What the label lists and what reports show
Cetrorelix side effects
Cetrorelix's FDA label lists its adverse reactions in its own words. FAERS holds 617 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is ovarian hyperstimulation syndrome (135 reports).
- Generic listed
- A presentation discontinued
Check it at the source: the cetrorelix FDA label on DailyMed (effective September 22, 2025, EMD Serono, Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe 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. …
Source: FDA drug label, EMD Serono, Inc., effective September 22, 2025 (SPL set aca7768e-28a7-4027-b1d8-e66247665f79), via openFDA; the full label on DailyMed
What do FAERS reports show?
617 reports list cetrorelix among the medicines taken, each a report of something that happened, not proof the medicine caused it; 7 are coded as a death and 217 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 21 reactions below, 7 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Cetrorelix: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions