Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Degarelix Accord

Degarelix Accord 80 mg powder and solvent for solution for injection Degarelix Accord 120 mg powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 5–6

HOS-151017 · Präparat HOS-100434

5  MedDRA Very Common Uncommon Rare System Organ common Class (SOC) Metabolism and Weight Hyperglycemia/Diabetes mellitus, nutrition increase* cholesterol increased, weight disorders decreased, appetite decreased, changes in blood calcium Psychiatric Insomnia Depression, libido decreased* disorders Nervous system Dizziness, Mental impairment, hypoaesthesia disorders headache Eye disorders Vision blurred Cardiac Cardiac arrhythmia (incl. atrial Myocardial disorders fibrillation), palpitations, QT infarction, cardiac prolongation*(see sections 4.4 and failure 4.5) Vascular Hot flush* Hypertension, vasovagal reaction disorders (incl. hypotension) Respiratory, Dyspnoea thoracic and mediastinal disorders Gastrointestinal Diarrhoea, Constipation, vomiting, abdominal disorders nausea pain, abdominal discomfort, dry mouth Hepatobiliary Liver Bilirubin increased, alkaline disorders transaminases phosphatase increased increased Skin and Hyperhidrosis Urticaria, skin nodule, alopecia, subcutaneous (incl. night pruritus, erythema tissue disorders sweats)*, rash Musculoskeletal Musculoskeletal Osteoporosis/osteopenia, Rhabdomyolysis , connective pain and arthralgia muscular weakness, tissue and bone discomfort muscle spasms, joint disorders swelling/stiffness Renal and Pollakiuria, micturition urgency, urinary disorders dysuria, nocturia, renal impairment, incontinence Reproductive Gynaecomastia*, Testicular pain, breast pain, pelvic system and testicular pain, genital irritation, ejaculation breast disorders atrophy*, failure erectile dysfunction* General Injection Chills, pyrexia, Malaise, peripheral oedema disorders and site fatigue*, administration adverse Influenza- like site conditions reactions illness * Known physiological consequence of testosterone suppression

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