Drug · FAERS side-effect profile with label screen
Povidone-Iodine side effects: what 4,202 FDA adverse event reports show
Brand names
Betadine
openFDA label
Who reports
4,202 reports · 83% serious · 457 with death outcome · 65% female
openFDA FAERS counts, all years, deduplication not applied
Used for
BETADINE 5% Sterile Ophthalmic Prep Solution for the eye is indicated for prepping of the periocular region (lids, brow, and cheek) and irrigation of the ocular surface (cornea, conjunctiva, and palpebral fornices).
FDA label, Indications and Usage
What it is
DESCRIPTION: Povidone-Iodine is a broad-spectrum microbicide with the chemical formulas: 2-pyrrolidinone, 1- ethenyl-, homopolymer, compound with iodine; 1-vinyl-2-pyrrolidinone polymer, compound with iodine.
FDA label, Description section
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 2Lab value / disease marker 2No label text to screen 36
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. 220 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 |
|---|---|---|---|---|---|---|
| Pemphigus | 122 | 49.4 41.5–58.9ROR 50.9 · χ² 5,687 / p <1e-300 | 48.6 EB05 41.8 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 34.2 · ♀ 100% (drug 65%) · 95% clinician | no trial data cached |
| Pericarditis | 131 | 39.5 33.4–46.8ROR 40.8 · χ² 4,845 / p <1e-300 | 39.0 EB05 33.7 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 27.5 · ♀ 100% (drug 65%) · 94% clinician | no trial data cached |
| Vitreous floaters | 74 | 38.2 30.4–47.9ROR 38.9 · χ² 2,624 / p <1e-300 | 37.6 EB05 30.9 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=64 | no trial data cached |
| Eye inflammation | 68 | 36.2 28.6–45.9ROR 36.8 · χ² 2,278 / p <1e-300 | 35.6 EB05 29.1 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=66 | no trial data cached |
| Folliculitis | 68 | 33.1 26.1–41.9ROR 33.6 · χ² 2,069 / p <1e-300 | 32.6 EB05 26.6 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 26.9 · ♀ 97% (drug 65%) · 96% clinician | no trial data cached |
| Synovitis | 112 | 31.1 25.9–37.4ROR 32.0 · χ² 3,220 / p <1e-300 | 30.8 EB05 26.3 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 22.6 · ♀ 100% (drug 65%) · 98% clinician | no trial data cached |
| Hypercholesterolaemia | 52 | 27.3 20.8–35.7ROR 27.6 · χ² 1,283 / p 3e-281 | 26.9 EB05 21.3 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 20.1 · ♀ 100% (drug 65%) · 90% clinician | no trial data cached |
| Helicobacter infection | 53 | 26.1 19.9–34.1ROR 26.4 · χ² 1,247 / p 2e-273 | 25.7 EB05 20.4 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 19.1 · ♀ 100% (drug 65%) · 94% clinician | no trial data cached |
| Intraocular pressure increased (raised eye pressure) | 66 | 25.8 20.3–32.8ROR 26.2 · χ² 1,540 / p <1e-300 | 25.5 EB05 20.7 · IC025 +4.0 3/3 methods agree | Lab value / disease marker | serious PRR 24.4 | no trial data cached |
| Visual acuity reduced | 165 | 24.7 21.3–28.7ROR 25.7 · χ² 3,715 / p <1e-300 | 24.5 EB05 21.5 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 22.8 | no trial data cached |
| Wound infection | 51 | 23.5 17.9–30.9ROR 23.8 · χ² 1,072 / p 2e-235 | 23.2 EB05 18.4 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 17.5 · ♀ 100% (drug 65%) · 94% clinician | no trial data cached |
| Wound | 129 | 23.3 19.6–27.6ROR 24.0 · χ² 2,715 / p <1e-300 | 23.1 EB05 19.9 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 19.2 · ♀ 92% (drug 65%) · 92% clinician | no trial data cached |
| Bursitis | 55 | 22.8 17.6–29.7ROR 23.1 · χ² 1,122 / p 2e-246 | 22.6 EB05 18.0 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 18.7 · ♀ 100% (drug 65%) · 96% clinician | no trial data cached |
| Hand deformity | 59 | 22.6 17.5–29.1ROR 22.9 · χ² 1,191 / p 2e-261 | 22.4 EB05 18.0 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 17.0 · ♀ 100% (drug 65%) · 98% clinician | no trial data cached |
| Blindness unilateral | 56 | 19.9 15.3–25.8ROR 20.2 · χ² 984 / p 3e-216 | 19.7 EB05 15.7 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.3 | no trial data cached |
| Type 2 diabetes mellitus | 132 | 19.6 16.5–23.2ROR 20.2 · χ² 2,302 / p <1e-300 | 19.4 EB05 16.8 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.3 · ♀ 98% (drug 65%) · 95% clinician | no trial data cached |
