Fludeoxyglucose F-18

What Fludeoxyglucose F-18 is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

Fludeoxyglucose F 18 Injection is indicated for positron emission tomography (PET) imaging in the following settings: Fludeoxyglucose F 18 Injection is indicated for positron emission tomography (PET) imaging in the following settings: Oncology …

— FDA label: Fludeoxyglucose F18, The Feinstein Institute for Medical Research, effective July 11, 2019. Read the full label on DailyMed →

Label quoted: the one for the most common form (injection, intravenous), Fludeoxyglucose F18, The Feinstein Institute for Medical Research; 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 24 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.

The label quoted above has no boxed warning.

0 of 24 FDA labels for this medicine have a boxed warning.

Fludeoxyglucose F-18 side effects

Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.

Hypersensitivity reactions with pruritus, edema and rash have been reported in the post-marketing setting. Have emergency resuscitation equipment and personnel immediately available. Hypersensitivity reactions have occurred; have emergency resuscitation equipment and personnel immediately available (6). To report SUSPECTED ADVERSE REACTIONS, contact The Feinstein Institute for Medical Research at 516-562-1042 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

— FDA label: Fludeoxyglucose F18, The Feinstein Institute for Medical Research, effective July 11, 2019. Read the full label on DailyMed →

Fludeoxyglucose F-18 drug interactions

Quoted from the “Drug Interactions” section of the FDA-approved label. Tell your pharmacist about every medicine, vitamin and herbal product you take.

The interaction of Fludeoxyglucose F 18 Injection with other drugs taken by patients undergoing PET imaging has not been studied.

— FDA label: Fludeoxyglucose F18, The Feinstein Institute for Medical Research, effective July 11, 2019. Read the full label on DailyMed →

Fludeoxyglucose F-18 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.

Fludeoxyglucose F 18 Injection emits radiation. Use procedures to minimize radiation exposure. Calculate the final dose from the end of synthesis (EOS) time using proper radioactive decay factors. Assay the final dose in a properly calibrated dose calibrator before administration to the patient [see Description (11.2)]. Fludeoxyglucose F 18 Injection emits radiation. Use procedures to minimize radiation exposure. Screen for blood glucose abnormalities.

Read more of this section

In the oncology and neurology settings, instruct patients to fast for 4 – 6 hours prior to the drug’s injection. Consider medical therapy and laboratory testing to assure at least two days of normoglycemia prior to the drug’s administration (5.2). In the cardiology setting, administration of glucose-containing food or liquids (e.g., 50 – 75 grams) prior to the drug’s injection facilitates localization of cardiac ischemia (2.3). Aseptically withdraw Fludeoxyglucose F 18 Injection from its container and administer by intravenous injection (2). The recommended dose: for adults is 5 – 10 mCi (185 – 370 MBq), in all indicated clinical settings (2.1). for pediatric patients is 2.6 mCi (96.2 MBq) in the neurology setting (2.2). Initiate imaging within 40 minutes following drug injection; acquire static emission images 30 – 100 minutes from time of injection (2). 2.1 Recommended Dose for Adults Within the oncology, cardiology and neurology settings, the recommended dose for adults is 5 – 10 mCi (185 – 370 MBq) as an intravenous injection. 2.2 Recommended Dose for Pediatric Patients Within the neurology setting, the recommended dose for pediatric patients is 2.6 mCi, as an intravenous injection. The optimal dose adjustment on the basis of body size or weight has not been determined [see Use in Special Populations (8.4)]. 2.3 Patient Preparation To minimize the radiation absorbed dose to the bladder, encourage adequate hydration. Encourage the patient to drink water or other fluids (as tolerated) in the 4 hours before their PET study. Encourage the patient to void as soon as the imaging study is completed and as often as possible thereafter for at least one hour. Screen patients for clinically significant blood glucose abnormalities by obtaining a history and/or laboratory tests [see Warnings and Precautions (5.2)]. Prior to Fludeoxyglucose F 18 PET imaging in the oncology and neurology settings, instruct patient to fast for 4 – 6 hours prior to the drug’s injection. In the cardiology setting, administration of glucose-containing food or liquids (e.g., 50 – 75 grams) prior to Fludeoxyglucose F 18 Injection facilitates localization of cardiac ischemia. 2.4 Radiation Dosimetry The estimated human absorbed radiation doses (rem/mCi) to a newborn (3.4 kg), 1-year old (9.8 kg), 5-year old (19 kg), 10-year old (32 kg), 15-year old (57 kg), and adult (70 kg) from intravenous administration of Fludeoxyglucose F 18 Injection are shown in Table 1. These estimates were calculated based on human 1 data and using the data published by the International Commission on Radiological Protection 2 for Fludeoxyglucose F 18. The dosimetry data show that there are slight variations in absorbed radiation dose for various organs in each of the age groups.

— FDA label: Fludeoxyglucose F18, The Feinstein Institute for Medical Research, effective July 11, 2019. This is part of the section. Read the full label on DailyMed →

Forms and how it is given

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.

• Biomedical Research Foundation of Northwest Louisiana2 products
• Massachusetts General Hospital1 product
• Barbara Ann Karmanos Cancer Hospital1 product
• Precision Nuclear LLC1 product
• Cardinal Health 414, LLC1 product
• SOFIE Co. dba SOFIE1 product
• 3D Imaging Drug Design and Development LLC1 product
• The University of Texas MD Anderson Cancer Center1 product
• The Methodist Hospital Research Institute1 product
• Mayo Clinic1 product
• The Regents of the University of Michigan1 product
• BAMF Health Inc.1 product
• The Feinstein Institute for Medical Research1 product
• UCSF Radiopharmaceutical Facility1 product
• Kettering Medical Center1 product
• PETNET Solutions, Inc.1 product
• SOFIE Co.1 product
• MIPS Cyclotron & Radiochemistry Facility1 product
• Jubilant DraxImage Inc., dba Jubilant Radiopharma1 product
• The University of Utah DBA Cyclotron Radiochemistry Lab Huntsman Cancer Institute1 product
• Washington University School of Medicine1 product
• UIHC P E T Imaging Center1 product
• The Brigham and Women`s Hospital, Inc.1 product
• Trustees of the University of Pennsylvania1 product
• Kreitchman PET Center1 product

FDA approval history

• NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
• ANDA: Abbreviated New Drug Application: how a generic version is approved.

Generic approvals (25)

• ANDA079086Petnet · February 25, 2011
• ANDA203612Mcprf · August 5, 2013
• ANDA203246Univ Tx Md Anderson · January 13, 2014
• ANDA203935Wusm Cyclotron · February 5, 2014
• ANDA203902Ucsf Rodiopharm · May 9, 2014
• ANDA203990Uihc Pet Imaging · August 6, 2014
• ANDA204333Ma General Hosp · September 25, 2014
• ANDA204463Sofie · October 21, 2014
• ANDA203801Trustees Univ Pa · October 29, 2014
• ANDA204385Barbara Ann Karmanos · October 29, 2014
• ANDA203816Brigham Womens · October 30, 2014
• ANDA204546Precision Nuclear · April 7, 2015
• ANDA203904Methodist Hosp Res · April 23, 2015
• ANDA203710Biomedcl Res Fdn · May 1, 2015
• ANDA203837Biomedcl Res Fdn · May 1, 2015
• ANDA203920Jubilant Draximage · June 23, 2015
• ANDA204498Univ Utah Cyclotron · June 23, 2015
• ANDA204531Univ Michigan · July 17, 2015
• ANDA203591Sofie · August 31, 2015
• ANDA204472Mips Crf · September 11, 2015
• ANDA204759Kettering Medctr · October 27, 2015
• ANDA2037783d Imaging Drug · October 30, 2015
• ANDA203603Cardinal Health 414 · November 13, 2015
• ANDA203942Kreitchman Pet Ctr · April 11, 2016
• ANDA216125Bamf · March 11, 2025

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

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.

1. February 17, 2021 · Class II · Terminated · D-0288-2021

   Lack of Assurance of Sterility

   Fludeoxyglucose F 18 Injection, 20-300 mCi/mL at End of Synthesis (EOS) Solution, 50 mL glass vial, Rx only, Manufactured by Massachusetts General Hospital PET Center, Boston, MA NDC 76318-334-50 — The General Hospital Corporation

Official identifiers

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
• Coronary artery diseaseCondition named on the label: hospitals that treat it
• Biomedical Research Foundation of Northwest LouisianaMaker or distributor
• Massachusetts General HospitalMaker or distributor
• Barbara Ann Karmanos Cancer HospitalMaker or distributor
• All prescription drugs A to ZSearch by generic, brand or Spanish name

Sources

1. FDA-approved label on DailyMed (National Library of Medicine) — Fludeoxyglucose F18, The Feinstein Institute for Medical Research, effective July 11, 2019; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
5. 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 →

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