Adverse reactions : תופעות לוואי

4.8 Undesirable effects
The most frequently reported adverse drug reactions during treatment with Endometrin in IVF patients during clinical trials are headache, vulvovaginal disorders and uterine spasm, reported in 1.5%, 1.5% and 1.4% subjects, respectively. The table below displays the main adverse drug reactions in women treated with Endometrin in the clinical trial distributed by system organ classes (SOCs) and frequency.

System Organ Class       Very common            Common                  Uncommon                  Not known*** (SOC)                    (<1/10)                (> 1/100 and <          (> 1/1000 and <           (cannot be estimated 1/10)                   1/100)                    from the available
data)
Nervous system                                  Headache                Dizziness,                Fatigue disorders                                                               Insomnia Gastrointestinal                                Abdominal               Diarrhoea                 Vomiting disorders                                       distension              Constipation Abdominal pain
Nausea
Skin and subcutaneous                                                   Urticaria                 Hypersensitivity tissue disorders                                                        Rash                      reactions Reproductive system                             Uterine spasm           Vulvovaginal and breast disorders                            Ovarian                 disorders* hyperstimulation        Vaginal mycosis
syndrome                Breast disorders**
Pruritus genital
General disorders and                                                   Oedema peripheral administration site
conditions


* Vulvovaginal disorders such as vulvovaginal discomfort, vaginal burning sensation, vaginal discharge, vulvovaginal dryness and vaginal haemorrhage, have been reported following use of Endometrin, with cumulative reporting frequency of 1.5%.

** Breast disorders, such as breast pain, breast swelling and breast tenderness have been reported in the clinical trial as single cases, with cumulative reporting frequency of 0.4%.

***Cases seen during post marketing experience.

Reporting of suspected adverse reactions
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 https://sideeffects.health.gov.il/