Quick answers
- What is Rubidium chloride RB-82 used for?
- The FDA-approved label (CardioGen-82, Bracco Diagnostics Inc, May 14, 2026) says: “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. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the side effects of Rubidium chloride RB-82?
- The “Adverse Reactions” section of the FDA label (CardioGen-82, Bracco Diagnostics Inc, May 14, 2026) begins: “The following clinically significant adverse reactions are described elsewhere in the labeling: High Level Radiation Exposure with Use of Incorrect Eluent [see Warnings and Precautions (5.1)] Excess Radiation Exposure with Failure to Follow Eluate Testing Protocol [see Warnings and Precautions (5.2)] The following serious adverse reactions have been identified during post-approval use of CardioGen-82.” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Rubidium chloride RB-82 have a boxed warning?
- Yes. The FDA label for CardioGen-82 has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Rubidium chloride RB-82?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Rubidium chloride RB-82 been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started June 1, 2012 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Rubidium chloride RB-82?
- 2 companies list prescription products of Rubidium chloride RB-82 in the FDA NDC Directory, including Bracco Diagnostics Inc and Jubilant DraxImage Inc., dba Jubilant Radiopharma.
What Rubidium chloride RB-82 is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
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: CardioGen-82, Bracco Diagnostics Inc, effective May 14, 2026. Read the full label on DailyMed →
Label quoted: the one for the most common form (injection, solution, intravenous), CardioGen-82, Bracco Diagnostics Inc; it covers 1 product in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.
The FDA has 2 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
2 of 2 FDA labels for this medicine have a boxed warning.
Rubidium chloride RB-82 boxed warning: what the label says
Quoted from the boxed warning of the FDA-approved label.
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. Use only additive-free 0.9% Sodium Chloride Injection to elute the generator.
Read more of this section
If an incorrect solution is used to elute the CardioGen-82 generator: Immediately stop the patient infusion; Evaluate the patient’s radiation absorbed dose, and monitor for the effects of radiation to critical organs such as bone marrow; Permanently discontinue the use of the affected generator [see Dosage and Administration (2.5) and Warnings and Precautions (5.1)]. Excess Radiation Exposure with Failure to Follow the Eluate Testing Protocol Excess radiation exposure occurs when the levels of Sr 82 or Sr 85 in the Rubidium Chloride Rb 82 Injection exceed specified limits. Strictly adhere to the generator eluate testing protocol, to minimize the risk of excess radiation exposure, including daily testing and additional testing at Alert Limits. Stop using the generator if it reaches any of its Expiration Limits: 17 L for the generator’s cumulative eluate volume 60 days post generator calibration date An eluate Sr 82 level of 0.01 microCi /mCi Rb 82 An eluate Sr 85 level of 0.1 microCi /mCi Rb 82 [see Dosage and Administration (2.5, 2.6, 2.7, 2.8) and Warnings and Precautions (5.2)] WARNING: HIGH LEVEL RADIATION EXPOSURE WITH USE OF INCORRECT ELUENT and FAILURE TO FOLLOW THE ELUATE TESTING PROTOCOL See full prescribing information for complete boxed warning. High Level Radiation Exposure with Use of Incorrect Eluent Using the incorrect eluent can cause high Strontium (Sr) 82 and Sr 85 breakthrough levels. Use only additive-free 0.9% Sodium Chloride Injection to elute CardioGen-82. If an incorrect solution is used to elute CardioGen-82: Immediately stop the patient infusion; Evaluate the patient’s radiation absorbed dose and monitor for the effects of radiation to critical organs such as bone marrow; Permanently discontinue use of the affected generator. (2.5, 2.9, 5.1) Excess Radiation Exposure with Failure to Follow the Eluate Testing Protocol Excess radiation exposure occurs when the levels of Sr 82 or Sr 85 in the Rubidium Chloride Rb 82 Injection exceed limits. Strictly adhere to the generator eluate testing protocol. Stop using the generator if it reaches any of its Expiration Limits. (2.5, 2.6, 2.7, 5.2)
— FDA label: CardioGen-82, Bracco Diagnostics Inc, effective May 14, 2026. Read the full label on DailyMed →
Rubidium chloride RB-82 side effects
Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.
The following clinically significant adverse reactions are described elsewhere in the labeling: High Level Radiation Exposure with Use of Incorrect Eluent [see Warnings and Precautions (5.1)] Excess Radiation Exposure with Failure to Follow Eluate Testing Protocol [see Warnings and Precautions (5.2)] The following serious adverse reactions have been identified during post-approval use of CardioGen-82.
Read more of this section
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Radiation Exposure High level radiation exposure to the bone marrow from using an incorrect eluent. Excess radiation exposure due to insufficient eluate testing. To report SUSPECTED ADVERSE REACTIONS, contact Bracco Diagnostics Inc. at 1-800-257-8151 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
— FDA label: CardioGen-82, Bracco Diagnostics Inc, effective May 14, 2026. Read the full label on DailyMed →
Rubidium chloride RB-82 dosage
Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.
Dosing: 10 MBq/kg to 30 MBq/kg actual body weight (0.27 mCi/kg to 0.81 mCi/kg) per rest or stress component of a procedure via intravenous infusion at 50 mL/minute or 20 mL/minute. (2.2) Do not exceed a maximum dose of 2,220 MBq (60 mCi) or a maximum volume of 100 mL per rest or stress component of a procedure. (2.2) The minimum interval between the rest and stress doses is 10 minutes to allow sufficient Rb 82 decay.
