Edual Side effects
Undesirable effects are more common during the 1st months after start of intake of Edual and subside with duration of treatment. The following undesirable effects have been reported in users of Edual.
The most frequently reported undesirable effects during treatment that were considered at least possibly related to Edual were headache (9%), breast discomfort (5.4%), depressed mood (5.1%), and acne (5.1%).
In addition, the majority of patients treated with Edual experience changes in their menstrual bleeding pattern. Menstrual bleeding patterns were assessed systematically using patient diaries and were analyzed using the World Health Organization (WHO) 90-days reference period method. During the first 90 days of treatment with Edual 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 (2.7%), irregular bleeding (21.5%), prolonged bleeding (4%), normal bleeding, ie, none of the previous categories (22.8%). Changes in menstrual bleeding patterns were only occasionally reported as adverse event by the patients.
The frequencies of adverse drug reactions (ADRs) by MedDRA system organ classes (MedDRA SOCs) reported with Edual are summarized in the list. 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%).
Blood and Lymphatic System Disorders: Uncommon: Anemia.
Metabolism and Nutrition Disorders: Common: Increased weight. Uncommon: Decreased weight, increased appetite.
Psychiatric Disorders: 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.
Eye Disorders: Uncommon: Dry eyes.
Ear and Labyrinth Disorders: Uncommon: Tinnitus.
Cardiac Disorders: Uncommon: Unspecified circulatory system disorder, palpitations.
Vascular Disorders: Uncommon: Hypotension.
Respiratory, Thoracic and Mediastinal Disorders: Uncommon: Dyspnoea.
Gastrointestinal 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 in extremity, 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.
Hypersensitivity to Edual or to any of the excipients of Edual.
Edual should not be used in the presence of any of the conditions listed as follows, which are partially derived from information on other progestogen-only preparations. Should any of the conditions appear during the use of Edual, treatment must be discontinued immediately: Active venous thromboembolic disorder, arterial and cardiovascular disease, present or in history (eg, myocardial infarction, cerebrovascular accident, ischemic heart disease); diabetes mellitus with vascular involvement; presence or history of severe hepatic disease as long as liver function values have not returned to normal, liver tumors (benign or malignant); known or suspected sex hormone-dependent malignancies; undiagnosed vaginal bleeding.
Use in pregnancy: There are limited data from the use of Edual in pregnant women. Animal studies and data from women exposed to Edual during pregnancy reveal no special risks on pregnancy, embryonic/fetal development, birth or development after birth for humans. However, Edual should not be administered to pregnant women because there is no need to treat endometriosis during pregnancy.
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Information checked by Dr. Sachin Kumar, MD Pharmacology