Drug · FAERS side-effect profile with label screen
Lactate and Dextrose side effects: what 8,147 FDA adverse event reports show
Drug class
No validated FDA label found
closest label found was a multi-ingredient product (Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride And Dextrose) and was not used
Who reports
8,147 reports · 90% serious · 3,940 with death outcome · 45% female
openFDA FAERS counts, all years, deduplication not applied
Used for
—
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
Reporting / coding artifact 4Outcome field, not a reaction 2No label text to screen 34
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.
- Outcome field, not a reaction Death is a report outcome, not a reaction term. It is dominated by the underlying illness; see the seriousness profile and the boxed warning instead.
- 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.
- No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.
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. 524 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 |
|---|---|---|---|---|---|---|
| Inadequate peritoneal dialysis | 28 | 618.2 409.2–933.8ROR 620.3 · χ² 13,383 / p <1e-300 | 371.0 EB05 269.4 · IC025 +5.0 3/3 methods agree | No label text to screen | serious n=27 · 79% consumer | no trial data cached |
| Peritoneal effluent abnormal | 29 | 310.7 211.4–456.6ROR 311.8 · χ² 7,702 / p <1e-300 | 234.3 EB05 171.1 · IC025 +5.0 3/3 methods agree | No label text to screen | serious n=29 · 79% consumer | no trial data cached |
| Ultrafiltration failure | 196 | 278.5 240.7–322.2ROR 285.3 · χ² 48,588 / p <1e-300 | 245.1 EB05 217.6 · IC025 +7.0 3/3 methods agree | No label text to screen | serious n=178 · 77% consumer | no trial data cached |
| Peritoneal cloudy effluent | 126 | 269.1 224.2–322.9ROR 273.3 · χ² 30,185 / p <1e-300 | 234.7 EB05 202.3 · IC025 +6.7 3/3 methods agree | No label text to screen | serious n=126 · 74% consumer | no trial data cached |
| Noninfectious peritonitis | 21 | 243.5 155.7–380.8ROR 244.1 · χ² 4,408 / p <1e-300 | 185.1 EB05 127.7 · IC025 +4.4 3/3 methods agree | No label text to screen | serious n=21 | no trial data cached |
| Peritoneal dialysis complication | 320 | 117.0 104.8–130.6ROR 121.7 · χ² 35,073 / p <1e-300 | 111.1 EB05 101.3 · IC025 +6.4 3/3 methods agree | Reporting / coding artifact | serious n=278 | no trial data cached |
| Diabetic foot | 124 | 108.5 90.8–129.7ROR 110.2 · χ² 12,567 / p <1e-300 | 102.5 EB05 88.2 · IC025 +5.9 3/3 methods agree | No label text to screen | serious n=124 | no trial data cached |
| Bacterial translocation | 11 | 92.5 50.7–168.7ROR 92.6 · χ² 874 / p 2e-192 | 77.7 EB05 46.3 · IC025 +3.2 3/3 methods agree | No label text to screen | serious n=11 | no trial data cached |
| Bloody peritoneal effluent | 30 | 79.0 55.0–113.6ROR 79.3 · χ² 2,166 / p <1e-300 | 73.2 EB05 53.8 · IC025 +4.5 3/3 methods agree | No label text to screen | serious n=30 · ♀ 24% (drug 45%) · 70% consumer | no trial data cached |
| Peritonitis | 601 | 76.9 71.1–83.2ROR 83.0 · χ² 43,678 / p <1e-300 | 74.5 EB05 69.6 · IC025 +6.0 3/3 methods agree | No label text to screen | serious PRR 48.0 | no trial data cached |
