Eligardleuprolide
According to the FDA label: ELIGARD ® is indicated for the palliative treatment of advanced prostate cancer. ELIGARD ® is a gonadotropin releasing hormone (GnRH) agonist indicated for the palliative treatment of advanced prostate cancer ( 1 )
51,984 adverse event reports submitted to the FDA (2004–2026)
Top Reported Adverse Events
The most frequently reported events in association with Eligard 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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- Intercepted Product Preparation Error 8,869 reports
- Syringe Issue 7,730 reports
Hot Flush 6,264 reports
A sudden feeling of heat, often in the face and upper body, sometimes with sweating. Often called a hot flash in American English.
Full definition in the glossary → See all drugs reporting this event →Death 6,260 reports
A report that the person died. A death appearing in reports for a drug does not mean the drug caused it. Reports record that a death occurred while the medication was being used, which can happen for many unrelated reasons.
Full definition in the glossary →- Device Leakage 5,988 reports
Wrong Technique in Product Usage Process 5,213 reports
A report that the medication was used or administered with the wrong technique, such as an incorrect injection or inhaler method. This is a usage category, not a sign of a problem with the drug itself.
Full definition in the glossary →Injection Site Pain 4,198 reports
Pain at the spot on the body where a medication was injected.
Full definition in the glossary →Fatigue 3,463 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →- Prostatic Specific Antigen Increased 1,923 reports
Intentional Product Use Issue 1,647 reports
A report that the medication was deliberately used in a way other than directed. This is a usage category describing what happened, not a judgment.
Full definition in the glossary →Asthenia 1,627 reports
Physical weakness or lack of strength.
Full definition in the glossary →- Prostate Cancer 1,469 reports
Fall 1,410 reports
A report that the person fell down. Falls are tracked because they can signal issues like dizziness, weakness, or balance problems.
Full definition in the glossary →Off Label Use 1,404 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 →Drug Ineffective 1,293 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 →
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 | 42,383 |
| Female | 2,967 |
| Unknown | 20 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 1,065 |
| 18-34 | 308 |
| 35-49 | 884 |
| 50-64 | 3,389 |
| 65-74 | 8,476 |
| 75+ | 12,700 |
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 Eligard. 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 |
|---|---|
| Non-Serious | 28,514 |
| Other Serious | 11,941 |
| Death | 8,767 |
| Hospitalization | 7,790 |
| Life-Threatening | 608 |
| Disability | 421 |
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 Eligard. 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 |
|---|---|
| 2004 | 97 |
| 2005 | 113 |
| 2006 | 109 |
| 2007 | 146 |
| 2008 | 376 |
| 2009 | 202 |
| 2010 | 275 |
| 2011 | 302 |
| 2012 | 417 |
| 2013 | 188 |
| 2014 | 291 |
| 2015 | 847 |
| 2016 | 2,118 |
| 2017 | 1,624 |
| 2018 | 1,701 |
| 2019 | 2,569 |
| 2020 | 4,922 |
| 2021 | 6,192 |
| 2022 | 7,124 |
| 2023 | 7,037 |
| 2024 | 8,802 |
| 2025 | 5,861 |
| 2026 (partial) | 671 |
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 Eligard
In FDA adverse event reports that mention Eligard, these medications appeared most often in the same report.
- Enzalutamide (2,645 reports)
- Bicalutamide (2,461 reports)
- Abiraterone (1,467 reports)
- Denosumab (1,213 reports)
- Prednisone (1,146 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