Prescription medicine
Follitropin alfa Brand names: Gonal-F
Follitropin alfa (Gonal-F) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the follitropin alfa FDA label on DailyMed (effective September 2, 2025); every follitropin alfa label on DailyMed.
Highlights of the record
FDA label of September 2, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageGONAL-f is indicated for: GONAL-f is a gonadotropin indicated for: Women: Induction of ovulation and pregnancy in oligo-anovulatory infertile women for whom the cause of infertility is functional and not due to primary ovarian failure.
Forms and strengths
Kit.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 2,009 through July 30, 2026
What is follitropin alfa used for?
From the label: indications and usageGONAL-f is indicated for: GONAL-f is a gonadotropin indicated for: Women: Induction of ovulation and pregnancy in oligo-anovulatory infertile women for whom the cause of infertility is functional and not due to primary ovarian failure. ( 1.1 ) Development of multiple follicles in ovulatory infertile women as part of Assisted Reproductive Technology (ART) cycles. ( 1.2 ) Men: Induction of spermatogenesis in infertile men with primary and secondary hypogonadotropic hypogonadism for whom the cause of infertility is not due to primary testicular failure. […]
Source: FDA drug label (Gonal-f), EMD Serono, Inc., effective September 2, 2025 (SPL set ae85b9c3-e7eb-4981-a5d9-346050e8f189), via openFDA; the full label on DailyMed
Is there a generic for follitropin alfa (Gonal-F)?
No generic follitropin alfa is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the follitropin alfa label say about other medicines?
The follitropin alfa label names 3 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Estradiol | warnings and precautions | The combination of both ultrasound and serum estradiol measurement are useful for monitoring follicular growth and maturation, timing of the ovulatory trigger, detecting ovarian enlargement and minimizing the risk of the OHSS and multiple gestation. |
| Follitropin | contraindications | CONTRAINDICATIONS GONAL-f is contraindicated in women and men who exhibit: Prior hypersensitivity to recombinant FSH products or one of their excipients. |
| Progesterone | warnings and precautions | Direct or indirect indices of progesterone production: Urinary or serum luteinizing hormone (LH) rise A rise in basal body temperature Increase in serum progesterone Menstruation following a shift in basal body temperature Sonographic evidence of ovulation: |
Source: FDA drug label (Gonal-f), EMD Serono, Inc., effective September 2, 2025 (SPL set ae85b9c3-e7eb-4981-a5d9-346050e8f189), via openFDA; the full label on DailyMed
What do FAERS reports show for follitropin alfa?
The FDA Adverse Event Reporting System holds 2,009 reports that list follitropin alfa among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 30 are coded as a death and 973 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?
- Follitropin alfa side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other