Drug · FAERS side-effect profile with label screen
Polyvinyl Alcohol and Povidone side effects: what 2,544 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Polyvinyl Alcohol (Rugby Polyvinyl Alcohol 1.4% Lubricating Eye Drops)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
2,544 reports · 52% serious · 222 with death outcome · 68% female
openFDA FAERS counts, all years, deduplication not applied
Used for
for use as a protectant against further irritation or to relieve dryness of the eye for the temporary relief of discomfort due to minor irritations of the eye, or to exposure to wind or sun
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 4Lab value / disease marker 4No label text to screen 32
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. 112 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 pain | 627 | 64.9 60.4–69.7ROR 77.8 · χ² 39,013 / p <1e-300 | 64.0 EB05 59.9 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 19.5 · 79% consumer | no trial data cached |
| Ocular discomfort | 101 | 53.0 43.7–64.3ROR 54.5 · χ² 5,058 / p <1e-300 | 52.0 EB05 44.1 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=9 · 75% consumer | no trial data cached |
| Eye irritation | 447 | 45.7 41.8–49.8ROR 51.8 · χ² 19,372 / p <1e-300 | 45.2 EB05 41.8 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 26.1 · 74% consumer | no trial data cached |
| Photophobia (light sensitivity) | 129 | 39.3 33.1–46.6ROR 40.7 · χ² 4,747 / p <1e-300 | 38.8 EB05 33.5 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.5 · 71% consumer | no trial data cached |
| Eye discharge | 65 | 36.2 28.4–46.1ROR 36.8 · χ² 2,174 / p <1e-300 | 35.6 EB05 28.9 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=6 | no trial data cached |
| Lacrimation increased | 150 | 28.5 24.4–33.3ROR 29.7 · χ² 3,938 / p <1e-300 | 28.3 EB05 24.7 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 16.7 | no trial data cached |
| Product use complaint | 77 | 28.2 22.6–35.2ROR 28.8 · χ² 1,984 / p <1e-300 | 27.9 EB05 23.0 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious n=40 | no trial data cached |
| Ocular hyperaemia | 205 | 24.9 21.8–28.4ROR 26.3 · χ² 4,667 / p <1e-300 | 24.7 EB05 22.0 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.2 · 70% consumer | no trial data cached |
| Dry eye | 189 | 22.1 19.2–25.4ROR 23.3 · χ² 3,784 / p <1e-300 | 22.0 EB05 19.5 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 18.5 · 70% consumer | no trial data cached |
| Eye inflammation | 36 | 21.6 15.6–30.0ROR 21.8 · χ² 686 / p 2e-151 | 21.3 EB05 16.1 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=10 | no trial data cached |
| Eye swelling | 113 | 17.3 14.4–20.8ROR 17.8 · χ² 1,719 / p <1e-300 | 17.2 EB05 14.7 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.3 · 74% consumer | no trial data cached |
| Eye pruritus | 94 | 16.1 13.2–19.7ROR 16.5 · χ² 1,319 / p 4e-289 | 16.0 EB05 13.5 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.3 · 72% consumer | no trial data cached |
| Product administration error | 55 | 15.6 12.0–20.3ROR 15.8 · χ² 736 / p 2e-162 | 15.4 EB05 12.2 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | serious PRR 3.4 · 76% consumer | no trial data cached |
| Vitreous floaters | 26 | 15.1 10.3–22.2ROR 15.2 · χ² 328 / p 1e-73 | 14.7 EB05 10.3 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=11 | no trial data cached |
| Cataract | 152 | 14.5 12.4–17.0ROR 15.1 · χ² 1,899 / p <1e-300 | 14.4 EB05 12.6 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.4 | no trial data cached |
| Eye infection | 28 | 14.1 9.8–20.5ROR 14.2 · χ² 328 / p 1e-73 | 13.7 EB05 9.7 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=3 | no trial data cached |
