Cetrotide Adverse Reactions

Summary of the safety profile: The most commonly reported side effects are local injection site reactions such as erythema, swelling and pruritus that are usually transient in nature and mild in intensity. In clinical trials, these effects were observed with a frequency of 9.4% following multiple injections of Cetrotide 0.25 mg.
Mild to moderate ovarian hyperstimulation syndrome (OHSS) (WHO grade I or II) have been commonly reported and should be considered as an intrinsic risk of the stimulation procedure. Inversely, severe OHSS remains uncommon.
Uncommonly, cases of hypersensitivity reactions including pseudo-allergic/anaphylactoid reactions have been reported.
List of adverse reactions: The adverse reactions reported as follows are classified according to frequency of occurrence as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000).
Immune system disorders: Uncommon: Systemic allergic/pseudo-allergic reactions including life-threatening anaphylaxis.
Nervous system disorders: Uncommon: Headache.
Gastrointestinal disorders: Uncommon: Nausea.
Reproductive system and breast disorders: Common: Mild to moderate OHSS (WHO grade I or II) can occur which is an intrinsic risk of the stimulation procedure (see Precautions). Uncommon: Severe OHSS (WHO grade III).
General disorders and administration site conditions: Common: Local reactions at the injection site (e.g. erythema, swelling and pruritus).