ADVERSE REACTIONS
The following adverse reactions have been observed, but there are not enough data to support an estimate of their frequency.
At the Injection Site:
localized irritation, pain, burning, swelling, induration, infiltration, pruritus, erythema, wheal formation, eschar, crust, vesicles, local edema. Injection site reactions may be associated with systemic allergic reactions (see
Body as a Whole
, below).
Hypersensitivity Reactions and Systemic Allergic Reactions:
generalized rash, urticaria, anaphylactic reaction with or without shock, angioedema.
Body as a Whole:
Local injection site reactions may be accompanied by systemic reactions like arthralgia, fever, headache, myalgia, nausea, vomiting, abdominal pain, or asthma.
Rare infections with
Yersinia
and
Mucormycosis
have been reported in association with deferoxamine mesylate use (see
PRECAUTIONS
).
Cardiovascular:
tachycardia, hypotension, shock.
Digestive:
abdominal discomfort, diarrhea, nausea, vomiting.
Hematologic:
blood dyscrasia (e.g., Cases of thrombocytopenia and/or leukopenia have been reported. A causal relationship has not been clearly established.)
Musculoskeletal:
Leg cramps. Growth retardation and bone changes (e.g., metaphyseal dysplasia) are common in chelated patients given doses above 60 mg/kg, especially those who begin iron chelation in the first three years of life. If doses are kept to 40 mg/kg or below, the risk may be reduced (see
WARNINGS
,
PRECAUTIONS
/Pediatric Use
).
Nervous system:
neurological disturbances including dizziness, peripheral sensory, motor, or mixed neuropathy, paresthesias; exacerbation or precipitation of aluminum-related dialysis encephalopathy (see
PRECAUTIONS
/Information for Patients
).
Special Senses:
High-frequency sensorineural hearing loss and/or tinnitus are uncommon if dosage guidelines are not exceeded and if dose is reduced when ferritin levels decline. Visual disturbances are rare if dosage guidelines are not exceeded. These may include decreased acuity, blurred vision, loss of vision, dyschromatopsia, night blindness, visual field defects, scotoma, retinopathy (pigmentary degeneration), optic neuritis, and cataracts (see
WARNINGS
).
Respiratory:
acute respiratory distress syndrome (with dyspnea, cyanosis, and/or interstitial infiltrates) (see
WARNINGS
).
Skin:
very rare generalized rash.
Urogenital:
dysuria, impaired renal function (see
CONTRAINDICATIONS
).
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