Oligest Adverse Reactions

Undesirable effects are more common during the first months after the start of treatment with dienogest, and subside with continued treatment. The following undesirable effects have been reported in users of dienogest.
The most frequently reported undesirable effects under treatment with dienogest (considered at least possibly dienogest-related) are headache (9.0%), breast discomfort (5.4%), depressed mood (5.1%) and acne (5.1%).
Adverse event summary 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. Frequencies are defined as common (≥1/100 to <1/10) and uncommon (≥1/1,000 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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No significant changes of the mean values of standard laboratory parameters (including haematology, blood chemistry, liver enzymes, lipids and HbA1C) were observed during treatment with dienogest for up to 15 months (n=168).
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 (see Precautions).