Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Adenuric

ADENURIC 80 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 7–8

HOS-117826 · Präparat HOS-094697

7  Dermatitis, urticaria, skin discolouration, skin lesion, petechiae, rash macular, rash maculopapular, rash papular, hyperhidrosis, alopecia, eczema #, erythema, night sweats #, psoriasis#, rash pruritic# Rare Toxic epidermal necrolysis*, Stevens-Johnson Syndrome*, angioedema*, drug reaction with eosinophilia and systemic symptoms*, generalized rash (serious)*, exfoliative rash, rash follicular, rash vesicular, rash pustular, rash erythematous, rash morbillifom Musculoskeletal and connective Common tissue disorders Arthralgia, myalgia, pain in extremity# Uncommon Arthritis, musculoskeletal pain, muscle weakness, muscle spasm, muscle tightness, bursitis, joint swelling #, back pain #, musculoskeletal stiffness#, joint stiffness Rare Rhabdomyolysis*, rotator cuff syndrome #, polymyalgia rheumatica# Renal and urinary disorders Uncommon Renal failure, nephrolithiasis, haematuria, pollakiuria, proteinuria, micturition urgency, urinary tract infection# Rare Tubulointerstitial nephritis* Reproductive system and breast Uncommon disorder Erectile dysfunction General disorders and Common administration site conditions Oedema, Fatigue Uncommon Chest pain, chest discomfort, pain #, malaise# Rare Thirst, feeling hot# Investigations Uncommon Blood amylase increase, platelet count decrease, WBC decrease, lymphocyte count decrease, blood creatine increase, blood creatinine increase, haemoglobin decrease, blood urea increase, blood triglycerides increase, blood cholesterol increase, haematocritic decrease, blood lactate dehydrogenase increased, blood potassium increase, INR increased# Rare Blood glucose increase, activated partial thromboplastin time prolonged, red blood cell count decrease, blood alkaline phosphatase increase, blood creatine phosphokinase increase* Injury, poisoning and procedural Uncommon complications Contusion# * Adverse reactions coming from post-marketing experience ** Treatment-emergent non-infective diarrhoea and abnormal liver function tests in the combined Phase 3 studies are more frequent in patients concomitantly treated with colchicine. *** See section 5.1 for incidences of gout flares in the individual Phase 3 randomized controlled studies. # Adverse reactions coming from post-authorisation safety studies

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.