Eligard: adverse event reports filed with FDA

44,385

reports as suspect product

0.2% of all reports · about 1,988 a year

2,388

reports, 12 months to June 2026

7,398 in the 12 months before

38.1%

marked serious by the reporter

50.5% across the class

17.3%

record death among outcomes, as reported

7,657 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Eligard reports recording the termmedian drug in gonadotropin releasing hormone receptor agonist

1. Intercepted product preparation error20.3%9,024
2. Syringe issue17.4%7,741
3. Device leakagethe device leaked13.7%6,086
4. Deaththe patient died; cause not stated by this term13.6%6,049
5. Hot flusha hot flush13.4%5,933
6. Wrong technique in product usage processthe product was used in the wrong way12%5,316
7. Injection site painpain where the injection was given9.3%4,126
8. Fatiguetiredness6.5%2,890
9. Prostatic specific antigen increased3.7%1,640
10. Intentional product use issuedeliberate use not as intended3.7%1,631
11. Astheniaweakness or lack of energy2.9%1,301
12. Injection site mass2.8%1,242
13. Prostate cancer2.8%1,235
14. Off label useused for a purpose or in a way not on the label2.6%1,147
15. Intercepted medication error2.5%1,124
16. Falla fall2.5%1,099
17. Drug ineffectivethe medicine did not work as expected2.1%954
18. Weight increasedweight gain2.1%928
19. Product physical consistency issue2.1%920
20. Device occlusionthe device blocked2%903
21. Inappropriate schedule of product administrationthe product was taken at the wrong times1.9%837
22. Dizzinesslight-headedness or unsteadiness1.8%785
23. Arthralgiajoint pain1.7%771
24. Needle issuea problem with the needle1.4%630
25. Product packaging quantity issue1.3%596
26. Terminal state1.3%587
27. Weight decreasedweight loss1.3%581
28. Malaisegeneral feeling of being unwell1.3%578
29. Back painback pain1.3%574
30. Injection site haemorrhagebleeding where the injection was given1.3%572

Top 30 of 1,474 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 7 drugs in the gonadotropin releasing hormone receptor agonist class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 61,409 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 24.5% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 44,385 reports.

Drugs most often listed in the same reports

Other products listed in reports where Eligard is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the gonadotropin releasing hormone receptor agonist class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Eligard as a suspect or interacting product; reports listing it only as a concomitant medication (2,126) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.