Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Olumiant

Olumiant 2 mg/mL oral suspension · Abschnitt 4.8 · PDF-Seite 49

HOS-134844 · Präparat HOS-097616

Infections and Upper respiratory tract Pneumoniad infestations infections Herpes zosterb Urinary tract infections Gastroenteritis Herpes simplex Folliculitisg Blood and Thrombocytosis Neutropenia lymphatic > 600 x 109 cells/La, d < 1 x 109 cells/La system disorders Immune system Swelling of the face, disorders Urticaria Metabolism and Hypercholesterolaemiaa Hypertriglyceridaemiaa nutrition disorders Nervous system Headache disorders Vascular Deep vein thrombosisb disorders Respiratory, Pulmonary embolismf thoracic, mediastinal disorders Gastrointestinal Abdominal paind Diverticulitis disorders Nausead Hepatobiliary ALT increased AST increased ≥ 3 x ULNa, e disorders ≥ 3 x ULNa, d Skin and Rash subcutaneous Acnec tissue disorders Investigations Creatine phosphokinase Weight increased increased > 5 x ULN a, c a Includes changes detected during laboratory monitoring (see text below). b Frequency for herpes zoster and deep vein thrombosis is based on rheumatoid arthritis clinical trials. c In rheumatoid arthritis clinical trials, the frequency of acne and creatine phosphokinase increased > 5 x ULN was uncommon. d In atopic dermatitis clinical trials, the frequency of nausea, and ALT ≥3 x ULN was uncommon. In alopecia areata clinical trials, the frequency of abdominal pain was uncommon. In atopic dermatitis and alopecia areata clinical trials, the frequency of pneumonia and thrombocytosis > 600 x 109 cells/L was uncommon. e In alopecia areata clinical trials, the frequency of AST ≥ 3 x ULN was common. f Frequency for pulmonary embolism is based on rheumatoid arthritis and atopic dermatitis clinical trials. g Folliculitis was observed in alopecia areata clinical trials. It was usually localized in the scalp region associated with hair regrowth.

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