| Fungal peritonitis | 38 | 65.8 47.7–90.7ROR 66.1 · χ² 2,300 / p <1e-300 | 62.2 EB05 47.3 · IC025 +4.6 3/3 methods agree | No label text to screen | serious n=38 | no trial data cached |
| Peritoneal disorder | 15 | 60.5 36.2–100.8ROR 60.6 · χ² 800 / p 3e-176 | 55.2 EB05 35.5 · IC025 +3.5 3/3 methods agree | No label text to screen | serious n=14 | no trial data cached |
| Multimorbidity | 27 | 58.9 40.2–86.2ROR 59.1 · χ² 1,446 / p <1e-300 | 55.4 EB05 40.0 · IC025 +4.2 3/3 methods agree | No label text to screen | serious n=27 | no trial data cached |
| Peritonitis bacterial | 214 | 55.9 48.9–63.9ROR 57.4 · χ² 11,241 / p <1e-300 | 54.5 EB05 48.6 · IC025 +5.4 3/3 methods agree | No label text to screen | serious PRR 35.1 | no trial data cached |
| Abdominal sepsis | 16 | 48.0 29.3–78.6ROR 48.1 · χ² 677 / p 2e-149 | 44.8 EB05 29.2 · IC025 +3.5 3/3 methods agree | No label text to screen | serious n=16 | no trial data cached |
| Extremity necrosis | 31 | 46.2 32.4–65.9ROR 46.4 · χ² 1,304 / p 9e-286 | 44.3 EB05 32.7 · IC025 +4.1 3/3 methods agree | No label text to screen | serious n=31 | no trial data cached |
| Fluid overload | 229 | 40.5 35.6–46.1ROR 41.7 · χ² 8,661 / p <1e-300 | 39.8 EB05 35.7 · IC025 +5.0 3/3 methods agree | No label text to screen | serious PRR 16.4 · 72% consumer | no trial data cached |
| Disease complication | 64 | 36.3 28.4–46.4ROR 36.6 · χ² 2,133 / p <1e-300 | 35.5 EB05 28.8 · IC025 +4.4 3/3 methods agree | Reporting / coding artifact | serious n=62 | no trial data cached |
| Catheter site infection | 49 | 34.2 25.8–45.3ROR 34.4 · χ² 1,524 / p <1e-300 | 33.3 EB05 26.2 · IC025 +4.2 3/3 methods agree | No label text to screen | serious n=44 | no trial data cached |
| Acute myocardial infarction | 328 | 28.8 25.9–32.1ROR 30.0 · χ² 8,695 / p <1e-300 | 28.5 EB05 26.0 · IC025 +4.6 3/3 methods agree | No label text to screen | serious PRR 18.3 · 91% clinician | no trial data cached |
| Pulmonary sepsis | 15 | 27.0 16.2–44.8ROR 27.0 · χ² 346 / p 2e-77 | 25.9 EB05 16.6 · IC025 +3.0 3/3 methods agree | No label text to screen | serious n=15 | no trial data cached |
| Device related infection | 142 | 23.9 20.3–28.2ROR 24.3 · χ² 3,066 / p <1e-300 | 23.6 EB05 20.5 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious PRR 15.5 | no trial data cached |
| Cardio-respiratory arrest | 349 | 21.5 19.4–23.8ROR 22.4 · χ² 6,762 / p <1e-300 | 21.3 EB05 19.5 · IC025 +4.2 3/3 methods agree | No label text to screen | serious PRR 13.7 | no trial data cached |
| Soft tissue infection | 15 | 21.5 12.9–35.7ROR 21.5 · χ² 270 / p 5e-61 | 20.7 EB05 13.1 · IC025 +2.8 3/3 methods agree | No label text to screen | serious n=15 | no trial data cached |
| Nosocomial infection | 18 | 21.1 13.3–33.6ROR 21.2 · χ² 323 / p 2e-72 | 20.5 EB05 13.6 · IC025 +3.0 3/3 methods agree | No label text to screen | serious n=18 | no trial data cached |
| Diabetic complication | 19 | 19.2 12.2–30.1ROR 19.2 · χ² 308 / p 4e-69 | 18.6 EB05 12.4 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious n=19 | no trial data cached |
| Hypervolaemia | 27 | 14.6 10.0–21.2ROR 14.6 · χ² 326 / p 4e-73 | 14.1 EB05 9.9 · IC025 +2.9 3/3 methods agree | No label text to screen | serious n=27 · 89% consumer | no trial data cached |
