List of adverse reactions: The following definitions apply to the frequency terminology used hereafter: 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), not known (cannot be estimated from the available data).
Immune system disorders: Very rare: Mild to severe hypersensitivity reactions including anaphylactic reactions and shock.
Nervous system disorders: Common: Headache.
Vascular disorders: Very rare: Thromboembolism (both in association with and separate from OHSS).
Gastrointestinal disorders: Common: Abdominal pain, abdominal distension, nausea, vomiting. Uncommon: Abdominal discomfort, diarrhoea.
Reproductive system and breast disorders: Common: Mild or moderate OHSS. Uncommon: Severe OHSS.
General disorders and administration site conditions: Common: Injection site reactions.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions.
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