Short answer: In the label's IVF and ICSI trials of 434 women, the most common Menopur side effects were abdominal pain (6.7%), headache (6.2%), ovarian hyperstimulation syndrome or OHSS (6.2%), injection site pain and reaction (3.9%), abdominal cramps (3.0%), and an enlarged abdomen and injection site inflammation (2.3% each). Menopur has no boxed warning; OHSS and multiple births are its main warnings.
What Menopur is approved for: Menopur is a gonadotropin, containing FSH and LH activity, approved for the development of multiple follicles and pregnancy in ovulatory women as part of an Assisted Reproductive Technology (ART) cycle (section 1). Before treatment, the label calls for a full gynecologic and endocrine evaluation, ruling out pregnancy and primary ovarian failure, and checking the male partner's fertility.
Source
MENOPUR (menotropins for injection), for subcutaneous use, prescribing information, Patient Information and Instructions for Use. Ferring Pharmaceuticals. DailyMed, version published May 11, 2026. DailyMed setid 22c8db95-c3db-1770-8086-31356fbabe35
No. The current Menopur 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 Menopur.
| Body system | Preferred term | IVF n=434, N | IVF n=434, % |
|---|---|---|---|
| Body as a whole | Abdominal cramps | 13 | 3.0 |
| Body as a whole | Abdomen enlarged | 10 | 2.3 |
| Body as a whole | Abdominal pain | 29 | 6.7 |
| Body as a whole | Headache | 27 | 6.2 |
| Body as a whole | Injection site pain + reaction | 17 | 3.9 |
| Body as a whole | Injection site inflammation | 10 | 2.3 |
| Urogenital | Ovarian Hyperstimulation Syndrome (OHSS) | 27 | 6.2 |
Two single-cycle, open-label trials; 434 ovulatory infertile women got Menopur under the skin after pituitary down-regulation with a GnRH agonist. There was no placebo group. Thrombophlebitis was reported in less than 1%.
In the IVF trial used for approval, OHSS occurred in 7.2% of the 373 women treated with Menopur.
In the same IVF trial, multiple pregnancy seen on ultrasound occurred in 35.3% (n=30) of 85 total pregnancies.
With Menopur and Bravelle mixed in the same syringe (60 women), OHSS, cramping and nausea after egg retrieval, and miscarriage were the most common reactions at 5% or more.
In an ovulation induction trial of 76 women, reactions at 5% or more were headache, OHSS, injection site reaction, abdominal cramps, fullness and pain, and nausea.
Reported after approval with gonadotropins: lower abdominal pain and bloating, nausea, vomiting, injection site pain, fatigue, dizziness, pelvic pain, ovarian cyst, breast pain, tenderness or swelling, acne, rash and hot flush.
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 menotropins, high FSH showing primary ovarian failure, pregnancy, 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.
Specialist use. Menopur is for physicians experienced in infertility treatment, with monitoring facilities available, at the lowest effective dose.
Abnormal ovarian enlargement. If the ovaries are abnormally enlarged on the last day of Menopur, hCG is not given, to lower the chance of OHSS. Intercourse is prohibited with significant enlargement 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 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 Menopur.
Ectopic pregnancy and miscarriage. Ectopic pregnancy may be more common in women undergoing ART (5.7). Miscarriage risk is increased with gonadotropins, though causality has not been established (5.8). Infrequent reports of ovarian tumors have not been shown to be caused by the drugs (5.9).
From the Patient Information that comes with Menopur:
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.