ganirelix acetate
Pharmaranks rates Ganirelix Acetate 2.9/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Ganirelix Acetate is a gonadotropin releasing hormone receptor antagonist used to treat Ovarian Hyperstimulation Syndrome.
Gonadotropin Releasing Hormone Receptor Antagonist · by Lupin
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Ganirelix Acetate
- Form
- Injectable, Solution
- Strength
- Ganirelix Acetate 250MCG/0.5ML
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- May treat
- ovarian hyperstimulation syndrome
- Manufacturer
- Lupin
- FDA application
- ANDA216075
What is Ganirelix Acetate?
From the FDA label:Ganirelix acetate injection is a synthetic decapeptide with high antagonistic activity against naturally occurring gonadotropin-releasing hormone (GnRH). Ganirelix acetate is derived from native GnRH with substitutions of amino acids at positions 1, 2, 3, 6, 8, and 10 to form the following molecular formula of the peptide: N-acetyl-3-(2-naphthyl)-D-alanyl-4-chloro-D-phenylalanyl-3-(3-pyridyl)-D-alanyl-L-seryl-L-tyrosyl-N 9 ,N 10 -diethyl-D-homoarginyl-L-leucyl-N 9 ,N 10 -diethyl-L-homoarginyl-L-prolyl-D-alanylamide acetate. The molecular weight for ganirelix acetate is 1570.42 as an anhydrous free base. The structural formula is as follows: Ganirelix Acetate Ganirelix acetate injection is supplied as a colorless, sterile, ready-to-use, aqueous solution intended for SUBCUTANEOUS administration only. Each single dose, sterile, prefilled syringe contains 250 mcg/0.5 mL of ganirelix acetate, 0.1 mg glacial acetic acid, 23.5 mg mannitol, and water for injection adjusted to pH 5 with glacial acetic acid, USP and/or sodium hydroxide, NF. Image
How to use
Ganirelix Acetate is sold in more than one form (Injectable and Solution), and each is dosed differently. The instructions below come from the FDA label for application ANDA216075 — follow the label that came with the product you were actually 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…
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…
Warnings
Important safety information
Ganirelix acetate injection should be prescribed by physicians who are experienced in infertility treatment. Before starting treatment with ganirelix acetate, pregnancy must be excluded. Safe use of ganirelix acetate during pregnancy has not been established (see CONTRAINDICATIONS and PRECAUTIONS ).
Who should not take Ganirelix Acetate
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 ).
Overdose — what happens if you take too much
There have been no reports of overdosage with ganirelix acetate injection in humans.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
No formal drug-drug interaction studies have been performed.
Drug class
May treat (source: NIH RxClass)
Dosage forms
Injectable and Solution
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
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Frequently asked questions
- What does Ganirelix Acetate treat?
- Ganirelix Acetate (Ganirelix Acetate) may be used to treat ovarian hyperstimulation syndrome, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How is Ganirelix Acetate rated?
- pharmaranks gives Ganirelix Acetate a composite score of 2.9 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- Is there a coupon or discount for Ganirelix Acetate?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Ganirelix Acetate. To pay less, Ganirelix Acetate is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Ganirelix Acetate?
- Ganirelix Acetate is marketed by Lupin. You can see Lupin's full profile, rating, and other products on pharmaranks.
- Is Ganirelix Acetate a brand-name or generic drug?
- Ganirelix Acetate is a generic medication; its active ingredient is Ganirelix Acetate. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Ganirelix Acetate available over the counter?
- No. Ganirelix Acetate is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Ganirelix Acetate come in?
- Ganirelix Acetate is currently marketed as injectable and solution, per the FDA's National Drug Code Directory.
- What class of drug is Ganirelix Acetate?
- Ganirelix Acetate is classified as gonadotropin releasing hormone receptor antagonist, per the FDA's Established Pharmacologic Class.
- Is Ganirelix Acetate FDA-registered?
- Ganirelix Acetate is on record with the U.S. FDA under application number ANDA216075. You can verify this on its official FDA label.
- Has Ganirelix Acetate been recalled by the FDA?
- Yes. Ganirelix Acetate has 1 recorded FDA recall event in the openFDA enforcement database. A recall removes specific lots from the market — usually for manufacturing, contamination, potency, or labeling issues — and does not mean the drug is unsafe to take; your specific lot was almost certainly never affected. This recall history is factored into its safety score above. Always check the FDA recall database or your pharmacist for current alerts.
- Is Ganirelix Acetate safe?
- There's no single safe-or-not verdict. pharmaranks gives Ganirelix Acetate a recall-safety score of 58/100, based on its FDA recall history (1 recorded recall event) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Ganirelix Acetate?
- Ganirelix Acetate's side effects are taken directly from its FDA label. From the label: 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.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
What people report to the FDA about Ganirelix Acetate
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 1,501 reports naming Ganirelix Acetate, 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 Acetate 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.
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ganirelix acetate
58/100