85/100 · Critical
Manufactured by Eli Lilly and Company
Olanzapine Adverse Events: High Seriousness and Diverse Reactions
204,278 FDA adverse event reports analyzed
Last updated: 2026-05-12
OLANZAPINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Eli Lilly and Company. Based on analysis of 204,278 FDA adverse event reports, OLANZAPINE has a safety score of 85 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for OLANZAPINE include DRUG INEFFECTIVE, WEIGHT INCREASED, OFF LABEL USE, DIABETES MELLITUS, DRUG INTERACTION. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for OLANZAPINE.
Olanzapine has a safety concern score of 85 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 204,278 adverse event reports for this medication, which is primarily manufactured by Eli Lilly And Company.
The most commonly reported adverse events include Drug Ineffective, Weight Increased, Off Label Use. Of classified reports, 86.1% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Olanzapine reports show a high percentage of serious adverse events, particularly related to weight increase, diabetes, and suicide attempts.
The drug is associated with a wide range of reactions, including neurological, cardiovascular, and metabolic issues. Overdose and intentional self-harm are significant concerns, with multiple reports of both.
Patients taking Olanzapine should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Olanzapine can cause drug interactions, particularly with other antipsychotics and sedatives, and warnings are issued for patients with certain medical conditions. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Olanzapine received a safety concern score of 85/100 (high concern). This is based on a 86.1% serious event ratio across 103,332 classified reports. The score accounts for 204,278 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Male: 47,225, Female: 46,485, Unknown: 489. The most frequently reported age groups are age 50 (1,406 reports), age 52 (1,387 reports), age 30 (1,374 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 103,332 classified reports for OLANZAPINE:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Olanzapine can cause drug interactions, particularly with other antipsychotics and sedatives, and warnings are issued for patients with certain medical conditions.
If you are taking Olanzapine, here are important things to know. The most commonly reported side effects include drug ineffective, weight increased, off label use, diabetes mellitus, drug interaction. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should strictly follow prescribed dosages and report any unusual symptoms to their healthcare provider immediately. Regular monitoring of blood glucose levels and weight is recommended, especially in patients with pre-existing conditions. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
Regulatory bodies monitor Olanzapine closely due to its high rate of serious adverse events, and healthcare providers should be vigilant about patient monitoring and management.
The FDA has received approximately 204,278 adverse event reports associated with Olanzapine. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Olanzapine include Drug Ineffective, Weight Increased, Off Label Use, Diabetes Mellitus, Drug Interaction. By volume, the top reported reactions are: Drug Ineffective (7,120 reports), Weight Increased (6,720 reports), Off Label Use (5,714 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Olanzapine.
Out of 103,332 classified reports, 88,940 (86.1%) were classified as serious and 14,392 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Olanzapine break down by patient sex as follows: Male: 47,225, Female: 46,485, Unknown: 489. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Olanzapine adverse events are: age 50: 1,406 reports, age 52: 1,387 reports, age 30: 1,374 reports, age 35: 1,369 reports, age 45: 1,349 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Olanzapine adverse event reports is Eli Lilly And Company. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Olanzapine include: Toxicity To Various Agents, Somnolence, Nausea, Fatigue, Anxiety. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Olanzapine to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Olanzapine has a safety concern score of 85 out of 100 (high concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. Olanzapine reports show a high percentage of serious adverse events, particularly related to weight increase, diabetes, and suicide attempts.
Key safety signals identified in Olanzapine's adverse event data include: High percentage of serious adverse events (86.1%). Weight increase and diabetes mellitus are common and serious reactions. Multiple reports of suicide attempts and intentional overdose. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Olanzapine can cause drug interactions, particularly with other antipsychotics and sedatives, and warnings are issued for patients with certain medical conditions. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Olanzapine.
Patients should strictly follow prescribed dosages and report any unusual symptoms to their healthcare provider immediately. Regular monitoring of blood glucose levels and weight is recommended, especially in patients with pre-existing conditions.
Olanzapine has 204,278 adverse event reports on file with the FDA. The drug is associated with a wide range of reactions, including neurological, cardiovascular, and metabolic issues. The volume of reports for Olanzapine reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory bodies monitor Olanzapine closely due to its high rate of serious adverse events, and healthcare providers should be vigilant about patient monitoring and management. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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