Drug · FAERS side-effect profile with label screen
Iodide side effects: what 1,474 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Potassium Iodide (Potassium Iodide (Saturated))
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
1,474 reports · 89% serious · 389 with death outcome · 62% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Potassium iodide oral solution, USP is for use as an expectorant in the symptomatic treatment of chronic pulmonary diseases where tenacious mucus complicates the problem, including bronchial asthma, bronchitis and pulmonary emphysema.
FDA label, Indications and Usage
What it is
Description Potassium iodide oral solution, USP is a saturated solution of potassium iodide containing 1 gram of potassium iodide per mL.
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
Labeled (related wording) 3Reporting / coding artifact 1Lab value / disease marker 1Not in label — unassessed 35
What the badges mean
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- 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.
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. 38 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 | 217 | 290.1 256.2–328.5ROR 340.0 · χ² 60,997 / p <1e-300 | 277.3 EB05 247.7 · IC025 +7.2 3/3 methods agree | Not in label — unassessed | serious n=217 · 92% clinician | no trial data cached |
| Generalised oedema | 191 | 224.1 196.1–256.2ROR 257.4 · χ² 41,568 / p <1e-300 | 215.9 EB05 191.4 · IC025 +6.9 3/3 methods agree | Not in label — unassessed | serious PRR 158.8 · 95% clinician | no trial data cached |
| Head discomfort | 210 | 171.6 151.3–194.7ROR 200.0 · χ² 35,058 / p <1e-300 | 167.0 EB05 148.9 · IC025 +6.7 3/3 methods agree | Not in label — unassessed | serious PRR 195.7 · 93% clinician | no trial data cached |
| Altered state of consciousness | 232 | 154.8 137.5–174.4ROR 183.5 · χ² 34,952 / p <1e-300 | 151.3 EB05 135.6 · IC025 +6.6 3/3 methods agree | Not in label — unassessed | serious PRR 100.3 · 92% clinician | no trial data cached |
| Photophobia (light sensitivity) | 164 | 126.1 109.0–145.7ROR 141.7 · χ² 20,060 / p <1e-300 | 123.2 EB05 108.2 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious PRR 131.4 · 94% clinician | no trial data cached |
| Haematemesis (vomiting blood) | 217 | 122.5 108.2–138.6ROR 143.4 · χ² 25,829 / p <1e-300 | 120.2 EB05 107.3 · IC025 +6.3 3/3 methods agree | Not in label — unassessed | serious PRR 80.7 · 93% clinician | no trial data cached |
| Presyncope (near-fainting) | 189 | 112.0 98.0–128.0ROR 128.3 · χ² 20,538 / p <1e-300 | 109.9 EB05 97.4 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious PRR 92.3 · 94% clinician | no trial data cached |
| Ascites | 225 | 109.6 97.2–123.7ROR 129.2 · χ² 23,961 / p <1e-300 | 107.8 EB05 96.5 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious PRR 71.6 · 92% clinician | no trial data cached |
| Diplopia (double vision) | 185 | 102.0 89.1–116.8ROR 116.5 · χ² 18,298 / p <1e-300 | 100.3 EB05 88.7 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious PRR 90.0 · 95% clinician | no trial data cached |
| Cardio-respiratory arrest | 239 | 81.2 72.3–91.3ROR 96.8 · χ² 18,790 / p <1e-300 | 80.3 EB05 72.1 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious PRR 52.5 · 92% clinician | no trial data cached |
| Haematuria (blood in urine) | 194 | 80.9 70.9–92.3ROR 93.0 · χ² 15,169 / p <1e-300 | 79.8 EB05 70.8 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious PRR 57.3 · 95% clinician | no trial data cached |
| Blindness | 214 | 75.2 66.4–85.1ROR 87.8 · χ² 15,533 / p <1e-300 | 74.3 EB05 66.3 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious PRR 49.7 · 92% clinician | no trial data cached |
| Coma | 213 | 63.8 56.4–72.3ROR 74.5 · χ² 13,083 / p <1e-300 | 63.2 EB05 56.4 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious PRR 41.3 · 92% clinician | no trial data cached |
| Tinnitus (ringing in the ears) | 194 | 60.2 52.8–68.7ROR 69.2 · χ² 11,216 / p <1e-300 | 59.6 EB05 52.9 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious PRR 60.0 · 95% clinician | no trial data cached |
| Eye pain | 215 | 55.6 49.1–62.9ROR 64.9 · χ² 11,457 / p <1e-300 | 55.1 EB05 49.2 · IC025 +5.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 82.7 · 93% clinician | no trial data cached |
| Hyperthyroidism | 45 | 44.4 33.3–59.2ROR 45.8 · χ² 1,861 / p <1e-300 | 43.5 EB05 33.8 · IC025 +4.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 30.8 · 93% clinician | no trial data cached |
| Tachycardia (fast heart rate) | 240 | 38.5 34.3–43.3ROR 45.8 · χ² 8,749 / p <1e-300 | 38.3 EB05 34.4 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 27.4 · 90% clinician | no trial data cached |
| Sepsis (blood infection) | 255 | 32.6 29.1–36.4ROR 39.2 · χ² 7,797 / p <1e-300 | 32.4 EB05 29.2 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 21.2 · 92% clinician | no trial data cached |
| Syncope (fainting) | 194 | 27.6 24.2–31.5ROR 31.7 · χ² 4,965 / p <1e-300 | 27.5 EB05 24.4 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 19.1 · 94% clinician | no trial data cached |
| Chills | 225 | 27.3 24.2–30.8ROR 32.1 · χ² 5,698 / p <1e-300 | 27.2 EB05 24.3 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 27.7 · 92% clinician | no trial data cached |
| Eructation (belching) | 31 | 23.2 16.4–32.9ROR 23.7 · χ² 637 / p 9e-141 | 22.9 EB05 16.9 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=31 | no trial data cached |
| Toxic epidermal necrolysis (severe skin peeling reaction) | 22 | 20.8 13.7–31.5ROR 21.1 · χ² 394 / p 5e-88 | 20.4 EB05 14.1 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 13.5 · 95% clinician | no trial data cached |
| Blood pressure increased | 202 | 18.8 16.5–21.3ROR 21.6 · χ² 3,403 / p <1e-300 | 18.7 EB05 16.7 · IC025 +3.9 3/3 methods agree | Lab value / disease marker | serious PRR 17.6 · 93% clinician | no trial data cached |
| Vision blurred (blurred vision) | 177 | 18.5 16.1–21.2ROR 20.8 · χ² 2,920 / p <1e-300 | 18.4 EB05 16.2 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 22.9 · 93% clinician | no trial data cached |
| Myalgia (muscle pain) | 197 | 16.5 14.5–18.8ROR 18.9 · χ² 2,874 / p <1e-300 | 16.5 EB05 14.6 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 18.5 · 94% clinician | no trial data cached |
| Somnolence (drowsiness) | 198 | 14.0 12.3–16.0ROR 16.0 · χ² 2,402 / p <1e-300 | 14.0 EB05 12.4 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 15.7 · 94% clinician | no trial data cached |
| Abdominal pain upper | 197 | 13.7 12.0–15.6ROR 15.6 · χ² 2,318 / p <1e-300 | 13.6 EB05 12.1 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 16.5 · 91% clinician | no trial data cached |
| Decreased appetite (loss of appetite) | 221 | 13.6 12.0–15.3ROR 15.8 · χ² 2,590 / p <1e-300 | 13.5 EB05 12.1 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 13.5 · 93% clinician | no trial data cached |
| Hypothyroidism | 30 | 13.4 9.4–19.1ROR 13.7 · χ² 333 / p 1e-74 | 13.0 EB05 9.3 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.6 · 93% clinician | no trial data cached |
| Insomnia (trouble sleeping) | 238 | 12.7 11.3–14.3ROR 15.0 · χ² 2,585 / p <1e-300 | 12.7 EB05 11.3 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 15.4 · ♀ 90% (drug 62%) · 91% clinician | no trial data cached |
| Abdominal pain | 198 | 12.1 10.7–13.8ROR 13.9 · χ² 2,031 / p <1e-300 | 12.1 EB05 10.7 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 10.4 · 92% clinician | no trial data cached |
| Cough | 236 | 12.0 10.7–13.5ROR 14.1 · χ² 2,401 / p <1e-300 | 11.9 EB05 10.7 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 13.7 · 94% clinician | no trial data cached |
| Apathy | 12 | 11.8 6.7–20.7ROR 11.8 · χ² 108 / p 2e-25 | 10.1 EB05 5.5 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 11.0 | no trial data cached |
| Brain fog | 11 | 10.7 6.0–19.3ROR 10.8 · χ² 88 / p 4e-21 | 8.8 EB05 4.8 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 13.4 | no trial data cached |
| Fall | 244 | 10.4 9.3–11.7ROR 12.3 · χ² 2,107 / p <1e-300 | 10.4 EB05 9.3 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 · 92% clinician | no trial data cached |
| Premature baby | 22 | 10.4 6.8–15.7ROR 10.5 · χ² 177 / p 1e-40 | 9.4 EB05 6.3 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 · 95% clinician | no trial data cached |
| Hypokalaemia (low potassium) | 31 | 9.6 6.8–13.6ROR 9.8 · χ² 231 / p 2e-52 | 8.9 EB05 6.4 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 · 97% clinician | no trial data cached |
| Frequent bowel movements | 18 | 9.5 6.0–15.1ROR 9.6 · χ² 129 / p 3e-30 | 8.4 EB05 5.3 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 9.5 | no trial data cached |
