Drug · FAERS side-effect profile with label screen
Polyethylene Glycol side effects: what 10,759 FDA adverse event reports show
Who reports
10,759 reports · 83% serious · 1,374 with death outcome · 54% 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 6Lab value / disease marker 4No 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. 1,079 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 | 20 | 388.2 240.2–627.5ROR 389.0 · χ² 6,108 / p <1e-300 | 247.0 EB05 168.9 · IC025 +4.4 3/3 methods agree | Reporting / coding artifact | serious n=20 | no trial data cached |
| Sleep disorder therapy | 28 | 344.9 230.8–515.5ROR 345.8 · χ² 7,852 / p <1e-300 | 244.0 EB05 177.1 · IC025 +4.9 3/3 methods agree | Reporting / coding artifact | serious n=28 · ♀ 0% (drug 54%) · 100% clinician | no trial data cached |
| Appendicolith | 48 | 282.1 208.5–381.7ROR 283.4 · χ² 11,480 / p <1e-300 | 224.2 EB05 175.9 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=48 · ♀ 0% (drug 54%) · 100% clinician | no trial data cached |
| Analgesic therapy | 29 | 203.4 138.8–298.1ROR 203.9 · χ² 5,100 / p <1e-300 | 164.3 EB05 120.0 · IC025 +4.9 3/3 methods agree | Reporting / coding artifact | serious n=29 · ♀ 0% (drug 54%) · 100% clinician | no trial data cached |
| Drug therapy | 27 | 179.5 121.1–266.2ROR 180.0 · χ² 4,222 / p <1e-300 | 147.4 EB05 106.4 · IC025 +4.7 3/3 methods agree | Reporting / coding artifact | serious n=27 · ♀ 0% (drug 54%) · 100% clinician | no trial data cached |
| Anticoagulant therapy | 20 | 151.3 96.0–238.5ROR 151.6 · χ² 2,631 / p <1e-300 | 124.0 EB05 84.8 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious n=20 | no trial data cached |
| Malignant melanoma stage 0 | 11 | 125.8 68.4–231.5ROR 126.0 · χ² 1,164 / p 2e-255 | 98.5 EB05 58.7 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=11 | no trial data cached |
| Congenital hiatus hernia | 13 | 121.3 69.3–212.4ROR 121.4 · χ² 1,348 / p 2e-295 | 98.1 EB05 61.0 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=13 | no trial data cached |
| Vaginal flatulence | 14 | 93.4 54.7–159.7ROR 93.5 · χ² 1,134 / p 6e-249 | 79.8 EB05 50.5 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=14 | no trial data cached |
| Aplastic anaemia | 204 | 78.9 68.6–90.6ROR 80.4 · χ² 14,994 / p <1e-300 | 75.3 EB05 67.0 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=204 · 97% clinician | no trial data cached |
| Chronic kidney disease-mineral and bone disorder | 39 | 73.3 53.2–100.8ROR 73.5 · χ² 2,609 / p <1e-300 | 68.3 EB05 52.2 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=39 | no trial data cached |
| Red blood cell transfusion | 13 | 65.4 37.6–113.6ROR 65.5 · χ² 736 / p 2e-162 | 58.2 EB05 36.2 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=13 | no trial data cached |
| Cerebral artery thrombosis | 16 | 62.2 37.8–102.4ROR 62.3 · χ² 876 / p 1e-192 | 56.5 EB05 36.9 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=16 | no trial data cached |
| Enterococcus test positive | 20 | 61.6 39.5–96.1ROR 61.7 · χ² 1,097 / p 7e-241 | 56.7 EB05 38.7 · IC025 +3.9 3/3 methods agree | Lab value / disease marker | serious n=20 | no trial data cached |
| Pseudomonal bacteraemia | 21 | 50.0 32.4–77.1ROR 50.1 · χ² 936 / p 8e-206 | 46.8 EB05 32.3 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=21 · 100% clinician | no trial data cached |
| Brain scan abnormal | 14 | 49.9 29.4–84.8ROR 50.0 · χ² 607 / p 2e-134 | 45.9 EB05 29.0 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | serious n=14 | no trial data cached |
| Urinary tract infection pseudomonal | 14 | 47.3 27.8–80.3ROR 47.3 · χ² 575 / p 3e-127 | 43.6 EB05 27.6 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=14 | no trial data cached |
| Hyperparathyroidism secondary | 57 | 44.9 34.5–58.3ROR 45.1 · χ² 2,346 / p <1e-300 | 43.3 EB05 34.6 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=57 | no trial data cached |
| Nephrogenic anaemia | 105 | 44.8 36.9–54.3ROR 45.2 · χ² 4,347 / p <1e-300 | 43.4 EB05 36.9 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=105 | no trial data cached |
| Platelet transfusion | 27 | 42.0 28.7–61.5ROR 42.2 · χ² 1,019 / p 7e-224 | 40.1 EB05 28.9 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=27 · 100% clinician | no trial data cached |
| Clostridium test positive | 46 | 42.0 31.3–56.2ROR 42.1 · χ² 1,760 / p <1e-300 | 40.4 EB05 31.6 · IC025 +4.4 3/3 methods agree | Lab value / disease marker | serious n=46 · 100% clinician | no trial data cached |
| Alpha haemolytic streptococcal infection | 19 | 40.6 25.8–64.0ROR 40.7 · χ² 681 / p 2e-150 | 38.4 EB05 26.0 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=19 | no trial data cached |
| Hyperphosphataemia | 37 | 34.6 25.0–47.9ROR 34.7 · χ² 1,153 / p 4e-253 | 33.5 EB05 25.4 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=37 · ♀ 0% (drug 54%) · 100% clinician | no trial data cached |
| Infective pulmonary exacerbation of cystic fibrosis | 92 | 33.2 27.1–40.8ROR 33.5 · χ² 2,796 / p <1e-300 | 32.5 EB05 27.3 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=86 | no trial data cached |
| Electrocardiogram repolarisation abnormality | 13 | 32.7 18.9–56.6ROR 32.7 · χ² 362 / p 5e-81 | 30.9 EB05 19.2 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=13 | no trial data cached |
| Intestinal pseudo-obstruction | 14 | 32.2 19.0–54.6ROR 32.2 · χ² 386 / p 3e-86 | 30.5 EB05 19.3 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=14 | no trial data cached |
| Rebound acid hypersecretion | 49 | 31.6 23.9–41.9ROR 31.8 · χ² 1,400 / p <1e-300 | 30.8 EB05 24.2 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=49 | no trial data cached |
| Streptococcal bacteraemia | 16 | 29.4 18.0–48.2ROR 29.5 · χ² 405 / p 2e-90 | 28.1 EB05 18.3 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=16 | no trial data cached |
| Bronchopulmonary aspergillosis allergic | 12 | 25.8 14.6–45.6ROR 25.9 · χ² 259 / p 2e-58 | 24.5 EB05 14.8 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=12 | no trial data cached |
| Febrile neutropenia | 854 | 25.4 23.8–27.1ROR 27.6 · χ² 19,832 / p <1e-300 | 25.1 EB05 23.7 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 17.6 · 97% clinician | no trial data cached |
| Blood phosphorus increased | 33 | 23.9 16.9–33.6ROR 23.9 · χ² 692 / p 9e-153 | 23.3 EB05 17.4 · IC025 +3.6 3/3 methods agree | Lab value / disease marker | serious n=33 · ♀ 0% (drug 54%) · 100% clinician | no trial data cached |
| Adenocarcinoma gastric | 11 | 23.5 13.0–42.6ROR 23.6 · χ² 213 / p 2e-48 | 22.2 EB05 12.9 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=11 | no trial data cached |
| Urinary tract infection enterococcal | 11 | 23.0 12.7–41.7ROR 23.1 · χ² 208 / p 2e-47 | 21.8 EB05 12.5 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=11 | no trial data cached |
| Escherichia bacteraemia | 27 | 23.0 15.7–33.6ROR 23.1 · χ² 540 / p 1e-119 | 22.4 EB05 16.1 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=27 · 100% clinician | no trial data cached |
| End stage renal disease | 197 | 21.1 18.3–24.2ROR 21.4 · χ² 3,706 / p <1e-300 | 20.8 EB05 18.5 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.5 | no trial data cached |
| Chronic respiratory failure | 12 | 19.8 11.2–35.0ROR 19.8 · χ² 194 / p 2e-44 | 18.7 EB05 10.8 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=12 | no trial data cached |
| Hypogonadism | 10 | 19.3 10.4–36.0ROR 19.3 · χ² 154 / p 1e-35 | 17.9 EB05 9.4 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=10 | no trial data cached |
| Systolic dysfunction | 10 | 18.7 10.0–34.8ROR 18.7 · χ² 148 / p 2e-34 | 17.2 EB05 8.9 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=10 | no trial data cached |
