Deferoxamine Side Effects

Some side effects of deferoxamine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to deferoxamine: injectable powder for injection

Get emergency medical help if you have any of these signs of an allergic reaction while taking deferoxamine: hives; joint or muscle pain; fever; headache; nausea or vomiting; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using deferoxamine and call your doctor at once if you have any of these serious side effects:

• cough, wheezing, gasping, or other breathing problems;

• urinating less than usual or not at all;

• drowsiness, confusion, mood changes, increased thirst, loss of appetite, nausea and vomiting;

• swelling, weight gain, feeling short of breath;

• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• hearing problems;

• blurred vision, eye pain, or seeing halos around lights;

• seizure (convulsions);

• fast heartbeats;

• blue lips, skin, or fingernails;

• severe, watery, bloody diarrhea with cramping;

• stuffy nose, fever, redness or swelling around your nose and eyes, scabbing inside your nose;

• stomach or back pain, coughing up blood;

• easy bruising or bleeding, unusual weakness; or

• leg cramps, bone problems, or growth changes (in a child using this medication).

Less serious side effects of deferoxamine may include:

• dizziness, ringing in your ears;

• flushing (warmth, redness, or tingly feeling);

• mild itching or skin rash;

• numbness or burning pain anywhere in the body;

• mild diarrhea, nausea, or upset stomach;

• reddish colored urine; or

• pain, burning, swelling, redness, irritation, or a hard lump where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to deferoxamine: injectable powder for injection

Local

Local side effects include localized irritation, pain, burning, swelling, induration, infiltration, pruritus, erythema, wheal formation, eschar, crust, vesicles, and local edema.

Injection site reactions are sometimes associated with systemic reactions like arthralgia, fever, headache, myalgia, nausea, vomiting, abdominal pain and/or asthma.

Cardiovascular

Cardiovascular side effects include tachycardia, hypotension, and shock.

Musculoskeletal

Musculoskeletal side effects include leg cramps, arthralgia, and myalgia. Growth retardation and bone changes are common in chelated patients at doses above 60 mg/kg, especially in children who begin iron chelation before four years of age. However, the risk is reduced considerably if the dose is 40 mg/kg or below. A case of pelvic osteomyelitis has also been reported.

Nervous system

Nervous system side effects include dizziness, peripheral sensory, motor, or mixed neuropathy, paresthesias, exacerbation or precipitation of aluminum related dialysis encephalopathy.

Dermatologic

Dermatologic side effects include generalized rash, urticaria, and angioedema.

Gastrointestinal

Gastrointestinal side effects include abdominal discomfort, diarrhea, nausea, and vomiting.

Hematologic

Hematologic side effects including thrombocytopenia and leukopenia have been reported.

Respiratory

Respiratory side effects include acute respiratory distress syndrome with dyspnea, cyanosis, and/or interstitial infiltrates.

Genitourinary

Genitourinary side effects include dysuria and impaired renal function.

General

General side effects include fever, headache, and abdominal pain.

Other

Otic side effects include clinical deafness, high frequency sensorineural hearing loss, and tinnitus.

Postmarketing reports suggest that there may be an increased risk of deafness and hearing loss in the geriatric population.

Ocular

Ocular side effects include decreased acuity, blurred vision, loss of vision, dyschromatopsia, night blindness, visual field defects, scotoma, retinopathy (pigmentary degeneration), optic neuritis, and cataracts.

Postmarketing reports suggest a possible trend for an increased risk of eye disorders in the geriatric population, specifically the occurrence of color blindness, maculopathy, and scotoma.

Although the number of reports was very small, certain elderly patients may be predisposed to eye disorders when taking deferoxamine.

Immunologic

Immunologic side effects rarely include enhanced susceptibility to Yersinia enterocolitica and Yersinia pseudotuberculosis. Very rare cases of mucormycosis have also been reported.

Renal

Renal side effects in postmarketing experience have included increases in serum creatinine (possibly dose-related), acute renal failure and renal tubular disorders.

Hepatic

Hepatic side effects have included hepatic dysfunction.

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