Puregon Adverse Reactions

Clinical use of Puregon by the intramuscular or subcutaneous routes may lead to local reactions at the site of injection (3% of all patients treated). The majority of these local reactions are mild and transient in nature. Generalised hypersensitivity reactions have been observed uncommonly (approximately 0.2% of all patients treated with follitropin beta).
Treatment of females: In approximately 4% of the women treated with follitropin beta in clinical trials, signs and symptoms related to ovarian hyperstimulation syndrome (OHSS) have been reported (see Precautions). Adverse reactions related to this syndrome include pelvic pain and/or congestion, abdominal pain and/or distension, breast complaints and ovarian enlargement.
The table as follows lists the adverse reactions with follitropin beta reported in clinical trials in females according to system organ class and frequency; common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100). (See Table 3.)

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In addition, ectopic pregnancy, miscarriage and multiple gestations have been reported. These are considered to be related to ART or subsequent pregnancy.
In rare instances, thromboembolism has been associated with follitropin beta/hCG therapy as with other gonadotrophins.
Treatment of males: The table as follows lists the adverse reactions with follitropin beta reported in a clinical trial in males (30 patients dosed), according to system organ class and frequency; common (≥ 1/100 to < 1/10). (See Table 4.)

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