Gonal-F

Gonal-F Adverse Reactions

follitropin alfa

Manufacturer:

Merck

Distributor:

Zuellig Pharma
Full Prescribing Info
Adverse Reactions
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 ovarian hyperstimulation syndrome (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 (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 women: 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 (both in association and separate from OHSS) (see Precautions).
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: Mild to moderate OHSS (including associated symptomatology).
Uncommon: Severe OHSS (including associated symptomatology).
Rare: Complication of severe OHSS.
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).
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