cetrotide
Pharmaranks rates Cetrotide 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Cetrotide (Cetrorelix Acetate) is a medication used to treat Ovarian Hyperstimulation Syndrome.
Cetrorelix Acetate · by Emd Serono
Available as a generic: Cetrorelix Acetate
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Cetrorelix Acetate
- Form
- Kit
- Strength
- Cetrorelix Acetate EQ 0.25MG BASE/VIAL · Cetrorelix Acetate EQ 3MG BASE/VIAL
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- ovarian hyperstimulation syndrome
- Manufacturer
- Emd Serono
- FDA application
- NDA021197
What is Cetrotide?
From the FDA label:Cetrotide ® (cetrorelix acetate for injection) is a synthetic decapeptide with gonadotropin-releasing hormone (GnRH) antagonistic activity. Cetrorelix acetate is an analog of native GnRH with substitutions of amino acids at positions 1, 2, 3, 6, and 10. The molecular formula is Acetyl-D-3-(2´-naphthyl)-alanine-D-4-chlorophenylalanine-D-3-(3´-pyridyl)-alanine-L-serine-L-tyrosine-D-citrulline-L-leucine-L-arginine-L-proline-D-alanine-amide, and the molecular weight is 1431.06, calculated as the anhydrous free base. The structural formula is as follows: Cetrorelix acetate (Ac-D-Nal 1 - D -Cpa 2 - D -Pal 3 -Ser 4 -Tyr 5 - D -Cit 6 -Leu 7 -Arg 8 -Pro 9 - D -Ala 10 -NH 2 ) Cetrotide ® (cetrorelix acetate for injection) 0.25 mg is a sterile lyophilized powder intended for subcutaneous injection after reconstitution with Sterile Water for Injection, that comes supplied in a 1.0 mL pre-filled syringe. Each vial of Cetrotide ® 0.25 mg contains 0.26-0.27 mg cetrorelix acetate, equivalent to 0.25 mg cetrorelix, and 54.80 mg mannitol. Chemical Structure
How to use
Ovarian stimulation therapy with gonadotropins (FSH, hMG) is started on cycle Day 2 or 3. The dose of gonadotropins should be adjusted according to individual response. Cetrotide ® (cetrorelix acetate for injection) 0.25 mg may be administered subcutaneously once daily during the early- to mid-follicular phase. Cetrotide ® 0.25 mg is administered on either stimulation day 5 (morning or evening) or day 6 (morning) and continued daily until the day of hCG administration. When assessment by ultrasound shows a sufficient number of follicles of adequate size, hCG is administered to induce ovulation and final maturation of the oocytes. No hCG should be administered if the ovaries show an excessive response to the treatment with gonadotropins to reduce the chance of developing ovarian hyperstimulation syndrome (OHSS). Administration Cetrotide ® 0.25 mg can be administered by the patient herself after appropriate instructions by her doctor. Directions for using Cetrotide ® 0.25 mg with the enclosed needles and pre-filled syringe: Wash hands thoroughly with soap and water. Flip off the plastic cover of the vial and wipe the aluminum ring and the rubber stopper with an alcohol swab. Twist the injection needle with the yellow mark (20 gauge) on the pre-filled syringe. Push the needle through the center of the rubber stopper of the vial and slowly inject the solvent into the vial. Leaving…
Side effects
The safety of Cetrotide ® (cetrorelix acetate for injection) in 949 patients undergoing controlled ovarian stimulation in clinical studies was evaluated. Women were between 19 and 40 years of age (mean: 32). 94.0% of them were Caucasian. Cetrotide ® was given in doses ranging from 0.1 mg to 5 mg as either a single or multiple dose. Table 3 shows systemic adverse events, reported in clinical studies without regard to causality, from the beginning of Cetrotide ® treatment until confirmation of pregnancy by ultrasound at an incidence ≥ 1% in Cetrotide ® treated subjects undergoing COS. Table 3: Adverse Events in ≥1% (WHO preferred term) Cetrotide ® N=949 % (n) Ovarian Hyperstimulation Syndrome Intensity moderate or severe, or WHO Grade II or III, respectively 3.5 (33) Nausea 1.3 (12) Headache 1.1 (10) Local site reactions (e.g. redness, erythema, bruising, itching, swelling, and pruritus) were reported. Usually, they were of a transient nature, mild intensity and short duration. During post-marketing surveillance, cases of mild to moderate Ovarian Hyperstimulation syndrome and cases of hypersensitivity reactions including anaphylactoid reactions have been reported. Two stillbirths were reported in Phase 3 studies of Cetrotide ® . Congenital Anomalies Clinical follow-up studies of 316 newborns of women administered Cetrotide ® were reviewed. One infant of a set of twin neonates…
Warnings
Important safety information
Cetrotide ® (cetrorelix acetate for injection) should be prescribed by physicians who are experienced in fertility treatment. Before starting treatment with Cetrotide ® , pregnancy must be excluded (see CONTRAINDICATIONS and PRECAUTIONS ).
