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Seroquel (quetiapine)
Seroquel (generic name: quetiapine) is a drug developed by AstraZeneca. It is currently FDA-approved for Bipolar affective disorder, current episode depression, Bipolar affective disorder, current episode manic, Bipolar disorder.
At a glance
| Generic name | quetiapine |
|---|---|
| Sponsor | AstraZeneca |
| Target | Aldehyde oxidase, 5-hydroxytryptamine receptor 1E, 5-hydroxytryptamine receptor 5A |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
Approved indications
- Bipolar affective disorder, current episode depression
- Bipolar affective disorder, current episode manic
- Bipolar disorder
- Bipolar disorder in remission
- Depression Treatment Adjunct
- Schizophrenia
Boxed warnings
- 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 )
Common side effects
- Somnolence
- Dizziness
- Dry mouth
- Constipation
- Weight gain
- ALT increased
- Dyspepsia
Serious adverse events
- Hypotension
- Somnolence (discontinuation)
Key clinical trials
- A Randomized, Double-Blind, Placebo-Controlled Pilot Study of Quetiapine in Social Anxiety Disorder (Phase 2)
- A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (Seroquel SR®) as Mono-Therapy in the Tr (Phase 3)
- NCT00838032 (Phase 4)
- Combination of Paroxetine CR and Quetiapine for the Treatment of Refractory Generalized Anxiety Disorder (Phase 4)
- Role of Quetiapine in the Prevention of ICU Delirium in Elderly Patients at a High Risk (Phase 2)
- Haloperidol vs Olanzapine for the Management of ICU Delirium: A Randomized Clinical Trial (NA)
- Anxiolytic Effects of Single-dose Quetiapine XR Administration on Clinical Symptoms and Amygdala Activation During Exposure in Patients With Simple Phobia (Phase 2)
- CSP #2015 - Multicenter, Randomized, Double-blind Comparator Study of Antipsychotics Pimavanserin and Quetiapine for Parkinson''s Disease Psychosis (C-SAPP) (Phase 4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Seroquel CI brief — competitive landscape report
- Seroquel updates RSS · CI watch RSS
- AstraZeneca portfolio CI
Frequently asked questions about Seroquel
What is Seroquel?
Seroquel (quetiapine) is a pharmaceutical drug developed by AstraZeneca, indicated for Bipolar affective disorder, current episode depression, Bipolar affective disorder, current episode manic, Bipolar disorder.
What is Seroquel used for?
Seroquel is indicated for Bipolar affective disorder, current episode depression, Bipolar affective disorder, current episode manic, Bipolar disorder, Bipolar disorder in remission, Depression Treatment Adjunct.
Who makes Seroquel?
Seroquel is developed and marketed by AstraZeneca (see full AstraZeneca pipeline at /company/astrazeneca).
What is the generic name of Seroquel?
quetiapine is the generic (nonproprietary) name of Seroquel.
What development phase is Seroquel in?
Seroquel is FDA-approved (marketed).
What are the side effects of Seroquel?
Common side effects of Seroquel include Somnolence, Dizziness, Dry mouth, Constipation, Weight gain, ALT increased. Serious adverse events: Hypotension, Somnolence (discontinuation).
What does Seroquel target?
Seroquel targets Aldehyde oxidase, 5-hydroxytryptamine receptor 1E, 5-hydroxytryptamine receptor 5A.
Related
- Target: All drugs targeting Aldehyde oxidase, 5-hydroxytryptamine receptor 1E, 5-hydroxytryptamine receptor 5A
- Manufacturer: AstraZeneca — full pipeline
- Therapeutic area: All drugs in Neuroscience
- Indication: Drugs for Bipolar affective disorder, current episode depression
- Indication: Drugs for Bipolar affective disorder, current episode manic
- Indication: Drugs for Bipolar disorder
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing