Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
The following adverse reactions are discussed in more detail in other sections of the labeling: Increased mortality in elderly patients with dementia-related psychosis [see WARNINGS AND PRECAUTIONS (5.1)] Suicidal thoughts and behaviors in adolescents and young adults [see WARNINGS AND PRECAUTIONS (5.2)] Cerebrovascular adverse reactions, including stroke in elderly patients with dementia-related psychosis [see WARNINGS AND PRECAUTIONS (5.3)] Neuroleptic Malignant Syndrome (NMS) [see WARNINGS AND PRECAUTIONS (5.4)] Metabolic changes (hyperglycemia, dyslipidemia, weight gain) [see WARNINGS AND PRECAUTIONS (5.5)] Tardive dyskinesia [see WARNINGS AND PRECAUTIONS (5.6)] Hypotension [see WARNINGS AND PRECAUTIONS (5.7)] Falls [see WARNINGS AND PRECAUTIONS (5.8)] Increases in blood pressure (children and adolescents) [see WARNINGS AND PRECAUTIONS (5.9)] Leukopenia, neutropenia and agranulocytosis [see WARNINGS AND PRECAUTIONS (5.10)] Cataracts [see WARNINGS AND PRECAUTIONS (5.11)] QT Prolongation [see WARNINGS AND PRECAUTIONS (5.12)] Seizures [see WARNINGS AND PRECAUTIONS (5.13)] Hypothyroidism [see WARNINGS AND PRECAUTIONS (5.14)] Hyperprolactinemia [see WARNINGS AND PRECAUTIONS (5.15)] Potential for cognitive and motor impairment [see WARNINGS AND PRECAUTIONS (5.16)] Body temperature regulation [see WARNINGS AND PRECAUTIONS (5.17)] Dysphagia [see WARNINGS AND PRECAUTIONS (5.18)] Discontinuation Syndrome [see WARNINGS AND PRECAUTIONS (5.19)] Anticholinergic (antimuscarinic) Effects [see WARNINGS AND PRECAUTIONS (5.20)] 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Adults The information below is derived from a clinical trial database for quetiapine extended-release tablets consisting of approximately 3400 patients exposed to quetiapine extended-release tablets for the treatment of Schizophrenia, Bipolar Disorder, and Major Depressive Disorder in placebo-controlled trials.
This experience corresponds to approximately 1020.1 patient-years.
Adverse reactions were assessed by collecting adverse reactions, results of physical examinations, vital signs, body weights, laboratory analyses and ECG results.
The stated frequencies of adverse reactions represent the proportion of individuals who experienced, at least once, an adverse reaction of the type listed.
Adverse Reactions Associated with Discontinuation of Treatment in Short-Term, Placebo-Controlled Trials: Schizophrenia: There were no adverse reactions leading to discontinuation that occurred at an incidence of ≥ 2% for quetiapine extended-release tablets in schizophrenia trials.
Bipolar I Disorder, Manic or Mixed Episodes: There were no adverse reactions leading to discontinuation that occurred at an incidence of ≥ 2% for quetiapine extended-release tablets in the bipolar mania trial.
Bipolar Disorder, Depressive Episode: In a single clinical trial in patients with bipolar depression, 14% (19/137) of patients on quetiapine extended-release tablets discontinued due to an adverse reaction compared to 4% (5/140) on placebo.
Somnolence 1 was the only adverse reaction leading to discontinuation that occurred at an incidence of ≥ 2% in quetiapine extended-release tablets in the bipolar depression trial.
MDD, Adjunctive Therapy: In adjunctive therapy clinical trials in patients with MDD, 12.1% (76/627) of patients on quetiapine extended-release tablets discontinued due to adverse reaction compared to 1.9% (6/309) on placebo.
5.1 Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.
Analysis of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients.
Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group.
Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature.
Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality.
Like all medications, Quetiapine Fumarate Er can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: