ions reported during chronic treatment with EXJADE in adult and paediatric patients include gastrointestinal disturbances in about 26% of patients (mainly nausea, vomiting, diarrhoea or abdominal pain) and skin rash in about 7% of patients. Diarrhoea is reported more commonly in paediatric patients aged 2 to 5 years and in the elderly. These reactions are dose-dependent, mostly mild to moderate, generally transient and mostly resolve even if treatment is continued.
During clinical trials, increases in serum creatinine of >33% on two or more consecutive occasions, sometimes above the upper limit of the normal range, occurred in about 36% of patients. These were dose-dependent. About two-thirds of the patients showing serum creatinine increase returned below the 33% level without dose adjustment. In the remaining third the serum creatinine increase did not always respond to a dose reduction or a dose interruption. Indeed, in some cases, only a stabilisation of the serum creatinine values has been observed after dose reduction (see section 4.4).
Tabulated list of adverse reactions
Adverse reactions are ranked below 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, adverse reactions are presented in order of decreasing seriousness.
Table 1
Blood and lymphatic system disorders
Not known:
Pancytopenia1, thrombocytopenia1
Immune system disorders
Not known:
Hypersensitivity reactions (including anaphylaxis and angioedema)1
Psychiatric disorders
Uncommon:
Anxiety, sleep disorder
Nervous system disorders
Common:
Headache
Uncommon:
Dizziness
Eye disorders
Uncommon:
Early cataract, maculopathy
Ear and labyrinth disorders
Uncommon:
Hearing loss
Respiratory, thoracic and mediastinal disorders
Uncommon:
Pharyngolaryngeal pain
Gastrointestinal disorders
Common:
Diarrhoea, constipation, vomiting, nausea, abdominal pain, abdominal distension, dyspepsia
Uncommon:
Gastrointestinal haemorrhage, gastric ulcer (including multiple ulcers), duodenal ulcer, gastritis
Rare:
Oesophagitis
Hepatobiliary disorders
Common:
Transaminases increased
Uncommon:
Hepatitis, cholelithiasis
Not known:
Hepatic failure1
Skin and subcutaneous tissue disorders
Common:
Rash, pruritus
Uncommon:
Pigmentation disorder
Not known:
Leukocytoclastic vasculitis1, urticaria1, erythema multiforme1, alopecia1
Renal and urinary disorders
Very common:
Blood creatinine increased
Common:
Proteinuria
Uncommon:
Renal tubulopathy (acquired Fanconi's syndrome), gly
