Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · ellaOne

ellaOne 30 mg tablet · Abschnitt 4.8 · PDF-Seite 6–7

HOS-121400 · Präparat HOS-095343

6 MedDRA Adverse reactions (frequency) System organ class Common Uncommon Rare Infections and Influenza infestations Immune system hypersensitivity reactions disorders including rash, urticaria, angioedema** Metabolism and Appetite disorders nutrition disorders Psychiatric disorders Mood disorders Emotional disorder Disorientation Anxiety Insomnia Hyperactivity disorder Libido changes Nervous system Headache Somnolence Tremor disorders Dizziness Migraine Disturbance in attention Dysgueusia Syncope Eye disorders Visual disturbance Abnormal sensation in eye Ocular hyperaemia Photophobia Ear and labyrinth Vertigo disorders Respiratory, thoracic Dry throat and mediastinal disorders Gastrointestinal Nausea* Diarrhoea disorders Abdominal pain* Dry mouth Abdominal discomfort Dyspepsia Vomiting* Flatulence Skin and Acne subcutaneous tissue Skin lesion disorders Pruritus Musculoskeletal and Myalgia connective tissue Back pain disorders Reproductive system Dysmenorrhea Menorrhagia Genital pruritus and breast disorders Pelvic pain Vaginal discharge Dyspareunia Breast tenderness Menstrual disorder Ruptured ovarian cyst Metrorrhagia Vulvovaginal pain Vaginitis Hypomenorrhea* Hot flush Premenstrual syndrome General disorders Fatigue Chills Thirst and administration Malaise site conditions Pyrexia *Symptom which could also be related to an undiagnosed pregnancy (or related complications) **Adverse reaction from spontaneous reporting

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