2%
1%
Gastrointestinal Disorders
Dry Mouth
8%
27%
40%
Constipation
4%
6%
11%
Nausea
7%
7%
8%
Dyspepsia
2%
2%
3%
Abdominal Distension
0%
0%
1%
Vomiting
1%
3%
1%
General Disorders and Administration Site Conditions
Fatigue
4%
14%
11%
Irritablility
3%
4%
2%
Chills
0%
1%
1%
Infections And Infestations
Upper Respiratory Tract Infection
2%
3%
2%
Influenza
0%
2%
1%
Injury, Poisoning And Procedural Complications
Fall
1%
2%
0%
Investigations
Weight Increased
0%
3%
5%
Metabolism And Nutrition Disorders
Increased Appetite
3%
3%
5%
Musculoskeletal And Connective Tissue Disorders
Back pain
1%
3%
3%
Muscle Spasms
1%
2%
1%
Nervous System Disorders
Somnolence†
9%
37%
43%
Dizziness
7%
11%
12%
Extrapyramidal Symptoms‡
4%
4%
6%
Hypersomnia
0%
1%
2%
Dysarthia
0%
1%
1%
Dysgeusia
0%
1%
1%
Lethargy
1%
2%
1%
Akathisia
1%
2%
2%
Psychiatric Disorders
Abnormal Dreams
1%
2%
2%
Anxiety
1%
2%
2%
Restlesness
1%
1%
2%
Libido Decreased
0%
0%
1%
Depression
1%
2%
1%
Adverse Reactions Occurring at an Incidence of 5% or More Among SEROQUEL XR Treated Patients in Long-Term, Placebo-Controlled Trials
In a longer-term placebo-controlled trial, adult patients with schizophrenia who remained clinically stable on SEROQUEL XR during open-label treatment for at least 4 months were randomized to placebo (n=103) or to continue on their current SEROQUEL XR (n=94) for up to 12 months of observation for possible relapse, the adverse reactions reported were generally consistent with those reported in the short-term, placebo-controlled trials. Insomnia (8.5%) and headache (7.4%) were the only adverse events reported by 5% or more patients.
Adverse Reactions that occurred in <5% of patients and were considered drug-related (incidence greater than placebo and consistent with known pharmacology of drug class) in order of decreasing frequency:
heart rate increased, hypotension, weight increased, tremor, akathisia, increased appetite, blurred vision, postural dizziness, pyrexia, dysarthria, dystonia, drooling, syncope, tardive dyskinesia, dysphagia, leukopen
