ing, undesirable effects are presented in order of frequency, the most frequent first.
Adverse reactions and their frequencies reported in Table 1 are based on the main registration studies.
Table 1 Adverse reactions in clinical studies
Infections and infestations
Uncommon:
Herpes zoster, herpes simplex, nasopharyngitis, pneumonia1, sinusitis, cellulitis, upper respiratory tract infection, influenza, urinary tract infection, gastroenteritis, sepsis
Rare:
Fungal infection
Neoplasm benign, malignant and unspecified (including cysts and polyps)
Rare:
Tumour lysis syndrome
Blood and lymphatic system disorders
Very common:
Neutropenia, thrombocytopenia, anaemia
Common:
Pancytopenia, febrile neutropenia
Uncommon:
Thrombocythaemia, lymphopenia, bone marrow depression, eosinophilia, lymphadenopathy
Rare:
Haemolytic anaemia
Metabolism and nutrition disorders
Common:
Anorexia
Uncommon:
Hypokalaemia, increased appetite, hypophosphataemia, decreased appetite, dehydration, gout, hyperuricaemia, hypercalcaemia, hyperglycaemia, hyponatraemia
Rare:
Hyperkalaemia, hypomagnesaemia
Psychiatric disorders
Common:
Insomnia
Uncommon:
Depression, libido decreased, anxiety
Rare:
Confusional state
Nervous system disorders
Very common:
Headache2
Common:
Dizziness, paraesthesia, taste disturbance, hypoaesthesia
Uncommon:
Migraine, somnolence, syncope, peripheral neuropathy, memory impairment, sciatica, restless leg syndrome, tremor, cerebral haemorrhage
Rare:
Increased intracranial pressure, convulsions, optic neuritis
Eye disorders
Common:
Eyelid oedema, lacrimation increased, conjunctival haemorrhage, conjunctivitis, dry eye, blurred vision
Uncommon:
Eye irritation, eye pain, orbital oedema, scleral haemorrhage, retinal haemorrhage, blepharitis, macular oedema
Rare:
Cataract, glaucoma, papilloedema
Ear and labyrinth disorders
Uncommon:
Vertigo, tinnitus, hearing loss
Cardiac disorders
Uncommon:
Palpitations, tachycardia, cardiac failure congestive3, pulmonary oedema
Rare:
Arrhythmia, atrial fibrillation, cardiac arrest, myocardial infarction, angina pectoris, pericardial effusion
Vascular disorders4
Common:
Flushing, haemorrhage
Uncommon:
Hypertension, haematoma, peripheral coldness, hypotension, Raynaud's phenomenon
Respiratory, thoracic and mediastinal disorders
Common:
Dyspnoea, epistaxis, cough
Uncommon:
Pleural effusion5, pharyngolaryngeal pain, pharyngitis
Rare:
Pleuritic pain, pulmonary fibrosis, pulmonary hypertension, pulmonary haemorrhage
Gastrointestinal disorders
Very common:
Nausea, diarrhoea, vomiting, dyspepsia, abdominal pain6
Common:
Flatulence, abdominal distension, gastro-oesophageal reflux, constipation, dry mouth, gastritis
Uncommon:
Stomatitis, mouth ulceration, gastrointestinal haemorrhage7, eructation, melaena, oesophagitis, ascites, gastric ulcer, haematemesis, cheilitis, dysphagia, pancreatitis
Rare:
Colitis, ileus, inflamma |
