Sodium fluoride F-18

What Sodium fluoride F-18 is used for

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

Sodium Fluoride F 18 Injection is indicated for diagnostic positron emission tomography (PET) imaging of bone to define areas of altered osteogenic activity. Sodium Fluoride F 18 Injection is a radioactive diagnostic agent for positron emission tomography (PET) indicated for imaging of bone to define areas of altered osteogenic activity.

— FDA label: Sodium Fluoride F 18, 3D Imaging Drug Design and Development LLC, effective January 7, 2026. Read the full label on DailyMed →

Label quoted: the one for the most common form (injection, intravenous), Sodium Fluoride F 18, 3D Imaging Drug Design and Development LLC; 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 9 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.

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 9 FDA labels for this medicine have a boxed warning.

Sodium fluoride 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.

No adverse reactions have been reported for Sodium Fluoride F 18 Injection based on a review of the published literature, publicly available reference sources, and adverse drug reaction reporting systems. However, the completeness of these sources is not known. No adverse reactions have been reported for Sodium Fluoride F 18 Injection based on a review of the published literature, publicly available reference sources, and adverse drug reaction reporting systems (6).

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To report SUSPECTED ADVERSE REACTIONS, contact 3D Imaging at 1-501-526-5550 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

— FDA label: Sodium Fluoride F 18, 3D Imaging Drug Design and Development LLC, effective January 7, 2026. Read the full label on DailyMed →

Sodium fluoride 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 possibility of interactions of Sodium Fluoride F 18 Injection with other drugs taken by patients undergoing PET imaging has not been studied.

— FDA label: Sodium Fluoride F 18, 3D Imaging Drug Design and Development LLC, effective January 7, 2026. Read the full label on DailyMed →

Sodium fluoride 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.

Sodium Fluoride F18 Injection emits radiation and must be handled with appropriate safety measures (2.1). Administer 300-450 MBq (8 to 12 mCi) as an intravenous injection in adults (2.4). Administer approximately 2.1 MBq/kg in children with a minimum of 19 MBq (0.5 mCi) and a maximum of 148 MBq (4 mCi) as an intravenous injection (2.5). Imaging can begin 1–2 hours after administration; optimally at one hour post administration (2.7).

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Encourage patients to void immediately prior to imaging the lumbar spine and bony pelvis (2.7). 2.1 Radiation Safety - Drug Handling Wear waterproof gloves and effective shielding when handling Sodium Fluoride F 18 Injection. Use appropriate safety measures, including shielding, consistent with proper patient management to avoid unnecessary radiation exposure to the patient, occupational workers, clinical personnel, and other persons. Radiopharmaceuticals should be used by or under the control of physicians 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 governmental agency authorized to license the use of radionuclides. Use aseptic technique to maintain sterility during all operations involved in the manipulation and administration of Sodium Fluoride F 18 Injection. The dose of Sodium Fluoride F 18 Injection should be minimized consistent with the objectives of the procedure, and the nature of the radiation detection devices employed. The final dose for the patient should be calculated using proper decay factors from the time of EOS, and measured by a suitable radioactivity calibration system before administration [Description (11.2)]. 2.2 Radiation Safety - Patient Preparation To minimize the radiation-absorbed dose to the bladder, encourage adequate hydration. Encourage the patient to ingest at least 500 mL of fluid immediately prior and subsequent to the administration of Sodium Fluoride F 18 Injection. Encourage the patient to void one-half hour after administration of Sodium Fluoride F 18 Injection and as frequently thereafter as possible for the next 12 hours. 2.3 Drug Preparation and Administration Calculate the necessary volume to administer based on calibration time and dose. Inspect Sodium Fluoride F 18 Injection visually for particulate matter and discoloration before administration, whenever solution and container permit. Do not administer Sodium Fluoride F 18 Injection containing particulate matter or discoloration; dispose of these unacceptable or unused preparations in a safe manner, in compliance with applicable regulations. Aseptically withdraw Sodium Fluoride F 18 Injection from its container. 2.4 Recommended Dose for Adults Administer 300–450 MBq (8–12 mCi) as an intravenous injection. 2.5 Recommended Dose for Pediatric Patients In reported clinical experience in approximately 100 children, weight based doses (2.1 MBq/kg) ranging from 19 MBq– 148 MBq (0.5 mCi- 4 mCi) were used. 2.6 Radiation Dosimetry The age/weight- based estimated absorbed radiation doses (mGy/MBq) from intravenous injection of Sodium Fluoride F 18 Injection are shown in Table 1.

