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 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, MIPS Cyclotron & Radiochemistry Facility at 650-725-4182 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
5 WARNINGS AND PRECAUTIONS Radiation risks: use smallest dose necessary for imaging (5.1) .
Blood glucose abnormalities: may cause suboptimal imaging (5.2) .
5.1 Radiation Risks Radiation-emitting products, including Fludeoxyglucose F 18 Injection, may increase the risk for cancer, especially in pediatric patients.
Use the smallest dose necessary for imaging and ensure safe handling to protect the patient and health care worker[ see Dosage and Administration (2.5) ].
5.2 Blood Glucose Abnormalities In the oncology and neurology setting, suboptimal imaging may occur in patients with inadequately regulated blood glucose levels.
Like all medications, Fludeoxyglucose 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: