Drug · FAERS side-effect profile with label screen
Polyethylene Glycol 3350 side effects: what 3,191 FDA adverse event reports show
Brand names
Purelax
openFDA label
Who reports
3,191 reports · 75% serious · 263 with death outcome · 61% 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 4Lab value / disease marker 1No label text to screen 35
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. 121 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 |
|---|---|---|---|---|---|---|
| Product taste abnormal | 142 | 70.1 59.6–82.4ROR 73.3 · χ² 9,509 / p <1e-300 | 68.8 EB05 59.8 · IC025 +5.5 3/3 methods agree | Reporting / coding artifact | serious n=23 · 96% consumer | no trial data cached |
| Ileus | 41 | 22.0 16.2–29.8ROR 22.2 · χ² 797 / p 1e-175 | 21.7 EB05 16.7 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 17.0 · 90% clinician | no trial data cached |
| Retching | 62 | 19.2 15.0–24.6ROR 19.6 · χ² 1,050 / p 1e-230 | 19.1 EB05 15.4 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.7 · ♀ 86% (drug 61%) · 85% consumer | no trial data cached |
| Aspiration | 31 | 18.9 13.3–26.8ROR 19.0 · χ² 505 / p 4e-112 | 18.6 EB05 13.6 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.9 · ♀ 30% (drug 61%) | no trial data cached |
| Paraesthesia oral | 38 | 17.4 12.7–23.9ROR 17.6 · χ² 571 / p 2e-126 | 17.2 EB05 13.0 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 21.4 · ♀ 100% (drug 61%) | no trial data cached |
| Product use complaint | 38 | 16.1 11.8–22.2ROR 16.3 · χ² 524 / p 3e-116 | 15.9 EB05 12.0 · IC025 +3.2 3/3 methods agree | Reporting / coding artifact | serious n=11 · ♀ 83% (drug 61%) · 95% consumer | no trial data cached |
| End stage renal disease | 44 | 15.7 11.7–21.1ROR 15.9 · χ² 591 / p 6e-131 | 15.5 EB05 12.0 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.1 · ♀ 36% (drug 61%) · 95% clinician | no trial data cached |
| Macular degeneration | 28 | 15.5 10.7–22.4ROR 15.6 · χ² 364 / p 2e-81 | 15.1 EB05 10.8 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.8 · ♀ 100% (drug 61%) | no trial data cached |
| Ventricular fibrillation | 26 | 15.4 10.5–22.6ROR 15.5 · χ² 335 / p 5e-75 | 15.0 EB05 10.5 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.8 · ♀ 40% (drug 61%) · 96% clinician | no trial data cached |
| Hyponatraemia (low sodium) | 126 | 14.8 12.4–17.5ROR 15.3 · χ² 1,603 / p <1e-300 | 14.7 EB05 12.6 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.6 · 94% clinician | no trial data cached |
| Electrolyte imbalance | 23 | 13.2 8.8–19.8ROR 13.3 · χ² 246 / p 9e-56 | 12.5 EB05 8.4 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.7 | no trial data cached |
| Circulatory collapse | 34 | 13.1 9.4–18.3ROR 13.2 · χ² 367 / p 4e-82 | 12.7 EB05 9.3 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.1 | no trial data cached |
| Presyncope (near-fainting) | 44 | 12.0 8.9–16.1ROR 12.1 · χ² 431 / p 5e-96 | 11.6 EB05 8.8 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.7 · ♀ 81% (drug 61%) | no trial data cached |
| Cold sweat | 30 | 11.2 7.8–16.0ROR 11.3 · χ² 268 / p 2e-60 | 10.6 EB05 7.5 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.7 | no trial data cached |
| Intestinal perforation | 18 | 10.5 6.6–16.7ROR 10.6 · χ² 146 / p 7e-34 | 9.4 EB05 5.9 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.1 | no trial data cached |
| Vaginal discharge | 16 | 10.5 6.4–17.1ROR 10.5 · χ² 128 / p 6e-30 | 9.2 EB05 5.6 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=16 | no trial data cached |
| Feeling cold | 43 | 10.1 7.5–13.7ROR 10.3 · χ² 345 / p 2e-77 | 9.7 EB05 7.3 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.7 · 74% consumer | no trial data cached |
| Hyperlipidaemia | 18 | 9.9 6.2–15.7ROR 9.9 · χ² 135 / p 2e-31 | 8.7 EB05 5.5 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.4 | no trial data cached |
| Haematemesis (vomiting blood) | 38 | 9.8 7.2–13.5ROR 9.9 · χ² 293 / p 6e-66 | 9.3 EB05 6.9 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.5 · 70% consumer | no trial data cached |
| Gout | 26 | 9.5 6.5–14.0ROR 9.6 · χ² 190 / p 2e-43 | 8.7 EB05 6.1 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.1 · ♀ 0% (drug 61%) | no trial data cached |
| Dehydration | 189 | 9.3 8.1–10.7ROR 9.8 · χ² 1,403 / p <1e-300 | 9.2 EB05 8.1 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.3 | no trial data cached |
| Ulcer | 22 | 9.1 6.0–13.8ROR 9.1 · χ² 150 / p 8e-35 | 8.1 EB05 5.5 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.8 · ♀ 14% (drug 61%) · 100% clinician | no trial data cached |
| Incorrect route of product administration | 23 | 9.0 6.0–13.5ROR 9.1 · χ² 156 / p 5e-36 | 8.1 EB05 5.5 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 13.8 · ♀ 9% (drug 61%) · 100% clinician | no trial data cached |
| Hypercholesterolaemia | 13 | 8.9 5.2–15.4ROR 9.0 · χ² 84 / p 3e-20 | 7.4 EB05 4.4 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.3 | no trial data cached |
| Blood test abnormal | 19 | 8.9 5.7–13.9ROR 9.0 · χ² 125 / p 2e-29 | 7.8 EB05 5.1 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 10.5 | no trial data cached |
| Micturition urgency | 15 | 8.7 5.3–14.4ROR 8.7 · χ² 95 / p 1e-22 | 7.4 EB05 4.6 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.3 | no trial data cached |
| Oral candidiasis (oral thrush) | 17 | 8.6 5.3–13.8ROR 8.6 · χ² 107 / p 3e-25 | 7.4 EB05 4.7 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.3 | no trial data cached |
| Altered state of consciousness | 28 | 8.5 5.9–12.4ROR 8.6 · χ² 179 / p 4e-41 | 7.8 EB05 5.5 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.6 · 96% clinician | no trial data cached |
| Thirst | 23 | 8.5 5.6–12.8ROR 8.5 · χ² 144 / p 1e-33 | 7.6 EB05 5.2 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.4 · ♀ 91% (drug 61%) | no trial data cached |
| Hypokalaemia (low potassium) | 58 | 8.3 6.4–10.7ROR 8.4 · χ² 366 / p 6e-82 | 7.9 EB05 6.3 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.5 · 93% clinician | no trial data cached |
| Frequent bowel movements | 34 | 8.3 5.9–11.6ROR 8.4 · χ² 211 / p 3e-48 | 7.7 EB05 5.7 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.4 · ♀ 91% (drug 61%) | no trial data cached |
| Vomiting | 589 | 8.3 7.7–8.9ROR 9.9 · χ² 3,835 / p <1e-300 | 8.2 EB05 7.7 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.4 | no trial data cached |
| Supraventricular tachycardia | 12 | 8.3 4.7–14.5ROR 8.3 · χ² 69 / p 4e-17 | 6.7 EB05 3.9 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.7 | no trial data cached |
| Full blood count abnormal | 13 | 8.1 4.7–14.0ROR 8.1 · χ² 74 / p 4e-18 | 6.7 EB05 4.0 · IC025 +1.7 3/3 methods agree | Lab value / disease marker | serious PRR 8.3 | no trial data cached |
| Eosinophilia | 20 | 7.5 4.9–11.7ROR 7.6 · χ² 107 / p 3e-25 | 6.6 EB05 4.4 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.1 · ♀ 95% (drug 61%) · 95% clinician | no trial data cached |
| Bacterial infection | 21 | 7.4 4.9–11.4ROR 7.5 · χ² 111 / p 4e-26 | 6.6 EB05 4.5 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.6 · ♀ 15% (drug 61%) · 100% clinician | no trial data cached |
| Abdominal distension (bloating) | 117 | 7.4 6.2–8.8ROR 7.6 · χ² 644 / p 2e-142 | 7.2 EB05 6.2 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.7 | no trial data cached |
