Drug · FAERS side-effect profile with label screen
Polyethylene Glycol (3350) side effects: what 12,332 FDA adverse event reports show
Drug class
Not stated in label
Who reports
12,332 reports · 54% serious · 1,195 with death outcome · 55% female
openFDA FAERS counts, all years, deduplication not applied
Used for
• relieves occasional constipation (irregularity) • generally produces a bowel movement in 1 to 3 days
FDA label, Indications and Usage
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
Reporting / coding artifact 8Lab value / disease marker 1No label text to screen 31
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. 695 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 |
|---|---|---|---|---|---|---|
| Incorrect product administration duration | 1,267 | 113.2 107.3–119.5ROR 126.1 · χ² 132,046 / p <1e-300 | 106.0 EB05 101.2 · IC025 +6.6 3/3 methods agree | Reporting / coding artifact | serious n=30 · 99% consumer | no trial data cached |
| Appendicitis | 210 | 39.3 34.3–45.0ROR 39.9 · χ² 7,620 / p <1e-300 | 38.3 EB05 34.1 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 41.3 · ♀ 8% (drug 55%) · 97% clinician | no trial data cached |
| Incorrect drug administration duration | 625 | 38.1 35.2–41.1ROR 40.0 · χ² 22,049 / p <1e-300 | 37.2 EB05 34.8 · IC025 +5.0 3/3 methods agree | Reporting / coding artifact | serious PRR 1.8 · 100% consumer | no trial data cached |
| Ventricular fibrillation | 202 | 31.4 27.3–36.0ROR 31.9 · χ² 5,807 / p <1e-300 | 30.7 EB05 27.4 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 32.8 · ♀ 4% (drug 55%) · 97% clinician | no trial data cached |
| Cardiogenic shock | 212 | 25.6 22.4–29.3ROR 26.1 · χ² 4,920 / p <1e-300 | 25.2 EB05 22.5 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 26.8 · ♀ 11% (drug 55%) · 97% clinician | no trial data cached |
| Macular degeneration | 162 | 23.4 20.1–27.3ROR 23.7 · χ² 3,408 / p <1e-300 | 23.1 EB05 20.2 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 26.5 · ♀ 100% (drug 55%) | no trial data cached |
| Bacterial infection | 162 | 15.0 12.8–17.4ROR 15.1 · χ² 2,078 / p <1e-300 | 14.8 EB05 13.0 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 18.2 · ♀ 12% (drug 55%) · 96% clinician | no trial data cached |
| Incorrect route of product administration | 146 | 14.9 12.7–17.5ROR 15.1 · χ² 1,863 / p <1e-300 | 14.7 EB05 12.8 · IC025 +3.5 3/3 methods agree | Reporting / coding artifact | serious PRR 30.0 · ♀ 9% (drug 55%) · 94% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 229 | 14.1 12.4–16.0ROR 14.3 · χ² 2,745 / p <1e-300 | 13.9 EB05 12.5 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.8 · ♀ 5% (drug 55%) · 97% clinician | no trial data cached |
| Underdose | 596 | 14.0 12.9–15.1ROR 14.6 · χ² 7,131 / p <1e-300 | 13.9 EB05 12.9 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious PRR 1.6 · 98% consumer | no trial data cached |
| Frequent bowel movements | 217 | 13.8 12.1–15.8ROR 14.0 · χ² 2,549 / p <1e-300 | 13.7 EB05 12.2 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.2 | no trial data cached |
| Ascites | 230 | 13.4 11.8–15.2ROR 13.6 · χ² 2,607 / p <1e-300 | 13.3 EB05 11.9 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.2 · ♀ 11% (drug 55%) · 96% clinician | no trial data cached |
| Hyperlipidaemia | 91 | 13.0 10.6–16.0ROR 13.1 · χ² 989 / p 3e-217 | 12.8 EB05 10.7 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 15.1 · ♀ 21% (drug 55%) · 93% clinician | no trial data cached |
| Drug effect less than expected | 106 | 12.9 10.6–15.6ROR 13.0 · χ² 1,141 / p 2e-250 | 12.7 EB05 10.7 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | serious n=8 · 95% consumer | no trial data cached |
| Vaginal discharge | 74 | 12.6 10.0–15.8ROR 12.7 · χ² 774 / p 1e-170 | 12.4 EB05 10.1 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=73 · ♀ 100% (drug 55%) | no trial data cached |
| Neuralgia | 177 | 12.5 10.8–14.5ROR 12.7 · χ² 1,848 / p <1e-300 | 12.3 EB05 10.9 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 19.3 · ♀ 9% (drug 55%) · 91% clinician | no trial data cached |
