Seroquel - Side Effects & Drug Interactions

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

The prescriber should be aware that the figures in the tables and tabulations cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators.

The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and nondrug factors to the side effect incidence in the population studied. In these studies, the most commonly observed adverse events associated with the use of SEROQUEL (incidence of 5% or greater) and observed at a rate on SEROQUEL at least twice that of placebo were dizziness (10%), postural hypotension (7%), dry mouth (7%), and dyspepsia (6%).

Table 1 enumerates the incidence, rounded to the nearest percent, of treatment-emergent adverse events that occurred during acute therapy (up to 6 weeks) of schizophrenia in 1% or more of patients treated with SEROQUEL (doses ranging from 75 to 750 mg/ day) where the incidence in patients treated with SEROQUEL was greater than the incidence in placebo-treated patients.

Table 1. Treatment-Emergent Adverse Experience Incidence in 3-to 6-Week

Placebo-Controlled Clinical Trials Body System/ SEROQUEL Placebo Preferred Term (n= 510) (n= 206)

Body as a Whole Headache 19% 18%

Asthenia 4% 3% Abdominal pain 3% 1%

Back pain 2% 1% Fever 2% 1%

Nervous System Somnolence 18% 11%

Dizziness 10% 4% Digestive System

Constipation 9% 5% Dry Mouth 7% 3%

Dyspepsia 6% 2% Cardiovascular System

Postural hypotension 7% 2% Tachycardia 7% 5%

Metabolic and Nutritional Disorders Weight gain 2% 0%

Skin and Appendages Rash 4% 3%

Respiratory System Rhinitis 3% 1%

Special Senses Ear pain 1% 0%