Quetiapine Indications: FDA-Approved and Off-label Uses

Last updated: February 9, 2018
Author: Flavio Guzman, MD

Quetiapine is a second generation antipsychotic approved for the treatment of schizophrenia, bipolar disorder and as adjunct treatment of major depressive disorder. This article is an overview of current FDA-approved indications and other non-approved clinical uses (the evidence for off-label uses is reviewed).

FDA-Approved Indications

The table below shows information on FDA-approved indications for quetiapine IR and quetiapine ER. The most recent FDA approval (2009) is for quetiapine ER (Seroquel XR) as adjunctive treatment for major depressive disorder.

FDA approved indicationsQuetiapine IR Quetiapine ER
AdultsApproved in 1997
Dose: 150-750 mg/day. BID, TID
Approved in 2007
Dose:400-800 mg/day
Adolescents (13-17 years)Dose: 400-800 mg/day. BIDNot FDA approved
Bipolar Disorder
Bipolar Mania, AdultsApproved in 2003
Dose: 400-800 mg/day, BID
Approved in 2008
Dose: 400-800 mg/day, once a day
Bipolar Mania, Children and Adolescents (10-17 years)Dose: 400-800 mg/day, BID
Not FDA approved
Bipolar DepressionApproved in 2006
Dose:300-600 mg/day
Approved in 2008
Dose: 300 mg/day
Maintenance TreatmentApproved in 2008
Dose:400-800 mg/day
Adjunct to lithium or divalproex
Approved in 2008
Dose: 400-800 mg/day
Adjunct to lithium or divalproex
Major Depressive DisorderNot FDA approvedApproved in 2009
Dose: 150-300 mg/day
Adjunct to antidepressants

References: [1,2,3]

Off-Label Uses

The use of quetiapine in clinical practice has extended beyond FDA-approved indications. The following sections reviewing off-label uses are based largely on the latest evidence update by the Agency for Healthcare Research and Quality [4].

Generalized Anxiety Disorder

The efficacy of quetiapine as treatment for generalized anxiety disorder has been proven in clinical trials. The ARHQ review [4] concludes that :

Three RCTs [5,6,7] of quetiapine monotherapy for GAD were pooled based on their clinical similarities, and a comparison of relative risk of responding on the HAM-A favored quetiapine over placebo. All 3 trials had a quetiapine 150 milligram (mg) comparison group, and the pooled estimate of the relative risk of responding on the HAM-A in favor of the quetiapine treatment groups was 1.26 (95% confidence interval [CI] = 1.02-1.56). For the treatment of GAD, at 8 weeks, one trial found 50 or 150 mg per day quetiapine as effective as paroxetine 20 mg per day, 43 and another trial found 150 or 300 mg per day quetiapine as effective as 10 mg per day escitalopram.


Antipsychotics carry a black box warning about increased mortality in elderly patients with dementia-related psychosis. The AHRQ report concludes that there is mixed evidence supporting the use of antipsychotics for psychosis and agitation in dementia [4].

Major Depressive Disorder (monotherapy)

A recent meta-analysis reported efficacy of quetiapine as monotherapy [8]. However, the authors report a high dropout rate due to side effects and recommend taking into account risk and benefit for an individual patient with major depressive disorder


Regarding the use of quetiapine for the treatment of obsessive compulsive disorder, the AHRQ report [4] concludes that:

  • The strength of evidence for using quetiapine in OCD patients is low.
  • Two new trials found quetiapine superior to placebo as augmentation for citalopram, according to Y-BOCS and CGI-scores.
  • Quetiapine might be efficacious as augmentation to citalopram in OCD patients.

Quetiapine for Psychosis in Patients with Parkinson’s Disease

In some cases, Parkinson’s disease can be associated with the emergence of psychotic symptoms. In addition, pharmacological management is complicated by the appearance of hallucinations linked to levodopa therapy. Because of its low risk of extrapyramidal symptoms, quetiapine is a preferred option for the treatment of psychotic symptoms in patients with Parkinson’s disease [9].

More Information on Quetiapine


  1. AstraZeneca Pharmaceuticals LP. Seroquel (quetiapine fumarate) prescribing information. Retrieved from http://www1.astrazeneca-us.com/pi/seroquel.pdf
  2. AstraZeneca Pharmaceuticals LP. Seroquel XR(quetiapine fumarate) prescribing information. Retrieved from http://www1.astrazeneca-us.com/pi/seroquelxr.pdf
  3. FDA Advisory Comitee Documentation: Seroquel XR® (quetiapine fumarate) for Major Depressive Disorder (MDD) or Generalized Anxiety Disorder (GAD), 2009.
  4. Maglione M, Ruelaz Maher A, Hu J, Wang Z, Shanman R, Shekelle PG, Roth B, Hilton L, Suttorp MJ, Ewing BA, Motala A, Perry T. Off-Label Use of Atypical Antipsychotics: An Update. Comparative Effectiveness Review No. 43. (Prepared by the Southern California Evidence-based Practice Center under Contract No. HHSA290-2007-10062-1.) Rockville, MD: Agency for Healthcare Research and Quality. September 2011. Available at: www.effectivehealthcare.ahrq.gov/reports/final.cfm.
  5. Bandelow B, Chouinard G, Bobes J, Ahokas A, Eggens I, Liu S, et al. Extended-release quetiapine fumarate (quetiapine XR): a once-daily monotherapy effective in generalized anxiety disorder. Data from a randomized, double-blind, placebo- and active-controlled study. Int J Neuropsychopharmacol. 2010;13(3):305-20.
  6. Katzman MA, Brawman-Mintzer O, Reyes EB, Olausson B, Liu S, Eriksson H. Extended release quetiapine fumarate (quetiapine XR) monotherapy as maintenance treatment for generalized anxiety disorder: a long-term, randomized, placebo-controlled trial. International clinical psychopharmacology. 2011;26(1):11-24.
  7. Khan A, Joyce M, Atkinson S, Eggens I, Baldytcheva I, Eriksson H. A randomized, double-blind study of once-daily extended release quetiapine fumarate (quetiapine XR) monotherapy in patients with generalized anxiety disorder. Journal of clinical psychopharmacology. 2011;31(4):418-28.
  8. Maneeton N, Maneeton B, Srisurapanont M, Martin SD. Quetiapine monotherapy in acute phase for major depressive disorder: a meta-analysis of randomized, placebo-controlled trials. BMC psychiatry. 2012;12(1):160.
  9. Friedman JH. Atypical antipsychotics in the EPS-vulnerable patient. Psychoneuroendocrinology. 2003;28 Suppl 1:39-51.


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