The most frequently reported adverse drug reactions during treatment with REKOVELLE in pivotal clinical trials (1,012 cycles) are headache (4.2%), pelvic discomfort (2.9%), ovarian hyperstimulation syndrome (2.3%), pelvic pain (1.6%), nausea (1.4%), adnexa uteri pain (1.4%) and fatigue (1.2 %).
The table as follows (Table 5) displays the adverse drug reactions in patients treated with REKOVELLE in the pivotal clinical trials according to system organ class and frequency; common (≥1/100 to <1/10) and uncommon (≥1/1,000 to <1/100). Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness. (See Table 5.)
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OHSS is an intrinsic risk of the ovarian stimulation. Known gastrointestinal symptoms associated with OHSS include abdominal pain, discomfort, and distension, nausea, vomiting and diarrhoea. Ovarian torsion and thromboembolic events are known to be rare complications of ovarian stimulation treatment.
Immunogenicity in terms of development of anti-FSH antibodies is a potential risk of gonadotropin therapy (see Pharmacology: Pharmacodynamics under Actions).