{"id":"quetiapine","brandName":"Seroquel","genericName":"quetiapine","companyId":"astrazeneca","companyName":"AstraZeneca","phase":"marketed","status":"active","modality":"","aliases":[],"developmentCodes":[],"firstApprovalDate":null,"firstApprovalCountry":null,"aiSummary":"","enrichmentLevel":3,"visitCount":1,"mechanism":{"target":"Aldehyde oxidase, 5-hydroxytryptamine receptor 1E, 5-hydroxytryptamine receptor 5A"},"administration":{"route":"Oral"},"safety":{"boxedWarnings":["WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND BEHAVIORS 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 [ see Warnings and Precautions (5.1) ]. Quetiapine is not approved for the treatment of patients with dementia-related psychosis [ see Warnings and Precautions (5.1) ]. Suicidal Thoughts and Behaviors Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older [ see Warnings and Precautions (5.2) ]. In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [ see Warnings and Precautions (5.2) ]. Quetiapine is not approved for use in pediatric patients under ten years of age [ see Use in Specific Populations (8.4) ]. WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning . 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. Quetiapine tablets is not approved for elderly patients with dementia-related psychosis ( 5.1 ) Suicidal Thoughts and Behaviors Increased risk of suicidal thoughts and behavior in children, adolescents and young adults taking antidepressants ( 5.2 ) Monitor for worsening and emergence of suicidal thoughts and behaviors ( 5.2 )"],"safetySignals":[{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"12347 reports"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"11796 reports"},{"date":"","signal":"TOXICITY TO VARIOUS AGENTS","source":"FDA FAERS","actionTaken":"9720 reports"},{"date":"","signal":"INSOMNIA","source":"FDA FAERS","actionTaken":"9101 reports"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"8864 reports"},{"date":"","signal":"DIABETES MELLITUS","source":"FDA FAERS","actionTaken":"8345 reports"},{"date":"","signal":"WEIGHT INCREASED","source":"FDA FAERS","actionTaken":"8154 reports"},{"date":"","signal":"DRUG 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breast","Cerebrovascular disease","Chronic heart failure","Conduction disorder of the heart","Congenital long QT syndrome","Dehydration","Diabetes mellitus","Disease of liver","Extrapyramidal disease","Hypercholesterolemia","Hyperglycemia","Hyperlipidemia","Hyperprolactinemia","Hypertensive disorder","Hypertriglyceridemia","Hypokalemia","Hypomagnesemia","Hypothyroidism","Hypovolemia","Impaired cognition","Leukopenia","Liver function tests abnormal","Lowered convulsive threshold","Metabolic syndrome X","Myocardial infarction","Myocardial ischemia","Neuroleptic malignant syndrome","Neutropenic disorder","Obesity","Orthostatic hypotension","Prolonged QT interval","Seizure disorder","Senile dementia","Smokes tobacco daily","Suicidal thoughts","Tardive dyskinesia","Torsades de pointes","Weight gain finding"],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[{"effect":"Hypotension","drugRate":"0.4%","severity":"serious"},{"effect":"Somnolence (discontinuation)","drugRate":"0.8%","severity":"serious"}]},"trials":["NCT00215254","NCT00326144","NCT00838032","NCT00113295","NCT05793632","NCT00833300","NCT00872716","NCT04373317","NCT00272025","NCT00674765","NCT02132286","NCT00852631","NCT00630981","NCT06949657","NCT00952757","NCT01062607","NCT02213887","NCT00704860","NCT00498004","NCT00206102","NCT02040883","NCT01634386","NCT01342120","NCT00122070","NCT04280965","NCT00295412","NCT01526148","NCT00312598","NCT00396214","NCT02435095","NCT01570907","NCT02307396","NCT00246259","NCT00334126","NCT01765829","NCT00388973","NCT01165541","NCT00257894","NCT00457899","NCT00931723","NCT00811473","NCT00579280","NCT06581302","NCT01552837","NCT00302770","NCT00328822","NCT01971203","NCT00668265","NCT01128114","NCT01331304"],"indications":{"approved":[{"name":"Bipolar affective disorder, current episode depression","diseaseId":"bipolar-affective-disorder-current-episode-depression","approvalDate":"","lineOfTherapy":"","approvalCountry":"United 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