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Label Changes for:

Seroquel (quetiapine fumarate) and Seroquel XR (quetiapine fumarate)

June 2016

Changes have been made to the ADVERSE REACTIONS sections of the safety label.

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

June 2016


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


  • 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.