Pergoveris Adverse Reactions

Summary of the safety profile: The most commonly reported adverse reactions are headache, ovarian cysts and local injection site reactions (e.g. pain, erythema, haematoma, swelling and/or irritation at the site of injection).
Mild or moderate OHSS has 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, usually associated with severe OHSS (see Precautions).
Tabulated list of adverse reactions: The frequency categories used are: 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: Very common: Headache.
Vascular disorders: Very rare: Thromboembolism, usually associated with severe OHSS.
Respiratory, thoracic and mediastinal disorders: Very rare: Exacerbation or aggravation of asthma.
Gastrointestinal disorders: Common: Abdominal pain, abdominal distension, abdominal discomfort, nausea, vomiting, diarrhoea.
Reproductive system and breast disorders: Very common: Ovarian cysts.
Common: Breast pain, pelvic pain, mild or moderate OHSS (including associated symptomatology).
Uncommon: Severe OHSS (including associated symptomatology) (see Precautions).
Rare: Complication of severe OHSS.
General disorders and administration site conditions: Very common: Mild to severe injection site reactions (e.g. pain, erythema, haematoma, bruising, swelling and/or irritation at the site of injection).