| Paraesthesia oral | 104 | 12.4 10.2–15.0ROR 12.5 · χ² 1,070 / p 6e-235 | 12.2 EB05 10.3 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 22.2 · ♀ 100% (drug 55%) | no trial data cached |
| Micturition urgency | 79 | 11.9 9.6–14.9ROR 12.0 · χ² 774 / p 1e-170 | 11.7 EB05 9.6 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 20.5 · ♀ 16% (drug 55%) | no trial data cached |
| Hepatic cytolysis | 77 | 10.8 8.6–13.5ROR 10.8 · χ² 669 / p 8e-148 | 10.5 EB05 8.6 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.4 · 97% clinician | no trial data cached |
| Expired product administered | 207 | 10.7 9.3–12.2ROR 10.8 · χ² 1,795 / p <1e-300 | 10.5 EB05 9.4 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | 98% consumer | no trial data cached |
| Oral candidiasis (oral thrush) | 80 | 10.5 8.4–13.1ROR 10.6 · χ² 675 / p 4e-149 | 10.2 EB05 8.4 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 15.5 · ♀ 90% (drug 55%) | no trial data cached |
| Hyponatraemia (low sodium) | 342 | 10.4 9.4–11.6ROR 10.7 · χ² 2,887 / p <1e-300 | 10.3 EB05 9.4 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.2 · ♀ 25% (drug 55%) · 94% clinician | no trial data cached |
| Ulcer | 84 | 9.0 7.3–11.1ROR 9.1 · χ² 587 / p 6e-130 | 8.7 EB05 7.2 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.0 · ♀ 8% (drug 55%) · 94% clinician | no trial data cached |
| Aspiration | 57 | 9.0 6.9–11.7ROR 9.0 · χ² 395 / p 4e-88 | 8.6 EB05 6.8 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.7 · ♀ 10% (drug 55%) · 91% clinician | no trial data cached |
| Gout | 91 | 8.6 7.0–10.6ROR 8.7 · χ² 605 / p 6e-134 | 8.4 EB05 7.0 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.7 · ♀ 21% (drug 55%) · 97% clinician | no trial data cached |
| End stage renal disease | 92 | 8.5 7.0–10.5ROR 8.6 · χ² 601 / p 4e-133 | 8.3 EB05 6.9 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.0 · ♀ 18% (drug 55%) · 95% clinician | no trial data cached |
| Abdominal distension (bloating) | 519 | 8.5 7.8–9.3ROR 8.9 · χ² 3,439 / p <1e-300 | 8.4 EB05 7.8 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.2 | no trial data cached |
| Blood test abnormal | 69 | 8.4 6.6–10.6ROR 8.4 · χ² 440 / p 6e-98 | 8.0 EB05 6.5 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 13.2 · ♀ 27% (drug 55%) · 93% clinician | no trial data cached |
| Flatulence (gas) | 272 | 8.2 7.3–9.2ROR 8.4 · χ² 1,710 / p <1e-300 | 8.1 EB05 7.3 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.0 · 89% consumer | no trial data cached |
| Swollen tongue | 141 | 7.7 6.5–9.1ROR 7.8 · χ² 812 / p 5e-179 | 7.5 EB05 6.5 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.8 · ♀ 87% (drug 55%) · 91% clinician | no trial data cached |
| Full blood count abnormal | 46 | 7.4 5.6–9.9ROR 7.5 · χ² 249 / p 2e-56 | 7.0 EB05 5.4 · IC025 +2.3 3/3 methods agree | Lab value / disease marker | serious PRR 10.2 · ♀ 18% (drug 55%) · 91% clinician | no trial data cached |
| Therapeutic product effect decreased | 187 | 7.2 6.2–8.3ROR 7.3 · χ² 988 / p 4e-217 | 7.1 EB05 6.2 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 0.7 · 97% consumer | no trial data cached |
| Stress | 287 | 6.8 6.1–7.6ROR 6.9 · χ² 1,415 / p <1e-300 | 6.7 EB05 6.1 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.8 · ♀ 17% (drug 55%) · 91% clinician | no trial data cached |
| Hypercholesterolaemia | 37 | 6.6 4.8–9.1ROR 6.6 · χ² 169 / p 5e-39 | 6.1 EB05 4.6 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.4 · ♀ 13% (drug 55%) · 95% clinician | no trial data cached |
| Febrile neutropenia | 250 | 6.4 5.7–7.3ROR 6.6 · χ² 1,142 / p 1e-250 | 6.3 EB05 5.7 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.8 · 95% clinician | no trial data cached |
| Procedural pain | 104 | 6.4 5.3–7.8ROR 6.5 · χ² 469 / p 3e-104 | 6.2 EB05 5.3 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.7 · ♀ 100% (drug 55%) | no trial data cached |
| Chronic obstructive pulmonary disease | 191 | 6.2 5.4–7.2ROR 6.3 · χ² 835 / p 5e-184 | 6.1 EB05 5.4 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.7 · ♀ 25% (drug 55%) · 91% clinician | no trial data cached |