| Unmasking of previously unidentified disease | 10 | 18.3 9.8–34.1ROR 18.3 · χ² 145 / p 9e-34 | 16.8 EB05 8.7 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=10 | no trial data cached |
| Carbon dioxide decreased | 10 | 17.2 9.3–32.1ROR 17.3 · χ² 136 / p 1e-31 | 15.7 EB05 7.9 · IC025 +2.2 3/3 methods agree | Lab value / disease marker | serious n=10 | 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 |
|---|---|---|---|---|---|---|
| Febrile neutropenia | 854 | 25.4 23.8–27.1ROR 27.6 · χ² 19,832 / p <1e-300 | 25.1 EB05 23.7 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 17.6 · 97% clinician | no trial data cached |
| Nausea | 682 | 1.7 1.6–1.8ROR 1.7 · χ² 196 / p 6e-45 | 1.7 EB05 1.6 · IC025 +0.6 | No label text to screen label has no adverse-reaction text | serious PRR 1.8 | no trial data cached |
| Fatigue (tiredness) | 583 | 1.5 1.4–1.6ROR 1.5 · χ² 88 / p 3e-21 | 1.5 EB05 1.4 · IC025 +0.4 | No label text to screen label has no adverse-reaction text | serious PRR 1.4 | no trial data cached |
| Dyspnoea (shortness of breath) | 548 | 1.9 1.7–2.0ROR 1.9 · χ² 234 / p 3e-53 | 1.9 EB05 1.8 · IC025 +0.8 | No label text to screen label has no adverse-reaction text | serious PRR 1.6 | no trial data cached |
| Vomiting | 518 | 2.2 2.0–2.3ROR 2.2 · χ² 326 / p 3e-73 | 2.2 EB05 2.0 · IC025 +1.0 | No label text to screen label has no adverse-reaction text | serious PRR 2.0 | no trial data cached |
| Off label use (used outside approved label) | 485 | 1.1 1.0–1.2ROR 1.1 · χ² 4 / p 0.029 | 1.1 EB05 1.0 · IC025 -0.0 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.1 | no trial data cached |
| Diarrhoea (diarrhea) | 485 | 1.5 1.3–1.6ROR 1.5 · χ² 75 / p 3e-18 | 1.5 EB05 1.4 · IC025 +0.4 | No label text to screen label has no adverse-reaction text | serious PRR 1.4 | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 475 | 6.1 5.6–6.7ROR 6.3 · χ² 2,025 / p <1e-300 | 6.0 EB05 5.6 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.2 | no trial data cached |
| Chronic kidney disease | 450 | 11.5 10.5–12.6ROR 12.0 · χ² 4,294 / p <1e-300 | 11.4 EB05 10.5 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.1 | no trial data cached |
| Constipation | 446 | 4.0 3.7–4.4ROR 4.2 · χ² 1,018 / p 1e-223 | 4.0 EB05 3.7 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.0 | no trial data cached |
| Pyrexia (fever) | 444 | 2.5 2.3–2.7ROR 2.6 · χ² 405 / p 3e-90 | 2.5 EB05 2.3 · IC025 +1.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.1 | no trial data cached |
| Pain | 431 | 1.4 1.2–1.5ROR 1.4 · χ² 43 / p 3e-11 | 1.4 EB05 1.3 · IC025 +0.3 | No label text to screen label has no adverse-reaction text | serious PRR 1.2 | no trial data cached |
| Fall | 428 | 2.5 2.3–2.8ROR 2.6 · χ² 393 / p 9e-88 | 2.5 EB05 2.3 · IC025 +1.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 1.9 | no trial data cached |
| Pneumonia (lung infection) | 426 | 2.6 2.3–2.8ROR 2.6 · χ² 413 / p 4e-92 | 2.6 EB05 2.4 · IC025 +1.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 1.8 | no trial data cached |
| Drug ineffective (drug did not work) | 413 | 0.6 0.6–0.7ROR 0.6 · χ² 109 / p 1e-25 | 0.6 EB05 0.6 · IC025 -0.9 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 0.8 | 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?
In FDA FAERS, the most frequently co-reported reaction terms for Polyethylene Glycol are febrile neutropenia, nausea, fatigue, dyspnoea, vomiting, diarrhoea. 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 have an FDA boxed warning?
No. The FDA label retrieved for Polyethylene Glycol has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Polyethylene 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, fieldpatient.drug.openfda.generic_name.exact, 1,119 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.