Drug · FAERS side-effect profile with label screen
Icodextrin and Lactate side effects: what 30,877 FDA adverse event reports show
Drug class
No validated FDA label found
closest label found was a multi-ingredient product (Icodextrin, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride) and was not used
Who reports
30,877 reports · 84% serious · 10,042 with death outcome · 40% 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 5Lab value / disease marker 2No label text to screen 33
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.
- 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.
- 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. 972 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 |
|---|---|---|---|---|---|---|
| Pseudomonas peritonitis | 19 | 794.6 408.6–1,544.9ROR 795.0 · χ² 6,525 / p <1e-300 | 266.4 EB05 180.2 · IC025 +4.4 3/3 methods agree | No label text to screen | serious n=19 | not reported in cached trials |
| Blood glucose false positive | 26 | 790.8 448.2–1,395.0ROR 791.4 · χ² 9,040 / p <1e-300 | 286.5 EB05 205.5 · IC025 +4.9 3/3 methods agree | Lab value / disease marker | serious n=25 · 100% clinician | not reported in cached trials |
| Device interaction | 115 | 630.7 489.0–813.5ROR 633.1 · χ² 36,895 / p <1e-300 | 308.5 EB05 264.0 · IC025 +6.8 3/3 methods agree | Reporting / coding artifact | serious n=109 | not reported in cached trials |
| Peritoneal cloudy effluent | 608 | 575.4 516.6–640.9ROR 586.9 · χ² 187,142 / p <1e-300 | 306.8 EB05 286.9 · IC025 +7.8 3/3 methods agree | No label text to screen | serious n=609 | not reported in cached trials |
| Increased intraperitoneal volume | 12 | 472.3 225.6–988.8ROR 472.5 · χ² 3,037 / p <1e-300 | 192.7 EB05 117.5 · IC025 +3.5 3/3 methods agree | No label text to screen | serious n=8 | not reported in cached trials |
| Inadequate peritoneal dialysis | 58 | 456.6 327.0–637.4ROR 457.4 · χ² 15,401 / p <1e-300 | 249.5 EB05 200.1 · IC025 +5.9 3/3 methods agree | No label text to screen | serious n=50 · 71% consumer | not reported in cached trials |
| Peritonitis sclerosing | 31 | 398.9 255.7–622.2ROR 399.3 · χ² 7,461 / p <1e-300 | 216.9 EB05 160.1 · IC025 +5.1 3/3 methods agree | No label text to screen | serious n=27 | not reported in cached trials |
| Sclerosing encapsulating peritonitis | 64 | 356.9 263.5–483.2ROR 357.6 · χ² 14,580 / p <1e-300 | 218.0 EB05 176.7 · IC025 +6.0 3/3 methods agree | No label text to screen | serious n=57 · 100% clinician | not reported in cached trials |
| Noninfectious peritonitis | 71 | 281.1 213.1–370.8ROR 281.7 · χ² 13,757 / p <1e-300 | 188.3 EB05 154.3 · IC025 +6.0 3/3 methods agree | No label text to screen | serious n=71 | not reported in cached trials |
| Peritoneal effluent abnormal | 75 | 262.7 201.2–343.1ROR 263.4 · χ² 13,854 / p <1e-300 | 180.3 EB05 148.6 · IC025 +6.0 3/3 methods agree | No label text to screen | serious n=71 | not reported in cached trials |
| Escherichia peritonitis | 13 | 223.0 119.1–417.8ROR 223.1 · χ² 1,992 / p <1e-300 | 134.8 EB05 83.9 · IC025 +3.6 3/3 methods agree | No label text to screen | serious n=13 | not reported in cached trials |
