• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services


  • Print
  • Share
  • E-mail

Seroquel (quetiapine fumarate) tablets

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


May 2011

Summary View


Tardive Dyskinesia
  • Addition of text regarding tardive dyskinesia syndrome may arise after discontinuation of treatment
  • Addition of the incidence rates of discontinuation symptoms
Drug Interactions
  • False positive urine drug screens using immunoassays for methadone or tricyclic antidepressants have been reported in patients taking quetiapine.
Adverse Reactions
  • Decreases in hemoglobin to ≤ 13 g/dl males and ≤ 12 g/dl females



December 2009

Summary View



  • Adults: 
    • Table 2: Fasting Glucose—Proportion of Patients Shifting to ≥ 126 mg/dL in short-term (≤ 12 weeks) Placebo Controlled Studies...and trial information (addition)
  • Children and Adolescents: In a placebo-controlled Seroquel monotherapy study of adolescent patients...
  • new section addition
Weight Gain
  • new section added
Increases in Blood Pressure in Children and Adolescents
  • In placebo-controlled trials in children and adolescents with schizophrenia (6-week duration) or bipolar mania (3-week duration), the incidence of increases at any time in systolic blood pressure (≥20 mmHg) was 15.2% (51/335) for Seroquel and 5.5% (9/163) for placebo; the incidence of increases at any time in diastolic blood pressure (≥10 mmHg) was 40.6% (136/335) for Seroquel and 24.5% (40/163) for placebo. In the 26-week open-label clinical trial, one child with a reported history of hypertension experienced a hypertensive crisis. Blood pressure in children and adolescents should be measured at the beginning of, and periodically during treatment.