Ganirelix: uses, dosing, side effects & brands
Ganirelix is a gonadotropin releasing hormone receptor antagonist sold in the U.S. under one brand, for ovarian hyperstimulation syndrome. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Gonadotropin Releasing Hormone Receptor Antagonist
- Treats (across its forms)
- Ovarian Hyperstimulation Syndrome
- Available as
- Injectable · Solution
- Sold as
- Ganirelix Acetate
- Prescription?
- Prescription only
- Generic available?
- Yes
How ganirelix is dosed
From the FDA label for Ganirelix Acetate (application ANDA216075). Other ganirelix products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
After initiating FSH therapy on Day 2 or 3 of the cycle, ganirelix acetate injection 250 mcg may be administered subcutaneously once daily during the mid to late portion of the follicular phase. By taking advantage of endogenous pituitary FSH secretion, the requirement for exogenously administered FSH may be reduced. Treatment with ganirelix acetate should be continued daily until the day of hCG administration. When a sufficient number of follicles of adequate size are present, as assessed by ultrasound, final maturation of follicles is induced by administering hCG. The administration of hCG should be withheld in cases where the ovaries are abnormally enlarged on the last day of FSH therapy to reduce the chance of developing OHSS (Ovarian Hyperstimulation Syndrome). Directions for Using Ganirelix Acetate Injection Ganirelix acetate injection is supplied in a single dose, sterile, prefilled syringe and is intended for SUBCUTANEOUS administration only. Air bubble(s) may be seen in the pre-filled syringe. This is expected, and removal of the air bubble(s) is not needed. Wash hands thoroughly with soap and water. The most convenient sites for SUBCUTANEOUS injection are in the abdomen around the navel or upper thigh. The injection site should be swabbed with a disinfectant to remove any surface bacteria. Clean about two inches around the point where the needle will be inserted and…
Ganirelix side effects
The 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 4 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 4: 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 (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 (8) During post-marketing surveillance, rare cases of hypersensitivity reactions, including anaphylaxis (including anaphylactic shock), angioedema and urticaria have been reported with ganirelix acetate, as early as with the first dose (see PRECAUTIONS ). Congenital Anomalies An observational study in more than 1000 newborns compared the incidence of congenital anomalies in newborns of women administered ganirelix acetate to historical controls of a GnRH agonist. This study demonstrated that the incidence of…
Who shouldn’t take ganirelix
Ganirelix acetate injection is contraindicated under the following conditions: Known hypersensitivity to ganirelix acetate or to any of its components. Known hypersensitivity to GnRH or any other GnRH analog. Known or suspected pregnancy (see PRECAUTIONS ).
Ganirelix drug interactions
No formal drug-drug interaction studies have been performed.
Every ganirelix product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Ganirelix Acetate.
Ganirelix recalls
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
How long ganirelix keeps
No ganirelix label we read sets a separate limit for after opening, but they do specify how it must be stored — and the stability behind any date assumes those conditions.
What people report to the FDA about ganirelix
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 1,501 reports naming ganirelix, and the FDA flagged 29% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- ovarian hyperstimulation syndrome261 reports
- headache94 reports
- inappropriate schedule of drug administration84 reports
- needle issue80 reports
- injection site pain77 reports
- nausea65 reports
- abdominal distension61 reports
- fatigue48 reports
Read these as a signal, not a rate. A report does not mean ganirelix caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label.
Source: openFDA drug/event (FAERS), retrieved September 25, 2026.
Related calculators
Frequently asked questions
What is ganirelix?
Ganirelix acetate injection is a synthetic decapeptide with high antagonistic activity against naturally occurring gonadotropin-releasing hormone (GnRH).
What kind of drug is ganirelix?
The FDA classifies ganirelix as a gonadotropin releasing hormone receptor antagonist. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take ganirelix with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run ganirelix against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does ganirelix come in?
Across the brands we track, ganirelix is currently marketed as injectable and solution, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic ganirelix?
Yes. Our catalog lists 1 generic ganirelix product alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.
Has ganirelix been recalled?
The FDA's Enforcement database lists 1 recall record whose product description mentions ganirelix. The most recent: Ganirelix Acetate Injection (Nov 13, 2025). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.
Cite this page
- APA
- pharmaranks. (2026, July 24). Ganirelix: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/ganirelix
- MLA
- “Ganirelix: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/ganirelix.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for ganirelix on DailyMed (NIH) ↗.