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U.S. Department of Health and Human Services

Safety

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Seroquel XR (quetiapine fumarate) Extended-Release tablets

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

 

October 2013

Summary View

ADVERSE REACTIONS

Post-Marketing Experience
  • rhabdomyolysis 

 

December 2009

Summary View

WARNINGS and PRECAUTIONS

Hyperglycemia
  • Table 2 and 3 added
  • Adults: In a 24-week trial (active-controlled, 115 patients treated with Seroquel) designed to evaluate glycemic status with oral glucose...
    • In 2 long-term placebo-controlled randomized withdrawal clinical trials for bipolar maintenance...
  • Children and Adolescents: Safety and effectiveness of Seroquel XR have not been established in pediatric patients and Seroquel XR is not approved for patients under the age of 18 years...
Hyperlipidemia
  • new section added
  • Table 4, 5, and 6 added
Weight Gain
  • new section added
  • Table 7, 8, and 9 added
Increases in Blood Pressure (Children and Adolescents) 
  • Safety and effectiveness of Seroquel XR have not been established in pediatric patients and Seroquel XR is not approved for patients under the age of 18 years. 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.
Potential for Cognitive and Motor Impairment
  • In short-term adjunctive therapy trials for MDD, somnolence was reported in 40% (252/627) of patients on Seroquel XR respectively compared to 9% (27/309) of placebo patients. Somnolence was dose related in these trials (37% (117/315) and 43% (135/312) for the 150 mg and 300 mg groups, respectively).
Suicide
  • In two, 6-week MDD adjunctive therapy trials (n=936, 627on Seroquel XR and 309 on placebo) the incidence of treatment emergent suicidal ideation or suicide attempt was 0.5% (n=3) in Seroquel XR treated patients and 0.6% (n=2) in placebo.