What the label lists and what reports show
Ganirelix side effects
Ganirelix's FDA label lists its adverse reactions in its own words. FAERS holds 639 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is ovarian hyperstimulation syndrome (253 reports).
- Generic listed
Check it at the source: the ganirelix FDA label on DailyMed (effective November 13, 2025, Organon LLC); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe safety of Ganirelix Acetate Injection was evaluated in two randomized, parallel-group, multicenter controlled clinical studies. Treatment duration for Ganirelix Acetate ranged from 1 to 14 days. Table IV represents adverse events (AEs) from first day of Ganirelix Acetate administration until confirmation of pregnancy by ultrasound at an incidence of ≥ 1% in Ganirelix Acetate-treated subjects without regard to causality. TABLE IV: Incidence of common adverse events (Incidence ≥ 1% in Ganirelix Acetate-treated subjects). Completed controlled clinical studies (All-subjects-treated group). …
TABLE IV: Incidence of common adverse events (Incidence ≥ 1% in Ganirelix Acetate-treated subjects). Completed controlled clinical studies (All-subjects-treated group).
| Adverse Events Occurring in ≥ 1% | Ganirelix Acetate N=794 % (n) |
|---|---|
| Abdominal Pain (gynecological) | 4.8 (38) |
| Death Fetal | 3.7 (29) |
| Headache | 3.0 (24) |
| Ovarian Hyperstimulation Syndrome | 2.4 (19) |
| Vaginal Bleeding | 1.8 (14) |
| Injection Site Reaction | 1.1 (9) |
| Nausea | 1.1 (9) |
| Abdominal Pain (gastrointestinal) | 1.0 (8) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
Source: FDA drug label, Organon LLC, effective November 13, 2025 (SPL set 32fb74ff-993a-49fe-8943-e029372b863e), via openFDA; the full label on DailyMed
What do FAERS reports show?
639 reports list ganirelix among the medicines taken, each a report of something that happened, not proof the medicine caused it; 3 are coded as a death and 272 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 21 reactions below, 5 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Ganirelix: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions