Prescription medicine
Quetiapine Brand names: Seroquel
Quetiapine (Seroquel) is a prescription medicine with an FDA approval on record since 1997. FDA's NDC Directory lists it from 48 generic labelers, and pharmacies paid $0.127 per quetiapine fumarate 300 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the quetiapine FDA label on DailyMed (effective April 10, 2026, H2-Pharma, LLC); the NDA 20639 record on Drugs@FDA; every quetiapine label on DailyMed.
Highlights of the record
FDA label of April 10, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
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) ]. SEROQUEL 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) ]. SEROQUEL is not approved for use in pediatric patients under ten years of age [see Use in Specific Populations (8.4) ]. […]
Used for
From the label: indications and usageSEROQUEL is an atypical antipsychotic indicated for the treatment of:
Schizophrenia ( 1.1 )
Bipolar I disorder manic episodes (1.2)
Bipolar disorder, depressive episodes (1.2) 1.1 Schizophrenia SEROQUEL is indicated for the treatment of schizophrenia.
Forms and strengths
- 25 mg
- 50 mg
- 100 mg
- 150 mg
- 200 mg
- 300 mg
- 400 mg
Film-coated tablet; tablet; extended-release tablet; film-coated extended-release tablet.
On the market
- Earliest approval on file
- September 26, 1997 Seroquel, Cheplapharm; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 38 first March 27, 2012; 25 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 50 of which 48 under generic applications, 2 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.127 per tablet Quetiapine fumarate 300 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 10 since 2012 0 Class I among all firms' recalls; latest February 27, 2020
- FAERS reports
- 191,480 through July 30, 2026
What is quetiapine used for?
From the label: indications and usageSEROQUEL is an atypical antipsychotic indicated for the treatment of:
Schizophrenia ( 1.1 )
Bipolar I disorder manic episodes (1.2)
Bipolar disorder, depressive episodes (1.2) 1.1 Schizophrenia SEROQUEL is indicated for the treatment of schizophrenia. The efficacy of SEROQUEL in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13-17 years). […]
Conditions named in the indications of quetiapine's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Atypical Antipsychotic.
Source: FDA drug label (SEROQUEL), NDA020639 (Cheplapharm), as published by H2-Pharma, LLC, effective April 10, 2026 (SPL set 8ae62aaf-f8c5-417f-baac-0098369ca322), via openFDA; the full label on DailyMed
What does the patient leaflet for quetiapine say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about SEROQUEL?SEROQUEL may cause serious side effects, including: 1. risk of death in the elderly with dementia. Medicines like SEROQUEL can increase the risk of death in elderly people who have memory loss (dementia). SEROQUEL is not for treating psychosis in the elderly with dementia.2. risk of suicidal thoughts or actions (antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions). • Talk to your or your family member’s healthcare provider about: ∘all risks and benefits of treatment with antidepressant medicines.∘all treatment choices for depression or other serious mental illness• Antidepressant medications may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment. • Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) depression, bipolar illness (also called manic-depressive illness), or suicidal thoughts or actions.• How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member? ∘Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.∘Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.∘Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms. […]
From the patient leaflet: What should I avoid while taking SEROQUEL?Do not drive, operate machinery, or do other dangerous activities until you know how SEROQUEL affects you. SEROQUEL may make you drowsy.•Avoid getting overheated or dehydrated.∘Do not over-exercise.∘In hot weather, stay inside in a cool place if possible.∘Stay out of the sun. Do not wear too much or heavy clothing.∘Drink plenty of water.•Do not drink alcohol while taking SEROQUEL. It may make some side effects of SEROQUEL worse.
From the patient leaflet: How should I store SEROQUEL?Store SEROQUEL at room temperature, between 68°F to 77°F (20°C to 25°C).• Keep SEROQUEL and all medicines out of the reach of children.
Source: FDA drug label (SEROQUEL), NDA020639 (Cheplapharm), as published by H2-Pharma, LLC, effective April 10, 2026 (SPL set 8ae62aaf-f8c5-417f-baac-0098369ca322), via openFDA; the full label on DailyMed
Is there a generic for quetiapine (Seroquel)?
