Iodide I 123 side effects: what 939 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Sodium Iodide I 123 (Sodium Iodide I 123)
Who reports
939 reports · 95% serious · 46 with death outcome · 75% female
Used for
Administration of Sodium Iodide I 123 Capsules is indicated as a diagnostic procedure to be used in evaluating thyroid function and/or morphology.
What it is
DESCRIPTION Sodium Iodide I 123 (Na 123 I) for diagnostic use is supplied in capsules for oral administration. The capsules are available in strengths of 3.7 and 7.4 megabecquerels (MBq) (100 and 200 μCi) I-123 at time of calibration.
Boxed warning
None in the current label
Causality screen of the 15 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.
- 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. 1 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 |
|---|---|---|---|---|---|---|
| Hypothyroidism | 384 | 272.9 252.5–294.9ROR 461.3 · χ² 102,637 / p <1e-300 | 266.0 EB05 244.4 · IC025 +7.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 178.5 · 100% clinician | no trial data cached |
| Acute myeloid leukaemia | 24 | 34.5 23.2–51.2ROR 35.4 · χ² 747 / p 9e-165 | 33.6 EB05 23.8 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 20.9 · 100% clinician | no trial data cached |
| Thyroid cancer | 17 | 31.4 19.6–50.3ROR 32.0 · χ² 470 / p 1e-104 | 30.4 EB05 20.1 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 19.0 | no trial data cached |
| Hyperthyroidism | 20 | 30.9 20.1–47.8ROR 31.6 · χ² 550 / p 8e-122 | 30.1 EB05 20.6 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 20.0 | no trial data cached |
| Hypocalcaemia (low calcium) | 14 | 16.6 9.9–27.9ROR 16.8 · χ² 190 / p 2e-43 | 15.7 EB05 9.3 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.6 | no trial data cached |
| Colon cancer | 11 | 16.5 9.2–29.7ROR 16.7 · χ² 145 / p 1e-33 | 15.2 EB05 8.0 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.0 | no trial data cached |
| Lacrimation increased | 19 | 14.2 9.1–22.2ROR 14.5 · χ² 221 / p 3e-50 | 13.5 EB05 8.7 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 22.3 | no trial data cached |
| Pulmonary fibrosis | 11 | 12.9 7.2–23.2ROR 13.0 · χ² 109 / p 9e-26 | 11.1 EB05 5.8 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.8 | no trial data cached |
| Abortion induced | 5 | 11.9 4.9–28.4ROR 11.9 · χ² 39 / p 2e-10 | 7.7 EB05 3.0 · IC025 +1.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.5 | no trial data cached |
| Contraindicated product administered | 15 | 11.1 6.7–18.4ROR 11.3 · χ² 128 / p 5e-30 | 9.8 EB05 5.8 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 8.4 | no trial data cached |
| Abortion spontaneous | 20 | 11.1 7.2–17.2ROR 11.3 · χ² 174 / p 4e-40 | 10.2 EB05 6.6 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.8 · 100% clinician | no trial data cached |
| Gastric cancer | 7 | 6.1 2.9–12.8ROR 6.1 · χ² 25 / p 3e-7 | 4.5 EB05 2.4 · IC025 +0.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.7 | no trial data cached |
| Drug exposure during pregnancy | 9 | 5.8 3.0–11.2ROR 5.9 · χ² 31 / p 1e-8 | 4.6 EB05 2.6 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 3.9 | no trial data cached |
| Premature baby | 6 | 4.4 2.0–9.9ROR 4.5 · χ² 13 / p 2e-4 | 3.5 EB05 1.8 · IC025 +0.4 | No label text to screen label has no adverse-reaction text | serious PRR 2.7 | no trial data cached |
| Breast cancer | 17 | 4.0 2.5–6.5ROR 4.1 · χ² 36 / p 9e-10 | 3.7 EB05 2.5 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.5 | 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 |
|---|---|---|---|---|---|---|
| Hypothyroidism | 384 | 272.9 252.5–294.9ROR 461.3 · χ² 102,637 / p <1e-300 | 266.0 EB05 244.4 · IC025 +7.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 178.5 · 100% clinician | no trial data cached |
| Acute myeloid leukaemia | 24 | 34.5 23.2–51.2ROR 35.4 · χ² 747 / p 9e-165 | 33.6 EB05 23.8 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 20.9 · 100% clinician | no trial data cached |
| Abortion spontaneous | 20 | 11.1 7.2–17.2ROR 11.3 · χ² 174 / p 4e-40 | 10.2 EB05 6.6 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.8 · 100% clinician | no trial data cached |
| Hyperthyroidism | 20 | 30.9 20.1–47.8ROR 31.6 · χ² 550 / p 8e-122 | 30.1 EB05 20.6 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 20.0 | no trial data cached |
| Lacrimation increased | 19 | 14.2 9.1–22.2ROR 14.5 · χ² 221 / p 3e-50 | 13.5 EB05 8.7 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 22.3 | no trial data cached |
| Breast cancer | 17 | 4.0 2.5–6.5ROR 4.1 · χ² 36 / p 9e-10 | 3.7 EB05 2.5 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.5 | no trial data cached |
| Thyroid cancer | 17 | 31.4 19.6–50.3ROR 32.0 · χ² 470 / p 1e-104 | 30.4 EB05 20.1 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 19.0 | no trial data cached |
| Contraindicated product administered | 15 | 11.1 6.7–18.4ROR 11.3 · χ² 128 / p 5e-30 | 9.8 EB05 5.8 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 8.4 | no trial data cached |
| Hypocalcaemia (low calcium) | 14 | 16.6 9.9–27.9ROR 16.8 · χ² 190 / p 2e-43 | 15.7 EB05 9.3 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.6 | no trial data cached |
| Pulmonary fibrosis | 11 | 12.9 7.2–23.2ROR 13.0 · χ² 109 / p 9e-26 | 11.1 EB05 5.8 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.8 | no trial data cached |
| Colon cancer | 11 | 16.5 9.2–29.7ROR 16.7 · χ² 145 / p 1e-33 | 15.2 EB05 8.0 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.0 | no trial data cached |
| Drug exposure during pregnancy | 9 | 5.8 3.0–11.2ROR 5.9 · χ² 31 / p 1e-8 | 4.6 EB05 2.6 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 3.9 | no trial data cached |
| Gastric cancer | 7 | 6.1 2.9–12.8ROR 6.1 · χ² 25 / p 3e-7 | 4.5 EB05 2.4 · IC025 +0.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.7 | no trial data cached |
| Premature baby | 6 | 4.4 2.0–9.9ROR 4.5 · χ² 13 / p 2e-4 | 3.5 EB05 1.8 · IC025 +0.4 | No label text to screen label has no adverse-reaction text | serious PRR 2.7 | no trial data cached |
| Abortion induced | 5 | 11.9 4.9–28.4ROR 11.9 · χ² 39 / p 2e-10 | 7.7 EB05 3.0 · IC025 +1.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.5 | 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 Iodide I 123?
In FDA FAERS, the most frequently co-reported reaction terms for Iodide I 123 are hypothyroidism, acute myeloid leukaemia, abortion spontaneous, hyperthyroidism, lacrimation increased, breast cancer. 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 I 123 have an FDA boxed warning?
No. The FDA label retrieved for Iodide I 123 has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Iodide I 123 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 493fa2ab-4eb0-4434-9739-3079b2f0e272, effective 20241017; matched on
openfda.generic_name.exact:"SODIUM IODIDE I 123") - 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.