Drug · FAERS side-effect profile with label screen
Instalax Polyethylene Glycol 3350 side effects: what 12,332 FDA adverse event reports show
Brand names
Polyethylene Glycol 3350
openFDA label
Who reports
12,332 reports · 54% serious · 1,195 with death outcome · 55% 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 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. 1,043 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 | 2,479.9 1,720.1–3,575.3ROR 2,494.3 · χ² 69,967 / p <1e-300 | 787.0 EB05 645.0 · 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 | 2,436.6 1,816.8–3,267.8ROR 2,458.3 · χ² 107,178 / p <1e-300 | 845.1 EB05 720.1 · 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 | 2,000.1 1,633.5–2,448.9ROR 2,033.7 · χ² 184,964 / p <1e-300 | 840.1 EB05 747.7 · 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 | 955.6 756.6–1,206.9ROR 964.1 · χ² 66,206 / p <1e-300 | 550.4 EB05 469.3 · 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 | 799.1 631.6–1,011.0ROR 805.8 · χ² 54,522 / p <1e-300 | 491.3 EB05 416.4 · 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 | 586.4 447.8–767.9ROR 589.8 · χ² 30,308 / p <1e-300 | 389.0 EB05 318.8 · 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 | 517.6 372.1–720.1ROR 519.5 · χ² 17,730 / p <1e-300 | 339.7 EB05 265.0 · 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 | 496.0 362.0–679.7ROR 498.0 · χ² 18,682 / p <1e-300 | 334.0 EB05 263.3 · IC025 +5.9 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 | 487.2 372.1–637.9ROR 489.9 · χ² 25,190 / p <1e-300 | 341.4 EB05 278.6 · IC025 +6.3 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 | 436.8 304.4–627.0ROR 438.2 · χ² 12,420 / p <1e-300 | 294.0 EB05 222.8 · 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 | 279.4 161.8–482.5ROR 279.8 · χ² 3,332 / p <1e-300 | 183.9 EB05 118.3 · 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 | 205.9 139.1–304.7ROR 206.4 · χ² 4,904 / p <1e-300 | 163.2 EB05 118.5 · 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 | 182.9 120.1–278.6ROR 183.3 · χ² 3,752 / p <1e-300 | 146.1 EB05 103.3 · 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 | 175.8 128.5–240.6ROR 176.4 · χ² 6,608 / p <1e-300 | 148.8 EB05 115.1 · 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 | 173.7 116.0–260.0ROR 174.0 · χ² 3,890 / p <1e-300 | 141.3 EB05 101.4 · 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 | 147.7 93.5–233.2ROR 148.0 · χ² 2,545 / p <1e-300 | 120.5 EB05 82.4 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious n=20 · 90% clinician | no trial arm names this drug |
| Neutropenia neonatal | 17 | 138.4 84.4–226.8ROR 138.5 · χ² 2,016 / p <1e-300 | 112.1 EB05 74.1 · 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 | 126.7 85.1–188.7ROR 127.0 · χ² 2,899 / p <1e-300 | 108.7 EB05 77.9 · 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 | 125.8 106.4–148.7ROR 127.3 · χ² 16,698 / p <1e-300 | 115.3 EB05 100.5 · 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 | 120.1 78.7–183.3ROR 120.3 · χ² 2,425 / p <1e-300 | 102.8 EB05 72.2 · 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 | 113.2 107.3–119.5ROR 126.1 · χ² 132,046 / p <1e-300 | 106.0 EB05 101.2 · IC025 +6.6 3/3 methods agree | Reporting / coding artifact | serious n=30 · 99% consumer | no trial arm names this drug |
| Blood phosphorus increased | 170 | 113.1 96.9–132.0ROR 114.7 · χ² 17,592 / p <1e-300 | 104.8 EB05 92.2 · 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 | 93.9 70.3–125.5ROR 94.3 · χ² 4,090 / p <1e-300 | 86.0 EB05 67.5 · IC025 +5.1 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 | 90.1 60.7–133.6ROR 90.3 · χ² 2,089 / p <1e-300 | 80.6 EB05 57.8 · 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 | 82.7 55.8–122.6ROR 82.9 · χ² 1,923 / p <1e-300 | 74.7 EB05 53.6 · 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 | 72.0 56.8–91.5ROR 72.4 · χ² 4,634 / p <1e-300 | 67.9 EB05 55.6 · 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 | 54.3 45.2–65.3ROR 54.8 · χ² 5,827 / p <1e-300 | 52.2 EB05 44.7 · 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 | 47.3 37.7–59.4ROR 47.6 · χ² 3,308 / p <1e-300 | 45.6 EB05 37.6 · IC025 +4.8 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 | 45.7 36.0–57.9ROR 45.9 · χ² 2,891 / p <1e-300 | 44.0 EB05 35.9 · 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 | 44.6 32.7–60.8ROR 44.8 · χ² 1,661 / p <1e-300 | 42.7 EB05 32.8 · 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 | 43.3 28.1–66.8ROR 43.4 · χ² 805 / p 2e-177 | 40.8 EB05 28.2 · 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 | 43.1 28.2–65.8ROR 43.2 · χ² 841 / p 3e-185 | 40.7 EB05 28.3 · 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 | 42.7 35.3–51.6ROR 43.1 · χ² 4,289 / p <1e-300 | 41.4 EB05 35.3 · 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 | 40.7 34.4–48.3ROR 41.2 · χ² 5,069 / p <1e-300 | 39.6 EB05 34.3 · 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 | 39.3 34.3–45.0ROR 39.9 · χ² 7,620 / p <1e-300 | 38.3 EB05 34.1 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 41.3 · ♀ 8% (drug 55%) · 97% clinician | no trial arm names this drug |