| Brain death | 17 | 14.2 8.8–22.8ROR 14.2 · χ² 194 / p 2e-44 | 13.3 EB05 8.2 · IC025 +2.5 3/3 methods agree | Outcome field, not a reaction | serious n=17 | no trial data cached |
| Umbilical hernia | 25 | 13.8 9.3–20.4ROR 13.8 · χ² 283 / p 1e-63 | 13.2 EB05 9.1 · IC025 +2.8 3/3 methods agree | No label text to screen | serious n=24 | no trial data cached |
| Cardiac failure congestive | 420 | 13.4 12.2–14.7ROR 14.1 · χ² 4,798 / p <1e-300 | 13.3 EB05 12.3 · IC025 +3.6 3/3 methods agree | No label text to screen | serious PRR 8.6 | no trial data cached |
| Hypertensive crisis | 57 | 13.2 10.2–17.1ROR 13.3 · χ² 628 / p 7e-139 | 13.0 EB05 10.3 · IC025 +3.1 3/3 methods agree | No label text to screen | serious PRR 8.5 · 95% clinician | no trial data cached |
| Cerebrovascular disorder | 14 | 11.9 7.0–20.1ROR 11.9 · χ² 128 / p 5e-30 | 10.5 EB05 6.0 · IC025 +2.2 3/3 methods agree | No label text to screen | serious n=14 | no trial data cached |
| Abdominal infection | 11 | 11.2 6.2–20.2ROR 11.2 · χ² 91 / p 6e-22 | 9.2 EB05 5.0 · IC025 +1.9 3/3 methods agree | No label text to screen | serious n=11 | no trial data cached |
| Azotaemia | 17 | 11.0 6.8–17.6ROR 11.0 · χ² 143 / p 2e-33 | 9.7 EB05 6.0 · IC025 +2.3 3/3 methods agree | No label text to screen | serious n=17 | no trial data cached |
| Peripheral vascular disorder | 20 | 10.0 6.4–15.4ROR 10.0 · χ² 152 / p 4e-35 | 8.9 EB05 5.8 · IC025 +2.3 3/3 methods agree | No label text to screen | serious n=20 | no trial data cached |
| Gangrene | 23 | 9.8 6.5–14.7ROR 9.8 · χ² 172 / p 1e-39 | 8.9 EB05 6.0 · IC025 +2.3 3/3 methods agree | No label text to screen | serious n=23 | no trial data cached |
| Cerebral thrombosis | 10 | 9.1 4.9–17.0ROR 9.1 · χ² 64 / p 6e-16 | 7.1 EB05 3.9 · IC025 +1.6 3/3 methods agree | No label text to screen | serious n=10 | no trial data cached |
| Sepsis (blood infection) | 392 | 9.1 8.2–10.0ROR 9.5 · χ² 2,811 / p <1e-300 | 9.0 EB05 8.3 · IC025 +3.0 3/3 methods agree | No label text to screen | serious PRR 5.8 | no trial data cached |
| Sudden death | 37 | 8.9 6.5–12.3ROR 9.0 · χ² 252 / p 5e-57 | 8.3 EB05 6.2 · IC025 +2.5 3/3 methods agree | Outcome field, not a reaction | serious PRR 5.7 · 100% clinician | no trial data cached |
| Inguinal hernia | 20 | 8.5 5.5–13.1ROR 8.5 · χ² 124 / p 5e-29 | 7.4 EB05 4.9 · IC025 +2.1 3/3 methods agree | No label text to screen | serious n=16 · ♀ 20% (drug 45%) | 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 |
|---|---|---|---|---|---|---|
| Death | 1,353 | 4.0 3.9–4.3ROR 4.7 · χ² 3,230 / p <1e-300 | 4.0 EB05 3.9 · IC025 +1.9 3/3 methods agree | Outcome field, not a reaction | serious PRR 2.6 | no trial data cached |
| Peritonitis | 601 | 76.9 71.1–83.2ROR 83.0 · χ² 43,678 / p <1e-300 | 74.5 EB05 69.6 · IC025 +6.0 3/3 methods agree | No label text to screen | serious PRR 48.0 | no trial data cached |
| Myocardial infarction (heart attack) | 510 | 7.5 6.9–8.1ROR 7.9 · χ² 2,874 / p <1e-300 | 7.4 EB05 6.9 · IC025 +2.7 3/3 methods agree | No label text to screen | serious PRR 4.8 | no trial data cached |
