Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Adcirca (previously Tadalafil Lilly)

ADCIRCA 2 mg/mL oral suspension · Abschnitt 4.8 · PDF-Seite 26–27

HOS-210159 · Präparat HOS-154449

26  Respiratory, Nasopharyngitis Epistaxis thoracic and (including nasal mediastinal congestion, sinus disorders congestion and rhinitis) Gastrointestinal Nausea, Vomiting, disorders Dyspepsia Gastroesophageal (including reflux abdominal pain/discomfort3) Skin and Rash Urticaria5, Stevens-Johnson subcutaneous Hyperhydrosis Syndrome, tissue disorders (sweating)5 Exfoliative dermatitis Musculoskeletal, Myalgia, connective tissue Back pain and bone Pain in extremity disorders (including limb discomfort) Renal and Haematuria urinary disorders Reproductive Increased uterine Priapism5, Penile Prolonged erections system and breast bleeding 4 haemorrhage, disorders Haematospermia General disorders Facial oedema, and Chest pain2 administration site conditions (1) Events not reported in registration trials and cannot be estimated from the available data. The adverse reactions have been included in the table as a result of post-marketing or clinical trial data from the use of tadalafil in the treatment of erectile dysfunction. (2) Most of the patients in whom these events have been reported had pre-existing cardiovascular risk factors. (3) Actual MedDRA terms included are abdominal discomfort, abdominal pain, abdominal pain lower, abdominal pain upper, and stomach discomfort. (4) Clinical non-MedDRA term to include reports of abnormal/excessive menstrual bleeding conditions such as menorrhagia, metrorrhagia, menometrorrhagia, or vaginal haemorrhage. (5) The adverse reactions have been included in the table as a result of post-marketing or clinical trial data from the use of tadalafil in the treatment of erectile dysfunction; and in addition, the frequency estimates are based on only 1 or 2 patients experiencing the adverse reaction in the pivotal placebo- controlled study of ADCIRCA. (6) Headache was the most commonly reported adverse reaction. Headache may occur at the beginning of therapy; and decreases over time even if treatment is continued.

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