Drug · FAERS side-effect profile with label screen
Dextrose and Lactate side effects: what 8,796 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Dextrose (Dextrose)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
8,796 reports · 54% serious · 680 with death outcome · 44% 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 adverse reaction 4Labeled (related wording) 4Reporting / coding artifact 4Lab value / disease marker 2Not in label — unassessed 26
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- 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. 269 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Bloody peritoneal effluent | 284 | 940.6 821.0–1,077.7ROR 972.0 · χ² 189,741 / p <1e-300 | 642.8 EB05 582.5 · IC025 +8.1 3/3 methods agree | Not in label — unassessed | serious n=29 | no trial data cached |
| Inadequate aseptic technique in use of product | 54 | 427.5 320.2–570.9ROR 430.2 · χ² 19,085 / p <1e-300 | 320.8 EB05 255.2 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious n=54 | no trial data cached |
| Peritonitis bacterial | 941 | 246.1 230.8–262.3ROR 275.4 · χ² 207,783 / p <1e-300 | 221.8 EB05 210.2 · IC025 +7.5 3/3 methods agree | Not in label — unassessed | serious PRR 236.9 · 94% clinician | no trial data cached |
| Peritonitis | 1,569 | 195.5 186.5–204.9ROR 237.8 · χ² 280,434 / p <1e-300 | 180.2 EB05 172.8 · IC025 +7.3 3/3 methods agree | Not in label — unassessed | serious PRR 192.2 | no trial data cached |
| Fungal peritonitis | 85 | 140.8 113.2–175.0ROR 142.1 · χ² 10,998 / p <1e-300 | 129.1 EB05 107.6 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious n=84 · 90% clinician | no trial data cached |
| Fluid imbalance | 36 | 128.1 91.6–179.0ROR 128.6 · χ² 4,185 / p <1e-300 | 114.3 EB05 86.3 · IC025 +5.0 3/3 methods agree | Labeled (related wording) related wording | serious n=6 | no trial data cached |
| Catheter site infection | 170 | 113.6 97.5–132.3ROR 115.8 · χ² 17,990 / p <1e-300 | 107.1 EB05 94.3 · IC025 +6.1 3/3 methods agree | Labeled (related wording) related wording | serious n=152 | no trial data cached |
| Noninfectious peritonitis | 10 | 102.2 54.3–192.5ROR 102.4 · χ² 866 / p 1e-190 | 83.0 EB05 48.2 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial data cached |
| Hypervolaemia | 182 | 94.0 81.2–108.8ROR 95.9 · χ² 16,013 / p <1e-300 | 89.6 EB05 79.2 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious n=158 | no trial data cached |
| Peritoneal cloudy effluent | 50 | 92.9 70.1–123.2ROR 93.5 · χ² 4,287 / p <1e-300 | 86.6 EB05 68.2 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=47 | no trial data cached |
| Fluid overload | 267 | 43.9 39.0–49.5ROR 45.2 · χ² 10,955 / p <1e-300 | 43.0 EB05 38.8 · IC025 +5.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 42.9 | no trial data cached |
| Staphylococcus test positive | 35 | 39.9 28.6–55.7ROR 40.1 · χ² 1,268 / p 6e-278 | 38.5 EB05 28.9 · IC025 +4.1 3/3 methods agree | Lab value / disease marker | serious n=35 · 97% clinician | no trial data cached |
| Ultrafiltration failure | 32 | 38.6 27.2–54.7ROR 38.7 · χ² 1,116 / p 7e-245 | 37.2 EB05 27.6 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=21 | no trial data cached |
| Hydrothorax | 11 | 31.8 17.6–57.7ROR 31.9 · χ² 294 / p 3e-66 | 29.9 EB05 17.7 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Scrotal swelling | 10 | 26.2 14.0–48.8ROR 26.2 · χ² 215 / p 5e-49 | 24.6 EB05 14.0 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=3 | no trial data cached |
| Azotaemia | 40 | 24.0 17.6–32.8ROR 24.1 · χ² 851 / p 2e-187 | 23.5 EB05 18.0 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=31 · ♀ 21% (drug 44%) | no trial data cached |
| Abdominal hernia | 39 | 20.5 15.0–28.1ROR 20.6 · χ² 699 / p 2e-154 | 20.2 EB05 15.4 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=18 | no trial data cached |
| Inguinal hernia | 52 | 20.5 15.6–26.9ROR 20.6 · χ² 936 / p 8e-206 | 20.2 EB05 16.0 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=19 · ♀ 6% (drug 44%) | no trial data cached |
| Umbilical hernia | 39 | 20.0 14.6–27.4ROR 20.1 · χ² 680 / p 4e-150 | 19.7 EB05 15.0 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=10 · 95% clinician | no trial data cached |
| Catheter site pain | 18 | 17.0 10.7–27.0ROR 17.0 · χ² 253 / p 2e-57 | 16.3 EB05 10.5 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious n=2 | no trial data cached |
| Catheter site haemorrhage | 16 | 15.6 9.5–25.5ROR 15.6 · χ² 203 / p 2e-46 | 14.8 EB05 9.0 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=2 | no trial data cached |
| Peritoneal dialysis complication | 45 | 14.7 10.9–19.6ROR 14.7 · χ² 556 / p 4e-123 | 14.4 EB05 11.1 · IC025 +3.2 3/3 methods agree | Reporting / coding artifact | serious n=41 · 91% clinician | no trial data cached |
| Abdominal distension (bloating) | 613 | 14.1 13.1–15.3ROR 15.1 · χ² 7,460 / p <1e-300 | 14.0 EB05 13.1 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 1.3 | no trial data cached |
| Hernia repair | 13 | 12.0 7.0–20.7ROR 12.1 · χ² 120 / p 3e-28 | 10.5 EB05 5.9 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=3 | no trial data cached |
| Device occlusion | 63 | 10.8 8.5–13.9ROR 10.9 · χ² 551 / p 4e-122 | 10.5 EB05 8.4 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious n=43 · 93% clinician | no trial data cached |
| Hernia | 84 | 10.4 8.4–12.9ROR 10.5 · χ² 706 / p 9e-156 | 10.2 EB05 8.4 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 3.0 · ♀ 23% (drug 44%) | no trial data cached |
| Discomfort | 222 | 8.8 7.7–10.0ROR 9.0 · χ² 1,517 / p <1e-300 | 8.6 EB05 7.7 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 1.1 | no trial data cached |
| Treatment noncompliance | 179 | 7.9 6.8–9.1ROR 8.0 · χ² 1,067 / p 3e-234 | 7.7 EB05 6.8 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 9.4 · 92% clinician | no trial data cached |
| Device related infection | 46 | 7.1 5.3–9.5ROR 7.2 · χ² 236 / p 2e-53 | 6.7 EB05 5.2 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 6.4 | no trial data cached |
| Fluid retention | 124 | 5.8 4.9–6.9ROR 5.9 · χ² 491 / p 5e-109 | 5.7 EB05 4.9 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.4 | no trial data cached |
| Intercepted medication error | 10 | 5.1 2.7–9.5ROR 5.1 · χ² 29 / p 4e-8 | 4.2 EB05 2.5 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Cardiac arrest (heart stopping) | 173 | 5.0 4.3–5.8ROR 5.1 · χ² 548 / p 2e-121 | 4.9 EB05 4.3 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 · 94% clinician | no trial data cached |
| Failure to thrive | 10 | 4.6 2.5–8.5ROR 4.6 · χ² 24 / p 4e-7 | 3.9 EB05 2.3 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Infection | 269 | 4.5 4.0–5.0ROR 4.6 · χ² 721 / p 5e-159 | 4.4 EB05 4.0 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.3 | no trial data cached |
| Abdominal pain | 428 | 4.4 4.0–4.8ROR 4.6 · χ² 1,130 / p 6e-248 | 4.4 EB05 4.0 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 1.9 | no trial data cached |
| Blood pressure abnormal | 36 | 4.3 3.1–6.0ROR 4.4 · χ² 89 / p 2e-21 | 4.1 EB05 3.1 · IC025 +1.5 3/3 methods agree | Lab value / disease marker | serious PRR 1.9 · 89% consumer | no trial data cached |
| Complication associated with device | 24 | 4.3 2.9–6.5ROR 4.3 · χ² 58 / p 1e-14 | 4.0 EB05 2.9 · IC025 +1.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.0 · 95% clinician | no trial data cached |
| Hyperkalaemia (high potassium) | 48 | 3.3 2.5–4.4ROR 3.3 · χ² 74 / p 4e-18 | 3.2 EB05 2.5 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 | no trial data cached |
| Groin pain | 11 | 3.0 1.6–5.4ROR 3.0 · χ² 13 / p 2e-4 | 2.7 EB05 1.7 · IC025 +0.4 | Not in label — unassessed | – | no trial data cached |
| Electrolyte imbalance | 14 | 2.9 1.7–4.9ROR 2.9 · χ² 16 / p 4e-5 | 2.7 EB05 1.7 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 3.0 | 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 |
|---|---|---|---|---|---|---|
| Peritonitis | 1,569 | 195.5 186.5–204.9ROR 237.8 · χ² 280,434 / p <1e-300 | 180.2 EB05 172.8 · IC025 +7.3 3/3 methods agree | Not in label — unassessed | serious PRR 192.2 | no trial data cached |
| Peritonitis bacterial | 941 | 246.1 230.8–262.3ROR 275.4 · χ² 207,783 / p <1e-300 | 221.8 EB05 210.2 · IC025 +7.5 3/3 methods agree | Not in label — unassessed | serious PRR 236.9 · 94% clinician | no trial data cached |
| Abdominal distension (bloating) | 613 | 14.1 13.1–15.3ROR 15.1 · χ² 7,460 / p <1e-300 | 14.0 EB05 13.1 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 1.3 | no trial data cached |
| Abdominal pain | 428 | 4.4 4.0–4.8ROR 4.6 · χ² 1,130 / p 6e-248 | 4.4 EB05 4.0 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 1.9 | no trial data cached |
| Death | 340 | 0.9 0.8–1.0ROR 0.9 · χ² 1 / p 0.132 | 0.9 EB05 0.9 · IC025 -0.3 PRR-only: not supported by EBGM or IC | Outcome field, not a reaction | serious PRR 1.0 | no trial data cached |
| Malaise (feeling unwell) | 319 | 1.7 1.6–1.9ROR 1.8 · χ² 100 / p 9e-24 | 1.7 EB05 1.6 · IC025 +0.6 | Not in label — unassessed | serious PRR 0.2 | no trial data cached |
| Dyspnoea (shortness of breath) | 285 | 1.2 1.1–1.3ROR 1.2 · χ² 10 / p 9e-4 | 1.2 EB05 1.1 · IC025 +0.1 | Not in label — unassessed | serious PRR 0.4 | no trial data cached |
| Bloody peritoneal effluent | 284 | 940.6 821.0–1,077.7ROR 972.0 · χ² 189,741 / p <1e-300 | 642.8 EB05 582.5 · IC025 +8.1 3/3 methods agree | Not in label — unassessed | serious n=29 | no trial data cached |
| Pain | 276 | 1.1 1.0–1.2ROR 1.1 · χ² 1 / p 0.136 | 1.1 EB05 1.0 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 0.2 | no trial data cached |
| Infection | 269 | 4.5 4.0–5.0ROR 4.6 · χ² 721 / p 5e-159 | 4.4 EB05 4.0 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.3 | no trial data cached |
| Fluid overload | 267 | 43.9 39.0–49.5ROR 45.2 · χ² 10,955 / p <1e-300 | 43.0 EB05 38.8 · IC025 +5.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 42.9 | no trial data cached |
| Discomfort | 222 | 8.8 7.7–10.0ROR 9.0 · χ² 1,517 / p <1e-300 | 8.6 EB05 7.7 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 1.1 | no trial data cached |
| Abdominal discomfort | 201 | 2.9 2.5–3.3ROR 2.9 · χ² 244 / p 2e-55 | 2.9 EB05 2.5 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 0.8 | no trial data cached |
| Vomiting | 184 | 0.9 0.8–1.1ROR 0.9 · χ² 1 / p 0.190 | 0.9 EB05 0.8 · IC025 -0.3 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 0.5 | no trial data cached |
| Diarrhoea (diarrhea) | 183 | 0.7 0.6–0.8ROR 0.7 · χ² 28 / p 5e-8 | 0.7 EB05 0.6 · IC025 -0.8 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious PRR 0.3 | 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.
- Bloody peritoneal effluent — n=284, PRR 940.6
- Inadequate aseptic technique in use of product — n=54, PRR 427.5
- Peritonitis bacterial — n=941, PRR 246.1
- Peritonitis — n=1,569, PRR 195.5
- Fungal peritonitis — n=85, PRR 140.8
- Hypervolaemia — n=182, PRR 94.0
- Peritoneal cloudy effluent — n=50, PRR 92.9
- Ultrafiltration failure — n=32, PRR 38.6
- Azotaemia — n=40, PRR 24.0
- Abdominal hernia — n=39, PRR 20.5
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 and Lactate?
In FDA FAERS, the most frequently co-reported reaction terms for Dextrose and Lactate are peritonitis, peritonitis bacterial, abdominal distension, abdominal pain, malaise, dyspnoea. 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 and Lactate have an FDA boxed warning?
No. The FDA label retrieved for Dextrose and Lactate has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Dextrose and Lactate 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, fieldpatient.drug.openfda.generic_name.exact, 309 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.