Puregon Adverse Reactions

In postmarketing surveillance anaphylactic reactions have been reported. The frequency cannot be estimated from the available data.
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. Generalized hypersensitivity reactions have been observed uncommonly (approximately 0.2% of all patients treated with Puregon).
Treatment of females: In approximately 4% of the women treated with Puregon in clinical trials, signs and symptoms related to ovarian hyperstimulation syndrome (OHSS) have been reported (see Precautions). Undesirable effects 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 Puregon 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 1.)

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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 Puregon/hCG treatment, as with other gonadotropins.
Treatment of males: The table as follows lists the adverse reactions with Puregon 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 2.)

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