Povidone Iodine 10% side effects: what 540 FDA adverse event reports show
Who reports
540 reports · 96% serious · 51 with death outcome · 59% female
Used for
first aid antiseptic to help prevent infection in minor cuts, scrapes and burns
Boxed warning
None in the current label
Causality screen of the 9 strongest signals
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. 7 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Eye inflammation | 18 | 74.2 47.1–117.0ROR 76.8 · χ² 1,226 / p 6e-269 | 68.9 EB05 46.1 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=18 | no trial data cached |
| Intraocular pressure increased (raised eye pressure) | 21 | 63.6 41.8–96.8ROR 66.1 · χ² 1,231 / p 6e-270 | 60.2 EB05 41.5 · IC025 +4.0 3/3 methods agree | Lab value / disease marker | serious PRR 56.3 | no trial data cached |
| Visual acuity reduced | 51 | 59.2 45.6–76.9ROR 65.3 · χ² 2,861 / p <1e-300 | 57.9 EB05 45.8 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 46.8 | no trial data cached |
| Post procedural complication | 25 | 50.5 34.4–74.1ROR 52.9 · χ² 1,164 / p 2e-255 | 48.7 EB05 34.7 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious PRR 32.9 | no trial data cached |
| Eyelid oedema | 10 | 33.2 18.0–61.4ROR 33.8 · χ² 281 / p 2e-63 | 31.3 EB05 18.1 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 29.1 | no trial data cached |
| Uveitis | 8 | 23.0 11.6–45.8ROR 23.3 · χ² 147 / p 4e-34 | 21.3 EB05 10.5 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.7 | no trial data cached |
| Blindness unilateral | 8 | 22.1 11.1–43.9ROR 22.4 · χ² 141 / p 1e-32 | 20.3 EB05 9.8 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.6 | no trial data cached |
| Blindness | 21 | 20.0 13.2–30.5ROR 20.8 · χ² 362 / p 6e-81 | 19.6 EB05 13.4 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.3 · 90% clinician | no trial data cached |
| Drug exposure during pregnancy | 8 | 9.0 4.5–17.9ROR 9.1 · χ² 49 / p 1e-12 | 6.7 EB05 3.4 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 6.0 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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 |
|---|---|---|---|---|---|---|
| Visual acuity reduced | 51 | 59.2 45.6–76.9ROR 65.3 · χ² 2,861 / p <1e-300 | 57.9 EB05 45.8 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 46.8 | no trial data cached |
| Post procedural complication | 25 | 50.5 34.4–74.1ROR 52.9 · χ² 1,164 / p 2e-255 | 48.7 EB05 34.7 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious PRR 32.9 | no trial data cached |
| Blindness | 21 | 20.0 13.2–30.5ROR 20.8 · χ² 362 / p 6e-81 | 19.6 EB05 13.4 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.3 · 90% clinician | no trial data cached |
| Intraocular pressure increased (raised eye pressure) | 21 | 63.6 41.8–96.8ROR 66.1 · χ² 1,231 / p 6e-270 | 60.2 EB05 41.5 · IC025 +4.0 3/3 methods agree | Lab value / disease marker | serious PRR 56.3 | no trial data cached |
| Eye inflammation | 18 | 74.2 47.1–117.0ROR 76.8 · χ² 1,226 / p 6e-269 | 68.9 EB05 46.1 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=18 | no trial data cached |
| Eyelid oedema | 10 | 33.2 18.0–61.4ROR 33.8 · χ² 281 / p 2e-63 | 31.3 EB05 18.1 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 29.1 | no trial data cached |
| Drug exposure during pregnancy | 8 | 9.0 4.5–17.9ROR 9.1 · χ² 49 / p 1e-12 | 6.7 EB05 3.4 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 6.0 | no trial data cached |
| Blindness unilateral | 8 | 22.1 11.1–43.9ROR 22.4 · χ² 141 / p 1e-32 | 20.3 EB05 9.8 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.6 | no trial data cached |
| Uveitis | 8 | 23.0 11.6–45.8ROR 23.3 · χ² 147 / p 4e-34 | 21.3 EB05 10.5 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.7 | no trial data cached |
| Pharmaceutical product complaint | 4 | 5.9 2.2–15.7ROR 5.9 · χ² 12 / p 3e-4 | 3.8 EB05 1.7 · IC025 +0.2 | No label text to screen label has no adverse-reaction text | serious PRR 4.3 | no trial data cached |
| Anorexia | 4 | 11.9 4.5–31.6ROR 12.0 · χ² 30 / p 2e-8 | 7.0 EB05 2.5 · IC025 +0.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.4 | no trial data cached |
| Retinal detachment | 4 | 16.9 6.4–44.9ROR 17.0 · χ² 45 / p 1e-11 | 11.0 EB05 3.3 · IC025 +0.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.2 | no trial data cached |
| Application site erythema | 3 | 4.4 1.4–13.7ROR 4.4 · χ² 5 / p 0.013 | 3.0 EB05 1.2 · IC025 -0.5 PRR-only: not supported by EBGM or IC | No label text to screen label has no adverse-reaction text | serious n=3 | no trial data cached |
| Drug toxicity | 3 | 8.4 2.7–26.1ROR 8.5 · χ² 13 / p 2e-4 | 4.5 EB05 1.6 · IC025 -0.0 PRR-only: not supported by EBGM or IC | No label text to screen label has no adverse-reaction text | serious PRR 5.3 | no trial data cached |
| Fistula | 3 | 10.3 3.3–32.0ROR 10.4 · χ² 17 / p 2e-5 | 5.3 EB05 1.8 · IC025 +0.1 | No label text to screen label has no adverse-reaction text | serious PRR 6.5 | 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 10%?
In FDA FAERS, the most frequently co-reported reaction terms for Povidone Iodine 10% are visual acuity reduced, blindness, intraocular pressure increased, eye inflammation, eyelid oedema, blindness unilateral. 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 10% have an FDA boxed warning?
No. The FDA label retrieved for Povidone Iodine 10% has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Povidone Iodine 10% 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 406b4a37-816a-5ea4-e054-00144ff88e88, effective 20250908; matched on
openfda.generic_name.exact:"POVIDONE IODINE 10%") - 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, 16 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.