Adverse Reactions Occurring at an Incidence of 1% or More Among SEROQUEL XR Treated Patients in Short-Term, Placebo-Controlled Trials

Table 10 enumerates the incidence, rounded to the nearest percent, of treatment-emergent adverse reactions that occurred during acute therapy of schizophrenia (up to 6 weeks) in 1% or more in patients treated with SEROQUEL XR (doses ranging from 300 to 800 mg/day) where the incidence in patients treated with SEROQUEL XR was greater than the incidence in placebo-treated patients. Table 12:

Table 10:Treatment-Emergent Adverse Reaction Incidence in 6- Week Placebo-Controlled Clinical Trials for the Treatment of Schizophrenia1

Table 10:Treatment-Emergent Adverse Reaction Incidence in 6- Week Placebo-Controlled Clinical Trials for the Treatment of Schizophrenia *   Table 10 
Body System/Preferred Term PLACEBO SEROQUEL XR
 (n=319) (n=951)
*
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, and nausea, vomiting, diarrhea, stomach discomfort, weight increased, diastolic blood pressure decreased, systolic blood pressure decreased, arthralgia, back pain, pain in extremity, extrapyramidal disorder, agitation, psychotic disorder, sleep disorder, nasal congestion, hypertension.
†
Somnolence combines adverse reaction terms somnolence and sedation.
‡
Extrapyramidal symptoms that were reported for SEROQUEL XR or placebo include the terms: akathisia, cogwheel rigidity, drooling, dyskinesia dystonia, extrapyramidal disorder, hypertonia, movement disorder, muscle rigidity, oculogyration, parkinsonism, parkinsonian gait, psychomotor hyperactivity, tardive dyskinesia, restlessness and tremor. 
Cardiac Disorders
 
Tachycardia
 1%
 3%
 
Eye Disorders
 
Vision blurred
 1%
 2%
 
Gastrointestinal Disorders
 
Dry Mouth
 1%
 12%
 
Constipation
 5%
 6%
 
Dyspepsia
 2%
 5%
 
Toothache
 0%
 2%
 
General Disorders and Administration Site Conditions
 
Fatigue
 2%
 3%
 
Irritability
 0%
 1%
 
Pyrexia
 0%
 1%
 
Investigations
 
Heart Rate Increased
 1%
 4%
 
Metabolism and Nutrition Disorders
 
Increased Appetite
 0%
 2%
 
Musculoskeletal and Connective Tissue Disorders
 
Muscle Spasms
 1%
 2%
 
Nervous System Disorders
 
Somnolence†
 10%
 25%
 
Dizziness
 4%
 10%
 
Tremor
 1%
 2%
 
Akathisia
 1%
 2%
 
Extrapyramidal Symptoms‡
 5%
 8%
 
Psychiatric Disorders
 
Anxiety
 1%
 2%