Evafact Side Effects

Presentation of undesirable effects is based on MedDRA.
The most appropriate MedDRA term is used to describe a certain reaction and its synonyms and related conditions.
Undesirable effects are more common during the first months after the start of treatment with dienogest, and subside with continued treatment. There may be changes in bleeding pattern, such as spotting, irregular bleeding or amenorrhea. The following undesirable effects have been reported in users of dienogest. The most frequently reported undesirable effects under treatment with dienogest are headache (9.0%), breast discomfort (5.4%), depressed mood (5.1%) and acne (5.1%).
In addition, the majority of patients treated with dienogest experience changes in their menstrual bleeding pattern. Menstrual bleeding patterns were assessed systematically using patient diaries and were analyzed using the WHO 90 days reference period method. During the first 90 days of treatment with dienogest the following bleeding patterns were observed (n=290; 100%): Amenorrhea (1.7%), infrequent bleeding (27.2%), frequent bleeding (13.4%), irregular bleeding (35.2%), prolonged bleeding (38.3%), normal bleeding, i.e., none of the previous categories (19.7%). During the fourth reference period the following bleeding patterns were observed (n=149; 100%): Amenorrhea (28.2%), infrequent bleeding (24.2%), frequent bleeding (2.7%), irregular bleeding (21.5%), prolonged bleeding (4.0%), normal bleeding, i.e., none of the previous categories (22.8%). Changes in menstrual bleeding patterns were only occasionally reported as adverse event by the patients (See adverse event table).
The frequencies of adverse drug reactions (ADRs) by MedDRA system organ classes (MedDRA SOCs) reported with dienogest are summarized in the table as follows. Within each frequency grouping, undesirable effects are presented in order of decreasing frequency. (See table.)

Click on icon to see table/diagram/image

Decrease of bone mineral density: In an uncontrolled clinical trial with 111 adolescent women (12 to <18 years) who were treated with dienogest, 103 had BMD measurements. Approximately 72% of these study participants experienced a decrease in BMD of the lumbar spine (L2-L4) after 12 months of use.