Who should not take Cetrotide
Cetrotide ® (cetrorelix acetate for injection) is contraindicated under the following conditions: Hypersensitivity to cetrorelix acetate, extrinsic peptide hormones or mannitol. Known hypersensitivity to GnRH or any other GnRH analogs. Known or suspected pregnancy, and lactation (see PRECAUTIONS ). Severe renal impairment
Overdose — what happens if you take too much
There have been no reports of overdosage with Cetrotide ® 0.25 mg or 3 mg in humans. Single doses up to 120 mg Cetrotide ® have been well tolerated in patients treated for other indications without signs of overdosage.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
No formal drug interaction studies have been performed with Cetrotide ® .
May treat (source: NIH RxClass)
Dosage forms
Kit
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
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Frequently asked questions
- What does Cetrotide treat?
- Cetrotide (Cetrorelix Acetate) may be used to treat ovarian hyperstimulation syndrome, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How is Cetrotide rated?
- pharmaranks gives Cetrotide a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- Is there a coupon or discount for Cetrotide?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Cetrotide. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Cetrotide?
- Cetrotide is marketed by Emd Serono. You can see Emd Serono's full profile, rating, and other products on pharmaranks.
- Is Cetrotide a brand-name or generic drug?
- Cetrotide is a brand-name product with the active ingredient Cetrorelix Acetate. Lower-cost generic equivalents containing Cetrorelix Acetate are available — ask your pharmacist.
- Is Cetrotide available over the counter?
- No. Cetrotide is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Cetrotide come in?
- Cetrotide is currently marketed as kit, per the FDA's National Drug Code Directory.
- Is Cetrotide FDA-registered?
- Cetrotide is on record with the U.S. FDA under application number NDA021197. You can verify this on its official FDA label.
- Has Cetrotide been recalled by the FDA?
- Yes. Cetrotide has 1 recorded FDA recall event in the openFDA enforcement database. A recall removes specific lots from the market — usually for manufacturing, contamination, potency, or labeling issues — and does not mean the drug is unsafe to take; your specific lot was almost certainly never affected. This recall history is factored into its safety score above. Always check the FDA recall database or your pharmacist for current alerts.
- Is Cetrotide safe?
- There's no single safe-or-not verdict. pharmaranks gives Cetrotide a recall-safety score of 70/100, based on its FDA recall history (1 recorded recall event) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Cetrotide?
- Cetrotide's side effects are taken directly from its FDA label. From the label: The safety of Cetrotide ® (cetrorelix acetate for injection) in 949 patients undergoing controlled ovarian stimulation in clinical studies was evaluated. Women were between 19 and 40 years of age (mean: 32). 94.0% of them were Caucasian.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
What people report to the FDA about CETRORELIX ACETATE
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 102 reports naming CETRORELIX ACETATE — the active ingredient in Cetrotide, and the FDA flagged 81% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- ovarian hyperstimulation syndrome21 reports
- generalised tonic-clonic seizure19 reports
- drug level decreased18 reports
- blood oestrogen increased10 reports
- abortion spontaneous8 reports
- ascites6 reports
- abdominal pain5 reports
- pleural effusion5 reports
Read these as a signal, not a rate. A report does not mean CETRORELIX ACETATE caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label.
Source: openFDA drug/event (FAERS), retrieved September 25, 2026.
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cetrotide
70/100