Polyethylene Glycol-3350 and Electrolytes side effects: what 772 FDA adverse event reports show

Polyethylene Glycol-3350 And Electrolytes · 18 reaction terms · 483 drug–reaction co-reports · data 2026-09-14

Drug class

Osmotic Laxative

FDA label (Established Pharmacologic Class) · compare the class

Who reports

772 reports · 31% serious · 23 with death outcome · 58% female

openFDA FAERS counts, all years, deduplication not applied

Used for

PEG-3350 and electrolytes for oral solution, USP is a combination of PEG 3350, an osmotic laxative, and electrolytes indicated for cleansing of the colon in preparation for colonoscopy and barium enema X-ray examination in adults ( 1 ) PEG-3350 and electrolytes for oral solution is indicated for bowel cleansing prior to colonoscopy and barium enema X-ray examination in adults.

FDA label, Indications and Usage

What it is

PEG-3350 and electrolytes for oral solution is a combination of polyethylene glycol 3350, an osmotic laxative, and electrolytes (sodium sulfate, sodium chloride, sodium bicarbonate and potassi.

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 14 strongest signals

Labeled (related wording) 1Reporting / coding artifact 8Lab value / disease marker 1Not in label — unassessed 4

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. 4 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
Product dispensing error	88	109.8 90.1–133.7ROR 123.7 · χ² 9,348 / p <1e-300	106.9 EB05 89.4 · IC025 +5.7 3/3 methods agree	Reporting / coding artifact	97% consumer	no trial data cached
Product prescribing error	33	37.7 27.0–52.7ROR 39.3 · χ² 1,143 / p 9e-251	36.9 EB05 27.5 · IC025 +4.0 3/3 methods agree	Reporting / coding artifact	97% consumer	no trial data cached
No adverse event	199	30.4 26.9–34.2ROR 40.5 · χ² 5,661 / p <1e-300	30.2 EB05 26.9 · IC025 +4.6 3/3 methods agree	Reporting / coding artifact	serious PRR 9.2 · 94% consumer	no trial data cached
Product prescribing issue	18	23.9 15.1–37.8ROR 24.5 · χ² 373 / p 2e-83	23.3 EB05 15.6 · IC025 +3.1 3/3 methods agree	Reporting / coding artifact	serious PRR 6.4	no trial data cached
Product taste abnormal	11	22.1 12.3–39.8ROR 22.4 · χ² 201 / p 6e-46	21.1 EB05 12.1 · IC025 +2.5 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
End stage renal disease	15	22.0 13.3–36.4ROR 22.4 · χ² 280 / p 3e-63	21.4 EB05 13.5 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 40.4	no trial data cached
Anhedonia	20	20.4 13.2–31.5ROR 20.9 · χ² 350 / p 2e-78	20.0 EB05 13.5 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 41.5 · ♀ 15% (drug 58%)	no trial data cached
Impaired gastric emptying	8	17.0 8.5–33.8ROR 17.1 · χ² 105 / p 7e-25	14.8 EB05 6.6 · IC025 +1.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 35.1	no trial data cached
Economic problem	9	15.8 8.2–30.2ROR 16.0 · χ² 110 / p 4e-26	13.9 EB05 6.5 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	serious PRR 31.7	no trial data cached
Impaired quality of life	7	13.2 6.3–27.5ROR 13.3 · χ² 67 / p 1e-16	10.1 EB05 4.3 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Product use complaint	7	12.2 5.8–25.5ROR 12.3 · χ² 61 / p 2e-15	9.2 EB05 4.0 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Circumstance or information capable of leading to medication error	11	8.9 4.9–15.9ROR 9.0 · χ² 69 / p 5e-17	7.1 EB05 4.0 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Bone density decreased	7	6.0 2.9–12.5ROR 6.0 · χ² 24 / p 4e-7	4.5 EB05 2.3 · IC025 +0.9 3/3 methods agree	Lab value / disease marker	serious PRR 13.7	no trial data cached
Wrong technique in product usage process	35	4.7 3.4–6.5ROR 4.9 · χ² 99 / p 1e-23	4.4 EB05 3.3 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	serious PRR 4.5 · 100% consumer	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
No adverse event	199	30.4 26.9–34.2ROR 40.5 · χ² 5,661 / p <1e-300	30.2 EB05 26.9 · IC025 +4.6 3/3 methods agree	Reporting / coding artifact	serious PRR 9.2 · 94% consumer	no trial data cached
Product dispensing error	88	109.8 90.1–133.7ROR 123.7 · χ² 9,348 / p <1e-300	106.9 EB05 89.4 · IC025 +5.7 3/3 methods agree	Reporting / coding artifact	97% consumer	no trial data cached
Wrong technique in product usage process	35	4.7 3.4–6.5ROR 4.9 · χ² 99 / p 1e-23	4.4 EB05 3.3 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	serious PRR 4.5 · 100% consumer	no trial data cached
Product prescribing error	33	37.7 27.0–52.7ROR 39.3 · χ² 1,143 / p 9e-251	36.9 EB05 27.5 · IC025 +4.0 3/3 methods agree	Reporting / coding artifact	97% consumer	no trial data cached
Anhedonia	20	20.4 13.2–31.5ROR 20.9 · χ² 350 / p 2e-78	20.0 EB05 13.5 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 41.5 · ♀ 15% (drug 58%)	no trial data cached
Product prescribing issue	18	23.9 15.1–37.8ROR 24.5 · χ² 373 / p 2e-83	23.3 EB05 15.6 · IC025 +3.1 3/3 methods agree	Reporting / coding artifact	serious PRR 6.4	no trial data cached
End stage renal disease	15	22.0 13.3–36.4ROR 22.4 · χ² 280 / p 3e-63	21.4 EB05 13.5 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 40.4	no trial data cached
Circumstance or information capable of leading to medication error	11	8.9 4.9–15.9ROR 9.0 · χ² 69 / p 5e-17	7.1 EB05 4.0 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Product taste abnormal	11	22.1 12.3–39.8ROR 22.4 · χ² 201 / p 6e-46	21.1 EB05 12.1 · IC025 +2.5 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Economic problem	9	15.8 8.2–30.2ROR 16.0 · χ² 110 / p 4e-26	13.9 EB05 6.5 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	serious PRR 31.7	no trial data cached
Impaired gastric emptying	8	17.0 8.5–33.8ROR 17.1 · χ² 105 / p 7e-25	14.8 EB05 6.6 · IC025 +1.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 35.1	no trial data cached
Bone density decreased	7	6.0 2.9–12.5ROR 6.0 · χ² 24 / p 4e-7	4.5 EB05 2.3 · IC025 +0.9 3/3 methods agree	Lab value / disease marker	serious PRR 13.7	no trial data cached
Product use complaint	7	12.2 5.8–25.5ROR 12.3 · χ² 61 / p 2e-15	9.2 EB05 4.0 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Impaired quality of life	7	13.2 6.3–27.5ROR 13.3 · χ² 67 / p 1e-16	10.1 EB05 4.3 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Dermatitis atopic	5	2.7 1.1–6.5ROR 2.7 · χ² 4 / p 0.025	2.3 EB05 1.1 · IC025 -0.3 PRR-only: not supported by EBGM or IC	Not in label — unassessed	–	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.

Anhedonia — n=20, PRR 20.4

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 Polyethylene Glycol-3350 and Electrolytes?

In FDA FAERS, the most frequently co-reported reaction terms for Polyethylene Glycol-3350 and Electrolytes are anhedonia, end stage renal disease, circumstance or information capable of leading to medication error, impaired gastric emptying, bone density decreased, impaired quality of life. 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 Polyethylene Glycol-3350 and Electrolytes have an FDA boxed warning?

No. The FDA label retrieved for Polyethylene Glycol-3350 and Electrolytes has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Polyethylene Glycol-3350 and Electrolytes 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 29d821ff-389c-41fb-8a27-89bd3f022b82, effective 20230208; matched on openfda.generic_name.exact:"POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES")
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, 18 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.