| Macular degeneration | 28 | 13.3 9.2–19.2ROR 13.4 · χ² 306 / p 9e-69 | 12.8 EB05 9.0 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.3 | no trial data cached |
| Intraocular pressure increased (raised eye pressure) | 26 | 11.5 7.8–16.8ROR 11.5 · χ² 238 / p 7e-54 | 10.8 EB05 7.4 · IC025 +2.6 3/3 methods agree | Lab value / disease marker | serious PRR 12.6 | no trial data cached |
| Impaired quality of life | 29 | 11.4 7.9–16.4ROR 11.5 · χ² 265 / p 8e-60 | 10.8 EB05 7.6 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 21.7 | no trial data cached |
| Ear discomfort | 19 | 10.5 6.7–16.5ROR 10.6 · χ² 154 / p 1e-35 | 9.4 EB05 6.0 · 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 |
| Vision blurred (blurred vision) | 249 | 10.3 9.1–11.6ROR 11.0 · χ² 2,095 / p <1e-300 | 10.2 EB05 9.2 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.7 | no trial data cached |
| Ear pain | 31 | 9.0 6.3–12.8ROR 9.1 · χ² 213 / p 2e-48 | 8.3 EB05 6.0 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.6 | no trial data cached |
| Eyelid ptosis | 16 | 8.9 5.5–14.5ROR 8.9 · χ² 104 / p 9e-25 | 7.6 EB05 4.8 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=4 | no trial data cached |
| Eyelid oedema | 18 | 8.7 5.5–13.8ROR 8.7 · χ² 115 / p 4e-27 | 7.6 EB05 4.9 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.9 | no trial data cached |
| Hospice care | 15 | 8.6 5.2–14.3ROR 8.6 · χ² 93 / p 2e-22 | 7.3 EB05 4.5 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.7 | no trial data cached |
| Device use issue | 25 | 8.2 5.5–12.1ROR 8.2 · χ² 150 / p 8e-35 | 7.4 EB05 5.1 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious n=2 | no trial data cached |
| Tinnitus (ringing in the ears) | 61 | 7.5 5.8–9.6ROR 7.6 · χ² 337 / p 1e-75 | 7.2 EB05 5.8 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.4 | no trial data cached |
| Eye disorder | 42 | 7.2 5.4–9.8ROR 7.3 · χ² 220 / p 5e-50 | 6.8 EB05 5.2 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.2 | no trial data cached |
| Seasonal allergy | 17 | 6.8 4.2–10.9ROR 6.8 · χ² 79 / p 4e-19 | 5.9 EB05 3.8 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=7 | no trial data cached |
| Diplopia (double vision) | 31 | 6.7 4.8–9.6ROR 6.8 · χ² 146 / p 6e-34 | 6.2 EB05 4.5 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.3 | no trial data cached |
| Blood urea increased | 20 | 6.7 4.3–10.4ROR 6.7 · χ² 92 / p 5e-22 | 5.9 EB05 4.0 · IC025 +1.8 3/3 methods agree | Lab value / disease marker | serious PRR 10.2 | no trial data cached |
| Neutrophil count increased | 12 | 6.6 3.8–11.6ROR 6.6 · χ² 52 / p 4e-13 | 5.4 EB05 3.3 · IC025 +1.5 3/3 methods agree | Lab value / disease marker | serious PRR 9.8 | no trial data cached |
| Visual acuity reduced | 38 | 6.4 4.7–8.8ROR 6.5 · χ² 168 / p 8e-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 8.5 | no trial data cached |
| Blood thyroid stimulating hormone increased | 10 | 6.1 3.3–11.4ROR 6.1 · χ² 38 / p 4e-10 | 4.9 EB05 2.8 · IC025 +1.2 3/3 methods agree | Lab value / disease marker | serious n=9 | no trial data cached |
| Discomfort | 59 | 5.5 4.3–7.1ROR 5.6 · χ² 213 / p 1e-48 | 5.3 EB05 4.2 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.7 | no trial data cached |
| Disability | 18 | 5.1 3.2–8.2ROR 5.2 · χ² 56 / p 4e-14 | 4.6 EB05 3.1 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.7 | no trial data cached |
| Sneezing | 20 | 5.1 3.3–7.8ROR 5.1 · χ² 61 / p 3e-15 | 4.6 EB05 3.1 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.1 | no trial data cached |
| Visual impairment | 110 | 5.1 4.2–6.1ROR 5.2 · χ² 355 / p 1e-79 | 5.0 EB05 4.2 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.0 | no trial data cached |
| Glaucoma | 17 | 5.0 3.1–8.0ROR 5.0 · χ² 50 / p 7e-13 | 4.4 EB05 2.9 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.1 | no trial data cached |
