Visanne Adverse Reactions

Summary of the Safety Profile: Adverse effects are more common during the first months after start of intake of Visanne and subside with duration of treatment. The following adverse effects have been reported in users of Visanne.
The most frequently reported adverse effects during treatment that were considered at least possibly related to Visanne were headache (9%), breast discomfort (5.4%), depressed mood (5.1%) and acne (5.1%).
The frequencies of adverse drug reactions (ADRs) by MedDRA system organ classes (MedDRA SOCs) reported with Visanne are summarized in the table as follows. Within each frequency grouping, adverse effects are presented in order of decreasing frequency. Frequencies are defined as common (≥1/100 to <1/10) and uncommon (≥1/1000 to <1/100).
*The frequencies are based on pooled data of 4 clinical trials including 332 patients (100%). (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.
Description of Selected Adverse Reactions: Uterine Bleeding Irregularities: Menstrual bleeding patterns were assessed systematically using patient diaries and were analyzed using the WHO 90 days reference period method. During the first reference period (ie, first 90 days of treatment with Visanne): 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 ie, none of the previous categories (19.7%).
During the 4th reference period, the following bleeding patterns were observed (n=149; 100%): Amenorrhea (28.2%), infrequent bleeding (24.2%), frequent bleeding (27.2%), irregular bleeding (21.5%), prolonged bleeding (4%), normal bleeding ie, none of the previous categories (22.8%), changes in menstrual bleeding were only occasionally reported as adverse event by the patients (see Table).