Table 12: enumerates the incidence, rounded to the nearest percent, of treatment-emergent adverse reactions that occurred during acute therapy of bipolar depression (up to 8 weeks) in 1% or more of patients treated with SEROQUEL XR 300 mg/day where the incidence in patients treated with SEROQUEL XR was greater than the incidence in placebo-treated patients.

Table 12: Treatment-Emergent Adverse Reactions in an 8-Week Placebo-Controlled Clinical Trial for the Treatment of Bipolar Depression *   Table 12 
Body System/Preferred Term Placebo SEROQUEL XR
 (n=140) (n=137)
*
Reactions for which the SEROQUEL XR incidence was 1% or more and equal to or less than placebo are not listed in the table, but included the following: headache insomnia, nausea, diarrhea, vomiting, nasopharyngitis, upper respiratory tract infection, influenza, pain in extremity, cough and nasal congestion.
†
Somnolence combines adverse reaction terms somnolence and sedation.
‡
Extrapyramidal symptoms that were reported for SEROQUEL XR or placebo include the terms: akathisia, dystonia, extrapyramidal disorder, hypertonia, and tremor. 
Ear And Labyrinth Disorders
 
Ear Pain
 1%
 2%
 
Gastrointestinal Disorders
 
Dry Mouth
 7%
 37%
 
Constipation
 6%
 8%
 
Dyspepsia
 1%
 7%
 
Toothache
 0%
 3%
 
Abdominal Distension
 0%
 1%
 
General Disorders and Administration Site Conditions
 
Fatigue
 2%
 6%
 
Irritability
 3%
 4%
 
Immune System Disorders
  
Seasonal Allergy
 1%
 2%
 
Infections And Infestations
 
Viral Gastroenteritis
 1%
 4%
 
Urinary Tract Infection
 0%
 2%
 
Sinusitis
 1%
 2%
 
Investigations
 
Weight Gain
 1%
 7%
 
Heart Rate Increased
 0%
 2%
 
Metabolism and Nutrition Disorder
 
Increased Appetite
 6%
 12%
 
Decreased Appetite
 1%
 2%
Musculoskeletal And Connective Tissue Disorders
Arthralgia
 1%
 4%
 
Back Pain
 1%
 3%
 
Muscle Spasms
 1%
 3%
 
Myalgia
 1%
 2%
 
Neck Pain
 0%
 2%
 
Nervous System Disord