Azalia Adverse Reactions

The most commonly reported undesirable effects were bleeding irregularity, acne, mood changes, breast pain, nausea and weight increase. The undesirable effects are mentioned in the table as follows. (See table.)

Click on icon to see table/diagram/image

Breast discharge may occur during use of Azalia. On rare occasions, ectopic pregnancies may occur (see "Precautions"). In addition, (aggravation of) angioedema and/or aggravation of hereditary angioedema may occur (see "Precautions").
In women using (combined) oral contraceptives a number of (serious) undesirable effects have been reported. These include venous thromboembolic disorders, arterial thromboembolic disorders, hormone-dependent tumours (e.g. liver tumours, breast cancer) and chloasma, some of which are discussed in more detail in "Precautions".
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. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting.