Summary of the Safety Profile:
Undesirable effects are more common during the 1st months after start of intake of Visanne, and subside with duration of treatment. The following undesirable effects have been reported in users of Visanne.
The most frequently reported undesirable 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 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 (≥1/1000 to <1/100). The frequencies are based on pooled data of 4 clinical trials including 332 patients (100%).
Categorized relative frequency of women with ADRs, by MedDRA SOC, Dienogest 2 mg group based on pooled data of 4 clinical trials including 332 patients: Blood and Lymphatic System Disorders:
Metabolism and Nutrition Disorders:
Common: Increased weight. Uncommon: Decreased weight, increased appetite.
Common: Depressed mood, sleep disorder, nervousness, loss of libido, altered mood. Uncommon: Anxiety, depression, mood swings.
Nervous System Disorders:
Common: Headache, migraine. Uncommon: Autonomic nervous system imbalance, attention disturbance.
Uncommon: Dry eye.
Ear and Labyrinth Disorders:
Uncommon: Unspecified circulatory system disorder, palpitations.
Respiratory, Thoracic and Mediastinal Disorders:
Common: Nausea, abdominal pain, flatulence, abdominal distension, vomiting. Uncommon: Diarrhoea, constipation, abdominal discomfort, gastrointestinal inflammation, gingivitis.
Skin and Subcutaneous Tissue Disorders:
Common: Acne, alopecia. Uncommon: Dry skin, hyperhidrosis, pruritus, hirsutism, onychoclasis, dandruff, dermatitis, abnormal hair growth, photosensitivity reaction, pigmentation disorder.
Musculoskeletal and Connective Tissue Disorders:
Common: Back pain. Uncommon: Bone pain, muscle spasms, pain and heaviness in extremities.
Renal and Urinary Disorders: Uncommon:
Urinary tract infection.
Reproductive System and Breast Disorders:
Common: Breast discomfort, ovarian cyst, hot flush, uterine/vaginal bleeding including spotting. Uncommon: Vaginal candidiasis, vulvovaginal dryness, genital discharge, pelvic pain, atrophic vulvovaginitis, breast mass, fibrocystic breast disease, breast induration.
General Disorders and Administration Site Conditions:
Common: Asthenic conditions, irritability. Uncommon: Oedema.
Description of Selected Adverse Reactions: Uterine Bleeding Irregularities:
The following bleeding patterns were observed: Amenorrhea, bleeding (infrequent, frequent, irregular, prolonged and normal).