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Table 6 Undesirable Effects System Organ Class Frequency Adverse Reaction Infections and Very widespread Respiratory tract infections (together with decrease and infestations* higher respiratory tract infection, pneumonia, sinusitis, pharyngitis, nasopharyngitis and pneumonia herpes viral) Common Systemic infections (together with sepsis, candidiasis and influenza), intestinal infections (together with gastroenteritis viral), skin and delicate tissue infections (together with paronychia, cellulitis, impetigo, necrotising fasciitis and herpes zoster), ear infections, oral infections (together with herpes simplex, oral herpes and tooth infections), reproductive tract infections (together with vulvovaginal mycotic infection), urinary tract infections (including pyelonephritis), fungal infections, joint infections 13 System Organ Class Frequency Adverse Reaction Uncommon Neurological infections (together with viral meningitis), opportunistic infections and tuberculosis (including coccidioidomycosis, histoplasmosis and mycobacterium avium complicated an infection), bacterial infections, eye infections, diverticulitis1) Neoplasms benign, Common Skin cancer excluding melanoma (including malignant and unspecified basal cell carcinoma and squamous cell (together with cysts and carcinoma), polyps)* benign neoplasm Uncommon Lymphoma**, stable organ neoplasm (together with breast most cancers, lung neoplasm and thyroid neoplasm), melanoma** Rare Leukaemia1) Not identified Hepatosplenic T-cell lymphoma1) Merkel cell carcinoma (neuroendocrine carcinoma of the skin)1) Blood and the lymphatic Very common Leukopenia (together with neutropenia and system problems* agranulocytosis), anaemia Common Leucocytosis, thrombocytopenia Uncommon Idiopathic thrombocytopenic purpura Rare Pancytopenia Immune system issues* Common Hypersensitivity, allergies (together with seasonal allergy) Uncommon Sarcoidosis1), vasculitis Rare Anaphylaxis1) Metabolism and nutrition Very frequent Lipids elevated disorders 14 System Organ Class Frequency Adverse Reaction Common Hypokalaemia, uric acid elevated, blood sodium abnormal, hypocalcaemia, hyperglycaemia, hypophosphatemia, dehydration Psychiatric issues Common Mood alterations (together with melancholy), anxiety, insomnia Nervous system issues* Very frequent Headache Common Paraesthesias (including hypoesthesia), migraine, nerve root compression Uncommon Cerebrovascular accident1), tremor, neuropathy Rare Multiple sclerosis, demyelinating disorders. 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