| Peritoneal effluent leukocyte count increased | 15 | 213.5 119.4–381.8ROR 213.6 · χ² 2,247 / p <1e-300 | 134.7 EB05 86.7 · IC025 +3.8 3/3 methods agree | Lab value / disease marker | serious n=12 | not reported in cached trials |
| Ultrafiltration failure | 470 | 207.8 187.5–230.4ROR 211.0 · χ² 73,669 / p <1e-300 | 157.8 EB05 146.2 · IC025 +6.9 3/3 methods agree | No label text to screen | serious n=382 | NCT01021878: 1/27 (3.7%) on Icodextrin and Lactate |
| Peritoneal dialysis complication | 1,480 | 171.1 161.8–181.0ROR 179.7 · χ² 199,290 / p <1e-300 | 136.3 EB05 130.5 · IC025 +6.9 3/3 methods agree | Reporting / coding artifact | serious n=1,286 | not reported in cached trials |
| Bloody peritoneal effluent | 176 | 144.0 122.4–169.4ROR 144.8 · χ² 20,446 / p <1e-300 | 117.2 EB05 103.3 · IC025 +6.2 3/3 methods agree | No label text to screen | serious n=166 | not reported in cached trials |
| Pleuroperitoneal communication | 23 | 137.4 87.7–215.2ROR 137.5 · χ² 2,472 / p <1e-300 | 104.5 EB05 73.3 · IC025 +4.4 3/3 methods agree | No label text to screen | serious n=23 | not reported in cached trials |
| Fungal peritonitis | 255 | 136.5 119.4–156.1ROR 137.6 · χ² 28,377 / p <1e-300 | 112.6 EB05 101.5 · IC025 +6.3 3/3 methods agree | No label text to screen | serious n=252 | not reported in cached trials |
| Peritonitis bacterial | 1,482 | 117.3 111.1–123.8ROR 123.2 · χ² 145,392 / p <1e-300 | 99.8 EB05 95.6 · IC025 +6.5 3/3 methods agree | No label text to screen | serious PRR 68.8 | not reported in cached trials |
| Peritoneal fluid analysis abnormal | 12 | 105.6 57.5–194.2ROR 105.7 · χ² 986 / p 1e-216 | 80.1 EB05 48.8 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | serious n=11 | not reported in cached trials |
| Diabetic vascular disorder | 33 | 104.6 72.5–151.0ROR 104.8 · χ² 2,840 / p <1e-300 | 86.2 EB05 64.3 · IC025 +4.7 3/3 methods agree | No label text to screen | serious n=33 · 85% consumer | not reported in cached trials |
| Encapsulating peritoneal sclerosis | 24 | 104.3 67.8–160.3ROR 104.4 · χ² 2,035 / p <1e-300 | 84.5 EB05 59.7 · IC025 +4.3 3/3 methods agree | No label text to screen | serious n=24 · 100% clinician | not reported in cached trials |
| Peritoneal disorder | 74 | 86.7 68.1–110.4ROR 86.9 · χ² 5,475 / p <1e-300 | 75.4 EB05 62.1 · IC025 +5.3 3/3 methods agree | No label text to screen | serious n=71 | not reported in cached trials |
| Peritoneal perforation | 17 | 77.4 46.8–127.8ROR 77.4 · χ² 1,081 / p 2e-237 | 64.7 EB05 42.7 · IC025 +3.7 3/3 methods agree | No label text to screen | serious n=17 | not reported in cached trials |
| Catheter site abscess | 17 | 75.8 45.9–125.2ROR 75.9 · χ² 1,061 / p 4e-233 | 63.6 EB05 42.0 · IC025 +3.7 3/3 methods agree | No label text to screen | serious n=16 | not reported in cached trials |
| Infectious peritonitis | 69 | 75.8 59.1–97.2ROR 76.0 · χ² 4,508 / p <1e-300 | 67.0 EB05 54.7 · IC025 +5.1 3/3 methods agree | No label text to screen | serious n=70 | not reported in cached trials |
| Peritonitis | 1,890 | 68.2 65.1–71.4ROR 72.6 · χ² 113,584 / p <1e-300 | 61.9 EB05 59.6 · IC025 +5.9 3/3 methods agree | No label text to screen | serious PRR 42.6 | NCT01021878: 2/33 (6.1%) on Icodextrin and Lactate (serious AE) |
| Diabetic gangrene | 25 | 64.6 42.8–97.4ROR 64.6 · χ² 1,370 / p 4e-300 | 56.6 EB05 40.3 · IC025 +4.1 3/3 methods agree | No label text to screen | serious n=25 · 88% consumer | not reported in cached trials |
| Multimorbidity | 99 | 60.7 49.4–74.5ROR 60.9 · χ² 5,272 / p <1e-300 | 55.1 EB05 46.6 · IC025 +5.1 3/3 methods agree | No label text to screen | serious n=99 | not reported in cached trials |
| Marasmus | 102 | 49.3 40.4–60.3ROR 49.5 · χ² 4,455 / p <1e-300 | 45.7 EB05 38.7 · IC025 +4.9 3/3 methods agree | No label text to screen | serious n=102 | not reported in cached trials |
| Catheter site infection | 246 | 47.8 42.0–54.4ROR 48.2 · χ² 10,477 / p <1e-300 | 44.5 EB05 40.1 · IC025 +5.1 3/3 methods agree | No label text to screen | serious n=225 | not reported in cached trials |
| Chemical peritonitis | 11 | 39.6 21.5–72.7ROR 39.6 · χ² 355 / p 2e-79 | 35.3 EB05 21.0 · IC025 +2.8 3/3 methods agree | No label text to screen | serious n=11 | not reported in cached trials |
| Peripheral circulatory failure | 21 | 36.7 23.6–56.9ROR 36.7 · χ² 658 / p 2e-145 | 33.9 EB05 23.4 · IC025 +3.6 3/3 methods agree | No label text to screen | serious n=21 · 76% consumer | not reported in cached trials |
| Fluid overload | 728 | 35.2 32.7–37.9ROR 36.0 · χ² 22,962 / p <1e-300 | 33.5 EB05 31.5 · IC025 +4.9 3/3 methods agree | No label text to screen | serious PRR 17.2 · 75% consumer | not reported in cached trials |
| Application site laceration | 19 | 32.8 20.7–52.1ROR 32.9 · χ² 529 / p 2e-117 | 30.5 EB05 20.6 · IC025 +3.4 3/3 methods agree | No label text to screen | serious n=7 | not reported in cached trials |
| Bacterial translocation | 13 | 29.0 16.6–50.5ROR 29.0 · χ² 310 / p 9e-70 | 26.8 EB05 16.6 · IC025 +2.9 3/3 methods agree | No label text to screen | serious n=13 | not reported in cached trials |
| Cardiac procedure complication | 25 | 28.9 19.4–43.1ROR 28.9 · χ² 619 / p 7e-137 | 27.2 EB05 19.4 · IC025 +3.5 3/3 methods agree | Reporting / coding artifact | serious n=25 · 92% consumer | not reported in cached trials |
| Diabetic complication | 103 | 28.4 23.3–34.6ROR 28.5 · χ² 2,585 / p <1e-300 | 27.1 EB05 23.0 · IC025 +4.3 3/3 methods agree | Reporting / coding artifact | serious n=102 · 78% consumer | not reported in cached trials |
| Gangrene | 238 | 27.7 24.3–31.5ROR 27.9 · χ² 5,857 / p <1e-300 | 26.6 EB05 23.9 · IC025 +4.4 3/3 methods agree | No label text to screen | serious n=238 | not reported in cached trials |
| Catheter site extravasation | 13 | 22.8 13.1–39.6ROR 22.8 · χ² 241 / p 1e-54 | 21.3 EB05 12.9 · IC025 +2.7 3/3 methods agree | No label text to screen | serious n=11 | not reported in cached trials |
| Catheter site inflammation | 17 | 21.5 13.3–34.9ROR 21.6 · χ² 303 / p 4e-68 | 20.4 EB05 13.3 · IC025 +2.9 3/3 methods agree | No label text to screen | serious n=14 | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Icodextrin and Lactate as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (2 of 40 signal terms matched).
