Short answer: In 949 women having controlled ovarian stimulation, the Cetrotide label lists moderate or severe ovarian hyperstimulation syndrome (3.5%), nausea (1.3%) and headache (1.1%) as the adverse events at 1% or more. Injection site redness, bruising, itching and swelling were reported and were usually mild and short-lived. There was no placebo group. Cetrotide has no boxed warning; allergic reactions are the main precaution.
What Cetrotide is approved for: Cetrotide is a GnRH antagonist approved to prevent premature LH surges (early ovulation) in women having controlled ovarian stimulation (Indications and Usage). It is used alongside FSH or hMG during an IVF or ICSI stimulation cycle.
Source
Cetrotide (cetrorelix acetate for injection) 0.25 mg, prescribing information and Patient Leaflet. EMD Serono. DailyMed, version published September 29, 2025. DailyMed setid aca7768e-28a7-4027-b1d8-e66247665f79
No. The current Cetrotide 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 Cetrotide.
| Adverse event (WHO preferred term) | Cetrotide N=949, % (n) |
|---|---|
| Ovarian Hyperstimulation Syndrome | 3.5 (33) |
| Nausea | 1.3 (12) |
| Headache | 1.1 (10) |
Systemic adverse events in 949 women aged 19 to 40 having controlled ovarian stimulation, given Cetrotide from 0.1 mg to 5 mg as single or multiple doses, counted from the start of Cetrotide until pregnancy was confirmed by ultrasound, without regard to cause. There was no placebo group. OHSS here means moderate or severe (WHO Grade II or III).
Local injection site reactions (redness, bruising, itching and swelling) were reported, usually short-lived, mild and brief. After approval, mild to moderate OHSS and allergic reactions including anaphylactoid reactions have been reported. Two stillbirths were reported in Phase 3 studies.
Liver enzyme rises (ALT, AST, GGT, alkaline phosphatase) were found in 1-2% of women during controlled ovarian stimulation, up to three times the upper limit of normal. Their clinical significance was not determined.
In follow-up of 316 newborns of women given Cetrotide, one twin had anencephaly and died after four days; a ventricular septal defect and congenital glaucoma were found in two other children. The label says the causal link between reported anomalies and Cetrotide is unknown.
In 732 women treated across five clinical trials, 184 pregnancies were reported. Clinical pregnancy rates per attempt were 22.6% (3 mg single dose), 20.8% and 19.8% (0.25 mg multiple dose). No drug-related allergic reactions were reported in these studies.
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 allergic to cetrorelix, outside peptide hormones, mannitol, GnRH or any GnRH analog; women who are or may be pregnant or are breastfeeding; and women with severe kidney impairment.
Specialist use and pregnancy. Cetrotide is prescribed by physicians experienced in fertility treatment, and pregnancy must be excluded before starting. In animal studies it caused loss of pregnancy, which could happen in humans as well.
Allergic reactions. Allergic reactions, including anaphylactoid reactions with the first dose, have been reported after approval. Special care is taken in women with active allergies or a history of allergy, and Cetrotide is not advised in women with severe allergic conditions.
Ovarian hyperstimulation. hCG is not given if the ovaries show an excessive response to gonadotropins, to reduce the chance of OHSS.
Liver enzymes. Liver enzyme rises up to three times normal were seen in 1-2% of women; their clinical significance was not determined.
Age and other groups. Cetrotide is not intended for people aged 65 and over. It has not been studied in people with kidney or liver impairment or in children.
From the Patient Leaflet that comes with Cetrotide:
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.