Mild or moderate ovarian hyperstimulation syndrome (OHSS) have been commonly reported and should be considered as an intrinsic risk of the stimulation procedure. Severe OHSS is uncommon (see Precautions).
Thromboembolism may occur very rarely (see Precautions).
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).
Treatment in general: Immune system disorders: Very rare: Mild to severe hypersensitivity reactions including anaphylactic reactions and shock.
Respiratory, thoracic and mediastinal disorders: Very rare: Exacerbation or aggravation of asthma.
General disorders and administration site conditions: Very common: Injection site reactions (e.g. pain, erythema, haematoma, swelling and/or irritation at the site of injection).
Treatment in women: Nervous system disorders: Very common: Headache.
Vascular disorders: Very rare: Thromboembolism, (both in association with and separate from OHSS) (see Precautions).
Gastrointestinal disorders: Common: Abdominal pain, abdominal distension, abdominal discomfort, nausea, vomiting, diarrhoea.
Reproductive system and breast disorders: Very common: Ovarian cysts.
Common: Mild or moderate OHSS (including associated symptomatology).
Uncommon: Severe OHSS (including associated symptomatology) (see Precautions).
Rare: Complication of severe OHSS.
Treatment in men: Skin and subcutaneous tissue disorders: Common: Acne.
Reproductive system and breast disorders: Common: Gynaecomastia, Varicocele.
Investigations: Common: Weight gain.
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