| Ischaemic stroke | 65 | 6.2 4.9–7.9ROR 6.2 · χ² 278 / p 1e-62 | 5.9 EB05 4.8 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.6 · ♀ 29% (drug 55%) | no trial data cached |
| Iron deficiency anaemia | 33 | 6.1 4.4–8.6ROR 6.1 · χ² 136 / p 1e-31 | 5.7 EB05 4.2 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.7 · ♀ 77% (drug 55%) | no trial data cached |
| Sputum discoloured | 33 | 6.0 4.2–8.4ROR 6.0 · χ² 131 / p 1e-30 | 5.5 EB05 4.1 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.0 | 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 |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 1,773 | 2.3 2.2–2.4ROR 2.5 · χ² 1,373 / p <1e-300 | 2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 2.1 · 73% consumer | no trial data cached |
| Off label use (used outside approved label) | 1,307 | 2.6 2.4–2.7ROR 2.7 · χ² 1,296 / p 5e-284 | 2.6 EB05 2.4 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 3.9 | no trial data cached |
| Incorrect product administration duration | 1,267 | 113.2 107.3–119.5ROR 126.1 · χ² 132,046 / p <1e-300 | 106.0 EB05 101.2 · IC025 +6.6 3/3 methods agree | Reporting / coding artifact | serious n=30 · 99% consumer | no trial data cached |
| Nausea | 950 | 2.0 1.9–2.2ROR 2.1 · χ² 528 / p 4e-117 | 2.0 EB05 1.9 · IC025 +0.9 | No label text to screen label has no adverse-reaction text | serious PRR 3.1 | no trial data cached |
| Diarrhoea (diarrhea) | 891 | 2.4 2.2–2.5ROR 2.5 · χ² 716 / p 6e-158 | 2.4 EB05 2.2 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 1.8 | no trial data cached |
| Constipation | 721 | 5.7 5.3–6.1ROR 6.0 · χ² 2,795 / p <1e-300 | 5.6 EB05 5.3 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.9 | no trial data cached |
| Vomiting | 641 | 2.3 2.2–2.5ROR 2.4 · χ² 494 / p 1e-109 | 2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.0 | no trial data cached |
| Incorrect drug administration duration | 625 | 38.1 35.2–41.1ROR 40.0 · χ² 22,049 / p <1e-300 | 37.2 EB05 34.8 · IC025 +5.0 3/3 methods agree | Reporting / coding artifact | serious PRR 1.8 · 100% consumer | no trial data cached |
| Abdominal pain | 609 | 4.5 4.1–4.8ROR 4.6 · χ² 1,646 / p <1e-300 | 4.4 EB05 4.2 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.2 | no trial data cached |
| Underdose | 596 | 14.0 12.9–15.1ROR 14.6 · χ² 7,131 / p <1e-300 | 13.9 EB05 12.9 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious PRR 1.6 · 98% consumer | no trial data cached |
| Fatigue (tiredness) | 567 | 1.2 1.1–1.3ROR 1.3 · χ² 27 / p 9e-8 | 1.2 EB05 1.2 · IC025 +0.2 | No label text to screen label has no adverse-reaction text | serious PRR 2.1 | no trial data cached |
| Headache | 532 | 1.4 1.3–1.6ROR 1.5 · χ² 75 / p 3e-18 | 1.4 EB05 1.3 · IC025 +0.4 | No label text to screen label has no adverse-reaction text | serious PRR 2.7 · ♀ 75% (drug 55%) | no trial data cached |
| Abdominal distension (bloating) | 519 | 8.5 7.8–9.3ROR 8.9 · χ² 3,439 / p <1e-300 | 8.4 EB05 7.8 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.2 | no trial data cached |
| Inappropriate schedule of product administration | 454 | 4.4 4.0–4.8ROR 4.5 · χ² 1,185 / p 5e-260 | 4.3 EB05 4.0 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 4.1 · 70% consumer | no trial data cached |
| Condition aggravated | 453 | 2.6 2.3–2.8ROR 2.6 · χ² 432 / p 3e-96 | 2.5 EB05 2.4 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 3.7 · ♀ 33% (drug 55%) | 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 Polyethylene Glycol (3350)?
In FDA FAERS, the most frequently co-reported reaction terms for Polyethylene Glycol (3350) are nausea, diarrhoea, constipation, vomiting, abdominal pain, fatigue. 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) have an FDA boxed warning?
No. The FDA label retrieved for Polyethylene Glycol (3350) has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Polyethylene Glycol (3350) 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 219bcbc4-b84a-4209-9f34-ef2b0ef0d273, effective 20260408; matched on
openfda.generic_name.exact:"POLYETHYLENE GLYCOL (3350)") - 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, 735 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.