Drug · FAERS side-effect profile with label screen
Iodine side effects: what 3,497 FDA adverse event reports show
Drug class
Not stated in label
Who reports
3,497 reports · 59% serious · 491 with death outcome · 76% female
openFDA FAERS counts, all years, deduplication not applied
Used for
First aid to help prevent skin infection in minor cuts scrapes burns
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 2No label text to screen 38
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.
- 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. 327 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 |
|---|---|---|---|---|---|---|
| Ocular discomfort | 142 | 79.4 67.5–93.4ROR 82.7 · χ² 10,777 / p <1e-300 | 77.6 EB05 67.5 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=141 | no trial data cached |
| Pemphigus | 139 | 67.8 57.5–79.8ROR 70.5 · χ² 8,980 / p <1e-300 | 66.4 EB05 57.7 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 65.6 · ♀ 100% (drug 76%) · 96% clinician | no trial data cached |
| Folliculitis | 113 | 66.3 55.2–79.6ROR 68.5 · χ² 7,125 / p <1e-300 | 64.9 EB05 55.4 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 75.2 · ♀ 100% (drug 76%) · 96% clinician | no trial data cached |
| Helicobacter infection | 100 | 59.4 48.9–72.1ROR 61.1 · χ² 5,627 / p <1e-300 | 58.2 EB05 49.2 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 60.7 · ♀ 100% (drug 76%) · 95% clinician | no trial data cached |
| Generalised oedema | 117 | 57.5 48.1–68.8ROR 59.4 · χ² 6,380 / p <1e-300 | 56.5 EB05 48.4 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 61.2 · 92% clinician | no trial data cached |
| Wound infection | 102 | 56.8 46.9–68.8ROR 58.5 · χ² 5,484 / p <1e-300 | 55.7 EB05 47.2 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 58.9 · 95% clinician | no trial data cached |
| Hypercholesterolaemia | 88 | 55.6 45.2–68.5ROR 57.0 · χ² 4,626 / p <1e-300 | 54.5 EB05 45.6 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 57.2 · ♀ 100% (drug 76%) · 94% clinician | no trial data cached |
| Hand deformity | 115 | 53.1 44.4–63.7ROR 54.9 · χ² 5,784 / p <1e-300 | 52.3 EB05 44.7 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 55.9 · ♀ 100% (drug 76%) · 97% clinician | no trial data cached |
| Synovitis | 157 | 52.6 45.1–61.3ROR 55.0 · χ² 7,832 / p <1e-300 | 51.8 EB05 45.4 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 53.3 · 96% clinician | no trial data cached |
| Pericarditis | 141 | 51.1 43.5–60.2ROR 53.3 · χ² 6,828 / p <1e-300 | 50.4 EB05 43.8 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 49.9 · 94% clinician | no trial data cached |
| Head discomfort | 140 | 48.0 40.8–56.5ROR 50.0 · χ² 6,352 / p <1e-300 | 47.4 EB05 41.1 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 82.1 | no trial data cached |
| Joint range of motion decreased | 86 | 38.8 31.5–47.9ROR 39.8 · χ² 3,112 / p <1e-300 | 38.3 EB05 31.9 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 48.0 · ♀ 97% (drug 76%) · 92% clinician | no trial data cached |
| Altered state of consciousness | 134 | 37.5 31.7–44.3ROR 39.0 · χ² 4,699 / p <1e-300 | 37.1 EB05 32.1 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 36.7 · 90% clinician | no trial data cached |
| Photophobia (light sensitivity) | 110 | 35.5 29.5–42.7ROR 36.6 · χ² 3,637 / p <1e-300 | 35.1 EB05 29.9 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 54.3 | no trial data cached |
| Drug hypersensitivity | 1,135 | 35.2 33.6–37.0ROR 51.7 · χ² 37,847 / p <1e-300 | 35.0 EB05 33.3 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 16.5 | no trial data cached |
| Wound | 160 | 34.7 29.8–40.4ROR 36.3 · χ² 5,178 / p <1e-300 | 34.4 EB05 30.1 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 39.9 · ♀ 97% (drug 76%) · 94% clinician | no trial data cached |
