Adverse reactions : תופעות לוואי

4.8       Undesirable effects

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 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).

List of adverse reactions

Adverse reactions are listed below by MedDRA system organ class and by frequency. 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).

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 section 4.4) 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)

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.
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form: http://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectMedi c@moh.gov.il