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Quetiapine: Difference between revisions

From Pharmacopedia
[checked revision][unchecked revision]
Repoint CYP2D6/CYP3A4 links to the new Enzyme: namespace
Link legal-status field to the USLegal: namespace
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| bioavailability  = Tablet ~100% relative to oral solution; extensive first-pass metabolism
| bioavailability  = Tablet ~100% relative to oral solution; extensive first-pass metabolism
| pregnancy        = Category C<ref name="lactmed-quet">S0</ref>
| pregnancy        = Category C<ref name="lactmed-quet">S0</ref>
| legal            = Prescription only; not a controlled substance
| legal            = [[USLegal:Prescription only|Prescription only]]; not a controlled substance
| mechanism        = Dopamine D2 and serotonin 5-HT2A receptor antagonist<ref name="quet-mech">S1</ref> <vote slug="atypical-claim-quet">Quetiapine acts as an antagonist at dopamine D2 and serotonin 5-HT2A receptors and has substantial activity at histaminergic, adrenergic, and other receptors that contribute to its clinical effects.</vote>
| mechanism        = Dopamine D2 and serotonin 5-HT2A receptor antagonist<ref name="quet-mech">S1</ref> <vote slug="atypical-claim-quet">Quetiapine acts as an antagonist at dopamine D2 and serotonin 5-HT2A receptors and has substantial activity at histaminergic, adrenergic, and other receptors that contribute to its clinical effects.</vote>
| intro            = Quetiapine, marketed as Seroquel, is the most widely prescribed neuroleptic medicine in the United States, accounting for approximately 28% of neuroleptic prescriptions.<ref name="dhc2025">Definitive Healthcare. Antipsychotic Prescription Trends, December 2024-November 2025. Prescription data aggregator.</ref> It is a dibenzothiazepine atypical neuroleptic developed in 1985 at the pharmaceutical division of [[Imperial Chemical Industries]] in Macclesfield, United Kingdom (later [[Zeneca]], then [[AstraZeneca]]), and approved by the United States [[Food and Drug Administration]] on 26 September 1997 for the treatment of [[Schizophrenia|schizophrenia]]. Subsequent FDA approvals expanded the labeled indications to include acute [[Bipolar disorder|bipolar mania]] (2004), bipolar depression (2006), bipolar maintenance (2008), and adjunctive treatment of [[Major depressive disorder|major depressive disorder]] (2009). Quetiapine is widely prescribed at low doses (25-150 mg) off-label for [[Insomnia|insomnia]], anxiety, agitation, [[Post-traumatic stress disorder|post-traumatic stress disorder]], and behavioral disturbances of [[Dementia|dementia]]; this off-label use accounts for the dominant share of quetiapine prescribing in the United States and most other markets. The off-label prescribing pattern was the subject of the largest civil settlement for off-label marketing in pharmaceutical history at the time, when AstraZeneca paid $520 million to the United States [[Department of Justice]] in 2010 to resolve allegations that the company had illegally marketed Seroquel for indications never approved by the FDA.
| intro            = Quetiapine, marketed as Seroquel, is the most widely prescribed neuroleptic medicine in the United States, accounting for approximately 28% of neuroleptic prescriptions.<ref name="dhc2025">Definitive Healthcare. Antipsychotic Prescription Trends, December 2024-November 2025. Prescription data aggregator.</ref> It is a dibenzothiazepine atypical neuroleptic developed in 1985 at the pharmaceutical division of [[Imperial Chemical Industries]] in Macclesfield, United Kingdom (later [[Zeneca]], then [[AstraZeneca]]), and approved by the United States [[Food and Drug Administration]] on 26 September 1997 for the treatment of [[Schizophrenia|schizophrenia]]. Subsequent FDA approvals expanded the labeled indications to include acute [[Bipolar disorder|bipolar mania]] (2004), bipolar depression (2006), bipolar maintenance (2008), and adjunctive treatment of [[Major depressive disorder|major depressive disorder]] (2009). Quetiapine is widely prescribed at low doses (25-150 mg) off-label for [[Insomnia|insomnia]], anxiety, agitation, [[Post-traumatic stress disorder|post-traumatic stress disorder]], and behavioral disturbances of [[Dementia|dementia]]; this off-label use accounts for the dominant share of quetiapine prescribing in the United States and most other markets. The off-label prescribing pattern was the subject of the largest civil settlement for off-label marketing in pharmaceutical history at the time, when AstraZeneca paid $520 million to the United States [[Department of Justice]] in 2010 to resolve allegations that the company had illegally marketed Seroquel for indications never approved by the FDA.