| Fibromyalgia | 132 | 32.8 27.7–38.7ROR 34.0 · χ² 4,014 / p <1e-300 | 32.4 EB05 28.1 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 40.9 · ♀ 97% (drug 76%) · 90% clinician | no trial data cached |
| Haematemesis (vomiting blood) | 138 | 32.7 27.8–38.5ROR 34.0 · χ² 4,193 / p <1e-300 | 32.4 EB05 28.1 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 32.5 · 91% clinician | no trial data cached |
| Bursitis | 64 | 32.0 25.1–40.8ROR 32.5 · χ² 1,880 / p <1e-300 | 31.5 EB05 25.6 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 36.5 · ♀ 100% (drug 76%) | no trial data cached |
| Autoimmune disorder | 50 | 31.5 23.9–41.5ROR 31.9 · χ² 1,438 / p <1e-300 | 31.0 EB05 24.4 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 32.0 · ♀ 98% (drug 76%) · 96% clinician | no trial data cached |
| Systemic lupus erythematosus | 172 | 29.3 25.3–33.9ROR 30.7 · χ² 4,655 / p <1e-300 | 29.1 EB05 25.6 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 29.2 · ♀ 100% (drug 76%) · 94% clinician | no trial data cached |
| Type 2 diabetes mellitus | 162 | 28.9 24.8–33.6ROR 30.2 · χ² 4,319 / p <1e-300 | 28.7 EB05 25.1 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 29.6 · ♀ 99% (drug 76%) · 95% clinician | no trial data cached |
| Ascites | 135 | 27.6 23.4–32.6ROR 28.7 · χ² 3,428 / p <1e-300 | 27.4 EB05 23.7 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 27.2 · 90% clinician | no trial data cached |
| Irritable bowel syndrome | 98 | 27.6 22.7–33.6ROR 28.4 · χ² 2,478 / p <1e-300 | 27.4 EB05 23.1 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 34.1 · ♀ 98% (drug 76%) · 97% clinician | no trial data cached |
| Glossodynia (burning tongue/mouth pain) | 102 | 27.5 22.7–33.3ROR 28.3 · χ² 2,566 / p <1e-300 | 27.2 EB05 23.1 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 38.3 · 93% clinician | no trial data cached |
| Diplopia (double vision) | 118 | 27.4 22.9–32.7ROR 28.3 · χ² 2,959 / p <1e-300 | 27.1 EB05 23.3 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 36.4 · 92% clinician | no trial data cached |
| Presyncope (near-fainting) | 108 | 26.9 22.3–32.4ROR 27.7 · χ² 2,655 / p <1e-300 | 26.6 EB05 22.7 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 33.1 | no trial data cached |
| Liver injury | 106 | 26.4 21.9–31.8ROR 27.2 · χ² 2,555 / p <1e-300 | 26.2 EB05 22.2 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 26.6 · ♀ 99% (drug 76%) · 95% clinician | no trial data cached |
| Psoriatic arthropathy | 175 | 26.2 22.7–30.3ROR 27.5 · χ² 4,205 / p <1e-300 | 26.0 EB05 22.9 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 31.2 · ♀ 99% (drug 76%) · 94% clinician | no trial data cached |
| Haematuria (blood in urine) | 136 | 23.9 20.2–28.1ROR 24.8 · χ² 2,949 / p <1e-300 | 23.7 EB05 20.5 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 25.6 | no trial data cached |
| Sciatica | 58 | 22.0 17.0–28.4ROR 22.4 · χ² 1,138 / p 8e-250 | 21.8 EB05 17.5 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 28.3 · ♀ 100% (drug 76%) | no trial data cached |
| Blindness | 144 | 21.3 18.1–25.0ROR 22.1 · χ² 2,757 / p <1e-300 | 21.2 EB05 18.4 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 21.2 | no trial data cached |
| Obesity | 56 | 21.1 16.3–27.4ROR 21.4 · χ² 1,050 / p 1e-230 | 20.9 EB05 16.7 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 23.4 · ♀ 98% (drug 76%) · 96% clinician | no trial data cached |
| Gait inability | 115 | 20.9 17.5–25.0ROR 21.6 · χ² 2,154 / p <1e-300 | 20.8 EB05 17.8 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 25.3 · ♀ 98% (drug 76%) | no trial data cached |
| Contraindicated product administered | 102 | 20.3 16.8–24.6ROR 20.9 · χ² 1,852 / p <1e-300 | 20.2 EB05 17.1 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious PRR 24.4 | no trial data cached |
| Pulmonary fibrosis | 63 | 19.8 15.5–25.3ROR 20.2 · χ² 1,104 / p 2e-242 | 19.7 EB05 15.9 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 19.5 · ♀ 100% (drug 76%) · 97% clinician | no trial data cached |