The FDA approved the first generic quetiapine on March 27, 2012. 38 generic applications are approved; 25 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists quetiapine from 48 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1997 earliest approval on file
- 2012 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for quetiapine (Seroquel)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.127 per Quetiapine fumarate 300 mg tablet, down 9% from $0.140 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Quetiapine fumarate 300 mg tablet (generic)
- Seroquel XR 400 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Quetiapine 150 mg tablet | Generic | $1.24 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $37.16 | +3% |
| Quetiapine ER 150 mg tablet | Generic | $0.184 per tablet | $5.51 | -4% |
| Quetiapine ER 200 mg tablet | Generic | $0.220 per tablet | $6.60 | -0.5% |
| Quetiapine ER 300 mg tablet | Generic | $0.272 per tablet | $8.15 | +4% |
| Quetiapine ER 400 mg tablet | Generic | $0.317 per tablet | $9.52 | +2% |
| Quetiapine ER 50 mg tablet | Generic | $0.119 per tablet | $3.58 | +5% |
| Quetiapine fumarate 100 mg tablet | Generic | $0.0483 per tablet | $1.45 | -8% |
| Quetiapine fumarate 200 mg tablet | Generic | $0.0896 per tablet | $2.69 | -7% |
| Quetiapine fumarate 25 mg tablet | Generic | $0.0215 per tablet | $0.644 | -33% |
| Quetiapine fumarate 300 mg tablet | Generic | $0.127 per tablet | $3.82 | -9% |
| Quetiapine fumarate 400 mg tablet | Generic | $0.162 per tablet | $4.85 | -6% |
| Quetiapine fumarate 50 mg tablet | Generic | $0.0282 per tablet | $0.845 | -43% |
| Seroquel XR 400 mg tablet | Brand | $26.36 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $790.74 | +10% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has quetiapine been recalled?
The FDA's Enforcement Report lists 10 recalls naming quetiapine since 2012: 0 Class I (the most serious), 6 Class II, 4 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| February 27, 2020 | Class III | The Harvard Drug Group | Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate … |
| November 14, 2018 | Class II | Ascend Laboratories LLC | Presence of Foreign Substance; metal shard found in tablet |
| July 2, 2013 | Class II | Aidapak Services, LLC | Labeling: Label Mixup; QUETIAPINE FUMARATE Tablet, 12.5 mg (1/2 of 25 mg) may be potentially mislabeled as SIMVASTATIN, Tablet, 40 mg, NDC 00093715598 … |
| July 2, 2013 | Class II | Aidapak Services, LLC | Labeling:Label Mixup; QUEtiapine FUMARATE, Tablet, 25 mg may be potentially mislabeled as MULTIVITAMIN/MULTIMINERAL, Chew Tablet, NDC 58914001460, Pedigree … |
| July 2, 2013 | Class II | Aidapak Services, LLC | Labeling:Label Mixup; QUEtiapine FUMARATE Tablet, 100 mg may be potentially mislabeled as DOCUSATE CALCIUM, Capsule, 240 mg, NDC 00536375501, Pedigree … |
| July 2, 2013 | Class II | Aidapak Services, LLC | Labeling:Label Mixup; QUEtiapine FUMARATE, Tablet, 25 mg may be potentially mislabeled as chlordiazePOXIDE HCl, Capsule, 25 mg, NDC 00555015902, Pedigree … |
| October 10, 2012 | Class II | American Health Packaging | Failed Dissolution Test Requirements: During analysis of long term stability studies at 3 months time point, an OOS was reported for Quetiapine Fumarate … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the quetiapine label say about other medicines?
