{"id":"quetiapin","rwe":[],"tags":[],"safety":{"boxedWarnings":[],"safetySignals":[],"drugInteractions":[],"commonSideEffects":[{"effect":"Somnolence","drugRate":"18%","severity":"common","organSystem":""},{"effect":"Dizziness","drugRate":"11%","severity":"common","organSystem":""},{"effect":"Dry mouth","drugRate":"9%","severity":"common","organSystem":""},{"effect":"Constipation","drugRate":"8%","severity":"common","organSystem":""},{"effect":"ALT increased","drugRate":"5%","severity":"common","organSystem":""},{"effect":"Weight gain","drugRate":"5%","severity":"common","organSystem":""},{"effect":"Dyspepsia","drugRate":"5%","severity":"common","organSystem":""}],"contraindications":["Acquired torsion dystonia","Agranulocytosis","Anemia","Asthenia","At risk for aspiration","Bilateral cataracts","Bradycardia","Carcinoma of female 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 (leading to discontinuation)","drugRate":"0.8%","severity":"serious"}]},"trials":[],"_chembl":{"chemblId":"CHEMBL3188993","moleculeType":"Small molecule","molecularWeight":"883.11"},"aliases":[],"patents":[],"pricing":[],"offLabel":[],"timeline":[],"_dailymed":{"setId":"070faf07-0ce7-4354-8643-9d222b72ecad","title":"QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [XLCARE PHARMACEUTICALS INC.]"},"ecosystem":[],"mechanism":{"target":"Aldehyde oxidase, 5-hydroxytryptamine receptor 1E, 5-hydroxytryptamine receptor 5A"},"_scrapedAt":"2026-03-27T23:36:49.615Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"references":[],"biosimilars":[],"competitors":[],"dataSources":[{"url":"https://drugcentral.org","name":"DrugCentral","fields":["indications","contraindications","safety","target","drugInteractions"],"retrievedDate":"2026-04-07"}],"indications":{"approved":[{"name":"Bipolar affective disorder, current episode depression","diseaseId":"bipolar-affective-disorder-current-episode-depression","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Bipolar affective disorder, current episode manic","diseaseId":"bipolar-affective-disorder-current-episode-manic","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Bipolar disorder","diseaseId":"bipolar-disorder","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Bipolar disorder in remission","diseaseId":"bipolar-disorder-in-remission","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Depression Treatment Adjunct","diseaseId":"depression-treatment-adjunct","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Schizophrenia","diseaseId":"schizophrenia","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"}],"offLabel":[],"pipeline":[]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT00883493","phase":"PHASE3","title":"Efficacy and Safety of Quetiapine Versus Quetiapine Plus Lithium in Bipolar Depression","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2009-04","conditions":"Acute Bipolar Depression","enrollment":421},{"nctId":"NCT00486798","phase":"PHASE3","title":"FAST-A Study to Evaluate the Efficacy and Safety of Quetiapin IR in Patients With Acute Psychosis","status":"TERMINATED","sponsor":"AstraZeneca","startDate":"2007-05","conditions":"Psychotic Disorders, Schizophrenia, Bipolar Disorder","enrollment":""},{"nctId":"NCT00433121","phase":"PHASE4","title":"Discontinuation of Antipsychotics and Antidepressants Among Patients With BPSD","status":"COMPLETED","sponsor":"Sykehuset Innlandet HF","startDate":"2006-09","conditions":"Dementia","enrollment":24}],"_emaApprovals":[],"_faersSignals":[{"count":230,"reaction":"GENERAL PHYSICAL HEALTH DETERIORATION"},{"count":135,"reaction":"FALL"},{"count":82,"reaction":"SOMNOLENCE"},{"count":75,"reaction":"INTENTIONAL OVERDOSE"},{"count":75,"reaction":"SUICIDE ATTEMPT"},{"count":71,"reaction":"HALLUCINATION"},{"count":65,"reaction":"FATIGUE"},{"count":64,"reaction":"DEATH"},{"count":64,"reaction":"PNEUMONIA"},{"count":63,"reaction":"AKINESIA"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{},"formularyStatus":[],"_approvalHistory":[],"developmentCodes":[],"ownershipHistory":[],"publicationCount":10,"therapeuticAreas":["Neuroscience"],"biosimilarFilings":[],"companionDiagnostics":[],"genericManufacturerList":[],"phase":"marketed","status":"active","brandName":"Quetiapin","genericName":"Quetiapin","companyName":"Sykehuset Innlandet HF","companyId":"sykehuset-innlandet-hf","modality":"Small molecule","firstApprovalDate":"","aiSummary":"","enrichmentLevel":3,"visitCount":1,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":false,"indications":true,"safety":true,"trials":true,"score":3}}