85/100 · Critical
Manufactured by H2-Pharma LLC
Olanzapine Pamoate Adverse Events: High Concern for Metabolic and Cardiovascular Risks
88,377 FDA adverse event reports analyzed
Last updated: 2026-05-12
OLANZAPINE PAMOATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by H2-Pharma LLC. Based on analysis of 88,377 FDA adverse event reports, OLANZAPINE PAMOATE 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 PAMOATE include DIABETES MELLITUS, WEIGHT INCREASED, DRUG INEFFECTIVE, OFF LABEL USE, PANCREATITIS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for OLANZAPINE PAMOATE.
Olanzapine Pamoate 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 88,377 adverse event reports for this medication, which is primarily manufactured by H2-Pharma Llc.
The most commonly reported adverse events include Diabetes Mellitus, Weight Increased, Drug Ineffective. Of classified reports, 77.3% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Serious metabolic events such as diabetes mellitus and hyperglycemia are frequently reported.
Cardiovascular issues like hypertension and dyspnea are also common adverse reactions. Significant weight gain and increased cholesterol levels are notable safety concerns.
Patients taking Olanzapine Pamoate should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Olanzapine Pamoate can cause serious metabolic and cardiovascular side effects, including diabetes, hypertension, and weight gain. Patients should be monitored for these conditions and informed of the risks associated with the drug. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Olanzapine Pamoate received a safety concern score of 85/100 (high concern). This is based on a 77.3% serious event ratio across 40,429 classified reports. The score accounts for 88,377 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: Female: 19,554, Male: 18,542, Unknown: 228. The most frequently reported age groups are age 45 (617 reports), age 40 (556 reports), age 50 (542 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 40,429 classified reports for OLANZAPINE PAMOATE:
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 Pamoate can cause serious metabolic and cardiovascular side effects, including diabetes, hypertension, and weight gain. Patients should be monitored for these conditions and informed of the risks associated with the drug.
If you are taking Olanzapine Pamoate, here are important things to know. The most commonly reported side effects include diabetes mellitus, weight increased, drug ineffective, off label use, pancreatitis. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Regularly monitor blood glucose levels and cholesterol levels in patients taking Olanzapine Pamoate. Inform patients about the risks of weight gain and cardiovascular issues and encourage a healthy lifestyle. Be cautious when prescribing Olanzapine Pamoate to patients with pre-existing metabolic or cardiovascular 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.
The FDA continues to monitor the safety of Olanzapine Pamoate and has issued warnings regarding its potential to cause serious metabolic and cardiovascular side effects. Healthcare providers should be vigilant in managing patient care and reporting a
The FDA has received approximately 88,377 adverse event reports associated with Olanzapine Pamoate. 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 Pamoate include Diabetes Mellitus, Weight Increased, Drug Ineffective, Off Label Use, Pancreatitis. By volume, the top reported reactions are: Diabetes Mellitus (4,874 reports), Weight Increased (4,128 reports), Drug Ineffective (1,924 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 Pamoate.
Out of 40,429 classified reports, 31,264 (77.3%) were classified as serious and 9,165 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 Pamoate break down by patient sex as follows: Female: 19,554, Male: 18,542, Unknown: 228. 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 Pamoate adverse events are: age 45: 617 reports, age 40: 556 reports, age 50: 542 reports, age 47: 538 reports, age 35: 518 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 Pamoate adverse event reports is H2-Pharma Llc. 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 Pamoate include: Hypertension, Type 2 Diabetes Mellitus, Anxiety, Nausea, Somnolence. 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 Pamoate 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 Pamoate 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. Serious metabolic events such as diabetes mellitus and hyperglycemia are frequently reported.
Key safety signals identified in Olanzapine Pamoate's adverse event data include: Diabetes Mellitus and Hyperglycemia. Hypertension and Cardiovascular Events. Weight Gain and Increased Cholesterol. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Olanzapine Pamoate can cause serious metabolic and cardiovascular side effects, including diabetes, hypertension, and weight gain. Patients should be monitored for these conditions and informed of the risks associated with the drug. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Olanzapine Pamoate.
Regularly monitor blood glucose levels and cholesterol levels in patients taking Olanzapine Pamoate. Inform patients about the risks of weight gain and cardiovascular issues and encourage a healthy lifestyle. Be cautious when prescribing Olanzapine Pamoate to patients with pre-existing metabolic or cardiovascular conditions.
Olanzapine Pamoate has 88,377 adverse event reports on file with the FDA. Cardiovascular issues like hypertension and dyspnea are also common adverse reactions. The volume of reports for Olanzapine Pamoate reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of Olanzapine Pamoate and has issued warnings regarding its potential to cause serious metabolic and cardiovascular side effects. Healthcare providers should be vigilant in managing patient care and reporting a For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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