2 · χ² 4,465 / p <1e-300	86.7 EB05 68.7 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	serious n=52 · ♀ 0% (drug 54%) · 100% clinician	no trial arm names this drug
Peripheral circulatory failure	22	89.6 58.3–137.7ROR 89.8 · χ² 1,740 / p <1e-300	79.2 EB05 55.1 · IC025 +4.2 3/3 methods agree	Labeled (related wording) related wording	serious n=22 · ♀ 100% (drug 54%) · 100% clinician	no trial arm names this drug
Myelosuppression	1,752	85.7 81.9–89.6ROR 98.6 · χ² 139,134 / p <1e-300	81.2 EB05 78.1 · IC025 +6.2 3/3 methods agree	Not in label — unassessed	serious PRR 50.6 · 95% clinician	no trial arm names this drug
Positive airway pressure therapy	11	77.8 42.5–142.5ROR 77.9 · χ² 723 / p 2e-159	66.0 EB05 39.4 · IC025 +3.1 3/3 methods agree	Reporting / coding artifact	serious n=11	no trial arm names this drug
Stoma closure	14	76.7 44.9–131.2ROR 76.8 · χ² 926 / p 1e-203	66.8 EB05 42.3 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=14	no trial arm names this drug
Hyperdynamic left ventricle	10	66.5 35.3–125.2ROR 66.6 · χ² 558 / p 1e-123	57.2 EB05 33.2 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious n=10	no trial arm names this drug
Oesophageal perforation	31	61.1 42.7–87.4ROR 61.2 · χ² 1,705 / p <1e-300	56.9 EB05 42.0 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious n=31 · ♀ 0% (drug 54%) · 100% clinician	no trial arm names this drug
Motor neurone disease	18	60.0 37.5–96.0ROR 60.1 · χ² 949 / p 9e-209	54.6 EB05 36.6 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious n=18	no trial arm names this drug
Renal ischaemia	19	57.2 36.2–90.4ROR 57.3 · χ² 958 / p 1e-210	52.5 EB05 35.5 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious n=19	no trial arm names this drug
Scrotal abscess	13	56.2 32.3–97.7ROR 56.3 · χ² 628 / p 7e-139	50.5 EB05 31.4 · 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	52.1 31.7–85.7ROR 52.2 · χ² 727 / p 2e-160	47.8 EB05 31.2 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=16	no trial arm names this drug
Neonatal infection	11	51.7 28.4–94.3ROR 51.8 · χ² 482 / p 5e-107	46.3 EB05 27.6 · IC025 +3.0 3/3 methods agree	Labeled (related wording) related wording	serious n=11	no trial arm names this drug
Po2 increased	16	50.9 31.0–83.8ROR 51.0 · χ² 711 / p 7e-157	46.8 EB05 30.5 · 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	50.8 38.4–67.3ROR 51.0 · χ² 2,317 / p <1e-300	48.4 EB05 38.2 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious n=50 · ♀ 14% (drug 54%) · 96% clinician	no trial arm names this drug
Vitamin b1 deficiency	13	50.3 29.0–87.4ROR 50.4 · χ² 562 / p 2e-124	45.7 EB05 28.4 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=13	no trial arm names this drug
Multiple drug therapy	21	48.9 31.7–75.5ROR 49.0 · χ² 910 / p 3e-200	45.6 EB05 31.5 · 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	1,752	85.7 81.9–89.6ROR 98.6 · χ² 139,134 / p <1e-300	81.2 EB05 78.1 · IC025 +6.2 3/3 methods agree	Not in label — unassessed	serious PRR 50.6 · 95% clinician	no trial arm names this drug
Off label use (used outside approved label)	1,039	1.9 1.8–2.0ROR 2.0 · χ² 453 / p 7e-101	1.9 EB05 1.8 · IC025 +0.8	Reporting / coding artifact	serious PRR 2.1	no trial arm names this drug
Nausea	1,002	2.0 1.9–2.1ROR 2.1 · χ² 523 / p 4e-116	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)	940	1.1 1.1–1.2ROR 1.1 · χ² 14 / p 8e-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	927	3.1 2.9–3.3ROR 3.3 · χ² 1,365 / p 4e-299	3.1 EB05 3.0 · IC025 +1.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 2.8	no trial arm names this drug
Acute kidney injury (sudden kidney damage)	792	8.2 7.7–8.8ROR 8.7 · χ² 5,045 / p <1e-300	8.2 EB05 7.7 · IC025 +2.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 5.1 · 95% clinician	no trial arm names this drug
White blood cell count decreased	719	10.5 9.8–11.3ROR 11.1 · χ² 6,176 / p <1e-300	10.4 EB05 9.8 · IC025 +3.3 3/3 methods agree	Lab value / disease marker	serious PRR 9.1	no trial arm names this drug
Pyrexia (fever)	700	3.2 3.0–3.4ROR 3.3 · χ² 1,069 / p 9e-235	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
Dyspnoea (shortness of breath)	671	1.9 1.7–2.0ROR 1.9 · χ² 280 / p 5e-63	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	8.1 7.5–8.8ROR 8.5 · χ² 3,582 / p <1e-300	8.1 EB05 7.5 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 5.1 · ♀ 24% (drug 54%) · 95% clinician	no trial arm names this drug
Abdominal pain	528	3.6 3.3–3.9ROR 3.7 · χ² 993 / p 3e-218	3.6 EB05 3.3 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 2.9 · ♀ 34% (drug 54%)	no trial arm names this drug
Hypotension (low blood pressure)	518	4.1 3.8–4.5ROR 4.2 · χ² 1,214 / p 2e-266	4.1 EB05 3.8 · IC025 +1.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 2.9	no trial arm names this drug
Neutrophil count decreased	509	20.1 18.4–21.9ROR 20.8 · χ² 9,105 / p <1e-300	19.8 EB05 18.4 · IC025 +4.1 3/3 methods agree	Lab value / disease marker	serious PRR 14.3	no trial arm names this drug
Condition aggravated	478	2.5 2.3–2.7ROR 2.6 · χ² 435 / p 8e-97	2.5 EB05 2.3 · IC025 +1.2 3/3 methods agree	Reporting / coding artifact	serious PRR 2.3 · ♀ 26% (drug 54%) · 91% clinician	no trial arm names this drug
Diarrhoea (diarrhea)	467	1.1 1.0–1.3ROR 1.2 · χ² 9 / p 0.002	1.1 EB05 1.1 · IC025 +0.0	Not in label — unassessed	serious PRR 1.1	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 11,964.5
Appendicolith — n=244, PRR 2,898.9
Congenital hiatus hernia — n=58, PRR 560.7
Malignant melanoma stage 0 — n=45, PRR 522.7
Neuroglycopenia — n=20, PRR 357.8
Delivery — n=122, PRR 356.9
Bacteroides infection — n=38, PRR 271.3
Soft tissue mass — n=34, PRR 125.4
Hyperphosphataemia — n=155, PRR 124.5
Bronchopulmonary aspergillosis allergic — n=52, PRR 94.9

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, white blood cell count decreased, pyrexia. 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, 1,089 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.