| Gastrointestinal pain | 12 | 7.2 4.1–12.7ROR 7.2 · χ² 58 / p 1e-14 | 5.9 EB05 3.5 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.7 | no trial data cached |
| Cardiovascular disorder | 28 | 7.2 5.0–10.4ROR 7.3 · χ² 143 / p 2e-33 | 6.5 EB05 4.7 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.0 | no trial data cached |
| Pneumonia aspiration | 27 | 7.1 4.9–10.4ROR 7.2 · χ² 136 / p 9e-32 | 6.5 EB05 4.6 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.5 | 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 |
|---|---|---|---|---|---|---|
| Vomiting | 589 | 8.3 7.7–8.9ROR 9.9 · χ² 3,835 / p <1e-300 | 8.2 EB05 7.7 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.4 | no trial data cached |
| Nausea | 468 | 3.9 3.6–4.2ROR 4.4 · χ² 1,045 / p 2e-229 | 3.9 EB05 3.6 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.9 | no trial data cached |
| Dehydration | 189 | 9.3 8.1–10.7ROR 9.8 · χ² 1,403 / p <1e-300 | 9.2 EB05 8.1 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.3 | no trial data cached |
| Abdominal pain | 183 | 5.2 4.5–6.0ROR 5.4 · χ² 619 / p 7e-137 | 5.1 EB05 4.5 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.3 | no trial data cached |
| Product taste abnormal | 142 | 70.1 59.6–82.4ROR 73.3 · χ² 9,509 / p <1e-300 | 68.8 EB05 59.8 · IC025 +5.5 3/3 methods agree | Reporting / coding artifact | serious n=23 · 96% consumer | no trial data cached |
| Hyponatraemia (low sodium) | 126 | 14.8 12.4–17.5ROR 15.3 · χ² 1,603 / p <1e-300 | 14.7 EB05 12.6 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.6 · 94% clinician | no trial data cached |
| Abdominal distension (bloating) | 117 | 7.4 6.2–8.8ROR 7.6 · χ² 644 / p 2e-142 | 7.2 EB05 6.2 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.7 | no trial data cached |
| Chills | 110 | 6.2 5.1–7.4ROR 6.3 · χ² 473 / p 4e-105 | 6.0 EB05 5.1 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.9 · 73% consumer | no trial data cached |
| Loss of consciousness | 105 | 5.4 4.5–6.5ROR 5.5 · χ² 373 / p 3e-83 | 5.3 EB05 4.5 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.2 | no trial data cached |
| Abdominal pain upper | 101 | 3.2 2.7–3.9ROR 3.3 · χ² 155 / p 7e-36 | 3.2 EB05 2.7 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.0 | no trial data cached |
| Tremor (shaking) | 88 | 3.5 2.8–4.3ROR 3.6 · χ² 154 / p 1e-35 | 3.4 EB05 2.9 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.6 | no trial data cached |
| Erythema (skin redness) | 80 | 2.6 2.1–3.2ROR 2.6 · χ² 75 / p 2e-18 | 2.5 EB05 2.1 · IC025 +1.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.9 | no trial data cached |
| Urticaria (hives) | 75 | 3.0 2.4–3.7ROR 3.0 · χ² 96 / p 5e-23 | 2.9 EB05 2.4 · IC025 +1.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.6 | no trial data cached |
| Chronic kidney disease | 72 | 6.2 4.9–7.8ROR 6.3 · χ² 308 / p 3e-69 | 6.0 EB05 4.9 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.8 | no trial data cached |
| General physical health deterioration | 70 | 4.0 3.2–5.1ROR 4.1 · χ² 156 / p 5e-36 | 3.9 EB05 3.2 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 3.6 | 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.
✓ A hand-written Bradford Hill causality assessment exists for this drug: Zoledronic acid (bisphosphonates) ↔ Osteonecrosis of the jaw.
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 vomiting, nausea, dehydration, abdominal pain, hyponatraemia, abdominal distension. 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 006a9eca-400f-47f5-bee5-facf7034043e, effective 20260902; 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, 161 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.