Ioflupane I-123 side effects: what 532 FDA adverse event reports show

Ioflupane I-123 · Ioflupane I 123 · 3 reaction terms · 341 drug–reaction co-reports · data 2026-09-14

Drug class

Radioactive Diagnostic Agent

FDA label (Established Pharmacologic Class) · compare the class

Brand names

Ioflupane I 123

openFDA label

Who reports

532 reports · 17% serious · 7 with death outcome · 57% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Ioflupane I 123 Injection is indicated as an adjunct to other diagnostic evaluations for striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imaging in adult patients with: ● suspected Parkinsonian syndromes (PS) or ● suspected dementia with Lewy bodies (DLB).

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 3 strongest signals

Labeled adverse reaction 1Likely indication confounding 1Reporting / coding artifact 1

What the badges mean

Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
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.

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. 0 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Parkinsonism	24	97.2 65.7–143.8ROR 101.8 · χ² 2,186 / p <1e-300	90.2 EB05 63.8 · IC025 +4.4 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 390.6 · 100% clinician	no trial data cached
No adverse event	258	57.4 52.6–62.7ROR 110.5 · χ² 14,346 / p <1e-300	57.1 EB05 51.5 · IC025 +5.5 3/3 methods agree	Reporting / coding artifact	serious PRR 25.4 · 100% clinician	no trial data cached
Injection site pain (pain where injected)	59	7.7 6.0–9.7ROR 8.5 · χ² 340 / p 3e-76	7.3 EB05 5.9 · IC025 +2.4 3/3 methods agree	Labeled adverse reaction exact term	98% 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
No adverse event	258	57.4 52.6–62.7ROR 110.5 · χ² 14,346 / p <1e-300	57.1 EB05 51.5 · IC025 +5.5 3/3 methods agree	Reporting / coding artifact	serious PRR 25.4 · 100% clinician	no trial data cached
Injection site pain (pain where injected)	59	7.7 6.0–9.7ROR 8.5 · χ² 340 / p 3e-76	7.3 EB05 5.9 · IC025 +2.4 3/3 methods agree	Labeled adverse reaction exact term	98% clinician	no trial data cached
Parkinsonism	24	97.2 65.7–143.8ROR 101.8 · χ² 2,186 / p <1e-300	90.2 EB05 63.8 · IC025 +4.4 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 390.6 · 100% clinician	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 Ioflupane I-123?

In FDA FAERS, the most frequently co-reported reaction terms for Ioflupane I-123 are injection site pain, parkinsonism. 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 Ioflupane I-123 have an FDA boxed warning?

No. The FDA label retrieved for Ioflupane I-123 has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Ioflupane 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 66d20aee-4530-48dd-a483-ed7604b36d97, effective 20221216; matched on openfda.generic_name.exact:"IOFLUPANE 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, field patient.drug.openfda.generic_name.exact, 3 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.