Olanzapine
According to the FDA label: Olanzapine is an atypical antipsychotic indicated: As oral formulation for the: • Treatment of schizophrenia. ( 1.1 ) • Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. ( 14.1 ) • Adolescents (ages 13 to 17): Efficacy was established in one 6-week trial in patients with schizophrenia ( 14.1 ).
66,336 adverse event reports submitted to the FDA (2004–2026)
Top Reported Adverse Events
The most frequently reported events in association with Olanzapine 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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Drug Ineffective 5,720 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 →Off Label Use 4,103 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 →Toxicity to Various Agents 3,762 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 Interaction 3,265 reports
A report that two or more medications may have affected each other when taken together.
Full definition in the glossary →Weight Increased 2,739 reports
Somnolence 2,640 reports
Drowsiness or strong sleepiness.
Full definition in the glossary → See all drugs reporting this event →Nausea 2,638 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 2,287 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 →Vomiting 2,268 reports
Throwing up the contents of the stomach.
Full definition in the glossary → See all drugs reporting this event →Suicide Attempt 2,253 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 →Fatigue 2,225 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Overdose 2,102 reports
Taking more of a medication than intended or recommended. This can be accidental.
Full definition in the glossary →Neuroleptic Malignant Syndrome 2,045 reports
A rare but serious reaction, usually to certain mental-health medications, involving high fever, muscle stiffness, and confusion. It needs urgent medical care.
Full definition in the glossary →Confusional State 2,006 reports
A state of being confused, disoriented, or unable to think clearly.
Full definition in the glossary →Drug Abuse 1,987 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 →
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 |
|---|---|
| Male | 30,313 |
| Female | 28,397 |
| Unknown | 257 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 4,082 |
| 18-34 | 12,522 |
| 35-49 | 11,516 |
| 50-64 | 12,052 |
| 65-74 | 6,114 |
| 75+ | 4,470 |
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 Olanzapine. 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 | 37,538 |
| Hospitalization | 31,446 |
| Death | 8,658 |
| Life-Threatening | 6,363 |
| Non-Serious | 5,542 |
| Disability | 2,073 |
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 Olanzapine. 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 |
|---|---|
| 2004 | 542 |
| 2005 | 683 |
| 2006 | 537 |
| 2007 | 540 |
| 2008 | 527 |
| 2009 | 685 |
| 2010 | 710 |
| 2011 | 851 |
| 2012 | 1,324 |
| 2013 | 1,411 |
| 2014 | 1,740 |
| 2015 | 2,241 |
| 2016 | 2,617 |
| 2017 | 3,498 |
| 2018 | 4,895 |
| 2019 | 5,506 |
| 2020 | 5,179 |
| 2021 | 5,511 |
| 2022 | 6,270 |
| 2023 | 6,238 |
| 2024 | 6,575 |
| 2025 | 6,732 |
| 2026 (partial) | 1,524 |
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 Olanzapine
In FDA adverse event reports that mention Olanzapine, these medications appeared most often in the same report.
- Quetiapine (9,039 reports)
- Risperidone (8,135 reports)
- Lorazepam (7,985 reports)
- Aripiprazole (7,529 reports)
- Clozapine (7,298 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