000 to <1/1000); Very rare (< 1/10,000), not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Table :1. Adverse drug reactions in clinical trials and postmarketing
System Organ Class
Frequency
Adverse Drug Reactions
Infections and infestations
Common
bacterial infections (including abscess), viral infections (including herpes, papillomavirus, influenza)
Uncommon
sepsis (including multi-organ failure, septic shock), tuberculosis, fungal infections (includes opportunistic)
Neoplasms benign, malignant and unspecified (including cysts and polyps)
Uncommon
blood and lymphatic system malignancies (including lymphoma and leukaemia), solid organ tumours, non-melanoma skin cancers, pre-cancerous lesions (including oral leukoplakia, melanocytic nevus), benign tumours and cysts (including skin papilloma)
Rare
gastrointestinal tumours, melanoma
Blood and the lymphatic system disorders
Common
eosinophilic disorders, leukopaenia (including neutropaenia, lymphopaenia)
Uncommon
anaemia, lymphadenopathy, thrombocytopaenia, thrombocytosis
Rare
pancytopaenia, splenomegaly, erythrocytosis, white blood cell morphology abnormal
Immune system disorders
Uncommon
vasculitides, lupus erythematosus, drug hypersensitivity (including anaphylactic shock), allergic disorders, autoantibody positive
Rare
angioneurotic oedema, sarcoidosis, serum sickness, panniculitis (including erythema nodosum)
Endocrine disorders
Rare
thyroid disorders
Metabolism and nutrition disorders
Uncommon
electrolyte imbalance, dyslipidaemia, appetite disorders, weight change
Rare
haemosiderosis
Psychiatric disorders
Uncommon
anxiety and mood disorders (including associated symptoms)
Rare
suicide attempt, delirium, mental impairment
Nervous system disorders
Common
headaches (including migraine), sensory abnormalities
Uncommon
peripheral neuropathies, dizziness, tremor
Rare
seizure, cranial nerve inflammation, impaired coordination or balance
Not known
multiple sclerosis*, Guillain-Barré syndrome*
Eye disorders
Uncommon
visual disorder (including decreased vision), eye and eyelid inflammation, lacrimation disorder
Ear and labyrinth disorders
Uncommon
vertigo
Rare
tinnitus
Cardiac disorders
Uncommon
cardiomyopathies (including heart failure), ischaemic coronary artery disorders , arrhythmias (including atrial fibrillation), palpitations
Rare
pericarditis, atrioventricular block
Vascular disorders
Common
hypertension
Uncommon
haemorrhage or bleeding (any site), hypercoagulation (including thrombophlebitis, pulmonary embolism), syncope, oedema (including peripheral, facial), ecchymoses (including haematoma, petechiae)
Rare
cerebrovascular accident, arteriosclerosis, Raynaud's phenomenon, livedo reticularis, telangiectasia
Respiratory, thoracic and mediastinal disorders
Uncommon
asthma and related symptoms, pleur |
