Drug · FAERS side-effect profile with label screen
Polyethylene Glycol 400 and Propylene Glycol side effects: what 3,797 FDA adverse event reports show
Drug class
Not stated in label
Who reports
3,797 reports · 24% serious · 93 with death outcome · 77% female
openFDA FAERS counts, all years, deduplication not applied
Used for
for protection against further irritation for temporary relief of burning and irritation due to dryness of the eye
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 37 strongest signals
Reporting / coding artifact 6Lab value / disease marker 1No label text to screen 30
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. 40 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 |
|---|---|---|---|---|---|---|
| Eye discharge | 177 | 97.4 84.2–112.6ROR 102.1 · χ² 16,497 / p <1e-300 | 94.7 EB05 83.6 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=25 · 88% consumer | no trial data cached |
| Eye irritation | 956 | 96.4 91.2–101.9ROR 128.4 · χ² 88,787 / p <1e-300 | 94.5 EB05 89.6 · IC025 +6.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 70.4 · 91% consumer | no trial data cached |
| Eye pruritus | 317 | 53.6 48.2–59.6ROR 58.4 · χ² 16,180 / p <1e-300 | 52.9 EB05 48.2 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 41.4 · 92% consumer | no trial data cached |
| Ocular hyperaemia | 406 | 48.4 44.1–53.1ROR 54.1 · χ² 18,679 / p <1e-300 | 47.9 EB05 44.1 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 47.9 · 88% consumer | no trial data cached |
| Eye pain | 450 | 45.4 41.6–49.5ROR 51.3 · χ² 19,369 / p <1e-300 | 44.9 EB05 41.5 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 30.8 · 88% consumer | no trial data cached |
| Dry eye | 390 | 44.8 40.8–49.2ROR 49.8 · χ² 16,563 / p <1e-300 | 44.4 EB05 40.8 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 45.1 · 88% consumer | no trial data cached |
| Product odour abnormal | 71 | 38.0 30.2–47.9ROR 38.7 · χ² 2,506 / p <1e-300 | 37.4 EB05 30.7 · IC025 +4.5 3/3 methods agree | Reporting / coding artifact | serious n=3 · 94% consumer | no trial data cached |
| Lacrimation increased | 190 | 35.3 30.8–40.6ROR 37.1 · χ² 6,274 / p <1e-300 | 35.0 EB05 31.0 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 28.5 · 92% consumer | no trial data cached |
| Ocular discomfort | 63 | 32.2 25.2–41.2ROR 32.7 · χ² 1,864 / p <1e-300 | 31.8 EB05 25.7 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=13 · 90% consumer | no trial data cached |
| Vision blurred (blurred vision) | 630 | 25.6 23.8–27.5ROR 30.5 · χ² 14,885 / p <1e-300 | 25.5 EB05 23.8 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.4 · 93% consumer | no trial data cached |
| Eye infection | 38 | 18.8 13.7–25.8ROR 19.0 · χ² 620 / p 4e-137 | 18.5 EB05 14.0 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=23 · 89% consumer | no trial data cached |
| Eyelid oedema | 36 | 17.0 12.3–23.6ROR 17.2 · χ² 526 / p 1e-116 | 16.8 EB05 12.6 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.2 · 77% consumer | no trial data cached |
| Eye inflammation | 27 | 15.8 10.9–23.1ROR 16.0 · χ² 360 / p 1e-80 | 15.5 EB05 11.0 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=10 · 78% consumer | no trial data cached |
| Eye swelling | 104 | 15.6 12.9–18.8ROR 16.0 · χ² 1,402 / p <1e-300 | 15.5 EB05 13.1 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 21.0 · 84% consumer | no trial data cached |
| Poor quality product administered | 24 | 13.0 8.7–19.4ROR 13.1 · χ² 253 / p 2e-57 | 12.4 EB05 8.4 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=22 · 96% consumer | no trial data cached |
| Intraocular pressure increased (raised eye pressure) | 30 | 12.9 9.0–18.5ROR 13.0 · χ² 318 / p 2e-71 | 12.5 EB05 8.9 · IC025 +2.8 3/3 methods agree | Lab value / disease marker | serious PRR 27.2 · 73% consumer | no trial data cached |
| Photophobia (light sensitivity) | 42 | 12.4 9.2–16.8ROR 12.6 · χ² 430 / p 7e-96 | 12.1 EB05 9.2 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.3 · 71% consumer | no trial data cached |
| Expired product administered | 71 | 11.8 9.4–14.9ROR 12.0 · χ² 693 / p 4e-153 | 11.6 EB05 9.4 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious n=11 · 97% consumer | no trial data cached |
| Product quality issue | 251 | 10.3 9.1–11.6ROR 11.0 · χ² 2,108 / p <1e-300 | 10.2 EB05 9.2 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious PRR 9.4 · 95% consumer | no trial data cached |
| Product packaging issue | 17 | 10.1 6.3–16.3ROR 10.2 · χ² 131 / p 1e-30 | 8.9 EB05 5.6 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious n=5 | no trial data cached |
| Madarosis | 21 | 9.9 6.5–15.2ROR 10.0 · χ² 159 / p 7e-37 | 8.9 EB05 5.9 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | 76% consumer | no trial data cached |
| Vitreous floaters | 14 | 7.9 4.7–13.4ROR 8.0 · χ² 78 / p 5e-19 | 6.6 EB05 4.1 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=7 | no trial data cached |
| Eye haemorrhage | 18 | 7.4 4.7–11.8ROR 7.5 · χ² 94 / p 2e-22 | 6.4 EB05 4.2 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 17.6 | no trial data cached |
| Glaucoma | 25 | 7.2 4.9–10.6ROR 7.2 · χ² 127 / p 1e-29 | 6.4 EB05 4.6 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 17.6 | no trial data cached |
| Seasonal allergy | 18 | 7.0 4.4–11.2ROR 7.1 · χ² 87 / p 4e-21 | 6.1 EB05 4.0 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=13 | no trial data cached |
| Conjunctivitis | 23 | 6.9 4.6–10.4ROR 7.0 · χ² 111 / p 4e-26 | 6.2 EB05 4.3 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 18.5 · 83% consumer | no trial data cached |
| Visual acuity reduced | 41 | 6.8 5.0–9.2ROR 6.8 · χ² 196 / p 8e-45 | 6.3 EB05 4.9 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.2 | no trial data cached |
| Eye disorder | 38 | 6.4 4.7–8.8ROR 6.5 · χ² 168 / p 9e-39 | 6.0 EB05 4.5 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.9 · 87% consumer | no trial data cached |
| Cyst | 12 | 5.3 3.0–9.4ROR 5.3 · χ² 38 / p 3e-10 | 4.5 EB05 2.8 · IC025 +1.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 16.6 | no trial data cached |
| Cataract | 57 | 5.3 4.1–6.9ROR 5.4 · χ² 196 / p 1e-44 | 5.1 EB05 4.1 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.9 · 84% consumer | no trial data cached |
| Secretion discharge | 11 | 4.9 2.7–8.9ROR 4.9 · χ² 31 / p 2e-8 | 4.2 EB05 2.5 · IC025 +1.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 17.4 | no trial data cached |
| Hypoaesthesia oral | 13 | 4.8 2.8–8.2ROR 4.8 · χ² 35 / p 2e-9 | 4.1 EB05 2.6 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 19.2 | no trial data cached |
| Visual impairment | 104 | 4.7 3.9–5.6ROR 4.8 · χ² 298 / p 5e-67 | 4.6 EB05 3.9 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.7 · 84% consumer | no trial data cached |
| Taste disorder | 14 | 3.9 2.3–6.5ROR 3.9 · χ² 27 / p 1e-7 | 3.5 EB05 2.2 · IC025 +0.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 17.1 | no trial data cached |
| Wrong technique in drug usage process | 23 | 3.4 2.3–5.2ROR 3.5 · χ² 38 / p 4e-10 | 3.3 EB05 2.3 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious PRR 2.4 | no trial data cached |
| Diplopia (double vision) | 16 | 3.4 2.1–5.5ROR 3.4 · χ² 25 / p 3e-7 | 3.1 EB05 2.1 · IC025 +0.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.9 | no trial data cached |
| Inappropriate schedule of drug administration | 28 | 2.1 1.5–3.1ROR 2.2 · χ² 16 / p 3e-5 | 2.1 EB05 1.5 · IC025 +0.4 | Reporting / coding artifact | serious PRR 1.9 · 74% 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 |
|---|---|---|---|---|---|---|
| Eye irritation | 956 | 96.4 91.2–101.9ROR 128.4 · χ² 88,787 / p <1e-300 | 94.5 EB05 89.6 · IC025 +6.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 70.4 · 91% consumer | no trial data cached |
| Vision blurred (blurred vision) | 630 | 25.6 23.8–27.5ROR 30.5 · χ² 14,885 / p <1e-300 | 25.5 EB05 23.8 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.4 · 93% consumer | no trial data cached |
| Eye pain | 450 | 45.4 41.6–49.5ROR 51.3 · χ² 19,369 / p <1e-300 | 44.9 EB05 41.5 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 30.8 · 88% consumer | no trial data cached |
| Ocular hyperaemia | 406 | 48.4 44.1–53.1ROR 54.1 · χ² 18,679 / p <1e-300 | 47.9 EB05 44.1 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 47.9 · 88% consumer | no trial data cached |
| Dry eye | 390 | 44.8 40.8–49.2ROR 49.8 · χ² 16,563 / p <1e-300 | 44.4 EB05 40.8 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 45.1 · 88% consumer | no trial data cached |
| Eye pruritus | 317 | 53.6 48.2–59.6ROR 58.4 · χ² 16,180 / p <1e-300 | 52.9 EB05 48.2 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 41.4 · 92% consumer | no trial data cached |
| Product quality issue | 251 | 10.3 9.1–11.6ROR 11.0 · χ² 2,108 / p <1e-300 | 10.2 EB05 9.2 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious PRR 9.4 · 95% consumer | no trial data cached |
| Lacrimation increased | 190 | 35.3 30.8–40.6ROR 37.1 · χ² 6,274 / p <1e-300 | 35.0 EB05 31.0 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 28.5 · 92% consumer | no trial data cached |
| Eye discharge | 177 | 97.4 84.2–112.6ROR 102.1 · χ² 16,497 / p <1e-300 | 94.7 EB05 83.6 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=25 · 88% consumer | no trial data cached |
| Visual impairment | 104 | 4.7 3.9–5.6ROR 4.8 · χ² 298 / p 5e-67 | 4.6 EB05 3.9 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.7 · 84% consumer | no trial data cached |
| Eye swelling | 104 | 15.6 12.9–18.8ROR 16.0 · χ² 1,402 / p <1e-300 | 15.5 EB05 13.1 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 21.0 · 84% consumer | no trial data cached |
| Expired product administered | 71 | 11.8 9.4–14.9ROR 12.0 · χ² 693 / p 4e-153 | 11.6 EB05 9.4 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious n=11 · 97% consumer | no trial data cached |
| Product odour abnormal | 71 | 38.0 30.2–47.9ROR 38.7 · χ² 2,506 / p <1e-300 | 37.4 EB05 30.7 · IC025 +4.5 3/3 methods agree | Reporting / coding artifact | serious n=3 · 94% consumer | no trial data cached |
| Ocular discomfort | 63 | 32.2 25.2–41.2ROR 32.7 · χ² 1,864 / p <1e-300 | 31.8 EB05 25.7 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=13 · 90% consumer | no trial data cached |
| Cataract | 57 | 5.3 4.1–6.9ROR 5.4 · χ² 196 / p 1e-44 | 5.1 EB05 4.1 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.9 · 84% consumer | 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 400?
In FDA FAERS, the most frequently co-reported reaction terms for Polyethylene Glycol 400 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 400 have an FDA boxed warning?
No. The FDA label retrieved for Polyethylene Glycol 400 has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Polyethylene Glycol 400 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 0018ade9-5856-db6c-e063-6394a90a2ccf, effective 20251230; matched on
openfda.generic_name.exact:"POLYETHYLENE GLYCOL 400") - 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, 77 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.