Cetrorelix (Cetrotide)

Safety Summary

In clinical studies of 949 patients, reported adverse events (≥1%) were OHSS (3.5%, moderate-severe), nausea (1.3%), and headache (1.1%). Injection site reactions were transient, mild, and short-duration (FDA label ANDA218150). Enzyme elevations (ALT, AST, GGT, alkaline phosphatase) found in 1-2% of patients, up to 3x upper limit of normal; clinical significance not determined (FDA label ANDA218150). Post-marketing: cases of hypersensitivity reactions including anaphylactoid reactions reported. One severe anaphylactic reaction (cough, rash, hypotension) observed in a patient after 7 months of treatment at 10mg/day for a non-infertility indication (FDA label ANDA218150). Single doses up to 120mg were tolerated without overdosage signs (FDA label ANDA218150). In a 2025 retrospective cohort (n=9,424), OHSS incidence was lower with cetrorelix than ganirelix (0.4% vs 1.1%, p=0.01), though this comparison was observational PMID 40297130. FDA FAERS data show 156 reports of OHSS, 42 drug ineffective, 40 spontaneous abortion, 40 premature ovulation, 28 each for abdominal distension, abdominal pain, and ascites (FDA FAERS data). Community reports from online communities confirm mild injection site rashes/itching resolving within an hour as the most common complaint, with occasional headaches, bloating, and fatigue.