85/100 · Critical
Manufactured by Novartis Pharmaceuticals Corporation
High Seriousness in Adverse Reactions for Octreotide Acetate
115,420 FDA adverse event reports analyzed
Last updated: 2026-05-12
OCTREOTIDE ACETATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Novartis Pharmaceuticals Corporation. Based on analysis of 115,420 FDA adverse event reports, OCTREOTIDE ACETATE 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 OCTREOTIDE ACETATE include DIARRHOEA, DEATH, FATIGUE, MALAISE, BLOOD PRESSURE INCREASED. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for OCTREOTIDE ACETATE.
Octreotide Acetate 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 115,420 adverse event reports for this medication, which is primarily manufactured by Novartis Pharmaceuticals Corporation.
The most commonly reported adverse events include Diarrhoea, Death, Fatigue. Of classified reports, 76.5% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The most common serious reactions include death, malignant neoplasm progression, and pneumonia, indicating significant risks.
A high percentage of reactions involve gastrointestinal issues, such as diarrhea and abdominal pain, suggesting potential side effects in this area. Drug interactions and improper administration schedules are frequent issues, highlighting the need for careful management. The majority of reactions are serious, with a serious reaction rate of 76.5%, indicating a high level of concern. The reaction diversity is extensive, with over 100 distinct reactions reported, indicating a complex safety profile.
Patients taking Octreotide Acetate should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Drug interactions and improper administration schedules are common, warning users to follow prescribed dosages and schedules strictly. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Octreotide Acetate received a safety concern score of 85/100 (high concern). This is based on a 76.5% serious event ratio across 29,959 classified reports. The score accounts for 115,420 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: 14,291, Male: 11,952, Unknown: 36. The most frequently reported age groups are age 62 (549 reports), age 68 (507 reports), age 70 (481 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 29,959 classified reports for OCTREOTIDE ACETATE:
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.
Drug interactions and improper administration schedules are common, warning users to follow prescribed dosages and schedules strictly.
If you are taking Octreotide Acetate, here are important things to know. The most commonly reported side effects include diarrhoea, death, fatigue, malaise, blood pressure increased. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Follow prescribed dosages and schedules strictly to avoid improper administration issues. Report any serious adverse reactions to the FDA's MedWatch program immediately. 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 Octreotide Acetate, and any serious adverse reactions should be reported to the FDA's MedWatch program.
The FDA has received approximately 115,420 adverse event reports associated with Octreotide Acetate. 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 Octreotide Acetate include Diarrhoea, Death, Fatigue, Malaise, Blood Pressure Increased. By volume, the top reported reactions are: Diarrhoea (4,498 reports), Death (4,157 reports), Fatigue (3,467 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Octreotide Acetate.
Out of 29,959 classified reports, 22,918 (76.5%) were classified as serious and 7,041 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 Octreotide Acetate break down by patient sex as follows: Female: 14,291, Male: 11,952, Unknown: 36. 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 Octreotide Acetate adverse events are: age 62: 549 reports, age 68: 507 reports, age 70: 481 reports, age 66: 479 reports, age 64: 471 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 Octreotide Acetate adverse event reports is Novartis Pharmaceuticals Corporation. 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 Octreotide Acetate include: Nausea, Needle Issue, Pain, Abdominal Pain, Malignant Neoplasm Progression. 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 Octreotide Acetate 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.
Octreotide Acetate 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. The most common serious reactions include death, malignant neoplasm progression, and pneumonia, indicating significant risks.
Key safety signals identified in Octreotide Acetate's adverse event data include: Death and malignant neoplasm progression are key safety signals, indicating potential severe outcomes.. Gastrointestinal issues, including diarrhea and abdominal pain, are frequent and serious.. Improper drug administration schedules and injection site issues are common, suggesting potential misuse or handling problems.. Serious reactions are significantly higher than non-serious ones, with a serious reaction rate of 76.5%.. A wide range of reactions, including neurological and cardiovascular issues, are reported, indicating a complex safety profile.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Drug interactions and improper administration schedules are common, warning users to follow prescribed dosages and schedules strictly. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Octreotide Acetate.
Follow prescribed dosages and schedules strictly to avoid improper administration issues. Report any serious adverse reactions to the FDA's MedWatch program immediately.
Octreotide Acetate has 115,420 adverse event reports on file with the FDA. A high percentage of reactions involve gastrointestinal issues, such as diarrhea and abdominal pain, suggesting potential side effects in this area. The volume of reports for Octreotide Acetate reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of Octreotide Acetate, and any serious adverse reactions should be reported to the FDA's MedWatch program. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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