Drug · FAERS side-effect profile with label screen

Rubidium Rb-82 side effects: what 115 FDA adverse event reports show

Rubidium Chloride Rb-82 · 3 reaction terms · 123 drug–reaction co-reports · data 2026-09-14

Drug class

Radioactive diagnostic agent

FDA label, Indications wording of the closest related product

Label matched

Rubidium Chloride Rb-82 (Cardiogen-82)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

115 reports · 33% serious · 0 with death outcome · 53% female

openFDA FAERS counts, all years, deduplication not applied

Used for

CardioGen-82, used to produce Rubidium Chloride Rb 82 Injection, is indicated for positron emission tomography (PET) of the myocardium under rest or pharmacologic stress conditions to evaluate regional myocardial perfusion in adult patients with suspected or existing coronary artery disease.

FDA label, Indications and Usage

What it is

11.1 Generator Characteristics CardioGen-82 (rubidium Rb 82 generator) contains accelerator-produced Sr 82 adsorbed on stannic oxide in a lead-shielded column and provides a means to produce sterile nonpyrogenic Rubidium Chloride Rb 82 Injection, a radioactive diagnostic agent, for intravenous use.

FDA label, Description section

Boxed warning

HIGH LEVEL RADIATION EXPOSURE WITH USE OF INCORRECT ELUENT and FAILURE TO FOLLOW THE ELUATE TESTING PROTOCOL High Level Radiation Exposure with Use of Incorrect Eluent Patients are exposed to high radiation levels when the CardioGen-82 generator is eluted with the incorrect eluent due to high strontium (Sr) 82 and Sr 85 breakthrough levels.

FDA 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

Reporting / coding artifact 3

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.

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
Product preparation error	21	183.5 124.6–270.3ROR 223.8 · χ² 3,631 / p <1e-300	157.3 EB05 108.6 · IC025 +4.4 3/3 methods agree	Reporting / coding artifact	serious n=1	no trial data cached
Expired product administered	26	141.8 101.0–198.9ROR 182.4 · χ² 3,497 / p <1e-300	128.5 EB05 92.1 · IC025 +4.6 3/3 methods agree	Reporting / coding artifact	serious n=10	no trial data cached
No adverse event	76	77.5 67.9–88.4ROR 222.8 · χ² 5,708 / p <1e-300	76.0 EB05 62.7 · IC025 +5.3 3/3 methods agree	Reporting / coding artifact	serious PRR 823.8	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
No adverse event	76	77.5 67.9–88.4ROR 222.8 · χ² 5,708 / p <1e-300	76.0 EB05 62.7 · IC025 +5.3 3/3 methods agree	Reporting / coding artifact	serious PRR 823.8	no trial data cached
Expired product administered	26	141.8 101.0–198.9ROR 182.4 · χ² 3,497 / p <1e-300	128.5 EB05 92.1 · IC025 +4.6 3/3 methods agree	Reporting / coding artifact	serious n=10	no trial data cached
Product preparation error	21	183.5 124.6–270.3ROR 223.8 · χ² 3,631 / p <1e-300	157.3 EB05 108.6 · IC025 +4.4 3/3 methods agree	Reporting / coding artifact	serious n=1	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 Rubidium Rb-82?

In FDA FAERS, the most frequently co-reported reaction terms for Rubidium Rb-82 are listed in the table above. 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 Rubidium Rb-82 have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: HIGH LEVEL RADIATION EXPOSURE WITH USE OF INCORRECT ELUENT and FAILURE TO FOLLOW THE ELUATE TESTING PROTOCOL High Level Radiation Exposure with Use of Incorrect Eluent Patients are exposed to high radiation levels when the CardioGen-82 generator is eluted with the incorrect eluent due to high strontium (Sr) 82 and Sr 85 breakthrough levels.

Do FAERS signals prove that Rubidium Rb-82 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 ee95aa18-9f2f-40eb-9b4c-583bea6f36bf, effective 20260514; matched on openfda.generic_name.exact:"RUBIDIUM CHLORIDE RB-82")
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.