Short answer: In the label's IVF studies, 33.1% of women on Ovidrel 250 µg had at least one adverse event, most often injection site reactions (14.0%), including pain (7.6%) and bruising (4.7%), then abdominal pain (4.2%) and nausea (3.4%). Ovarian hyperstimulation syndrome (OHSS) occurred in 1.7% in IVF trials and 3.0% in the ovulation induction trial. There is no boxed warning.
What Ovidrel is approved for: Ovidrel is a recombinant hCG used as the final trigger for egg maturation and early luteinization in infertile women in an assisted reproduction program such as IVF, after pituitary desensitization and pretreatment with follicle stimulating hormone. It is also used to induce ovulation and pregnancy in anovulatory infertile women whose infertility is functional and not due to primary ovarian failure (Indications and Usage).
Source
OVIDREL PreFilled Syringe (choriogonadotropin alfa injection), for subcutaneous use, prescribing information. EMD Serono. DailyMed, version published December 28, 2023. DailyMed setid a683e58a-63ea-44b8-a326-1a99a537bcf2
No. The current Ovidrel 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 Ovidrel.
| Body System / Preferred Term | Ovidrel 250 µg (n=236) Incidence Rate % (n) |
|---|---|
| At Least One Adverse Event | 33.1% (78) |
| Application Site Disorders | 14.0% (33) |
| Injection Site Pain | 7.6% (18) |
| Injection Site Bruising | 4.7% (11) |
| Gastro-Intestinal System Disorders | 8.5% (20) |
| Abdominal Pain | 4.2% (10) |
| Nausea | 3.4% (8) |
| Vomiting | 2.5% (6) |
| Post-Operative Pain | 4.7% (11) |
Women in assisted reproduction (ART) programs given Ovidrel 250 µg after follicle stimulation. Events at 2% or more, whether or not caused by Ovidrel. There was no placebo group; in a comparison, application site problems were 14.6% on Ovidrel 250 µg vs 28% on urine-derived hCG.
| Body System / Preferred Term | Ovidrel 250 µg (n=99) Incidence Rate % (n) |
|---|---|
| At Least One Adverse Event | 26.2% (26) |
| Application Site Disorders | 16.2% (16) |
| Injection site pain | 8.1% (8) |
| Injection site inflammation | 2.0% (2) |
| Injection site bruising | 3.0% (3) |
| Injection site reaction | 3.0% (3) |
| Reproductive Disorders, Female | 7.1% (7) |
| Ovarian cyst | 3.0% (3) |
| Ovarian hyperstimulation | 3.0% (3) |
| Gastro-Intestinal System Disorders | 4.0% (4) |
| Abdominal pain | 3.0% (3) |
Women having ovulation induction (OI) with Ovidrel 250 µg. Events at 2% or more, whether or not caused by Ovidrel.
OHSS occurred in 4 of 236 (1.7%) women on Ovidrel 250 µg in the IVF trials, 3 of 99 (3.0%) in the ovulation induction trial, and 8 of 89 (9.0%) on Ovidrel 500 µg, two of them severe.
Multiple births: 17 of 55 live deliveries (30.9%) in the IVF studies on Ovidrel 250 µg and 2 of 15 (13.3%) in the ovulation induction trial. In IVF, the risk tracks the number of embryos transferred.
ALT (a liver enzyme) rose in 10 of 335 (3%) on Ovidrel 250 µg, 9 of 89 (10%) on 500 µg and 16 of 328 (4.8%) on urine-derived hCG, up to 1.2 times the upper limit of normal. The clinical meaning is not known.
Of 125 pregnancies after FSH and Ovidrel, three involved a congenital anomaly (2.4%), which the label says is consistent with rates after natural or assisted conception; investigators judged them unlikely or of unknown relation to treatment.
Reported after approval: allergic reactions including anaphylaxis and mild reversible rashes, and blood clots with or without OHSS.
The Warnings and Precautions part of the label lists these. Each line gives the label's heading and what it means in plain words.
Specialist use and monitoring. Ovidrel is used only by physicians familiar with infertility, with regular monitoring of ovarian response by serum estradiol and transvaginal ultrasound. Blood clot risk is weighed in women with a personal or family history.
Ovarian enlargement. Mild to moderate ovarian enlargement with bloating or stomach pain can occur and usually goes away within 2 to 3 weeks. If the ovaries are abnormally enlarged on the last day of FSH, Ovidrel is not given that cycle.
Ovarian hyperstimulation syndrome (OHSS). Severe OHSS can progress within 24 hours to several days, with fluid building up in the abdomen and chest. Early signs are severe pelvic pain, nausea, vomiting and weight gain. It usually peaks 7 to 10 days after treatment, so women are followed for at least two weeks, and it can be worse if pregnancy occurs.
Multiple births. Multiple births have been reported. In IVF the risk relates to the number of embryos transferred.
Blood clots. As with other hCG products, arterial thromboembolism can occur.
Lab test interference. hCG can cross-react in gonadotropin blood tests, especially LH, so the lab should be told when someone is on hCG.
Events reported with menotropin therapy. Adnexal torsion (twisting of an enlarged ovary), ovarian enlargement and bleeding into the abdomen. Ovarian tumors have been reported infrequently after multiple ovulation induction regimens, with no causal link established.
Who should not use it. Women with prior allergy to hCG or its ingredients, primary ovarian failure, uncontrolled thyroid or adrenal problems, a pituitary tumor or other uncontrolled brain lesion, unexplained uterine bleeding or ovarian cysts or enlargement, sex hormone dependent reproductive tumors, or pregnancy.
From the Warnings section (the label has no separate Patient Information leaflet) that comes with Ovidrel:
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.