Zyprexaolanzapine
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 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia ( 14.1 ).
104,389 adverse event reports submitted to the FDA (2003–2026)
Top Reported Adverse Events
The most frequently reported events in association with Zyprexa 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 7,218 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 →Weight Increased 6,703 reports
Off Label Use 5,817 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 →Diabetes Mellitus 5,376 reports
A condition where the body cannot properly regulate blood sugar, commonly called diabetes.
Full definition in the glossary →Drug Interaction 4,108 reports
A report that two or more medications may have affected each other when taken together.
Full definition in the glossary →Toxicity to Various Agents 4,079 reports
A broad reporting category used when the body has a harmful response, sometimes involving more than one substance.
Full definition in the glossary →Nausea 3,931 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Somnolence 3,869 reports
Drowsiness or strong sleepiness.
Full definition in the glossary → See all drugs reporting this event →Fatigue 3,495 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Anxiety 3,389 reports
A feeling of worry, nervousness, or unease.
Full definition in the glossary → See all drugs reporting this event →Overdose 3,362 reports
Taking more of a medication than intended or recommended. This can be accidental.
Full definition in the glossary →Vomiting 3,198 reports
Throwing up the contents of the stomach.
Full definition in the glossary → See all drugs reporting this event →Suicide Attempt 3,147 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 →Condition Aggravated 2,899 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 →Confusional State 2,853 reports
A state of being confused, disoriented, or unable to think clearly.
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 | 47,651 |
| Female | 46,882 |
| Unknown | 485 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 5,344 |
| 18-34 | 17,560 |
| 35-49 | 18,311 |
| 50-64 | 17,607 |
| 65-74 | 8,481 |
| 75+ | 6,418 |
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 Zyprexa. 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 | 54,512 |
| Hospitalization | 46,003 |
| Non-Serious | 14,361 |
| Death | 12,921 |
| Life-Threatening | 8,408 |
| Disability | 3,469 |
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 Zyprexa. 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 |
|---|---|
| 2003 | 1 |
| 2004 | 2,191 |
| 2005 | 3,175 |
| 2006 | 3,604 |
| 2007 | 3,533 |
| 2008 | 1,856 |
| 2009 | 3,604 |
| 2010 | 3,236 |
| 2011 | 3,253 |
| 2012 | 2,973 |
| 2013 | 2,560 |
| 2014 | 2,943 |
| 2015 | 7,854 |
| 2016 | 3,892 |
| 2017 | 4,787 |
| 2018 | 6,067 |
| 2019 | 6,663 |
| 2020 | 6,146 |
| 2021 | 6,265 |
| 2022 | 7,084 |
| 2023 | 6,871 |
| 2024 | 7,031 |
| 2025 | 7,178 |
| 2026 (partial) | 1,622 |
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 Zyprexa
In FDA adverse event reports that mention Zyprexa, these medications appeared most often in the same report.
- Quetiapine (14,800 reports)
- Risperidone (12,657 reports)
- Aripiprazole (11,017 reports)
- Lorazepam (10,796 reports)
- Clozapine (8,395 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