This grade answers one narrow question: how strong is the public evidence and safety record behind this drug, and how clean is its money trail and court record? It is not a verdict on whether the drug is right for you.
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) ]. Que...
Listed on the WHO Model List of Essential Medicines: a global expert panel judged it among the medicines a health system should always have, on evidence of value, not marketing.
Quetiapine fumarate tablet 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 Quetiapine fumarate tablet is indicated for the treatment of schizophrenia. The efficacy of quetiapine fumarate tablets in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13 to 17 years). The effectiveness of quetiapine fumarate tablets for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials. [see Clinical Studies (14.1)] 1.2 Bipolar Disorder Quetiapine fumarate tablet is indicated for the acute treatment of manic episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or divalproex. Efficacy was established in two 12- week monotherapy trials in adults, in one 3-week adjunctive trial in adults, and in one 3-week monotherapy trial in pediatric patients (10 to 17 years) [ see Clinical Studies (14.2)] . Quetiapine fumarate tablet is indicated as monotherapy for the acute treatment of depressive episodes associated with b...
Hypersensitivity to quetiapine or to any excipients in the quetiapine fumarate tablets formulation. Anaphylactic reactions have been reported in patients treated with quetiapine fumarate tablets. Known hypersensitivity to quetiapine or any components in the formulation.
Cerebrovascular Adverse Reactions: Increased incidence of cerebrovascular adverse events (e.g. stroke, transient ischemic attack) has been seen in elderly patients with dementia-related psychoses treated with atypical antipsychotic drugs ( Error! Hyperlink reference not valid. ) Neuroleptic Malignant Syndrome (NMS): Manage with immediate discontinuation and close monitoring. ( Error! Hyperlink reference not valid. ) Metabolic Changes: Atypical antipsychotics have been associated with metabolic changes. These metabolic changes include hyperglycemia, dyslipidemia, and weight gain ( 5.5 ) Hyperglycemia and Diabetes Mellitus: Monitor patients for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Monitor glucose regularly in patients with diabetes or at risk for diabetes Dyslipidemia: Undesirable alterations have been observed in patients treated with atypical antipsychotics. Appropriate clinical monitoring is recommended, including fasting blood lipid testing at the beginning of, and periodically, during treatment Weight Gain: Gain in body weight has been observed; clinical monitoring of weight is recommended Tardive Dyskinesia: Discontinue if clinical...
The following adverse reactions are discussed in more detail in other sections of the labeling: • Increased mortality in elderly patients with dementia-related psychosis [see Warnings and Precautions (5.1)] • Suicidal thoughts and behaviors in adolescents and young adults [see Warnings and Precautions (5.2)] • Cerebrovascular adverse reactions, including stroke in elderly patients with dementia-related psychosis [see Warnings and Precautions (5.3)] • Neuroleptic Malignant Syndrome (NMS) [see Warnings and Precautions (5.4)] • Metabolic changes (hyperglycemia, dyslipidemia, weight gain) [see Warnings and Precautions (5.5)] • Tardive dyskinesia [see Warnings and Precautions (5.6)] • Hypotension [see Warnings and Precautions (5.7)] • Increases in blood pressure (children and adolescents) [see Warnings and Precautions (5.8)] • Leukopenia, neutropenia and agranulocytosis [see Warnings and Precautions (5.9)] • Cataracts [see Warnings and Precautions (5.10)] • QT Prolongation [see Warnings and Precautions (5.11)] • Seizures [see Warnings and Precautions (5.12)] • Hypothyroidism [see Warnings and Precautions (5.13)] • Hyperprolactinemia [see Warnings and Precautions (5.14)] • Potential for ...
Warnings and Precautions, Cerebrovascular Adverse Reactions, Including Stroke, in Elderly Patients with Dementia-Related Psychosis ( Error! Hyperlink reference not valid. ) 4/2013
Source: FDA SPL label for Quetiapine fumarate (Proficient Rx LP), effective 20221001. Full label on DailyMed.
These are counts of reports people filed, not rates of harm. Anyone can file one, and nobody checks whether the drug was the cause. Millions of doses are taken for every report sent, so the useful part is how this drug compares with the average across all drugs.
| 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | 2026 |
|---|---|---|---|---|---|---|---|
| 13,317 | 13,313 | 12,510 | 11,311 | 11,094 | 11,895 | 11,608 | 5,664 |
2,879 reports blaming this drug for every million Medicare prescriptions filled, which is 1.0× the typical drug on this site. (28,400 reports in 2024–2026, against 9,863,943 Medicare fills in one year. This is the one number here that accounts for how many people take the drug.)
Source: the FDA's Adverse Event Reporting System (FAERS). Reports are voluntary and unverified. Drugs that are prescribed a lot, in the news, or in lawsuits attract more reports, so the percentages are compared with the whole database to correct for that partly, not fully.
| Date | Class | Firm | Reason |
|---|---|---|---|
| 02/2020 | 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 Extended-Release Tablets. |
| 02/2020 | 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 Extended-Release Tablets. |
| 02/2020 | 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 Extended-Release Tablets. |
| 02/2020 | 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 Extended-Release Tablets. |
| 11/2018 | Class II | Ascend Laboratories LLC | Presence of Foreign Substance; metal shard found in tablet |
Class I = reasonable probability of serious harm. Class II = temporary or reversible harm. Class III = unlikely to harm. Most generic recalls are manufacturing or labeling defects for one lot, not a verdict on the molecule.
Counts measure how much evidence exists and how transparent it is, not how big the benefit is. For that, ask your prescriber: if 100 people like me took this, how many would get better because of it, and how many would be harmed? (Doctors call these the "number needed to treat" and "number needed to harm.") It differs by condition and is the number drug ads leave out. Sources: PubMed, ClinicalTrials.gov.
In 2024, drug companies reported $1,782 in payments to US physicians and hospitals tied to this drug across 101 transactions (Seroquel $1,782).
No pending federal MDL names this drug or its brands.
Settlements of $100M+ in which this drug (Seroquel) was a named product, as recorded by the Department of Justice. A settlement resolves allegations; civil settlements are not admissions and not findings of wrongdoing. They are shown because off-label promotion cases describe how the evidence many prescribers saw was shaped.
Sources: CMS Open Payments (Sunshine Act); Judicial Panel on Multidistrict Litigation pending docket list; DOJ settlements as tabulated on Wikipedia with links to the primary record. State-court and individual suits are not included.
| Product | Fills | $/fill |
|---|---|---|
| Quetiapine Fumarate | 9,340,374 | $17 |
| Quetiapine Fumarate ER | 504,595 | $65 |
| Seroquel | 11,938 | $729 |
| Seroquel XR | 7,036 | $1,064 |
Same ATC pharmacological class, graded ones first, best grade at the top. Being in the same class does not make them interchangeable for your condition; it makes them worth asking about.