Adverse reactions : תופעות לוואי

4.8 Undesirable effects

Adverse reactions (ADRs) reported in clinical trials with FOSTIMON are listed in the table below by body system and frequency. Most events were of mild to moderate severity.
Within each system organ class, the ADRs are ranked under headings of frequency, most frequent reactions first, using the following convention:
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).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
For other undesirable effects which may be associated with the use of gonadotropins such as FSH, see section 4.4.
MedDRA System Organ Class                Frequency    Adverse Drug Reaction (MedDRA Preferred term)

Endocrine disorders                      Uncommon     Hyperthyroidism Psychiatric disorders                    Uncommon     Mood swings
Nervous system disorders                 Common       Headache
Uncommon     Lethargy
Dizziness
Respiratory, thoracic and mediastinal    Uncommon     Dyspnoea disorders                                             Epistaxis

Gastro-intestinal disorders              Common       Constipation
Abdominal distension
Uncommon     Nausea
Abdominal pain
Dyspepsia
Skin and subcutaneous tissue disorders   Uncommon     Erythema
Pruritus
Renal and urinary disorders              Uncommon     Cystitis

Reproductive system and breast           Common       Ovarian hyperstimulation syndrome disorders
Uncommon     Breast enlargement
Breast pain
Hot flush
General disorders and administration     Common       Pain site conditions
Uncommon     Fatigue

Investigations                           Uncommon     Bleeding time prolonged 

Local reactions at the site of injection (pain, redness and haematoma) have been rarely observed.
In rare cases, arterial and venous thromboembolism have been associated with a treatment with human menotrophins/chorionic gonadotropins.

The incidence of miscarriage with gonadotropins therapy is comparable to the incidence in women with other fertility disorders. A slightly increased risk of ectopic pregnancy and multiple gestations has been observed.

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorization 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 the online form: https://sideeffects.health.gov.il