Pharmacologic class (EPC) · 7 drug pages

Gonadotropin releasing hormone receptor agonist: adverse event reports filed with FDA

61,409 reports list a drug in this class as a suspect or interacting product, 2004–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

61,409
reports across the class: 0.3% of all reports; 4,101
reports, 12 months to June 2026: 9,109 in the 12 months before; 50.5%
marked serious by the reporter: 57.4% across all reports; 7
drugs with a page: brand and generic names counted separately

Gonadotropin releasing hormone receptor agonist is a pharmacologic class (an FDA Established Pharmacologic Class) with 7 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 61,409 adverse event reports received by FDA, 0.3% of the database, from January 2004 to June 2026.

4,101 reports arrived in the 12 months to June 2026, down 55% from 9,109 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 50.5% of the class's reports are marked serious, 17.7% record death among the outcomes and 15.1% record hospitalisation, as reported.

Across the class the reactions recorded most often are intercepted product preparation error (15%), death (13.1%) and syringe issue (12.9%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is 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."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
EligardLeuprolide acetate	brand	44,385	2,388	38.1%	Intercepted product preparation error
ZoladexGoserelin	brand	7,058	396	88.5%	Death
Leuprolide acetate	generic	4,951	702	90.1%	Drug ineffective
Goserelin	generic	2,789	383	95.9%	Malignant neoplasm progression
SupprelinHistrelin acetate	brand	815	12	18%	Drug ineffective
FensolviLeuprolide acetate	brand	748	114	4.4%	Off label use
Leuprolide	generic	663	106	79%	Drug ineffective

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."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Intercepted product preparation error15%9,225
Deaththe patient died; cause not stated by this term13.1%8,015
Syringe issue12.9%7,895
Hot flusha hot flush10.8%6,612
Device leakagethe device leaked10.1%6,216
Wrong technique in product usage processthe product was used in the wrong way8.8%5,425
Injection site painpain where the injection was given7.1%4,340
Fatiguetiredness5.8%3,570
Off label useused for a purpose or in a way not on the label3.2%1,959
Prostatic specific antigen increased3.2%1,936
Astheniaweakness or lack of energy2.9%1,808
Drug ineffectivethe medicine did not work as expected2.9%1,760
Intentional product use issuedeliberate use not as intended2.7%1,651
Prostate cancer2.5%1,552
Falla fall2.5%1,518
Malignant neoplasm progression2.4%1,485
Injection site mass2.1%1,306
Arthralgiajoint pain1.9%1,152
Weight increasedweight gain1.9%1,140
Intercepted medication error1.8%1,124
Dizzinesslight-headedness or unsteadiness1.8%1,085
Metastases to bone1.7%1,071
Product physical consistency issue1.5%949
Inappropriate schedule of product administrationthe product was taken at the wrong times1.5%947
Device occlusionthe device blocked1.5%925

Solid bar: share of all class reports. Hollow bar: the median share across the 7 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death17.7%10,861

Life-threatening1.4%839

Hospitalisation (initial or prolonged)15.1%9,269

Disability1.1%697

Congenital anomaly0.1%46

Other serious27.4%16,835

Not serious49.5%30,399

Patient age

Under 20%11

2 to 112.5%1,527

12 to 170.4%260

18 to 443.1%1,899

45 to 647.7%4,721

65 to 7414.3%8,787

75 and over21.5%13,191

Age not given50.5%31,013

Who reported

Physician15.6%9,552

Pharmacist8.9%5,469

Other health professional25%15,332

Lawyer0%10

Consumer or non-health professional47.9%29,426

Not given2.6%1,620

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Gonadotropin releasing hormone receptor agonist reports

Which drugs are in the Gonadotropin releasing hormone receptor agonist class on this site?

Eligard, Zoladex, Leuprolide acetate, Goserelin, Supprelin and Fensolvi and 1 more. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

61,409 reports through June 2026, 4,101 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

intercepted product preparation error (15%), death (13.1%), syringe issue (12.9%), hot flush (10.8%) and device leakage (10.1%).

Can the members table be used to rank the drugs?

No. 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." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. See the guide on how to report.

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 class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. 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.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.