Desferal Adverse Reactions





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Adverse Reactions
Adverse drug reactions (Table 1) are listed according to system organ classes in MedDRA. Within each system organ class, the adverse drug reactions are ranked by frequency, with the most frequent reactions first. Within each frequency grouping, adverse drug reactions are ranked in order of decreasing seriousness. In addition, the corresponding frequency category using the following convention (CIOMS III) is also provided for each adverse drug reaction: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000) including isolated reports; "unknown" (when not possible to reliably estimate the frequency of the adverse reactions reported from post-marketing experience because reports are from a population of uncertain size).
Some of the signs and symptoms reported as adverse effects may also be manifestations of the underlying disease (iron and/or aluminum overload). (See Table 1.)

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Special remarks: Deafness neurosensory and tinnitus are uncommon if doses are kept within guidelines and if doses are reduced when ferritin levels fall (ratio of the mean daily dose of Desferal divided by serum ferritin should be below 0.025) (see Precautions).
The various eye disorders are rare, except if high doses are given (see Precautions).
Growth retardation and bone disorders (e.g. metaphyseal dysplasia) are common with doses above 60 mg/kg, especially in patients who begin iron chelation during the first three years of life. The risk is considerably reduced with doses of 40 mg/kg or less.
At the injection site pain, swelling, infiltration, erythema, pruritus, and eschar/crust are very common, while vesicles, local edema and burning are uncommon. Local manifestations may be accompanied by systemic reactions such as arthralgia/myalgia (very common), headache (common), urticaria (common), nausea (common), pyrexia (common), vomiting (uncommon), abdominal pain (uncommon) or asthma (uncommon).
Excretion of the iron complex may cause reddish-brown discoloration of the urine.
Convulsions have mainly been reported in dialyzed patients with aluminum overload (see Precautions).
Rare cases of increased transaminases have been reported in patients who have been treated with Desferal, however a causality with the drug is not established.
Patients treated for chronic aluminum overload: Desferal chelation therapy aluminum overload may result in hypocalcemia and aggravation of hyperparathyroidism (see Precautions).
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