Prescription medicine
Follitropin Brand names: Follistim, Gonal-F
Follitropin (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 FDA label on DailyMed (effective May 26, 2026); every follitropin label on DailyMed.
Highlights of the record
FDA label of May 26, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageFOLLISTIM ® AQ Cartridge (follitropin beta) injection, is indicated: In Women for: FOLLISTIM AQ Cartridge is a gonadotropin indicated: In Women for: Induction of Ovulation and Pregnancy in Anovulatory Infertile Women in Whom the Cause of Infertility is Functional and Not Due to Primary Ovarian Failure ( 1.1 ) Pregnancy in Normal Ovulatory Women Undergoing Controlled Ovarian Stimulation as Part of an In Vitro Fertiliz
Forms and strengths
- 0.36ml
- 0.5ml
- 0.72ml
- 0.75ml
- 1.08ml
- 1.5ml
Injection (solution).
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 2 of which 0 under generic applications, 2 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
- 954 through July 30, 2026
What is follitropin used for?
From the label: indications and usageFOLLISTIM ® AQ Cartridge (follitropin beta) injection, is indicated: In Women for: FOLLISTIM AQ Cartridge is a gonadotropin indicated: In Women for: Induction of Ovulation and Pregnancy in Anovulatory Infertile Women in Whom the Cause of Infertility is Functional and Not Due to Primary Ovarian Failure ( 1.1 ) Pregnancy in Normal Ovulatory Women Undergoing Controlled Ovarian Stimulation as Part of an In Vitro Fertilization (IVF) or Intracytoplasmic Sperm Injection (ICSI) Cycle ( 1.2 ) In Men for: Induction of Spermatogenesis in Men with Primary and Secondary Hypogonadotropic Hypogonadism (HH) in Whom the Cause of Infertility is Not Due to Primary Testicular Failure ( 1.3 ) 1.1 Induction of Ovulation and Pregnancy in Anovulatory Infertile Women in Whom the Cause of Infertility is Functional and Not Due to Primary Ovarian Failure Prior to initiation of treatment with FOLLISTIM AQ Cartridge: Women should have a complete gynecologic and endocrinologic evaluation. […]
FDA pharmacologic class: Gonadotropin.
Source: FDA drug label (Follistim AQ), Organon LLC, effective May 26, 2026 (SPL set 48489027-e52b-4b10-ae74-4ba03839150c), via openFDA; the full label on DailyMed
Is there a generic for follitropin (Gonal-F)?
No generic follitropin 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 label say about other medicines?
The follitropin label names 4 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name follitropin. 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. |
| Neomycin | contraindications | … pituitary disorders) [see Indications and Usage (1.1 , 1.2 , 1.3) ] Hypersensitivity reactions to streptomycin or neomycin. |
| Progesterone | warnings and precautions | Direct or indirect indices of progesterone production are: Urinary or serum luteinizing hormone (LH) rise A rise in basal body temperature Increase in serum progesterone Menstruation following the shift in basal body temperature The following provide sonographic evidence of ovulation: |
| Streptomycin | contraindications | … adrenal, or pituitary disorders) [see Indications and Usage (1.1 , 1.2 , 1.3) ] Hypersensitivity reactions to streptomycin or neomycin. |
Other labels that name follitropin
Source: FDA drug label (Follistim AQ), Organon LLC, effective May 26, 2026 (SPL set 48489027-e52b-4b10-ae74-4ba03839150c), via openFDA; the full label on DailyMed
What do FAERS reports show for follitropin?
The FDA Adverse Event Reporting System holds 954 reports that list follitropin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2 are coded as a death and 64 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 gonadotropins
- the pharmacologic class, with prices and generics
- Follitropin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other