| Steroid dependence | 19 | 38.8 24.7–61.2ROR 38.9 · χ² 648 / p 3e-143 | 36.7 EB05 24.8 · 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 | 38.1 35.2–41.1ROR 40.0 · χ² 22,049 / p <1e-300 | 37.2 EB05 34.8 · IC025 +5.0 3/3 methods agree | Reporting / coding artifact | serious PRR 1.8 · 100% consumer | no trial arm names this drug |
| Gingival abscess | 16 | 36.6 22.3–60.0ROR 36.6 · χ² 508 / p 9e-113 | 34.5 EB05 22.5 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=16 | no trial arm names this drug |
| Faecal volume decreased | 10 | 35.9 19.2–67.1ROR 35.9 · χ² 299 / p 3e-67 | 33.1 EB05 19.2 · IC025 +2.7 3/3 methods agree | Lab value / disease marker | – | no trial arm names this drug |
| Activated partial thromboplastin time prolonged | 100 | 34.1 28.0–41.5ROR 34.4 · χ² 3,118 / p <1e-300 | 33.3 EB05 28.1 · 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)
No completed trial with posted adverse-event results was found on ClinicalTrials.gov for Instalax Polyethylene Glycol 3350 (searched INSTALAX POLYETHYLENE GLYCOL 3350).
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) | 1,773 | 2.3 2.2–2.4ROR 2.5 · χ² 1,373 / 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) | 1,307 | 2.6 2.4–2.7ROR 2.7 · χ² 1,296 / p 5e-284 | 2.6 EB05 2.4 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 3.9 | no trial arm names this drug |
| Incorrect product administration duration | 1,267 | 113.2 107.3–119.5ROR 126.1 · χ² 132,046 / p <1e-300 | 106.0 EB05 101.2 · IC025 +6.6 3/3 methods agree | Reporting / coding artifact | serious n=30 · 99% consumer | no trial arm names this drug |
| Nausea | 950 | 2.0 1.9–2.2ROR 2.1 · χ² 528 / p 4e-117 | 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) | 891 | 2.4 2.2–2.5ROR 2.5 · χ² 716 / p 6e-158 | 2.4 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 | 721 | 5.7 5.3–6.1ROR 6.0 · χ² 2,795 / 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 9.9 | no trial arm names this drug |
| Vomiting | 641 | 2.3 2.2–2.5ROR 2.4 · χ² 494 / p 1e-109 | 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 3.0 | no trial arm names this drug |
| Incorrect drug administration duration | 625 | 38.1 35.2–41.1ROR 40.0 · χ² 22,049 / p <1e-300 | 37.2 EB05 34.8 · IC025 +5.0 3/3 methods agree | Reporting / coding artifact | serious PRR 1.8 · 100% consumer | no trial arm names this drug |
| Abdominal pain | 609 | 4.5 4.1–4.8ROR 4.6 · χ² 1,646 / p <1e-300 | 4.4 EB05 4.2 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.2 | no trial arm names this drug |
| Underdose | 596 | 14.0 12.9–15.1ROR 14.6 · χ² 7,131 / p <1e-300 | 13.9 EB05 12.9 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious PRR 1.6 · 98% consumer | no trial arm names this drug |
| Fatigue (tiredness) | 567 | 1.2 1.1–1.3ROR 1.3 · χ² 27 / p 9e-8 | 1.2 EB05 1.2 · IC025 +0.2 | No label text to screen label has no adverse-reaction text | serious PRR 2.1 | no trial arm names this drug |
| Headache | 532 | 1.4 1.3–1.6ROR 1.5 · χ² 75 / p 3e-18 | 1.4 EB05 1.3 · 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) | 519 | 8.5 7.8–9.3ROR 8.9 · χ² 3,439 / p <1e-300 | 8.4 EB05 7.8 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.2 | no trial arm names this drug |
| Inappropriate schedule of product administration | 454 | 4.4 4.0–4.8ROR 4.5 · χ² 1,185 / p 5e-260 | 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 | 453 | 2.6 2.3–2.8ROR 2.6 · χ² 432 / p 3e-96 | 2.5 EB05 2.4 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 3.7 · ♀ 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 Instalax Polyethylene Glycol 3350?
In FDA FAERS, the most frequently co-reported reaction terms for Instalax Polyethylene Glycol 3350 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 Instalax Polyethylene Glycol 3350 have an FDA boxed warning?
No. The FDA label retrieved for Instalax Polyethylene Glycol 3350 has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Instalax 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 40bd1be7-de67-8dff-e063-6294a90aca95, effective 20260724; matched on
openfda.generic_name.exact:"INSTALAX 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, 1,083 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
INSTALAX POLYETHYLENE GLYCOL 3350, 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.