| Hyperkalaemia (high potassium) | 23 | 9.4 6.3–14.1ROR 9.5 · χ² 164 / p 7e-38 | 8.5 EB05 5.7 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 · ♀ 38% (drug 62%) · 100% clinician | no trial data cached |
| Drug interaction | 103 | 9.2 7.7–11.1ROR 9.9 · χ² 754 / p 3e-166 | 9.0 EB05 7.6 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 6.7 · 95% clinician | 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 |
|---|---|---|---|---|---|---|
| Sepsis (blood infection) | 255 | 32.6 29.1–36.4ROR 39.2 · χ² 7,797 / p <1e-300 | 32.4 EB05 29.2 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 21.2 · 92% clinician | no trial data cached |
| Fall | 244 | 10.4 9.3–11.7ROR 12.3 · χ² 2,107 / p <1e-300 | 10.4 EB05 9.3 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 · 92% clinician | no trial data cached |
| Tachycardia (fast heart rate) | 240 | 38.5 34.3–43.3ROR 45.8 · χ² 8,749 / p <1e-300 | 38.3 EB05 34.4 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 27.4 · 90% clinician | no trial data cached |
| Cardio-respiratory arrest | 239 | 81.2 72.3–91.3ROR 96.8 · χ² 18,790 / p <1e-300 | 80.3 EB05 72.1 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious PRR 52.5 · 92% clinician | no trial data cached |
| Insomnia (trouble sleeping) | 238 | 12.7 11.3–14.3ROR 15.0 · χ² 2,585 / p <1e-300 | 12.7 EB05 11.3 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 15.4 · ♀ 90% (drug 62%) · 91% clinician | no trial data cached |
| Dizziness | 236 | 6.7 6.0–7.6ROR 7.8 · χ² 1,177 / p 3e-258 | 6.7 EB05 6.0 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.7 · 91% clinician | no trial data cached |
| Cough | 236 | 12.0 10.7–13.5ROR 14.1 · χ² 2,401 / p <1e-300 | 11.9 EB05 10.7 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 13.7 · 94% clinician | no trial data cached |
| Altered state of consciousness | 232 | 154.8 137.5–174.4ROR 183.5 · χ² 34,952 / p <1e-300 | 151.3 EB05 135.6 · IC025 +6.6 3/3 methods agree | Not in label — unassessed | serious PRR 100.3 · 92% clinician | no trial data cached |
| Arthralgia (joint pain) | 229 | 7.9 7.0–8.9ROR 9.1 · χ² 1,392 / p <1e-300 | 7.8 EB05 7.0 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.4 · 92% clinician | no trial data cached |
| Chills | 225 | 27.3 24.2–30.8ROR 32.1 · χ² 5,698 / p <1e-300 | 27.2 EB05 24.3 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 27.7 · 92% clinician | no trial data cached |
| Ascites | 225 | 109.6 97.2–123.7ROR 129.2 · χ² 23,961 / p <1e-300 | 107.8 EB05 96.5 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious PRR 71.6 · 92% clinician | no trial data cached |
| Decreased appetite (loss of appetite) | 221 | 13.6 12.0–15.3ROR 15.8 · χ² 2,590 / p <1e-300 | 13.5 EB05 12.1 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 13.5 · 93% clinician | no trial data cached |
| Pruritus (itching) | 219 | 8.2 7.3–9.3ROR 9.5 · χ² 1,412 / p <1e-300 | 8.1 EB05 7.3 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 13.0 · 93% clinician | no trial data cached |
| Asthenia (weakness) | 219 | 8.3 7.3–9.4ROR 9.6 · χ² 1,421 / p <1e-300 | 8.2 EB05 7.3 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 · 92% clinician | no trial data cached |
| Haematemesis (vomiting blood) | 217 | 122.5 108.2–138.6ROR 143.4 · χ² 25,829 / p <1e-300 | 120.2 EB05 107.3 · IC025 +6.3 3/3 methods agree | Not in label — unassessed | serious PRR 80.7 · 93% clinician | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Ocular discomfort — n=217, PRR 290.1
- Generalised oedema — n=191, PRR 224.1
- Head discomfort — n=210, PRR 171.6
- Altered state of consciousness — n=232, PRR 154.8
- Photophobia — n=164, PRR 126.1
- Haematemesis — n=217, PRR 122.5
- Presyncope — n=189, PRR 112.0
- Ascites — n=225, PRR 109.6
- Diplopia — n=185, PRR 102.0
- Cardio-respiratory arrest — n=239, PRR 81.2
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 Iodide?
In FDA FAERS, the most frequently co-reported reaction terms for Iodide are sepsis, fall, tachycardia, cardio-respiratory arrest, insomnia, dizziness. 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 Iodide have an FDA boxed warning?
No. The FDA label retrieved for Iodide has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Iodide 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 0bdf305f-ed4a-49d1-8901-edaed8d67850, effective 20260825; matched on
openfda.generic_name.exact:"POTASSIUM IODIDE") - 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, 78 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.