Drug · FAERS side-effect profile with label screen

Polyethylene Glycol and Propylene Glycol side effects: what 725 FDA adverse event reports show

Polyethylene Glycol And Propylene Glycol · 19 reaction terms · 532 drug–reaction co-reports · data 2026-09-14

Drug class

Osmotic Laxative

FDA label (Established Pharmacologic Class) of the closest related product

Label matched

Polyethylene Glycol (Polyethylene Glycol)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

725 reports · 40% serious · 35 with death outcome · 82% 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 18 strongest signals

Reporting / coding artifact 2Lab value / disease marker 1No label text to screen 15

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. 1 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
Eye discharge	23	65.3 43.6–97.6ROR 67.4 · χ² 1,389 / p <1e-300	61.9 EB05 43.5 · IC025 +4.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=6	no trial data cached
Eye irritation	121	62.9 53.5–74.0ROR 75.3 · χ² 7,313 / p <1e-300	62.2 EB05 53.4 · IC025 +5.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 40.8	no trial data cached
Eye pruritus	35	30.7 22.2–42.5ROR 32.2 · χ² 978 / p 6e-215	30.3 EB05 22.7 · IC025 +3.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 28.0	no trial data cached
Lacrimation increased	31	30.0 21.3–42.4ROR 31.3 · χ² 842 / p 2e-185	29.5 EB05 21.8 · IC025 +3.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 25.3 · 71% consumer	no trial data cached
Ocular hyperaemia	46	28.5 21.5–37.7ROR 30.4 · χ² 1,195 / p 4e-262	28.2 EB05 22.0 · IC025 +4.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 18.3	no trial data cached
Eyelid oedema	11	27.2 15.1–48.9ROR 27.6 · χ² 252 / p 5e-57	26.0 EB05 15.3 · IC025 +2.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 5.2	no trial data cached
Eye pain	49	25.7 19.6–33.7ROR 27.5 · χ² 1,140 / p 4e-250	25.4 EB05 20.0 · IC025 +3.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 13.9	no trial data cached
Photophobia (light sensitivity)	16	24.8 15.3–40.3ROR 25.3 · χ² 342 / p 1e-76	24.1 EB05 15.7 · IC025 +3.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 3.6	no trial data cached
Dry eye	39	23.3 17.2–31.6ROR 24.6 · χ² 811 / p 9e-179	23.1 EB05 17.6 · IC025 +3.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 32.7	no trial data cached
Madarosis	8	19.8 9.9–39.4ROR 20.0 · χ² 124 / p 3e-29	17.9 EB05 8.2 · IC025 +2.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial data cached
Visual acuity reduced	19	16.4 10.5–25.6ROR 16.8 · χ² 260 / p 8e-59	15.9 EB05 10.4 · IC025 +2.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 23.4	no trial data cached
Intraocular pressure increased (raised eye pressure)	7	15.8 7.5–33.0ROR 15.9 · χ² 83 / p 5e-20	13.0 EB05 5.3 · IC025 +1.7 3/3 methods agree	Lab value / disease marker	serious PRR 9.6	no trial data cached
Eye inflammation	5	15.3 6.4–36.7ROR 15.4 · χ² 53 / p 1e-13	10.9 EB05 3.8 · IC025 +1.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=1	no trial data cached
Eye haemorrhage	7	15.1 7.2–31.7ROR 15.3 · χ² 79 / p 3e-19	12.3 EB05 5.1 · IC025 +1.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 20.9	no trial data cached
Wrong technique in drug usage process	19	14.9 9.6–23.3ROR 15.3 · χ² 233 / p 6e-53	14.3 EB05 9.2 · IC025 +2.7 3/3 methods agree	Reporting / coding artifact	serious PRR 7.5	no trial data cached
Vitreous floaters	5	14.9 6.2–35.6ROR 15.0 · χ² 51 / p 4e-13	10.4 EB05 3.6 · IC025 +1.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=4	no trial data cached
Vision blurred (blurred vision)	70	14.8 11.9–18.5ROR 16.3 · χ² 894 / p 9e-197	14.7 EB05 12.0 · IC025 +3.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 10.5 · 73% consumer	no trial data cached
