Adverse reactions : תופעות לוואי

4.8   Undesirable effects
The adverse reactions reported below are classified according to frequency of occurrence as follows:
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)

Crinone is generally well tolerated. In clinical studies, the following adverse events have been reported during Crinone therapy. Most adverse events observed in clinical studies cannot be distinguished from the symptoms common in early pregnancy.

Common
Breast tenderness, itching or burning.

Post Marketing Reports
For adverse reactions identified during post-marketing surveillance, the frequency is not known (cannot be estimated from the available data).
In addition, intermenstrual bleeding (spotting), vaginal irritation hypersensitivity reactions usually manifesting as skin rash, and other mild application site reactions have been reported post-marketing.
Rare events of urticaria and pruritis were noted.

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/