Prescription medicine
Ganirelix Brand names: Fyremadel
Ganirelix (Fyremadel) is a prescription medicine with an FDA approval on record since 1999. FDA's NDC Directory lists it from 9 generic labelers, and pharmacies paid $62.35 per mL (Ganirelix acet 250 mcg/0.5 mL) in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the ganirelix FDA label on DailyMed (effective November 13, 2025, Organon LLC); the NDA 21057 record on Drugs@FDA; every ganirelix label on DailyMed.
Highlights of the record
FDA label of November 13, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageGanirelix Acetate Injection is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian hyperstimulation.
Forms and strengths
- 0.5ml
Injection (solution); injection.
On the market
- Earliest approval on file
- July 29, 1999 Ganirelix Acetate, Organon Usa Organon; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 7 first November 30, 2018; 6 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 10 of which 9 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $62.35 per mL Ganirelix acet 250 mcg/0.5 mL
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 3 since 2021 0 Class I among all firms' recalls; latest November 13, 2025
- FAERS reports
- 639 through July 30, 2026
What is ganirelix used for?
From the label: indications and usageGanirelix Acetate Injection is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian hyperstimulation.
FDA pharmacologic class: Gonadotropin Releasing Hormone Receptor Antagonist.
Source: FDA drug label (Ganirelix Acetate), Organon LLC, effective November 13, 2025 (SPL set 32fb74ff-993a-49fe-8943-e029372b863e), via openFDA; the full label on DailyMed
Is there a generic for ganirelix (Fyremadel)?
The FDA approved the first generic ganirelix on November 30, 2018. 7 generic applications are approved; 6 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists ganirelix from 9 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1999 earliest approval on file
- 2018 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for ganirelix (Fyremadel)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $62.35 per mL (Ganirelix acet 250 mcg/0.5 mL), down 14% from $72.92 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Ganirelix acet 250 mcg/0.5 mL (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Fyremadel 250 mcg/0.5 mL syringe | Generic | $62.35 per mL | n/a | -14% |
| Ganirelix acet 250 mcg/0.5 mL | Generic | $62.35 per mL | n/a | -14% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has ganirelix been recalled?
The FDA's Enforcement Report lists 3 recalls naming ganirelix since 2021: 0 Class I (the most serious), 3 Class II, 0 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| November 13, 2025 | Class II | Lupin Pharmaceuticals Inc. | Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity. |
| April 19, 2023 | Class II | Sun Pharmaceutical Industries Ltd. | Presence of Particulate Matter: A piece of glass was found in a prefilled syringe. |
| March 15, 2021 | Class II | SUN PHARMACEUTICAL INDUSTRIES INC | Failed Impurities/Degradation Specifications |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for ganirelix?
The FDA Adverse Event Reporting System holds 639 reports that list ganirelix among the medicines taken, through July 30, 2026, 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.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other gonadotropin releasing hormone receptor antagonists
- the pharmacologic class, with prices and generics
- Ganirelix side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other