Miscellaneous adverse reactions such as pleural effusion, ascites, pulmonary oedema and rapid weight gain with or without superficial oedema may be collectively described as “fluid retention”. These reactions can usually be managed by withholding Glivec temporarily and with diuretics and other appropriate supportive care measures. However, some of these reactions may be serious or life-threatening and several patients with blast crisis died with a complex clinical history of pleural effusion, congestive heart failure and renal failure. There were no special safety findings in paediatric clinical trials.
Adverse reactions

Adverse reactions reported as more than an isolated case are listed below, by system organ class and by frequency. Frequency categories are defined using the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), 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 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, con