Summary of the safety profile The most commonly reported adverse reactions were headache, nausea, abdominal pain and dysmenorrhea. Safety of ulipristal acetate has been evaluated in 4,718 women during the clinical development program.
Tabulated list of adverse reactions The adverse reactions reported in the phase III program of 2,637 women are provided in the table below. Adverse reactions listed below are classified according to frequency and system organ class using the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
MedDRA Adverse reactions (frequency) System organ class Common Uncommon Rare Infections and infestations Influenza Immune system disorders hypersensitivity reactions including rash, urticaria, angioedema** Metabolism and nutrition disorders Appetite disorders Psychiatric disorders Mood disorders Emotional disorder Anxiety Insomnia Hyperactivity disorder Libido changes Disorientation Nervous system disorders Headache Dizziness Somnolence Migraine Tremor Disturbance in attention Dysgueusia Syncope Eye disorders Visual disturbance Abnormal sensation in eye Ocular hyperaemia Photophobia Ear and labyrinth disorders Vertigo Respiratory, thoracic and mediastinal disorders Dry throat Gastrointestinal disorders Nausea* Abdominal pain* Abdominal discomfort Vomiting* Diarrhoea Dry mouth Dyspepsia Flatulence Skin and subcutaneous tissue disorders Acne Skin lesion Pruritus Musculoskeletal and connective tissue disorders Myalgia Back pain Reproductive system and breast disorders Dysmenorrhea Pelvic pain Breast tenderness Menorrhagia Vaginal discharge Menstrual disorder Metrorrhagia Genital pruritus Dyspareunia Ruptured ovarian cyst Vulvovaginal pain Vaginitis Hot flush Premenstrual syndrome Hypomenorrhea* General disorders and administration site conditions Fatigue Chills Malaise Pyrexia Thirst *Symptom which could also be related to an undiagnosed pregnancy (or related complications) **Adverse reaction from spontaneous reporting Adolescents: the safety profile observed in women less than 18 years old in studies and post-marketing is similar to the safety profile in adults during the phase III program (see section Error!
). Post-marketing experience: the adverse reactions spontaneously reported in post- marketing experience were similar in nature and frequency to the safety profile described during the phase III program. 5% had a delay of more than 7 days beyond the anticipated onset of menses.
The delay was greater than 20 days in 4 % of the women. 4 days. 2%), this bleeding was reported as spotting. 4% reported heavy intermenstrual bleeding. In the phase III studies, 82 women entered a study more than once and therefore received more than one dose of Ulipristal Acetate 30 mg tablet (73 women enrolled twice and 9 enrolled three times).
There were no safety differences in these subjects in terms of incidence and severity of adverse reactions, change in duration or volume of menses or incidence of intermenstrual bleeding. Reporting of suspected adverse reactions Reporting of suspected adverse reactions after authorisation of the medicinal product is important.
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