| Impaired healing | 107 | 19.6 16.3–23.6ROR 20.2 · χ² 1,866 / p <1e-300 | 19.5 EB05 16.6 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | serious PRR 22.4 · ♀ 98% (drug 76%) | no trial data cached |
| Back injury | 35 | 19.4 14.0–27.0ROR 19.6 · χ² 592 / p 4e-131 | 19.2 EB05 14.4 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 25.0 · ♀ 100% (drug 76%) · 94% clinician | no trial data cached |
| Cardio-respiratory arrest | 133 | 19.0 16.1–22.5ROR 19.7 · χ² 2,247 / p <1e-300 | 18.9 EB05 16.3 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 18.5 | no trial data cached |
| Coma | 145 | 18.3 15.6–21.4ROR 19.0 · χ² 2,350 / p <1e-300 | 18.2 EB05 15.8 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 17.8 | 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 |
|---|---|---|---|---|---|---|
| Drug hypersensitivity | 1,135 | 35.2 33.6–37.0ROR 51.7 · χ² 37,847 / p <1e-300 | 35.0 EB05 33.3 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 16.5 | no trial data cached |
| Nausea | 455 | 3.5 3.2–3.8ROR 3.8 · χ² 823 / p 2e-181 | 3.4 EB05 3.2 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.8 | no trial data cached |
| Fatigue (tiredness) | 430 | 3.3 3.0–3.6ROR 3.6 · χ² 721 / p 4e-159 | 3.3 EB05 3.1 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.4 | no trial data cached |
| Diarrhoea (diarrhea) | 388 | 3.6 3.3–4.0ROR 3.9 · χ² 755 / p 2e-166 | 3.6 EB05 3.3 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.6 | no trial data cached |
| Dyspnoea (shortness of breath) | 380 | 4.0 3.7–4.4ROR 4.4 · χ² 886 / p 6e-195 | 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 5.3 | no trial data cached |
| Headache | 360 | 3.4 3.1–3.8ROR 3.7 · χ² 642 / p 6e-142 | 3.4 EB05 3.1 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.2 | no trial data cached |
| Arthralgia (joint pain) | 346 | 5.0 4.5–5.5ROR 5.4 · χ² 1,128 / p 2e-247 | 5.0 EB05 4.5 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.3 | no trial data cached |
| Dizziness | 310 | 3.7 3.4–4.2ROR 4.0 · χ² 633 / p 7e-140 | 3.7 EB05 3.4 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.2 | no trial data cached |
| Vomiting | 305 | 3.9 3.5–4.3ROR 4.2 · χ² 670 / p 5e-148 | 3.9 EB05 3.5 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.4 | no trial data cached |
| Pruritus (itching) | 288 | 4.6 4.1–5.1ROR 4.9 · χ² 814 / p 3e-179 | 4.5 EB05 4.1 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.8 | no trial data cached |
| Fall | 277 | 5.0 4.5–5.6ROR 5.3 · χ² 895 / p 5e-197 | 5.0 EB05 4.5 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.8 | no trial data cached |
| Malaise (feeling unwell) | 268 | 3.7 3.3–4.1ROR 3.9 · χ² 525 / p 1e-116 | 3.6 EB05 3.3 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.5 | no trial data cached |
| Abdominal pain | 262 | 6.8 6.0–7.6ROR 7.2 · χ² 1,294 / p 1e-283 | 6.7 EB05 6.0 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.5 | no trial data cached |
| Pyrexia (fever) | 261 | 4.5 4.0–5.1ROR 4.8 · χ² 724 / p 1e-159 | 4.5 EB05 4.0 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.4 | no trial data cached |
| Rash | 246 | 3.4 3.0–3.8ROR 3.6 · χ² 423 / p 2e-94 | 3.4 EB05 3.0 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.9 | 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 Iodine?
In FDA FAERS, the most frequently co-reported reaction terms for Iodine are drug hypersensitivity, nausea, fatigue, diarrhoea, dyspnoea, headache. 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 Iodine have an FDA boxed warning?
No. The FDA label retrieved for Iodine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that 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 857f13fe-51c9-4e5b-b5e2-a981dedabf71, effective 20260312; matched on
openfda.generic_name.exact:"IODINE") - 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, 367 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.