Infed Side Effects

Generic name: iron dextran

Note: This document contains side effect information about iron dextran. Some of the dosage forms listed on this page may not apply to the brand name Infed.

Some side effects of Infed 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 iron dextran: injectable solution

Cases of severe, sometimes fatal, allergic reactions (loss of consciousness, collapse, difficulty breathing, hives, swelling, or convulsions) and severe low blood pressure (hypotension) have been reported with the use of iron dextran (the active ingredient contained in Infed) This medication should be administered under the supervision of a healthcare professional.

Other less serious side effects are more likely to occur. Continue using iron dextran and talk to your doctor or pharmacist if you experience:

• dizziness;

• nausea or vomiting;

• diarrhea;

• fever, sweating, or chills;

• soreness, pain, swelling, redness, or other reaction at the injection site;

• muscle or joint pain or aches;

• metallic taste in the mouth; or

• headache.

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 iron dextran: injectable solution

Hypersensitivity

Hypersensitivity side effects have included dyspnea, urticaria, rashes, itching, arthralgia, myalgia, fever, and sweating. Hypersensitivity reactions to iron dextran (the active ingredient contained in Infed) are reported to occur in 2.47% of patients. Anaphylaxis, usually occurring within minutes and characterized by sudden onset of cardiorespiratory collapse, has occurred rarely (< 1% of patients).

There have been reports of fatal anaphylaxis. Anaphylaxis may occur following iron administration by the intravenous or intramuscular route. Epinephrine, intravenous diphenhydramine, methylprednisolone and oxygen should be available for immediate use when administering iron dextran.

General

General side effects have rarely included severe adverse reactions (less than 5%).

Delayed reactions may occur 1 to 2 days after administration of iron dextran (the active ingredient contained in Infed) manifested by arthralgia, backache, myalgia, fever, chills, dizziness, headache, nausea and/or vomiting. The etiology of these reactions is unknown.

Delayed reactions tended to subside within 2 to 7 days. This type of reaction may be more common after total dose infusion, although still may occur after intramuscular injection. The severity or frequency of delayed reactions may be reduced by lowering the dose or increasing the dosing interval.

Cardiovascular

Cardiovascular side effects have included chest pain or tightness, shock, hypotension, hypertension, tachycardia, flushing, and arrhythmias. Rapid administration of iron dextran (the active ingredient contained in Infed) intravenously may precipitate flushing and hypotension.

Gastrointestinal

Gastrointestinal side effects have included abdominal pain, nausea, vomiting, and diarrhea.

Hematologic

Hematologic side effects have included leukocytosis, lymphadenopathy, latent folic acid deficiency, pleocytosis, pancytopenia, thrombocytopenia, and purpura. Hemosiderosis resulting from excess storage of iron has been reported as a possible result of unwarranted therapy with parenteral iron.

Musculoskeletal

Musculoskeletal side effects have included arthralgia, arthritis (possible reactivation of quiescent rheumatoid arthritis), myalgia, and backache. Rhabdomyolysis has been reported in one case report.

Local

Local side effects have included injection site pain, inflammation and swelling, cellulitis, phlebitis, sterile abscess, brown skin staining at injection site (harmless), sarcoma formation, and necrosis. These effects have especially been observed with intramuscular injections of iron dextran (the active ingredient contained in Infed)

When dextrose 5% is used as a diluent in total dose infusion of iron dextran, a higher incidence of phlebitis and local injection pain has been seen. Sodium chloride 0.9% should be used as the diluent in total dose infusion.

Nervous system

Nervous system side effects have included headache, transient paresthesia, weakness, dizziness, syncope, disorientation, unresponsiveness and seizures.

Respiratory

Respiratory side effects have included dyspnea, bronchospasm and respiratory arrest.

Immunologic

Immunologic side effects have included a possible increase in susceptibility to infections.

Increased susceptibility to infections has been observed in malnourished patients receiving iron dextran. Blood transfusions may be an option to consider in patients who are severely protein malnourished.

Studies have indicated a possible increase in susceptibility to infections in hemodialysis patients receiving iron dextran intravenously.

Renal

Renal side effects have included hematuria or anuria.

Oncologic

Oncologic side effects have included reports of sarcoma.

Ocular

Ocular side effects have rarely included pigment epitheliopathy with serious detachment of the retina (one case report).

Hepatic

Hepatic side effects have included hemosiderosis, the accumulation of unusable iron in the liver and spleen. This has been associated with chronic intravenous use of this drug in patients undergoing hemodialysis. These patients may not have had adequate iron required for erythropoiesis.

Other

Other sided effects have included altered taste, meningism and a red- brown color pigmentation to the plasma.

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