Table 11 enumerates the incidence, rounded to the nearest percent, of treatment-emergent adverse reactions that occurred during acute therapy of bipolar mania (up to 3 weeks) in 1% or more of patients treated with SEROQUEL XR (doses ranging from 400 to 800 mg/day) where the incidence in patients treated with SEROQUEL XR was greater than the incidence in placebo-treated patients.

Table 11: Treatment-Emergent Adverse Reactions in a 3-Week Placebo-Controlled Clinical Trial for the Treatment of Bipolar Mania *   Table 11 
Body System/Preferred Term PLACEBO SEROQUEL XR
 n=160 n=151
*
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, peripheral edema, diarrhea, nausea, vomiting, decreased appetite, muscle spasms, musculoskeletal stiffness, myalgia, tremor, akathisia, insomnia, agitation, nightmare, restlessness, erectile dysfunction, pharyngolaryngeal pain, cough, and hypotension.
†
Extrapyramidal symptoms that were reported for SEROQUEL XR or placebo include the terms: akathisia, cogwheel rigidity, dystonia, extrapyramidal disorder, restlessness and tremor.
‡
Somnolence combines adverse reaction terms somnolence and sedation. 
Cardiac Disorders
 
Tachycardia
 1%
 2%
 
Eye Disorders
 
Vision blurred
 1%
 2%
 
Gastrointestinal Disorders
 
Dry Mouth
 7%
 34%
 
Constipation
 3%
 10%
 
Dyspepsia
 4%
 7%
 
Toothache
 1%
 3%
 
General Disorders and Administration Site Conditions
 
Fatigue
 4%
 7%
 
Sluggishness
 1%
 2%
 
Pain
 0%
 1%
 
Investigations
 
Weight Gain
 1%
 7%
 
Heart Rate Increased
 0%
 3%
 
Injury, Poisoning And Procedural Complications
 
Contusion
 0%
 1%
 
Metabolism and Nutrition Disorder
 
Increased Appetite
 2%
 4%
 
Nervous System Disorders
 
Extrapyramidal Symptoms†
 4%
 7%
 
Somnolence‡
 12%
 50%
 
Dizziness
 4%
 10%
 
Dysarthia
 0%
 5%
 
Lethargy
 1%
 2%
 
Postural Dizziness
 0%
 1%
 
Musculoskeletal And Connective Tissue Disorders
 
Back Pain
 2%
 3%
 
Arthralgia
 0%
 1%