Pharmacologic class (EPC) · 4 drug pages

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

28,126 reports list a drug in this class as a suspect or interacting product, 2005–2026.

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.

28,126
reports across the class: 0.1% of all reports; 5,779
reports, 12 months to June 2026: 10,306 in the 12 months before; 23.4%
marked serious by the reporter: 57.4% across all reports; 4
drugs with a page: brand and generic names counted separately

Gonadotropin releasing hormone receptor antagonist is a pharmacologic class (an FDA Established Pharmacologic Class) with 4 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 28,126 adverse event reports received by FDA, 0.1% of the database, from October 2005 to June 2026.

5,779 reports arrived in the 12 months to June 2026, down 44% from 10,306 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 23.4% of the class's reports are marked serious, 3.8% record death among the outcomes and 8% record hospitalisation, as reported.

Across the class the reactions recorded most often are hot flush (27.9%), fatigue (20.5%) and therapy interrupted (13.6%). 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
OrgovyxRelugolix	brand	22,329	5,602	22.5%	Hot flush
OrilissaElagolix	brand	3,198	29	32.4%	Hot flush
MyfembreeRelugolix, estradiol hemihydrate, and norethindrone acetate	brand	1,481	118	10.5%	Therapy interrupted
Ganirelix acetate	generic	1,118	30	32.4%	Ovarian hyperstimulation syndrome

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

Hot flusha hot flush27.9%7,853
Fatiguetiredness20.5%5,755
Therapy interrupted13.6%3,823
Incorrect dose administeredthe wrong dose was given7.4%2,077
Astheniaweakness or lack of energy6.7%1,882
Arthralgiajoint pain6.1%1,707
Diarrhoealoose or frequent stools5.4%1,514
Dizzinesslight-headedness or unsteadiness4.8%1,345
Product dose omission issuea dose was missed4.7%1,317
Painpain, site not specified4.5%1,271
Constipationconstipation3.6%1,010
Nauseafeeling sick3.5%995
Insomniadifficulty sleeping3.4%962
Deaththe patient died; cause not stated by this term3.3%940
Weight increasedweight gain3.3%938
Headachehead pain3.3%917
Myalgiamuscle pain2.9%806
Hyperhidrosisexcessive sweating2.8%781
Blood glucose increasedraised blood sugar reading2.2%619
Night sweatssweating at night2.2%611
Pollakiuriapassing urine more often2.1%594
Back painback pain2.1%583
Feeling abnormalfeeling odd or not right1.8%517
Pain in extremitypain in an arm or leg1.8%503
Depressionlow mood1.6%462

Solid bar: share of all class reports. Hollow bar: the median share across the 4 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death3.8%1,079

Life-threatening0.2%64

Hospitalisation (initial or prolonged)8%2,248

Disability0.2%49

Congenital anomaly0%7

Other serious17.6%4,939

Not serious76.6%21,539

Patient age

Under 20%8

2 to 110%1

12 to 170%14

18 to 446.1%1,712

45 to 645.6%1,583

65 to 7411.1%3,125

75 and over13.4%3,777

Age not given63.7%17,906

Who reported

Physician6.7%1,896

Pharmacist0.9%257

Other health professional6%1,690

Lawyer0%4

Consumer or non-health professional86.1%24,216

Not given0.2%63

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 antagonist reports

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

Orgovyx, Orilissa, Myfembree and Ganirelix acetate. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

28,126 reports through June 2026, 5,779 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?

hot flush (27.9%), fatigue (20.5%), therapy interrupted (13.6%), incorrect dose administered (7.4%) and asthenia (6.7%).

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.