Dienosis Adverse Reactions

Undesirable effects are more common during the first months after start of intake of Dienogest 2 mg tablets, and subside with duration of treatment. The following undesirable effects have been reported in users of Dienogest 2 mg tablets.
The most frequently reported undesirable effects during treatment that were considered at least possibly related to Dienogest 2 mg tablets were headache (9.0%), breast discomfort (5.4%), depressed mood (5.1%), and acne (5.1%).
The table, the frequencies of adverse drug reactions (ADRs) by MedDRA system organ classes (MedDRA SOCs) reported with Dienogest 2 mg tablets are summarized in the table as follows. Within each frequency grouping, undesirable effects are presented in order of decreasing frequency. Frequencies are defined as common (2:1/100 to <1/10) and uncommon (2:1/1000 to <1/100).* The frequencies are based on pooled data of four clinical trials including 332 patients (100.0%). (See table.)

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*The most appropriate MedDRA term (version 11.0) to describe a certain adverse reaction is listed. Synonyms or related conditions are not listed, but should be taken into account as well.
Uterine bleeding irregularities: Menstrual bleeding patterns were assessed systematically using patient diaries and were analysed using the WHO 90 days reference period method. During the first reference period (i.e. first 90 days of treatment with Dienogest 2 mg tablets): 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%). 13 Changes in menstrual bleeding patterns were only occasionally reported as adverse event by the patients (see previous table).