Drug · FAERS side-effect profile with label screen
Polyethylene Glycol 400 side effects: what 12,605 FDA adverse event reports show
Drug class
Not stated in label
Who reports
12,605 reports · 54% serious · 1,202 with death outcome · 55% 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 40 strongest signals
Reporting / coding artifact 10Lab value / disease marker 4No label text to screen 26
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. 1,047 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 |
|---|---|---|---|---|---|---|
| Antacid therapy | 71 | 2,426.0 1,682.7–3,497.6ROR 2,439.7 · χ² 68,445 / p <1e-300 | 773.5 EB05 633.9 · IC025 +6.6 3/3 methods agree | Reporting / coding artifact | serious n=71 · ♀ 21% (drug 55%) · 100% clinician | no trial arm names this drug |
| Sleep disorder therapy | 109 | 2,383.6 1,777.3–3,196.8ROR 2,404.4 · χ² 104,845 / p <1e-300 | 829.5 EB05 706.8 · IC025 +7.2 3/3 methods agree | Reporting / coding artifact | serious n=109 · ♀ 6% (drug 55%) · 100% clinician | no trial arm names this drug |
| Appendicolith | 204 | 1,956.6 1,598.0–2,395.7ROR 1,988.8 · χ² 180,938 / p <1e-300 | 823.3 EB05 732.7 · IC025 +7.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=204 · ♀ 7% (drug 55%) · 97% clinician | no trial arm names this drug |
| Analgesic therapy | 110 | 934.8 740.1–1,180.6ROR 943.0 · χ² 64,763 / p <1e-300 | 539.5 EB05 460.1 · IC025 +7.0 3/3 methods agree | Reporting / coding artifact | serious n=110 · ♀ 13% (drug 55%) · 96% clinician | no trial arm names this drug |
| Drug therapy | 102 | 781.7 617.9–989.0ROR 788.1 · χ² 53,334 / p <1e-300 | 481.6 EB05 408.2 · IC025 +6.9 3/3 methods agree | Reporting / coding artifact | serious n=102 · ♀ 14% (drug 55%) · 96% clinician | no trial arm names this drug |
| Anticoagulant therapy | 71 | 573.6 438.0–751.2ROR 576.9 · χ² 29,647 / p <1e-300 | 381.4 EB05 312.6 · IC025 +6.4 3/3 methods agree | Reporting / coding artifact | serious n=71 · ♀ 21% (drug 55%) · 97% clinician | no trial arm names this drug |
| Exposure to unspecified agent | 46 | 506.3 364.0–704.4ROR 508.2 · χ² 17,343 / p <1e-300 | 333.4 EB05 260.1 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | 100% consumer | no trial arm names this drug |
| Congenital hiatus hernia | 50 | 485.2 354.1–664.9ROR 487.2 · χ² 18,274 / p <1e-300 | 327.7 EB05 258.3 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=50 · ♀ 0% (drug 55%) · 100% clinician | no trial arm names this drug |
| Vaginal flatulence | 68 | 476.6 364.0–624.0ROR 479.2 · χ² 24,640 / p <1e-300 | 334.7 EB05 273.1 · IC025 +6.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=68 · ♀ 100% (drug 55%) | no trial arm names this drug |
| Malignant melanoma stage 0 | 37 | 427.4 297.7–613.4ROR 428.6 · χ² 12,149 / p <1e-300 | 288.6 EB05 218.7 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=37 · ♀ 0% (drug 55%) · 100% clinician | no trial arm names this drug |
| Foreign body ingestion | 15 | 273.4 158.3–472.1ROR 273.7 · χ² 3,259 / p <1e-300 | 180.9 EB05 116.3 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial arm names this drug |
| Bacteroides infection | 28 | 201.4 136.1–298.1ROR 201.9 · χ² 4,796 / p <1e-300 | 160.1 EB05 116.2 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=28 · ♀ 0% (drug 55%) · 100% clinician | no trial arm names this drug |
| Victim of child abuse | 24 | 178.9 117.4–272.6ROR 179.3 · χ² 3,670 / p <1e-300 | 143.3 EB05 101.3 · IC025 +4.6 3/3 methods agree | Reporting / coding artifact | serious n=24 · ♀ 0% (drug 55%) | no trial arm names this drug |
| Cerebral hypoperfusion | 43 | 172.0 125.7–235.4ROR 172.6 · χ² 6,463 / p <1e-300 | 145.8 EB05 112.8 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=43 · ♀ 0% (drug 55%) | no trial arm names this drug |
| Binocular eye movement disorder | 26 | 169.9 113.5–254.3ROR 170.2 · χ² 3,804 / p <1e-300 | 138.6 EB05 99.4 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=26 · ♀ 0% (drug 55%) | no trial arm names this drug |
| Child abuse | 20 | 144.5 91.5–228.2ROR 144.7 · χ² 2,489 / p <1e-300 | 118.2 EB05 80.8 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious n=20 · 90% clinician | no trial arm names this drug |
| Neutropenia neonatal | 17 | 135.3 82.6–221.9ROR 135.5 · χ² 1,972 / p <1e-300 | 110.0 EB05 72.7 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=17 | no trial arm names this drug |
| Cerebellar stroke | 26 | 124.0 83.2–184.6ROR 124.2 · χ² 2,835 / p <1e-300 | 106.5 EB05 76.4 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=26 · ♀ 0% (drug 55%) | no trial arm names this drug |
| Hyperphosphataemia | 146 | 123.0 104.1–145.5ROR 124.5 · χ² 16,329 / p <1e-300 | 112.9 EB05 98.3 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=146 · ♀ 11% (drug 55%) · 95% clinician | no trial arm names this drug |