| Therapy interrupted | 59 | 4.8 3.8–6.2ROR 4.9 · χ² 176 / p 2e-40 | 4.7 EB05 3.7 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 3.0 · 83% 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 pain | 627 | 64.9 60.4–69.7ROR 77.8 · χ² 39,013 / p <1e-300 | 64.0 EB05 59.9 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 19.5 · 79% consumer | no trial data cached |
| Eye irritation | 447 | 45.7 41.8–49.8ROR 51.8 · χ² 19,372 / p <1e-300 | 45.2 EB05 41.8 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 26.1 · 74% consumer | no trial data cached |
| Vision blurred (blurred vision) | 249 | 10.3 9.1–11.6ROR 11.0 · χ² 2,095 / p <1e-300 | 10.2 EB05 9.2 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.7 | no trial data cached |
| Ocular hyperaemia | 205 | 24.9 21.8–28.4ROR 26.3 · χ² 4,667 / p <1e-300 | 24.7 EB05 22.0 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.2 · 70% consumer | no trial data cached |
| Dry eye | 189 | 22.1 19.2–25.4ROR 23.3 · χ² 3,784 / p <1e-300 | 22.0 EB05 19.5 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 18.5 · 70% consumer | no trial data cached |
| Cataract | 152 | 14.5 12.4–17.0ROR 15.1 · χ² 1,899 / p <1e-300 | 14.4 EB05 12.6 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.4 | no trial data cached |
| Lacrimation increased | 150 | 28.5 24.4–33.3ROR 29.7 · χ² 3,938 / p <1e-300 | 28.3 EB05 24.7 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 16.7 | no trial data cached |
| Product dose omission issue | 148 | 2.9 2.5–3.4ROR 3.0 · χ² 190 / p 2e-43 | 2.9 EB05 2.5 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 2.3 · 84% consumer | no trial data cached |
| Photophobia (light sensitivity) | 129 | 39.3 33.1–46.6ROR 40.7 · χ² 4,747 / p <1e-300 | 38.8 EB05 33.5 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.5 · 71% consumer | no trial data cached |
| Eye swelling | 113 | 17.3 14.4–20.8ROR 17.8 · χ² 1,719 / p <1e-300 | 17.2 EB05 14.7 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.3 · 74% consumer | no trial data cached |
| Visual impairment | 110 | 5.1 4.2–6.1ROR 5.2 · χ² 355 / p 1e-79 | 5.0 EB05 4.2 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.0 | no trial data cached |
| Ocular discomfort | 101 | 53.0 43.7–64.3ROR 54.5 · χ² 5,058 / p <1e-300 | 52.0 EB05 44.1 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=9 · 75% consumer | no trial data cached |
| Wrong technique in product usage process | 99 | 2.8 2.3–3.4ROR 2.8 · χ² 111 / p 3e-26 | 2.7 EB05 2.3 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | 84% consumer | no trial data cached |
| Eye pruritus | 94 | 16.1 13.2–19.7ROR 16.5 · χ² 1,319 / p 4e-289 | 16.0 EB05 13.5 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.3 · 72% consumer | no trial data cached |
| Product use complaint | 77 | 28.2 22.6–35.2ROR 28.8 · χ² 1,984 / p <1e-300 | 27.9 EB05 23.0 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious n=40 | 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 Polyvinyl Alcohol and Povidone?
In FDA FAERS, the most frequently co-reported reaction terms for Polyvinyl Alcohol and Povidone are eye pain, eye irritation, vision blurred, ocular hyperaemia, dry eye, cataract. 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 Polyvinyl Alcohol and Povidone have an FDA boxed warning?
No. The FDA label retrieved for Polyvinyl Alcohol and Povidone has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Polyvinyl Alcohol and Povidone 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 081673b2-5c74-1200-e063-6394a90ae363, effective 20251230; matched on
openfda.generic_name.exact:"POLYVINYL ALCOHOL") - 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, 152 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.