Adverse reactions : תופעות לוואי

4.8     Undesirable effects

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 section 4.4).

Thromboembolism may occur very rarely, usually associated with severe OHSS (see section 4.4).

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)



Gonal f Dr. L                                             Page 6 of 9 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, usually associated with severe OHSS
(see section 4.4)
Respiratory, thoracic and        Very rare:                         Exacerbation or aggravation of mediastinal disorders                                               asthma Gastrointestinal disorders       Common:                            Abdominal pain, abdominal distension, abdominal discomfort, nausea, vomiting,
diarrhoea,
Reproductive system and          Very Common:                       Ovarian cysts breast disorders


Common:                            Mild to moderate OHSS
(including associated symptomatology)
Uncommon:                          Severe OHSS (including associated symptomatology)
(see section 4.4)
Rare:                              Complication of sever OHSS
General disorders and            Very Common:                       Injection site reaction (e.g. pain, administration site conditions                                      erythema, haematoma, swelling and/or irritation at the site of injection)

Treatment in men
Immune system disorders          Very rare:                         Mild to severe hypersensitivity reactions including anaphylactic reactions and shock
Respiratory, thoracic and        Very rare:                         Exacerbation or aggravation of mediastinal disorders                                               asthma 

Skin and subcutaneous tissue     Common:                            Acne disorders
Reproductive system and          Common:                            Gynaecomastia breast disorders                                                    Varicocele General disorders and            Very Common:                       Injection site reactions (pain, administration site conditions                                      erythema, haematoma, swelling and/or irritation )
Investigations                   Common:                            Weight gain