- NCT01021878 — Study to Evaluate the Effects Icodextrin Versus Dianeal on Insulin Resistance in Nondiabetic Automated Periton (N=60, PHASE4; 6 AE terms posted; arms: Icodextrin; Dextrose)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
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 | 6,008 | 4.8 4.7–4.9ROR 5.7 · χ² 18,495 / p <1e-300 | 4.7 EB05 4.6 · IC025 +2.2 3/3 methods agree | Outcome field, not a reaction | serious PRR 3.3 | NCT01021878: 1/27 (3.7%) on Icodextrin and Lactate (serious AE) |
| Peritonitis | 1,890 | 68.2 65.1–71.4ROR 72.6 · χ² 113,584 / p <1e-300 | 61.9 EB05 59.6 · IC025 +5.9 3/3 methods agree | No label text to screen | serious PRR 42.6 | NCT01021878: 2/33 (6.1%) on Icodextrin and Lactate (serious AE) |
| Peritonitis bacterial | 1,482 | 117.3 111.1–123.8ROR 123.2 · χ² 145,392 / p <1e-300 | 99.8 EB05 95.6 · IC025 +6.5 3/3 methods agree | No label text to screen | serious PRR 68.8 | not reported in cached trials |
| Peritoneal dialysis complication | 1,480 | 171.1 161.8–181.0ROR 179.7 · χ² 199,290 / p <1e-300 | 136.3 EB05 130.5 · IC025 +6.9 3/3 methods agree | Reporting / coding artifact | serious n=1,286 | not reported in cached trials |
| Hypotension (low blood pressure) | 1,181 | 4.0 3.8–4.3ROR 4.1 · χ² 2,688 / p <1e-300 | 4.0 EB05 3.8 · IC025 +1.9 3/3 methods agree | No label text to screen | serious PRR 2.4 · 78% consumer | not reported in cached trials |
| Pneumonia (lung infection) | 972 | 2.0 1.9–2.2ROR 2.1 · χ² 525 / p 2e-116 | 2.0 EB05 1.9 · IC025 +0.9 | No label text to screen | serious PRR 1.5 | not reported in cached trials |
| Myocardial infarction (heart attack) | 971 | 3.8 3.5–4.0ROR 3.9 · χ² 1,975 / p <1e-300 | 3.7 EB05 3.6 · IC025 +1.8 3/3 methods agree | No label text to screen | serious PRR 2.6 · 70% consumer | not reported in cached trials |
| Infection | 798 | 3.8 3.5–4.0ROR 3.8 · χ² 1,626 / p <1e-300 | 3.8 EB05 3.5 · IC025 +1.8 3/3 methods agree | No label text to screen | serious PRR 3.1 · 81% consumer | NCT01021878: 2/33 (6.1%) on Icodextrin and Lactate (serious AE) |
| Sepsis (blood infection) | 743 | 4.5 4.2–4.9ROR 4.6 · χ² 2,048 / p <1e-300 | 4.5 EB05 4.2 · IC025 +2.1 3/3 methods agree | No label text to screen | serious PRR 3.1 | not reported in cached trials |
| Fluid overload | 728 | 35.2 32.7–37.9ROR 36.0 · χ² 22,962 / p <1e-300 | 33.5 EB05 31.5 · IC025 +4.9 3/3 methods agree | No label text to screen | serious PRR 17.2 · 75% consumer | not reported in cached trials |
| Fall | 708 | 1.4 1.3–1.6ROR 1.5 · χ² 99 / p 1e-23 | 1.4 EB05 1.4 · IC025 +0.4 | No label text to screen | serious PRR 1.1 · 72% consumer | not reported in cached trials |
| Dehydration | 664 | 3.4 3.1–3.7ROR 3.4 · χ² 1,119 / p 1e-245 | 3.4 EB05 3.2 · IC025 +1.6 3/3 methods agree | No label text to screen | serious PRR 1.8 · 80% consumer | not reported in cached trials |
| Abdominal pain | 658 | 1.9 1.8–2.1ROR 1.9 · χ² 294 / p 4e-66 | 1.9 EB05 1.8 · IC025 +0.8 | No label text to screen | serious PRR 1.6 | not reported in cached trials |
| Asthenia (weakness) | 652 | 1.2 1.1–1.3ROR 1.2 · χ² 18 / p 1e-5 | 1.2 EB05 1.1 · IC025 +0.1 | No label text to screen | serious PRR 1.1 · 74% consumer | not reported in cached trials |
| Dyspnoea (shortness of breath) | 641 | 0.8 0.7–0.8ROR 0.8 · χ² 45 / p 9e-12 | 0.8 EB05 0.7 · IC025 -0.5 PRR-only: not supported by EBGM or IC | No label text to screen | serious PRR 0.6 · 72% consumer | not reported in cached trials |
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 Icodextrin and Lactate?
In FDA FAERS, the most frequently co-reported reaction terms for Icodextrin and Lactate are peritonitis, peritonitis bacterial, hypotension, pneumonia, myocardial infarction, 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 Icodextrin and Lactate 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 Icodextrin 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
- 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, 1,012 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
ICODEXTRIN, 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.