| Epidural lipomatosis | 23 | 117.5 77.0–179.3ROR 117.7 · χ² 2,372 / p <1e-300 | 100.8 EB05 70.7 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=23 · ♀ 0% (drug 55%) · 91% clinician | no trial arm names this drug |
| Incorrect product administration duration | 1,267 | 110.8 104.9–116.9ROR 123.0 · χ² 129,124 / p <1e-300 | 103.7 EB05 99.0 · IC025 +6.5 3/3 methods agree | Reporting / coding artifact | serious n=30 · 99% consumer | no trial arm names this drug |
| Blood phosphorus increased | 170 | 110.6 94.8–129.1ROR 112.1 · χ² 17,203 / p <1e-300 | 102.5 EB05 90.2 · IC025 +6.1 3/3 methods agree | Lab value / disease marker | serious n=170 · ♀ 10% (drug 55%) · 96% clinician | no trial arm names this drug |
| Bronchopulmonary aspergillosis allergic | 48 | 91.9 68.7–122.8ROR 92.2 · χ² 4,000 / p <1e-300 | 84.2 EB05 66.1 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=48 · ♀ 0% (drug 55%) · 96% clinician | no trial arm names this drug |
| Cerebral artery thrombosis | 26 | 88.1 59.4–130.7ROR 88.3 · χ² 2,043 / p <1e-300 | 79.0 EB05 56.6 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=26 · ♀ 0% (drug 55%) | no trial arm names this drug |
| Brain scan abnormal | 26 | 80.9 54.6–119.9ROR 81.1 · χ² 1,880 / p <1e-300 | 73.2 EB05 52.5 · IC025 +4.3 3/3 methods agree | Reporting / coding artifact | serious n=26 · ♀ 0% (drug 55%) | no trial arm names this drug |
| Female genital tract fistula | 70 | 70.5 55.5–89.5ROR 70.9 · χ² 4,531 / p <1e-300 | 66.4 EB05 54.4 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=70 · ♀ 100% (drug 55%) | no trial arm names this drug |
| Chronic sinusitis | 116 | 53.1 44.2–63.8ROR 53.6 · χ² 5,696 / p <1e-300 | 51.1 EB05 43.7 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=115 · ♀ 90% (drug 55%) | no trial arm names this drug |
| Proctitis | 76 | 46.3 36.9–58.1ROR 46.6 · χ² 3,233 / p <1e-300 | 44.6 EB05 36.8 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=76 · ♀ 100% (drug 55%) | no trial arm names this drug |
| Radiculopathy | 69 | 44.7 35.2–56.7ROR 44.9 · χ² 2,825 / p <1e-300 | 43.0 EB05 35.2 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=69 · ♀ 100% (drug 55%) | no trial arm names this drug |
| Total lung capacity decreased | 41 | 43.7 32.0–59.5ROR 43.8 · χ² 1,624 / p <1e-300 | 41.8 EB05 32.1 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=41 · ♀ 17% (drug 55%) · 100% clinician | no trial arm names this drug |
| Foetal disorder | 21 | 42.4 27.5–65.3ROR 42.4 · χ² 787 / p 2e-173 | 39.9 EB05 27.6 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=21 · 100% clinician | no trial arm names this drug |
| Catarrh | 22 | 42.2 27.6–64.3ROR 42.2 · χ² 822 / p 4e-181 | 39.8 EB05 27.7 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=22 · 100% clinician | no trial arm names this drug |
| Iron deficiency | 109 | 41.8 34.6–50.5ROR 42.1 · χ² 4,191 / p <1e-300 | 40.5 EB05 34.5 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=109 · ♀ 7% (drug 55%) · 96% clinician | no trial arm names this drug |
| Blood uric acid increased | 135 | 39.8 33.6–47.2ROR 40.3 · χ² 4,954 / p <1e-300 | 38.7 EB05 33.5 · IC025 +4.8 3/3 methods agree | Lab value / disease marker | serious n=135 · ♀ 11% (drug 55%) · 98% clinician | no trial arm names this drug |
| Appendicitis | 210 | 38.4 33.5–44.0ROR 39.1 · χ² 7,446 / p <1e-300 | 37.4 EB05 33.4 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 40.7 · ♀ 8% (drug 55%) · 97% clinician | no trial arm names this drug |
| Gingival abscess | 17 | 38.1 23.6–61.6ROR 38.1 · χ² 564 / p 5e-125 | 35.9 EB05 23.7 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=16 | no trial arm names this drug |
| Steroid dependence | 19 | 38.0 24.1–59.9ROR 38.1 · χ² 633 / p 5e-140 | 35.9 EB05 24.3 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=19 | no trial arm names this drug |
| Incorrect drug administration duration | 625 | 37.2 34.5–40.2ROR 39.1 · χ² 21,544 / p <1e-300 | 36.4 EB05 34.1 · IC025 +5.0 3/3 methods agree | Reporting / coding artifact | serious PRR 1.8 · 100% consumer | no trial arm names this drug |
| Faecal volume decreased | 10 | 35.1 18.8–65.7ROR 35.1 · χ² 292 / p 9e-66 | 32.4 EB05 18.8 · IC025 +2.7 3/3 methods agree | Lab value / disease marker | – | no trial arm names this drug |
| Activated partial thromboplastin time prolonged | 100 | 33.4 27.4–40.6ROR 33.6 · χ² 3,046 / p <1e-300 | 32.5 EB05 27.5 · IC025 +4.5 3/3 methods agree | Lab value / disease marker | serious n=100 · ♀ 14% (drug 55%) · 97% clinician | no trial arm names this drug |
Trial evidence (ClinicalTrials.gov)
ClinicalTrials.gov returned results-bearing trials mentioning Polyethylene Glycol 400 only as a background or rescue medication (NCT01190930, NCT02883049); no trial listing it as the tested intervention was cached, so no trial cross-check is shown.
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) | 1,801 | 2.3 2.2–2.4ROR 2.5 · χ² 1,372 / 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 arm names this drug |
| Off label use (used outside approved label) | 1,312 | 2.5 2.4–2.6ROR 2.7 · χ² 1,247 / p 2e-273 | 2.5 EB05 2.4 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 3.8 | no trial arm names this drug |
| Incorrect product administration duration | 1,267 | 110.8 104.9–116.9ROR 123.0 · χ² 129,124 / p <1e-300 | 103.7 EB05 99.0 · IC025 +6.5 3/3 methods agree | Reporting / coding artifact | serious n=30 · 99% consumer | no trial arm names this drug |
| Nausea | 959 | 2.0 1.9–2.1ROR 2.1 · χ² 514 / p 5e-114 | 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 arm names this drug |
| Diarrhoea (diarrhea) | 900 | 2.3 2.2–2.5ROR 2.4 · χ² 702 / p 6e-155 | 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 1.8 | no trial arm names this drug |
| Constipation | 729 | 5.6 5.2–6.0ROR 5.9 · χ² 2,782 / 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 9.8 | no trial arm names this drug |
| Vomiting | 644 | 2.3 2.1–2.5ROR 2.4 · χ² 475 / p 2e-105 | 2.3 EB05 2.1 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.0 | no trial arm names this drug |
| Incorrect drug administration duration | 625 | 37.2 34.5–40.2ROR 39.1 · χ² 21,544 / p <1e-300 | 36.4 EB05 34.1 · IC025 +5.0 3/3 methods agree | Reporting / coding artifact | serious PRR 1.8 · 100% consumer | no trial arm names this drug |
| Abdominal pain | 612 | 4.4 4.1–4.7ROR 4.6 · χ² 1,610 / p <1e-300 | 4.4 EB05 4.1 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.1 | no trial arm names this drug |
| Underdose | 596 | 13.7 12.6–14.8ROR 14.3 · χ² 6,952 / p <1e-300 | 13.6 EB05 12.7 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious PRR 1.6 · 98% consumer | no trial arm names this drug |
| Fatigue (tiredness) | 584 | 1.3 1.2–1.4ROR 1.3 · χ² 30 / p 2e-8 | 1.3 EB05 1.2 · IC025 +0.2 | No label text to screen label has no adverse-reaction text | serious PRR 2.0 | no trial arm names this drug |
| Headache | 560 | 1.5 1.4–1.6ROR 1.5 · χ² 92 / p 5e-22 | 1.5 EB05 1.4 · IC025 +0.4 | No label text to screen label has no adverse-reaction text | serious PRR 2.7 · ♀ 75% (drug 55%) | no trial arm names this drug |
| Abdominal distension (bloating) | 522 | 8.4 7.7–9.1ROR 8.7 · χ² 3,388 / p <1e-300 | 8.3 EB05 7.7 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.1 | no trial arm names this drug |
| Inappropriate schedule of product administration | 463 | 4.4 4.0–4.8ROR 4.5 · χ² 1,204 / p 4e-264 | 4.3 EB05 4.0 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 4.1 · 70% consumer | no trial arm names this drug |
| Condition aggravated | 458 | 2.5 2.3–2.8ROR 2.6 · χ² 426 / p 7e-95 | 2.5 EB05 2.3 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 3.6 · ♀ 33% (drug 55%) | no trial arm names this drug |
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 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 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, 1,087 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 - ClinicalTrials.gov API v2 (query
POLYETHYLENE GLYCOL 400, results-bearing studies sorted by enrollment)
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.