| Joint range of motion decreased | 50 | 18.7 14.2–24.7ROR 18.9 · χ² 819 / p 2e-180 | 18.5 EB05 14.6 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 16.6 · ♀ 100% (drug 65%) · 92% clinician | no trial data cached |
| Eye pain | 201 | 18.2 15.9–20.9ROR 19.1 · χ² 3,251 / p <1e-300 | 18.1 EB05 16.1 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 22.5 | no trial data cached |
| Eyelid oedema | 41 | 17.5 12.9–23.8ROR 17.7 · χ² 621 / p 2e-137 | 17.3 EB05 13.2 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 17.0 | no trial data cached |
| C-reactive protein increased | 126 | 17.3 14.6–20.6ROR 17.8 · χ² 1,921 / p <1e-300 | 17.2 EB05 14.8 · IC025 +3.7 3/3 methods agree | Lab value / disease marker | serious PRR 12.5 · ♀ 93% (drug 65%) · 95% clinician | no trial data cached |
| Systemic lupus erythematosus | 122 | 17.3 14.5–20.6ROR 17.7 · χ² 1,849 / 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 12.3 · ♀ 100% (drug 65%) · 96% clinician | no trial data cached |
| Toxic skin eruption | 33 | 16.3 11.6–23.0ROR 16.5 · χ² 459 / p 4e-102 | 16.1 EB05 11.8 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.4 · ♀ 45% (drug 65%) | no trial data cached |
| Psoriatic arthropathy | 131 | 16.3 13.8–19.3ROR 16.8 · χ² 1,864 / p <1e-300 | 16.2 EB05 14.0 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.3 · ♀ 100% (drug 65%) · 95% clinician | no trial data cached |
| Ocular discomfort | 34 | 15.7 11.2–21.9ROR 15.8 · χ² 451 / p 2e-100 | 15.4 EB05 11.4 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=24 | no trial data cached |
| Fibromyalgia | 75 | 15.5 12.3–19.3ROR 15.7 · χ² 997 / p 4e-219 | 15.3 EB05 12.6 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.1 · ♀ 100% (drug 65%) · 91% clinician | no trial data cached |
| Glossodynia (burning tongue/mouth pain) | 68 | 15.2 12.0–19.3ROR 15.5 · χ² 887 / p 3e-195 | 15.1 EB05 12.3 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 15.3 · ♀ 98% (drug 65%) · 96% clinician | no trial data cached |
| Retinal detachment | 26 | 14.1 9.6–20.8ROR 14.2 · χ² 304 / p 2e-68 | 13.7 EB05 9.5 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.0 | no trial data cached |
| Uveitis | 38 | 14.1 10.2–19.3ROR 14.2 · χ² 447 / p 1e-99 | 13.8 EB05 10.3 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.1 | no trial data cached |
| Obesity | 44 | 13.8 10.3–18.5ROR 13.9 · χ² 508 / p 7e-113 | 13.5 EB05 10.4 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.1 · ♀ 100% (drug 65%) · 93% clinician | no trial data cached |
| Dermatitis contact | 31 | 13.7 9.6–19.4ROR 13.7 · χ² 350 / p 2e-78 | 13.2 EB05 9.5 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=23 | no trial data cached |
| Contraindicated product administered | 81 | 13.4 10.8–16.7ROR 13.7 · χ² 918 / p 5e-202 | 13.3 EB05 11.0 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | serious PRR 11.5 · ♀ 97% (drug 65%) · 91% clinician | no trial data cached |
| Conjunctivitis | 49 | 13.3 10.1–17.6ROR 13.5 · χ² 546 / p 5e-121 | 13.1 EB05 10.2 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 16.8 | no trial data cached |
| Post procedural complication | 49 | 12.7 9.6–16.8ROR 12.9 · χ² 517 / p 8e-115 | 12.5 EB05 9.7 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 9.1 | no trial data cached |
| Epilepsy | 77 | 12.6 10.1–15.7ROR 12.8 · χ² 811 / p 1e-178 | 12.4 EB05 10.2 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.8 · ♀ 90% (drug 65%) | no trial data cached |
| Genital haemorrhage | 32 | 12.4 8.8–17.5ROR 12.5 · χ² 322 / p 2e-72 | 11.9 EB05 8.6 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.7 · ♀ 100% (drug 65%) | no trial data cached |
| Anaphylactic shock | 63 | 12.3 9.6–15.7ROR 12.5 · χ² 641 / p 8e-142 | 12.1 EB05 9.7 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.6 · 90% clinician | no trial data cached |
| Taste disorder | 49 | 12.2 9.3–16.2ROR 12.4 · χ² 493 / p 1e-109 | 11.9 EB05 9.2 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 17.1 · ♀ 100% (drug 65%) · 100% clinician | no trial data cached |
| Liver injury | 57 | 11.8 9.1–15.3ROR 11.9 · χ² 551 / p 4e-122 | 11.5 EB05 9.1 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.5 · ♀ 100% (drug 65%) · 96% clinician | no trial data cached |
| Back injury | 24 | 11.1 7.4–16.5ROR 11.1 · χ² 210 / p 8e-48 | 10.3 EB05 6.9 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.2 · ♀ 100% (drug 65%) · 92% clinician | no trial data cached |
| Blindness | 82 | 10.1 8.1–12.5ROR 10.2 · χ² 660 / p 6e-146 | 9.8 EB05 8.1 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.2 | 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 |
|---|---|---|---|---|---|---|
| Off label use (used outside approved label) | 482 | 2.8 2.5–3.0ROR 3.0 · χ² 567 / p 1e-125 | 2.8 EB05 2.6 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 3.4 | no trial data cached |
| Drug hypersensitivity | 382 | 9.8 8.9–10.8ROR 10.7 · χ² 3,043 / p <1e-300 | 9.8 EB05 9.0 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.6 · ♀ 93% (drug 65%) | no trial data cached |
| Rash | 273 | 3.1 2.8–3.5ROR 3.3 · χ² 405 / p 3e-90 | 3.1 EB05 2.8 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.8 | no trial data cached |
| Eye pain | 201 | 18.2 15.9–20.9ROR 19.1 · χ² 3,251 / p <1e-300 | 18.1 EB05 16.1 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 22.5 | no trial data cached |
| Product use in unapproved indication | 166 | 3.4 2.9–3.9ROR 3.5 · χ² 281 / p 3e-63 | 3.4 EB05 3.0 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 5.1 | no trial data cached |
| Vision blurred (blurred vision) | 166 | 6.1 5.2–7.0ROR 6.3 · χ² 701 / p 7e-155 | 6.0 EB05 5.2 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.4 | no trial data cached |
| Visual acuity reduced | 165 | 24.7 21.3–28.7ROR 25.7 · χ² 3,715 / p <1e-300 | 24.5 EB05 21.5 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 22.8 | no trial data cached |
| Hypersensitivity (allergic reaction) | 162 | 4.4 3.8–5.1ROR 4.5 · χ² 420 / p 1e-93 | 4.3 EB05 3.8 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.7 | no trial data cached |
| Visual impairment | 138 | 5.6 4.8–6.6ROR 5.8 · χ² 520 / p 3e-115 | 5.5 EB05 4.8 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.8 | no trial data cached |
| Confusional state (confusion) | 137 | 4.2 3.6–5.0ROR 4.3 · χ² 336 / p 2e-75 | 4.2 EB05 3.6 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.7 · ♀ 93% (drug 65%) · 91% clinician | no trial data cached |
| Rheumatoid arthritis | 132 | 5.8 4.9–6.9ROR 6.0 · χ² 526 / p 1e-116 | 5.7 EB05 4.9 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.0 · ♀ 100% (drug 65%) · 95% clinician | no trial data cached |
| Type 2 diabetes mellitus | 132 | 19.6 16.5–23.2ROR 20.2 · χ² 2,302 / p <1e-300 | 19.4 EB05 16.8 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.3 · ♀ 98% (drug 65%) · 95% clinician | no trial data cached |
| Psoriatic arthropathy | 131 | 16.3 13.8–19.3ROR 16.8 · χ² 1,864 / p <1e-300 | 16.2 EB05 14.0 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.3 · ♀ 100% (drug 65%) · 95% clinician | no trial data cached |
| Pericarditis | 131 | 39.5 33.4–46.8ROR 40.8 · χ² 4,845 / p <1e-300 | 39.0 EB05 33.7 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 27.5 · ♀ 100% (drug 65%) · 94% clinician | no trial data cached |
| Urticaria (hives) | 130 | 3.9 3.3–4.6ROR 4.0 · χ² 279 / p 5e-63 | 3.8 EB05 3.3 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.6 · ♀ 88% (drug 65%) | 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 Povidone-Iodine?
In FDA FAERS, the most frequently co-reported reaction terms for Povidone-Iodine are drug hypersensitivity, rash, eye pain, vision blurred, visual acuity reduced, hypersensitivity. 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 Povidone-Iodine have an FDA boxed warning?
No. The FDA label retrieved for Povidone-Iodine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Povidone-Iodine 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 b026de1b-9949-4557-ac49-c7b0038c24cd, effective 20220629; matched on
openfda.generic_name.exact:"POVIDONE-IODINE" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG") - 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, 260 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.