Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS No adverse reactions have been reported for Sodium Fluoride F-18 Injection, USP, 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, USP, based on a review of the published literature, publicly available reference sources, and adverse drug reaction reporting systems ( 6 ).
To report SUSPECTED ADVERSE REACTIONS, contact Cardinal Health at 1-800-618-2768 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
5 WARNINGS AND PRECAUTIONS • Allergic Reactions: As with any injectable drug product, allergic reactions and anaphylaxis may occur.
Emergency resuscitation equipment and personnel should be immediately available ( 5.1 ).
• Cancer Risk: Sodium Fluoride F-18 Injection, USP, may increase the risk of cancer.
Use the smallest dose necessary for imaging and ensure safe handling to protect the patient and health care worker ( 5.2 ).
5.1 Allergic Reactions As with any injectable drug product, allergic reactions and anaphylaxis may occur.
Like all medications, Sodium Fluoride F18 can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: