78/100 · Elevated
Manufactured by TOLMAR Inc.
Leuprolide Acetate Adverse Events: High Seriousness and Diverse Reactions
133,873 FDA adverse event reports analyzed
Last updated: 2026-05-12
LEUPROLIDE ACETATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by TOLMAR Inc.. Based on analysis of 133,873 FDA adverse event reports, LEUPROLIDE ACETATE has a safety score of 78 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 LEUPROLIDE ACETATE include HOT FLUSH, INTERCEPTED PRODUCT PREPARATION ERROR, DEATH, SYRINGE ISSUE, DEVICE LEAKAGE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for LEUPROLIDE ACETATE.
Leuprolide Acetate has a safety concern score of 78 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 133,873 adverse event reports for this medication, which is primarily manufactured by Tolmar Inc..
The most commonly reported adverse events include Hot Flush, Intercepted Product Preparation Error, Death. Of classified reports, 45.7% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. High percentage of serious adverse events (45.7%) indicates significant safety concerns.
A wide range of reactions, including serious conditions like death and cancer progression, are reported. Injection site issues and device problems are frequent, suggesting potential misuse or handling errors.
Patients taking Leuprolide Acetate should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Interactions and warnings include potential for serious adverse events, especially in elderly patients, and need for proper administration techniques. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Leuprolide Acetate received a safety concern score of 78/100 (high concern). This is based on a 45.7% serious event ratio across 75,326 classified reports. The score accounts for 133,873 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: 52,321, Female: 15,382, Unknown: 127. The most frequently reported age groups are age 75 (1,244 reports), age 76 (1,243 reports), age 77 (1,243 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 75,326 classified reports for LEUPROLIDE 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.
Interactions and warnings include potential for serious adverse events, especially in elderly patients, and need for proper administration techniques.
If you are taking Leuprolide Acetate, here are important things to know. The most commonly reported side effects include hot flush, intercepted product preparation error, death, syringe issue, device leakage. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should report any unusual symptoms to their healthcare provider immediately. Ensure proper administration techniques are followed to avoid injection site issues and device problems. 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 oversight is ongoing, with frequent updates to safety information and warnings for healthcare providers.
The FDA has received approximately 133,873 adverse event reports associated with Leuprolide 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 Leuprolide Acetate include Hot Flush, Intercepted Product Preparation Error, Death, Syringe Issue, Device Leakage. By volume, the top reported reactions are: Hot Flush (9,491 reports), Intercepted Product Preparation Error (8,862 reports), Death (8,129 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Leuprolide Acetate.
Out of 75,326 classified reports, 34,405 (45.7%) were classified as serious and 40,921 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 Leuprolide Acetate break down by patient sex as follows: Male: 52,321, Female: 15,382, Unknown: 127. 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 Leuprolide Acetate adverse events are: age 75: 1,244 reports, age 76: 1,243 reports, age 77: 1,243 reports, age 74: 1,220 reports, age 78: 1,197 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 Leuprolide Acetate adverse event reports is Tolmar Inc.. 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 Leuprolide Acetate include: Wrong Technique In Product Usage Process, Fatigue, Injection Site Pain, Prostatic Specific Antigen Increased, Asthenia. 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 Leuprolide 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.
Leuprolide Acetate has a safety concern score of 78 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. High percentage of serious adverse events (45.7%) indicates significant safety concerns.
Key safety signals identified in Leuprolide Acetate's adverse event data include: Death is one of the most reported serious adverse events.. Prostatic specific antigen increased and prostate cancer are frequently reported, indicating potential side effects in men.. Injection site pain and device leakage are common, suggesting issues with administration.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Interactions and warnings include potential for serious adverse events, especially in elderly patients, and need for proper administration techniques. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Leuprolide Acetate.
Patients should report any unusual symptoms to their healthcare provider immediately. Ensure proper administration techniques are followed to avoid injection site issues and device problems.
Leuprolide Acetate has 133,873 adverse event reports on file with the FDA. A wide range of reactions, including serious conditions like death and cancer progression, are reported. The volume of reports for Leuprolide Acetate reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is ongoing, with frequent updates to safety information and warnings for healthcare providers. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
The following drugs share commonly reported adverse reactions with LEUPROLIDE ACETATE:
Drugs related to LEUPROLIDE ACETATE based on therapeutic use, drug class, or shared indications: