"Today, the U.S. Food and Drug Administration issued a proposal designed to assist companies developing new treatments for patients in the early stages of Alzheimer's disease, before the onset of noticeable (overt) dementia.
- Clinician Information:
Amyvid Side Effects Center
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Amyvid FDA Prescribing Information: Side Effects
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 rates observed in clinical practice.
In clinical studies, 496 patients were exposed to Amyvid. Amyvid caused no serious adverse reactions in the studies and the reported adverse reactions were predominantly mild to moderate in severity. The adverse reactions reported in more than one subject within the studies are shown in Table 2.
Table 2: Adverse Reactions
Reported in Clinical Trials (N=496 patients)
|Adverse Reactions||N (Percent of patients)|
|Musculoskeletal pain||4 (0.8%)|
|Back pain||2 (0.4%)|
|Blood pressure increased||2 (0.4%)|
|Feeling cold||2 (0.4%)|
|Neck pain||2 (0.4%)|
Read the entire FDA prescribing information for Amyvid (Florbetapir F 18 Injection) »
Additional Amyvid 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.
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