| Cardiac failure congestive | 420 | 13.4 12.2–14.7ROR 14.1 · χ² 4,798 / p <1e-300 | 13.3 EB05 12.3 · IC025 +3.6 3/3 methods agree | No label text to screen | serious PRR 8.6 | no trial data cached |
| Sepsis (blood infection) | 392 | 9.1 8.2–10.0ROR 9.5 · χ² 2,811 / p <1e-300 | 9.0 EB05 8.3 · IC025 +3.0 3/3 methods agree | No label text to screen | serious PRR 5.8 | no trial data cached |
| Infection | 362 | 6.5 5.9–7.2ROR 6.7 · χ² 1,678 / p <1e-300 | 6.4 EB05 5.9 · IC025 +2.5 3/3 methods agree | No label text to screen | serious PRR 5.1 · 87% consumer | no trial data cached |
| Hypotension (low blood pressure) | 355 | 4.6 4.1–5.1ROR 4.7 · χ² 994 / p 2e-218 | 4.5 EB05 4.2 · IC025 +2.0 3/3 methods agree | No label text to screen | serious PRR 2.6 | no trial data cached |
| Cardio-respiratory arrest | 349 | 21.5 19.4–23.8ROR 22.4 · χ² 6,762 / p <1e-300 | 21.3 EB05 19.5 · IC025 +4.2 3/3 methods agree | No label text to screen | serious PRR 13.7 | no trial data cached |
| Acute myocardial infarction | 328 | 28.8 25.9–32.1ROR 30.0 · χ² 8,695 / p <1e-300 | 28.5 EB05 26.0 · IC025 +4.6 3/3 methods agree | No label text to screen | serious PRR 18.3 · 91% clinician | no trial data cached |
| Peritoneal dialysis complication | 320 | 117.0 104.8–130.6ROR 121.7 · χ² 35,073 / p <1e-300 | 111.1 EB05 101.3 · IC025 +6.4 3/3 methods agree | Reporting / coding artifact | serious n=278 | no trial data cached |
| Pneumonia (lung infection) | 261 | 2.1 1.8–2.3ROR 2.1 · χ² 147 / p 3e-34 | 2.1 EB05 1.9 · IC025 +0.8 | No label text to screen | serious PRR 1.4 | no trial data cached |
| Fluid overload | 229 | 40.5 35.6–46.1ROR 41.7 · χ² 8,661 / p <1e-300 | 39.8 EB05 35.7 · IC025 +5.0 3/3 methods agree | No label text to screen | serious PRR 16.4 · 72% consumer | no trial data cached |
| Dyspnoea (shortness of breath) | 217 | 1.0 0.9–1.1ROR 1.0 · χ² 0 / p 0.439 | 1.0 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC | No label text to screen | serious PRR 0.8 | no trial data cached |
| Peritonitis bacterial | 214 | 55.9 48.9–63.9ROR 57.4 · χ² 11,241 / p <1e-300 | 54.5 EB05 48.6 · IC025 +5.4 3/3 methods agree | No label text to screen | serious PRR 35.1 | no trial data cached |
| Asthenia (weakness) | 210 | 1.4 1.3–1.6ROR 1.4 · χ² 28 / p 6e-8 | 1.4 EB05 1.3 · IC025 +0.3 | No label text to screen | serious PRR 1.3 · 80% consumer | no trial data cached |
Unlabeled candidate signals
Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.
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 Lactate and Dextrose?
In FDA FAERS, the most frequently co-reported reaction terms for Lactate and Dextrose are peritonitis, myocardial infarction, cardiac failure congestive, sepsis, infection, hypotension. 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 Lactate and Dextrose have an FDA boxed warning?
No validated FDA label could be retrieved for this product name, so this page cannot say.
Do FAERS signals prove that Lactate and 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
- No FDA label passed the name-validation check for this product string, so label-based screening was skipped
- 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, 564 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.