Short answer: In the label's ovulation induction study, the most common Gonal-f RFF side effects were headache (26.5%), abdominal pain (12.0%) and ovarian hyperstimulation (7.2%). In the ART study they were abdominal pain (23.2%), headache (18.6%), abdominal enlargement (13.9%), injection site bruising (9.7%) and nausea (8.0%). There is no boxed warning; OHSS, allergic reactions and multiple births are the main warnings.
What Gonal-f RFF Redi-ject is approved for: Gonal-f RFF Redi-ject is a prefilled FSH pen approved to induce ovulation and pregnancy in oligo-anovulatory women whose infertility is functional and not due to primary ovarian failure, and to develop multiple follicles in ovulatory women as part of an Assisted Reproductive Technology (ART) cycle (section 1). This page covers the Redi-ject pen label; the Gonal-f multi-dose vial has a separate label.
Source
GONAL-f RFF Redi-ject (follitropin alfa) injection, for subcutaneous use, prescribing information, Patient Information and Instructions for Use. EMD Serono. DailyMed, version published April 7, 2025. DailyMed setid b6d11c45-b502-478e-bb28-2ff596ea259c
No. The current Gonal-f RFF Redi-ject label has no boxed warning.
These are the label's own numbers from the Adverse Reactions section. Where the label compares with placebo (a dummy treatment), both columns are shown, so you can see how much more often a reaction happened on Gonal-f RFF Redi-ject.
| System organ class / adverse reaction | GONAL-f RFF, N=83 |
|---|---|
| Central and Peripheral Nervous System: Headache | 22 (26.5%) |
| Gastrointestinal System: Abdominal Pain | 10 (12.0%) |
| Gastrointestinal System: Nausea | 3 (3.6%) |
| Gastrointestinal System: Flatulence | 3 (3.6%) |
| Gastrointestinal System: Diarrhea | 3 (3.6%) |
| Neoplasm: Ovarian Cyst | 3 (3.6%) |
| Reproductive, Female: Ovarian Hyperstimulation | 6 (7.2%) |
| Application Site: Injection Site Pain | 4 (4.8%) |
| Application Site: Injection Site Inflammation | 2 (2.4%) |
Up to 3 cycles of ovulation induction in 83 oligo-anovulatory women (176 treatment cycles), compared with another recombinant FSH rather than placebo. Values are number of women with the reaction (%).
| System organ class / adverse reaction | GONAL-f RFF, N=237 |
|---|---|
| Gastrointestinal System: Abdominal Pain | 55 (23.2%) |
| Gastrointestinal System: Nausea | 19 (8.0%) |
| Body as a Whole- General: Abdomen Enlarged | 33 (13.9%) |
| Central and Peripheral Nervous System: Headache | 44 (18.6%) |
| Application Site Disorders: Injection Site Bruising | 23 (9.7%) |
| Application Site Disorders: Injection Site Pain | 13 (5.5%) |
| Application Site Disorders: Injection Site Inflammation | 10 (4.2%) |
| Application Site Disorders: Injection Site Reaction | 10 (4.2%) |
| Application Site Disorders: Application Site Edema | 6 (2.5%) |
| Reproductive, Female: Ovarian Hyperstimulation | 11 (4.6%) |
One ART (IVF or ICSI) cycle in 237 ovulatory women after GnRH agonist down-regulation, compared with another recombinant FSH rather than placebo. Values are number of women with the reaction (%).
OHSS occurred in 7.2% of 83 women in ovulation induction and 4.6% of 237 women in ART in the Gonal-f RFF trials.
Multiple births made up 20% of live births with ovulation induction and 35.1% of live births with ART in the Gonal-f RFF trials.
Reported after approval: allergic reactions including anaphylactoid reactions, asthma and blood clots (thromboembolism).
The Warnings and Precautions part of the label lists these. Each line gives the label's heading and what it means in plain words.
Who should not use it. Women with a prior allergy to recombinant FSH, high FSH showing primary gonadal failure, uncontrolled thyroid, adrenal or pituitary disorders, sex-hormone-dependent tumors of the reproductive organs, pituitary or hypothalamic tumors, unexplained abnormal uterine bleeding, or ovarian cysts or enlargement not due to PCOS.
Serious allergic reactions. Anaphylaxis and other serious allergic reactions, with trouble breathing, facial swelling, itching and hives, have been reported with Gonal-f and Gonal-f RFF. If one occurs, use is stopped.
Abnormal ovarian enlargement. If the ovaries are abnormally enlarged on the last day of treatment, hCG is not given, to lower the chance of OHSS. Intercourse is prohibited with significant enlargement after ovulation because a ruptured cyst can cause internal bleeding.
Ovarian hyperstimulation syndrome (OHSS). OHSS can progress rapidly to a serious condition with fluid build-up in the abdomen, chest and around the heart, and blood clots. It develops after treatment stops, peaking about 7 to 10 days later, and is more common, severe and longer if pregnancy occurs. Women are watched for at least two weeks after hCG.
Lung and blood vessel complications. Serious lung problems and blood clots, with or without OHSS, have been reported with gonadotropins including Gonal-f RFF, including stroke, loss of a limb and, rarely, heart attack; in rare cases they caused death.
Ovarian torsion. Twisting of the ovary has been reported, possibly linked to OHSS, pregnancy, past abdominal surgery, past torsion, ovarian cysts and polycystic ovaries.
Multiple pregnancy and birth. Multiple pregnancies and births have been reported with all gonadotropins, including Gonal-f RFF.
Ectopic pregnancy, miscarriage and ovarian tumors. Ectopic pregnancy may be more common in women undergoing ART (5.8). Miscarriage risk is increased with gonadotropins, though causality has not been established (5.9). Infrequent reports of ovarian tumors have not been shown to be caused by the drugs (5.10).
From the Patient Information that comes with Gonal-f RFF Redi-ject:
Dose Track has a side-effect log. Each entry records the symptom, a severity (none, mild, moderate, severe or life-threatening), the date and an optional note, and can be tied to a specific dose or logged on its own. The history screen shows what you logged over time, which makes it easier to tell your prescriber when a reaction started and whether it is easing. The app records what you enter; it does not judge whether a symptom is serious. For anything on the label's call-your-doctor list, call your doctor.
This page is what the FDA label says, in plain words. It is not medical advice. Follow your prescriber, and ask them or your pharmacist about anything here.