The quetiapine label names 11 other medicines in its interaction, contraindication or warning sections. The labels of 23 other medicines name quetiapine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Aripiprazole | warnings and precautions | Patients with Dementia-Related Psychosis In placebo-controlled trials with risperidone, aripiprazole, and olanzapine in elderly subjects with dementia, there was a higher incidence of cerebrovascular adverse reactions (cerebrovascular accidents and transient ischemic attacks) including fatalities compared to … |
| Carbamazepine | drug interactions | Quetiapine exposure is increased by the prototype CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, indinavir, ritonavir, nefazodone, etc.) and decreased by the prototype CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampin, avasimibe, St. John’s wort etc.). |
| Itraconazole | drug interactions | Quetiapine exposure is increased by the prototype CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, indinavir, ritonavir, nefazodone, etc.) and decreased by the prototype CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampin, avasimibe, St. John’s wort etc.). |
| Ketoconazole | drug interactions | Concomitant use of strong CYP3A4 inhibitors: Reduce quetiapine dose to one sixth when coadministered with strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) |
| Levodopa | drug interactions | SEROQUEL may antagonize the effects of levodopa and dopamine agonists. |
| Nefazodone | drug interactions | Quetiapine exposure is increased by the prototype CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, indinavir, ritonavir, nefazodone, etc.) and decreased by the prototype CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampin, avasimibe, St. John’s wort etc.). |
| Olanzapine | warnings and precautions | Patients with Dementia-Related Psychosis In placebo-controlled trials with risperidone, aripiprazole, and olanzapine in elderly subjects with dementia, there was a higher incidence of cerebrovascular adverse reactions (cerebrovascular accidents and transient ischemic attacks) including fatalities compared to … |
| Phenytoin | drug interactions | Concomitant use of strong CYP3A4 inducers: Increase quetiapine dose up to 5 fold when used in combination with a chronic treatment (more than 7-14 days) of potent CYP3A4 inducers (e.g., phenytoin, rifampin, St. John’s wort) |
| Rifampin | drug interactions | Concomitant use of strong CYP3A4 inducers: Increase quetiapine dose up to 5 fold when used in combination with a chronic treatment (more than 7-14 days) of potent CYP3A4 inducers (e.g., phenytoin, rifampin, St. John’s wort) |
| Risperidone | warnings and precautions | Patients with Dementia-Related Psychosis In placebo-controlled trials with risperidone, aripiprazole, and olanzapine in elderly subjects with dementia, there was a higher incidence of cerebrovascular adverse reactions (cerebrovascular accidents and transient ischemic attacks) including fatalities compared to … |
| Ritonavir | drug interactions | Concomitant use of strong CYP3A4 inhibitors: Reduce quetiapine dose to one sixth when coadministered with strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) |
Other labels that name quetiapine
Source: FDA drug label (SEROQUEL), NDA020639 (Cheplapharm), as published by H2-Pharma, LLC, effective April 10, 2026 (SPL set 8ae62aaf-f8c5-417f-baac-0098369ca322), via openFDA; the full label on DailyMed
What do FAERS reports show for quetiapine?
The FDA Adverse Event Reporting System holds 191,480 reports that list quetiapine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 28,195 are coded as a death and 70,149 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as quetiapine?
21 other medicines are given the same way (oral) and in the same FDA class as quetiapine or labeled mainly for the same use (schizophrenia), the same class first. Schizophrenia lists all 24 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Aripiprazole | Depression, Bipolar disorder, Schizophrenia | 47 labelers | $0.110 per tablet 5 mg tablet | No current entry |
| Olanzapine | Depression, Bipolar disorder, Schizophrenia | 33 labelers | $0.147 per tablet 20 mg tablet | No current entry |
| Risperidone | Bipolar disorder, Schizophrenia | 35 labelers | $0.0368 per tablet 0.25 mg tablet | No current entry |
| Lurasidone | Depression, Bipolar disorder, Schizophrenia | 29 labelers | $0.142 per tablet 20 mg tablet | No current entry |
| Ziprasidone | Bipolar disorder, Schizophrenia | 16 labelers | $0.269 per capsule 20 mg capsule | No current entry |
| Paliperidone | Schizophrenia | 18 labelers | $0.972 per tablet 3 mg tablet | No current entry |
| Clozapine | Schizophrenia | 11 labelers | $0.610 per tablet 100 mg tablet | No current entry |
| Iloperidone | Bipolar disorder, Schizophrenia | 1 labeler | $60.01 per tablet 12 mg tablet | No current entry |
Every medicine labeled for the same conditions as quetiapine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does quetiapine compare with medicines for the same use?
18 side-by-side pages set quetiapine beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to quetiapine
- 21 medicines for the same use
- Other atypical antipsychotics
- the pharmacologic class, with prices and generics
- Quetiapine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other