Seroquel/Seroquel XR Adverse Reactions

The most commonly reported Adverse Drug Reactions (ADRs) with quetiapine (≥10%) are somnolence, dizziness, dry mouth, withdrawal (discontinuation) symptoms, elevations in serum triglyceride levels, elevations in total cholesterol (predominantly LDL cholesterol), decreases in HDL cholesterol, weight gain, decreased haemoglobin and extrapyramidal symptoms.
The incidences of ADRs associated with quetiapine therapy, are tabulated as follows (Table 1) according to the format recommended by the Council for International Organizations of Medical Sciences (CIOMS III Working Group; 1995) (See Table 1).

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Extrapyramidal Symptoms: The following clinical trials (monotherapy and combination therapy) in adult patients included treatment with Quetiapine immediate release tablets (SEROQUEL) and Quetiapine extended release tablets (SEROQUEL XR).
In short-term, placebo-controlled clinical trials in schizophrenia and bipolar mania the aggregated incidence of extrapyramidal symptoms was similar to placebo (schizophrenia: 7.8% for quetiapine and 8.0% for placebo; bipolar mania: 11.2% for quetiapine and 11.4% for placebo. In short-term, placebo-controlled clinical trials in bipolar depression the aggregated incidence of extrapyramidal symptoms was 8.9% for quetiapine compared to 3.8% for placebo, though the incidence of the individual adverse events (e.g., akathisia, extrapyramidal disorder, tremor, dyskinesia, dystonia, restlessness, muscle contractions involuntary, psychomotor hyperactivity and muscle rigidity) were generally low and did not exceed 4% in any treatment group).
Seroquel: In long-term studies of schizophrenia and bipolar disorder the aggregated exposure adjusted incidence of treatment-emergent extrapyramidal symptoms was similar between quetiapine and placebo.
Seroquel XR: In short-term, placebo-controlled monotherapy clinical trials in major depressive disorder the aggregated incidence of extrapyramidal symptoms was 5.4% for Quetiapine (SEROQUEL XR) and 3.2% for placebo. In a short-term placebo-controlled monotherapy trial in elderly patients with major depressive disorder, the aggregated incidence of extrapyramidal symptoms was 9.0% for Quetiapine (SEROQUEL XR) and 2.3% for placebo. In short-term, placebo-controlled monotherapy clinical trials in generalised anxiety disorder, the aggregated incidence of extrapyramidal symptoms was 4.9% for Quetiapine (SEROQUEL XR) and 3.2% for placebo. In a short-term, placebo-controlled monotherapy trial in elderly patients with generalised anxiety disorder, the aggregated incidence of extrapyramidal symptoms was 5.4% for Quetiapine (SEROQUEL XR) and 2.2% for placebo. In long-term studies of schizophrenia, bipolar disorder, major depressive disorder, and generalised anxiety disorder the aggregated exposure adjusted incidence of treatment-emergent extrapyramidal symptoms was similar between quetiapine and placebo.
Thyroid Levels: Quetiapine treatment was associated with dose-related decreases in thyroid hormone levels. In short term placebo-controlled clinical trials, the incidence of potentially clinically significant shifts in thyroid hormone levels were: total T₄: 3.4 % for quetiapine versus 0.6 % for placebo; free T₄: 0.7% for quetiapine versus 0.1% for placebo; total T₃: 0.54 % for quetiapine versus 0.0% for placebo and free T₃: 0.2% for quetiapine versus 0.0% for placebo. The incidence of shifts in TSH was 3.2 % for quetiapine versus 2.7 % for placebo. In short term placebo-controlled monotherapy trials, the incidence of reciprocal, potentially clinically significant shifts in T₃ and TSH was 0.0 % for both quetiapine and placebo and 0.1% for quetiapine versus 0.0 % for placebo for shifts in T₄ and TSH. These changes in thyroid hormone levels are generally not associated with clinically symptomatic hypothyroidism. The reduction in total and free T₄ was maximal within the first six weeks of quetiapine treatment, with no further reduction during long-term treatment. In nearly all cases, cessation of quetiapine treatment was associated with a reversal of the effects on total and free T₄, irrespective of the duration of treatment. In eight patients, where TBG was measured, levels of TBG were unchanged.
Children and adolescents (10 to 17 years of age): The same ADRs described previously for adults should be considered for children and adolescents. The following table summarises ADRs that occur in a higher frequency category in children and adolescents patients (10-17 years of age) than in the adult population or ADRs that have not been identified in the adult population. (See Table 2.)

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Weight Gain in Children and Adolescents: In one 6-week, placebo-controlled trial in adolescent patients (13-17 years of age) with schizophrenia, the mean increase in body weight, was 2.0 kg in the Quetiapine (SEROQUEL) group and -0.4 kg in the placebo group. Twenty one percent of Quetiapine (SEROQUEL)-treated patients and 7% of placebo-treated patients gained ≥7% of their body weight.
In one 3-week, placebo-controlled trial in children and adolescent patients (10-17 years of age) with bipolar mania, the mean increase in body weight was 1.7 kg in the Quetiapine (SEROQUEL) group and 0.4 kg in the placebo group. Twelve percent of Quetiapine (SEROQUEL)-treated patients and 0% of placebo-treated patients gained ≥7% of their body weight.
In the open-label study that enrolled patients from the above two trials, 63% of patients (241/380) completed 26 weeks of therapy with Quetiapine (SEROQUEL). After 26 weeks of treatment, the mean increase in body weight was 4.4 kg. Forty five percent of the patients gained ≥7% of their body weight, not adjusted for normal growth. In order to adjust for normal growth over 26 weeks an increase of at least 0.5 standard deviation from baseline in BMI was used as a measure of a clinically significant change; 18.3% of patients on Quetiapine (SEROQUEL) met this criterion after 26 weeks of treatment.
In one 8-week, placebo-controlled trial in children and adolescent patients (10-17 years of age) with bipolar depression, in which efficacy was not established, the mean increase in body weight was 1.4 kg in the Quetiapine (SEROQUEL XR) group and 0.6 kg in the placebo group. 13.7% of Quetiapine (SEROQUEL XR)-treated patients and 6.8% of placebo-treated patients gained ≥ 7% of their body weight.
Extrapyramidal Symptoms in Children and Adolescent Population: In a short-term placebo-controlled monotherapy trial in adolescent patients (13-17 years of age) with schizophrenia, the aggregated incidence of extrapyramidal symptoms was 12.9% for Quetiapine (SEROQUEL) and 5.3% for placebo, though the incidence of the individual adverse events (e.g., akathisia, tremor, extrapyramidal disorder, hypokinesia, restlessness, psychomotor hyperactivity, muscle rigidity, dyskinesia) was generally low and did not exceed 4.1% in any treatment group.
In a short-term placebo-controlled monotherapy trial in children and adolescent patients (10-17 years of age) with bipolar mania, the aggregated incidence of extrapyramidal symptoms was 3.6% for Quetiapine (SEROQUEL) and 1.1% for placebo. In a short-term placebo-controlled monotherapy trial in children and adolescent patients (10-17 years of age) with bipolar depression in which efficacy was not established, the aggregated incidence of extrapyramidal symptoms was 1.1% for Quetiapine (SEROQUEL XR) and 0.0% for placebo.