Desferal Side Effects

Generic Name: deferoxamine

Please note - some side effects for Desferal may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Desferal - for the Consumer

Desferal

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Desferal:

Diarrhea; dizziness; headache; leg cramps; nausea; stomach upset; vomiting.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); change in the amount of urine produced; decreased hearing; fainting; fast heartbeat; fever, chills, or sore throat; muscle or joint pain; numbness or tingling of the face, hands, feet, or skin; pain, burning, swelling, blistering, or redness at the injection site; ringing in the ears; seizures; severe dizziness; unusual bruising or bleeding; vision changes.

Desferal Side Effects - for the Professional

Desferal

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.

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 Desferal use.

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.

Nervous System:  Neurological disturbances including dizziness, peripheral sensory, motor, or mixed neuropathy, paresthesias; exacerbation or precipitation of aluminum-related dialysis encephalopathy.

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.

Respiratory:  Acute respiratory distress syndrome (with dyspnea, cyanosis, and/or interstitial infiltrates).

Skin:  Very rare generalized rash.

Urogenital:  Dysuria, impaired renal function.

Side Effects by Body System

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 mucor-mycosis have also been reported.

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