"The U.S. Food and Drug Administration today approved Vizamyl (flutemetamol F 18 injection), a radioactive diagnostic drug for use with positron emission tomography (PET) imaging of the brain in adults being evaluated for Alzheimer's disease (AD) "...
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rate observed in clinical practice.
The overall safety profile of Neuraceq is based on data from 978 administrations of Neuraceq to 872 subjects and 12 subjects who received vehicle only. No serious adverse reactions related to Neuraceq administration have been reported. The most frequently observed adverse drug reactions in subjects receiving Neuraceq were injection site reactions consisting of erythema, irritation and pain. All adverse reactions were mild to moderate in severity and of short duration. The most commonly reported adverse reactions (occurring in at least 0.5% of subjects) during Neuraceq clinical trials are shown in Table 2.
Table 2 : Adverse Reactions with a Frequency
≥ 0.5% Reported in Clinical Trials (n = 978 Administrations in 872
|Adverse drug reaction||n (%)|
|Injection / application site erythema||17 (1.7)|
|Injection site irritation||12 (1.2)|
|Injection site pain||38 (3.9)|
Read the Neuraceq (florbetaben f 18 injection) Side Effects Center for a complete guide to possible side effects
Drug-drug interaction studies have not been performed in patients to establish the extent, if any, to which concomitant medications may alter Neuraceq image results.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 3/31/2014
Additional Neuraceq Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Get breaking medical news.