Safety

Seroquel and Seroquel XR (Quetiapine Fumarate)

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

June 2016

Summary View

ADVERSE REACTIONS

Post Marketing Experience
  • Adverse reactions reported since market introduction which were temporally related to quetiapine therapy include (addition of)… drug reaction with eosinophilia and systemic symptoms (DRESS),...

 

April 2013

Summary View

WARNINGS AND PRECAUTIONS

  • Cerebrovascular Adverse Reactions, Including Stroke, in Elderly Patients with Dementia-Related Psychosis - In placebo-controlled trials with risperidone, aripiprazole, and olanzapine in elderly subjects with dementia, there was a higher incidence of cerebrovascular adverse reactions (cerebrovascular accidents and transient ischemic attacks) including fatalities compared to placebo-treated subjects.  Seroquel/Seroquel XR is not approved for the treatment of patients with dementia-related psychosis.

 

Page Last Updated: 07/07/2016
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