Inappropriate schedule of drug administration	18	7.2 4.6–11.4ROR 7.4 · χ² 91 / p 9e-22	6.3 EB05 4.1 · IC025 +1.8 3/3 methods agree	Reporting / coding artifact	serious PRR 6.0	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
Eye irritation	121	62.9 53.5–74.0ROR 75.3 · χ² 7,313 / p <1e-300	62.2 EB05 53.4 · IC025 +5.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 40.8	no trial data cached
Vision blurred (blurred vision)	70	14.8 11.9–18.5ROR 16.3 · χ² 894 / p 9e-197	14.7 EB05 12.0 · IC025 +3.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 10.5 · 73% consumer	no trial data cached
Eye pain	49	25.7 19.6–33.7ROR 27.5 · χ² 1,140 / p 4e-250	25.4 EB05 20.0 · IC025 +3.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 13.9	no trial data cached
Ocular hyperaemia	46	28.5 21.5–37.7ROR 30.4 · χ² 1,195 / p 4e-262	28.2 EB05 22.0 · IC025 +4.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 18.3	no trial data cached
Dry eye	39	23.3 17.2–31.6ROR 24.6 · χ² 811 / p 9e-179	23.1 EB05 17.6 · IC025 +3.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 32.7	no trial data cached
Eye pruritus	35	30.7 22.2–42.5ROR 32.2 · χ² 978 / p 6e-215	30.3 EB05 22.7 · IC025 +3.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 28.0	no trial data cached
Lacrimation increased	31	30.0 21.3–42.4ROR 31.3 · χ² 842 / p 2e-185	29.5 EB05 21.8 · IC025 +3.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 25.3 · 71% consumer	no trial data cached
Eye discharge	23	65.3 43.6–97.6ROR 67.4 · χ² 1,389 / p <1e-300	61.9 EB05 43.5 · IC025 +4.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=6	no trial data cached
Wrong technique in drug usage process	19	14.9 9.6–23.3ROR 15.3 · χ² 233 / p 6e-53	14.3 EB05 9.2 · IC025 +2.7 3/3 methods agree	Reporting / coding artifact	serious PRR 7.5	no trial data cached
Visual acuity reduced	19	16.4 10.5–25.6ROR 16.8 · χ² 260 / p 8e-59	15.9 EB05 10.4 · IC025 +2.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 23.4	no trial data cached
Inappropriate schedule of drug administration	18	7.2 4.6–11.4ROR 7.4 · χ² 91 / p 9e-22	6.3 EB05 4.1 · IC025 +1.8 3/3 methods agree	Reporting / coding artifact	serious PRR 6.0	no trial data cached
Photophobia (light sensitivity)	16	24.8 15.3–40.3ROR 25.3 · χ² 342 / p 1e-76	24.1 EB05 15.7 · IC025 +3.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 3.6	no trial data cached
Eyelid oedema	11	27.2 15.1–48.9ROR 27.6 · χ² 252 / p 5e-57	26.0 EB05 15.3 · IC025 +2.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 5.2	no trial data cached
Madarosis	8	19.8 9.9–39.4ROR 20.0 · χ² 124 / p 3e-29	17.9 EB05 8.2 · IC025 +2.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial data cached
Eye haemorrhage	7	15.1 7.2–31.7ROR 15.3 · χ² 79 / p 3e-19	12.3 EB05 5.1 · IC025 +1.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 20.9	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 and Propylene Glycol?

In FDA FAERS, the most frequently co-reported reaction terms for Polyethylene Glycol and Propylene Glycol are eye irritation, vision blurred, eye pain, ocular hyperaemia, dry eye, eye pruritus. 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 and Propylene Glycol have an FDA boxed warning?

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

Do FAERS signals prove that Polyethylene Glycol and Propylene Glycol 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 c4cae70c-68da-0bbc-e053-2a95a90a395a, effective 20210920; matched on openfda.generic_name.exact:"POLYETHYLENE GLYCOL")
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, 19 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.