Read more of this section
(2.2) Start image acquisition 60 seconds to 90 seconds after completion of the infusion; if a longer circulation time is anticipated, wait for 120 seconds. Image acquisition is 5 minutes long. (2.3) For radiation safety, infusion system, elution instruction, eluate testing, dose delivery, and expiration limits of CardioGen-82, and radiation dosimetry see full prescribing information. (2.1, 2.5, 2.6, 2.7, 2.8, 2.9) 2.1 Radiation Safety - Drug Handling CardioGen-82, when eluted with additive-free 0.9% Sodium Chloride Injection, produces Rubidium Chloride Rb 82 Injection. Handle CardioGen-82, Rubidium Chloride Rb 82 Injection, and Infusion Systems with appropriate safety measures to minimize radiation exposure. Wear waterproof gloves and effective shielding throughout the entire preparation and handling [See Warnings and Precautions (5.4)]. Limit the use of radiopharmaceuticals to healthcare providers who are qualified by specific training and experience in the safe use and handling of radionuclides and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides. 2.2 Dosing and Administration of Rubidium Chloride Rb 82 Injection Dosing The recommended dose of Rubidium Chloride Rb 82 Injection per rest or stress component of a PET MPI procedure in adults is 10 MBq/kg to 30 MBq/kg actual body weight (0.27 mCi/kg to 0.81 mCi/kg) administered by intravenous infusion at 50 mL/minute or 20 mL/minute through a catheter inserted into a large peripheral vein. Do not exceed a maximum dose of 2,220 MBq (60 mCi) or a maximum volume of 100 mL per rest or stress component of a procedure. Administration Instructions Observe aseptic techniques in all drug handling and administration. Use CardioGen-82 with the CardioGen-82 Model 1700 Infusion System to elute and administer Rubidium Chloride Rb 82 Injection. Use the lowest dose necessary, consistent with the goal of as low as reasonably achievable (ALARA), to obtain adequate cardiac visualization based on patient body weight and the imaging equipment and acquisition methodology used to perform the procedure. For example, 3D image acquisition may require doses at the lower end of the recommended range, compared to 2D imaging. Administer two single doses to complete rest and stress myocardial perfusion imaging (MPI) [see Dosage and Administration (2.3)]. The minimum interval between the rest and stress doses is 10 minutes to allow sufficient Rb 82 decay. Instruct patients to void as soon as a study is completed and as often as possible thereafter for at least one hour [see Warnings and Precautions (5.4)]. 2.3 Image Acquisition Instructions Rest Imaging Administer a single dose of Rubidium Chloride Rb 82 Injection.
— FDA label: CardioGen-82, Bracco Diagnostics Inc, effective May 14, 2026. This is part of the section. Read the full label on DailyMed →
Rubidium chloride RB-82 in pregnancy
Quoted from the pregnancy part of the FDA-approved label. Ask your doctor before you take any medicine while pregnant or planning a pregnancy.
Risk Summary There are no data available on the use of rubidium chloride Rb 82 in pregnant women. Animal reproductive studies have not been conducted with rubidium chloride Rb 82. However, all radiopharmaceuticals, including Rubidium Chloride Rb 82 Injection generated by CardioGen-82, have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose.
Read more of this section
If considering Rubidium Chloride Rb 82 Injection administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from rubidium-82 (Rb 82) and the gestational timing of exposure. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
— FDA label: CardioGen-82, Bracco Diagnostics Inc, effective May 14, 2026. Read the full label on DailyMed →
Forms and how it is given
| Dosage forms | Injection, solution |
|---|---|
| Route | Intravenous |
| Prescription products | 2 in the FDA NDC Directory |
| Brand names | Cardiogen-82, Ruby-Fill |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Bracco Diagnostics Inc1 product
- Jubilant DraxImage Inc., dba Jubilant Radiopharma1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
June 1, 2012 · Class II · Terminated · D-1684-2012
GMP deviation; Sr-82 levels exceeded alert limit specification
CARDIOGEN-82 (Rubidium Rb 82 Generator), 140 millicurie, Rx Only, For Elution of sterile nonpyrogenic Rubidium Chloride Rb 82, Manufactured for: Bracco Diagnostics Inc. Princeton, NJ 08543 by Medi-Physics, Inc. South Pla — Bracco Diagnostics Inc
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| SPL set ID of the quoted label | ee95aa18-9f2f-40eb-9b4c-583bea6f36bf |
|---|---|
| FDA labels (SPL) | 2 |
| FDA applications | NDA019414, NDA202153 |
| Active ingredients (FDA) | RUBIDIUM CHLORIDE RB-82 |
Next steps
- Find a pharmacy near youAsk which price applies to you and whether your product is affected by a recall
- Latest FDA drug recallsAll medicines, newest first
- CardioGen-82Brand page: products, maker and price
- Ruby-FillBrand page: products, maker and price
- Coronary artery diseaseCondition named on the label: hospitals that treat it
- Bracco Diagnostics IncMaker or distributor
- Jubilant DraxImage Inc., dba Jubilant RadiopharmaMaker or distributor
- All prescription drugs A to ZSearch by generic, brand or Spanish name
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — CardioGen-82, Bracco Diagnostics Inc, effective May 14, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →