Short answer: In the label's IVF/ICSI study of 751 women on Follistim AQ Cartridge, the most common side effects were pelvic discomfort (8.3%), headache (7.3%), ovarian hyperstimulation syndrome (6.4%), pelvic pain (5.5%), nausea (3.9%) and fatigue (2.3%). In men, headache, acne and injection site reactions were each 6.7%. There is no boxed warning; OHSS, blood clots and multiple births are the main warnings.
What Follistim AQ Cartridge is approved for: Follistim AQ Cartridge is an FSH approved to induce ovulation and pregnancy in anovulatory infertile women whose infertility is functional and not due to primary ovarian failure; for pregnancy in ovulatory women having controlled ovarian stimulation as part of IVF or ICSI; and to induce sperm production in men with hypogonadotropic hypogonadism not due to primary testicular failure (sections 1.1 to 1.3).
Source
FOLLISTIM AQ Cartridge (follitropin beta) injection, for subcutaneous use, prescribing information, Patient Information and Instructions for Use. Organon. DailyMed, version published May 28, 2026. DailyMed setid 48489027-e52b-4b10-ae74-4ba03839150c
No. The current Follistim AQ Cartridge 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 Follistim AQ Cartridge.
| Adverse reaction | FOLLISTIM AQ Cartridge, N = 751 |
|---|---|
| Headache | 55 (7.3%) |
| Nausea | 29 (3.9%) |
| Ovarian Hyperstimulation Syndrome | 48 (6.4%) |
| Pelvic discomfort | 62 (8.3%) |
| Pelvic Pain | 41 (5.5%) |
| Fatigue | 17 (2.3%) |
One IVF or ICSI cycle with a GnRH antagonist; 751 women on Follistim AQ Cartridge out of 1509 randomized. The comparator was another FSH, not placebo, and the label gives only the Follistim AQ column. Values are number of women (%).
| Adverse reaction | FOLLISTIM N=105 | Comparator N=67 |
|---|---|---|
| Abdominal discomfort | 3 (2.9) | 1 (1.5) |
| Abdominal pain | 3 (2.9) | 2 (3.0) |
| Abdominal pain lower | 3 (2.9) | 1 (1.5) |
| Ovarian cyst | 3 (2.9) | 2 (3.0) |
| Ovarian hyperstimulation syndrome | 8 (7.6) | 3 (4.5) |
| Pyrexia | 0 (0.0) | 2 (3.0) |
One ovulation induction cycle in women who had not ovulated or conceived on clomiphene. This study used Follistim (the earlier powder form) against a urofollitropin comparator, not placebo. Values are number of women (%).
| Adverse reaction | FOLLISTIM N=30 |
|---|---|
| Headache | 2 (6.7) |
| Injection site reaction | 2 (6.7) |
| Injection site pain | 2 (6.7) |
| Acne | 2 (6.7) |
| Rash | 1 (3.3) |
| Gynecomastia | 1 (3.3) |
| Dermoid cyst | 1 (3.3) |
Open-label study with no comparison group: 30 men on Follistim 450 IU a week with hCG, 24 of them for 48 weeks. Values are number of men (%).
In clinical trials, OHSS occurred in 7.6% of 105 women having ovulation induction on Follistim and 6.4% of 751 women having IVF or ICSI on Follistim AQ Cartridge.
Other side effects reported in at least 2% of women on Follistim in other ovulation induction trials: headache, abdominal bloating, constipation, diarrhea, nausea, pelvic pain, uterine enlargement, vaginal bleeding and injection site reaction.
Reported after approval: abdominal bloating and pain, constipation, diarrhea, injection site reaction, allergic reactions including anaphylaxis, itching, rash and hives, breast tenderness, irregular bleeding, ovarian enlargement and blood clots.
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. People with a prior allergy to recombinant FSH or to streptomycin or neomycin (traces may be present), high FSH showing primary gonadal failure, uncontrolled thyroid, adrenal or pituitary disorders, or tumors of the ovary, breast, uterus, testis, hypothalamus or pituitary. In women also: pregnancy, unexplained heavy or irregular vaginal bleeding, or ovarian cysts or enlargement not due to PCOS.
Switching products changes the dose. Switching to Follistim AQ Cartridge from other brands, types (recombinant or urinary) or methods (pen or syringe) may need a dose adjustment. The cartridge with the pen delivers on average 18% more follitropin beta than reconstituted Follistim by syringe.
Abnormal ovarian enlargement. The lowest effective dose is used, with ultrasound and estradiol monitoring. If the ovaries are abnormally enlarged on the last day, hCG is not given. Intercourse is prohibited with significant enlargement after ovulation because a ruptured cyst can bleed internally.
Ovarian hyperstimulation syndrome (OHSS). OHSS can quickly become serious, with fluid build-up in the abdomen, chest and possibly around the heart, and blood clots. Early signs are severe pelvic pain, nausea, vomiting and weight gain. It peaks about 7 to 10 days after treatment, is worse if pregnancy occurs, and 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 stroke, loss of a limb and rarely heart attack; in rare cases they caused death. A personal or family history of clots, severe obesity or thrombophilia raises the risk.
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 births and birth defects. Multiple pregnancies and births have been reported with all gonadotropins. Birth defects after IVF or ICSI may be slightly more common than after natural conception, thought to be linked to parent factors and multiple pregnancies rather than the gonadotropins.
Ectopic pregnancy, miscarriage and ovarian tumors. Ectopic pregnancy may be more common in women having IVF or ICSI. Miscarriage risk is increased with gonadotropins, though causality has not been established. Infrequent reports of ovarian tumors after multiple stimulation regimens have not been shown to be caused by the drugs.
Follistim Pen. The Follistim Pen is only for Follistim AQ Cartridge and is not recommended for blind or visually impaired people without help from a trained person with good vision.
From the Patient Information that comes with Follistim AQ Cartridge:
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.