Quetiapine
According to the FDA label: Quetiapine tablets are 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 tablets are indicated for the treatment of schizophrenia. The efficacy of quetiapine tablets in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13-17 years).
76,595 adverse event reports submitted to the FDA (2001–2026)
Top Reported Adverse Events
The most frequently reported events in association with Quetiapine in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
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Toxicity to Various Agents 7,369 reports
A broad reporting category used when the body has a harmful response, sometimes involving more than one substance.
Full definition in the glossary →Drug Ineffective 5,392 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Completed Suicide 5,113 reports
A report that a person died by suicide. This is recorded in adverse event data when it occurs during medication use, and its presence does not establish that the drug was the cause. If you or someone you know is struggling, the 988 Suicide and Crisis Lifeline (call or text 988 in the US) is available 24 hours a day.
Full definition in the glossary →Off Label Use 5,034 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →Drug Interaction 4,928 reports
A report that two or more medications may have affected each other when taken together.
Full definition in the glossary →Somnolence 3,490 reports
Drowsiness or strong sleepiness.
Full definition in the glossary → See all drugs reporting this event →Drug Abuse 3,425 reports
A report that a medication was used in a way other than prescribed, or for non-medical reasons. The term describes a pattern of use, not a judgment about the person.
Full definition in the glossary →Fatigue 3,327 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Intentional Overdose 3,273 reports
A report that a person deliberately took more of a medication than prescribed. Its presence in reports does not establish that a medication was the cause. If you or someone you know is struggling, the 988 Suicide and Crisis Lifeline (call or text 988 in the US) is available 24 hours a day.
Full definition in the glossary →Suicide Attempt 3,015 reports
A report that a person attempted suicide. Its presence in reports does not establish that a medication was the cause. If you or someone you know is struggling, the 988 Suicide and Crisis Lifeline (call or text 988 in the US) is available 24 hours a day.
Full definition in the glossary →Confusional State 2,996 reports
A state of being confused, disoriented, or unable to think clearly.
Full definition in the glossary →Nausea 2,995 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Condition Aggravated 2,934 reports
A report that the person's existing health condition got worse. This describes a worsening of something the person already had, not necessarily a new problem caused by the drug.
Full definition in the glossary →Overdose 2,813 reports
Taking more of a medication than intended or recommended. This can be accidental.
Full definition in the glossary →Anxiety 2,689 reports
A feeling of worry, nervousness, or unease.
Full definition in the glossary → See all drugs reporting this event →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 39,878 |
| Male | 29,610 |
| Unknown | 193 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 3,824 |
| 18-34 | 12,416 |
| 35-49 | 14,617 |
| 50-64 | 14,526 |
| 65-74 | 7,470 |
| 75+ | 8,189 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Quetiapine. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Other Serious | 43,408 |
| Hospitalization | 34,833 |
| Death | 15,437 |
| Life-Threatening | 8,282 |
| Non-Serious | 5,096 |
| Disability | 3,253 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Quetiapine. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2001 | 1 |
| 2004 | 211 |
| 2005 | 149 |
| 2006 | 133 |
| 2007 | 84 |
| 2008 | 256 |
| 2009 | 246 |
| 2010 | 831 |
| 2011 | 1,004 |
| 2012 | 1,214 |
| 2013 | 1,556 |
| 2014 | 2,283 |
| 2015 | 2,910 |
| 2016 | 3,046 |
| 2017 | 4,900 |
| 2018 | 6,348 |
| 2019 | 7,077 |
| 2020 | 7,511 |
| 2021 | 7,050 |
| 2022 | 6,812 |
| 2023 | 7,220 |
| 2024 | 7,218 |
| 2025 | 6,764 |
| 2026 (partial) | 1,771 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Quetiapine
In FDA adverse event reports that mention Quetiapine, these medications appeared most often in the same report.
- Lorazepam (7,711 reports)
- Clonazepam (6,765 reports)
- Olanzapine (6,687 reports)
- Sertraline (6,391 reports)
- Acetaminophen (6,134 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026