Iron dextran Side Effects

Not all side effects for iron dextran may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to iron dextran: parenteral injection

Side effects include:

Sensitivity (e.g., anaphylactoid or anaphylactic) reactions; can be immediate or delayed and vary widely in severity.

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 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).[Ref]

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.[Ref]

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, manifested by arthralgia, backache, myalgia, fever, chills, dizziness, headache, nausea and/or vomiting. The etiology of these reactions is unknown.[Ref]

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.[Ref]

Cardiovascular

Cardiovascular side effects have included chest pain or tightness, shock, hypotension, hypertension, tachycardia, flushing, and arrhythmias. Rapid administration of iron dextran intravenously may precipitate flushing and hypotension.[Ref]

Gastrointestinal

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

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

Nervous system

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

Respiratory

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

Immunologic

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

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.[Ref]

Renal

Renal side effects have included hematuria or anuria.[Ref]

Oncologic

Oncologic side effects have included reports of sarcoma.[Ref]

Ocular

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

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.[Ref]

Other

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

References

1. Jacobs J "Death due to iron parenterally." South Med J 62 (1969): p216assim

2. Amitai A, Acker M "Adverse effects of intramuscular iron injection." Acta Haematol 68 (1982): 341-2

3. Kumpf VJ, Holland EG "Parenteral iron dextran therapy." DICP 24 (1990): 162-6

4. Hart GD, Soots M "An anaphylactic reaction complicating total dose infusion therapy of iron deficiency." Appl Ther 11 (1969): 645-6

5. Sane R, Baribeault D, Rosenberg CL "Safe administration of iron sucrose in a patient with a previous hypersensitivity reaction to ferric gluconate." Pharmacotherapy 27 (2007): 613-5

6. Fishbane S "Safety in iron management." Am J Kidney Dis 41(5 Suppl) (2003): 18-26

7. Bielory L "Serum sickness from iron-dextran administration." Acta Haematol 83 (1990): 166-8

8. Becker CE, MacGregor RR, Walker KS, Jandl JH "Fatal anaphylaxis after intramuscular iron-dextran." Ann Intern Med 65 (1966): 745-8

9. Zipf RE Jr "Fatal anaphylaxis after intravenous iron dextran." J Forensic Sci 20 (1975): 326-33

10. Gupta A "Pathogenesis of anaphylactoid reactions to intravenous iron." Am J Kidney Dis 35 (2000): 360-1

11. Altman LC, Petersen PE "Successful prevention of an anaphylactoid reaction to iron dextran." Ann Intern Med 109 (1988): 346-7

12. Berliner S, Shoenfeld Y, Livni E, Pinkhas J "Allergic purpura following intravenous administration of iron dextran." Acta Haematol 62 (1979): 178

13. Fahmy K "Systemic reactions with total dose infusion of iron dextran complex in obstetric patients." Int J Gynaecol Obstet 16 (1978): 170-2

14. Shimada A "Adverse reactions to total-dose infusion of iron dextran." Clin Pharm 1 (1982): 248-9

15. "Product Information. INFeD (iron dextran)." Schein Pharmaceuticals Inc, Florham Park, NJ.

16. Hurvitz H, Kerem E, Gross-Kieselstein E, Brand A, Branski D "Pancytopenia caused by iron-dextran." Arch Dis Child 61 (1986): 194-6

17. Go RS, Porrata LF, Call TG "Thrombocytopenia after iron dextran administration in a patient with severe iron deficiency anemia." Ann Intern Med 132 (2000): 925

18. Forristal T, Witt M "Pleocytosis after iron dextran injection." Lancet 1 (1968): 1428

19. Foulkes WD, Sewry C, Calam J, Hodgson HJ "Rhabdomyolysis after intramuscular iron-dextran in malabsorption." Ann Rheum Dis 50 (1991): 184-6

20. Guo D, Jaber BL, Lee S, et al. "Impact of iron dextran on polymorphonuclear cell function among hemodialysis patients." Clin Nephrol 58 (2002): 134-42

21. Thorpe GJ "Anuria following intravenous iron-dextran complex." Br J Clin Pract 19 (1965): 703

22. Weinbren K, Salm R, Greenberg G "Intramuscular injections of iron compounds and oncogenesis in man." Br Med J 1 (1978): 683-5

23. Grasso P "Sarcoma after intramuscular iron injection." Br Med J 2 (1973): 667

24. Fielding J "Does sarcoma occur in man after intramuscular iron?" Scand J Haematol Suppl 32 (1977): 100-4

25. Robertson AG, Dick WC "Intramuscular iron and local oncogenesis." Br Med J 1 (1977): 946

26. MacKinnon AE, Bancewicz J "Sarcoma after injection of intramuscular iron." Br Med J 2 (1973): 277-9

27. Hodgkins PR, Morrell AJ, Luff AJ, Fetherston TJ, Good P "Pigment epitheliopathy with serous detachment of the retina following intravenous iron dextran." Eye 6(Pt 4) (1992): 414-5

28. Colburn WJ, Barnes A "Intravenous Imferon masquerading as an acute hemolytic transfusion reaction." Transfusion 22 (1982): 163-4

29. Shuttleworth D, Spence C, Slade R "Meningism due to intravenous iron dextran." Lancet 2 (1983): 453

30. Simon SD, Kuriyan MA, Kim HC ""Pseudo-hemolytic" transfusion reaction caused by intravenous iron- dextran therapy." Transfusion 22 (1982): 341-2

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