— FDA label: Sodium Fluoride F 18, 3D Imaging Drug Design and Development LLC, effective January 7, 2026. This is part of the section. Read the full label on DailyMed →

Sodium fluoride F-18 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.

Pregnancy Category C Any radiopharmaceutical including Sodium Fluoride F18 Injection has a potential to cause fetal harm. The likelihood of fetal harm depends on the stage of fetal development, and the radionuclide dose. Animal reproduction studies have not been conducted with Sodium Fluoride F 18 Injection. Prior to the administration of Sodium Fluoride F 18 Injection to women of childbearing potential, assess for presence of pregnancy.

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Sodium Fluoride F 18 Injection should be given to a pregnant woman only if clearly needed.

— FDA label: Sodium Fluoride F 18, 3D Imaging Drug Design and Development LLC, effective January 7, 2026. Read the full label on DailyMed →

Sodium fluoride F-18 and breastfeeding

Quoted from the nursing mothers / lactation part of the FDA-approved label.

It is not known whether Sodium Fluoride F 18 Injection is excreted into human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to interrupt nursing after administration of Sodium Fluoride F 18 Injection or not to administer Sodium Fluoride F 18 Injection, taking into account the importance of the drug to the mother.

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The body of scientific information related to radioactivity decay, drug tissue distribution and drug elimination shows that less than 0.01% of the radioactivity administered remains in the body after 24 hours (10 half-lives). To minimize the risks to a nursing infant, interrupt nursing for at least 24 hours.

— FDA label: Sodium Fluoride F 18, 3D Imaging Drug Design and Development LLC, effective January 7, 2026. 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.

• PETNET Solutions, Inc.1 product
• Kreitchman PET Center1 product
• Cardinal Health 414, LLC1 product
• The University of Utah DBA Cyclotron Radiochemistry Lab Huntsman Cancer Institute1 product
• BAMF Health Inc.1 product
• Mayo Clinic1 product
• The Feinstein Institutes for Medical Research1 product
• SOFIE Co.1 product
• 3D Imaging Drug Design and Development LLC1 product
• Biomedical Research Foundation of Northwest Louisiana1 product
• Precision Nuclear LLC1 product

FDA approval history

• ANDA: Abbreviated New Drug Application: how a generic version is approved.

Generic approvals (10)

• ANDA203605Mcprf · June 28, 2013
• ANDA204328The Feinstein Inst · November 19, 2014
• ANDA204351Biomedcl Res Fdn · January 9, 2015
• ANDA204542Precision Nuclear · February 27, 2015
• ANDA204497Univ Utah Cyclotron · April 20, 2015
• ANDA203780Cardinal Health 414 · July 30, 2015
• ANDA203592Sofie · August 18, 2015
• ANDA203890Petnet · September 28, 2015
• ANDA2037773d Imaging Drug · October 19, 2015
• ANDA203936Kreitchman Pet Ctr · May 19, 2016

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.

Official identifiers

Next steps

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• PETNET Solutions, Inc.Maker or distributor
• Kreitchman PET CenterMaker or distributor
• Cardinal Health 414, LLCMaker or distributor
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Sources

1. FDA-approved label on DailyMed (National Library of Medicine) — Sodium Fluoride F 18, 3D Imaging Drug Design and Development LLC, effective January 7, 2026; 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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