Published: 2018-04-23

Hypersensitivity reactions to intravenous ferric carboxymaltose in a patient with iron deficiency anemia: a rare case report

Shadma H. Quazi, Sushil K. Varma, Sharjeel H. Khan, Sonali S. Kirde, Harshada Arun Bhoware


Ferric carboxymaltose (FCM) is a non-dextran iron preparation recently approved in the United States for intravenous treatment of iron deficiency anemia (IDA) in adult patients with intolerance or poor response to oral iron therapy. Acute hypersensitivity reactions (HSRs) during iron infusions are very rare but can be life-threatening. Adverse events, including immune system disorders (0% in FCM) and skin disorders (7.3% in FCM), are less frequently observed with FCM. On treatment with FCM, the change in hemoglobin from baseline to the highest observed level is about 2.8g/dL. Treatment of IDA with FCM resulted in fewer hypersensitivity reactions. Here, authors report a case of a 23 years old female diagnosed for IDA presented with the picture of adverse drug reaction due to injection FCM given by the physician. The patient was managed with Antibiotics, Corticosteroids and Intravenous fluids and recovered well within 12 hours of admission from this adverse drug reaction. Since such cases have been rarely reported, authors are intended to notify about this potentially dangerous drug reaction due to FCM which is used extensively in the treatment of IDA. Hence management of iron infusions requires very careful and precise observation, and, in the event of an adverse reaction, prompt recognition and severity-related interventions by well-trained medical and nursing staff.


Ferric carboxymaltose, Hypersensitivity reactions, Iron deficiency anemia

Full Text:



Bregman DB, Goodnough LT. Experience with intravenous ferric carboxymaltose in patients with iron deficiency anemia. Ther Adv Hematol. 2014;5(2):48-60.

Rampton D, Folkersen J, Fishbane S, Hedenus M, Howaldt S, Locatelli F, et al. Hypersensitivity reactions to intravenous iron: Guidance for risk minimization and management. Haematologica. 2014;99(11):1671-6.

Barish CF, Koch T, Butcher A, Morris D, Bregman DB. Safety and efficacy of intravenous ferric carboxymaltose (750mg) in the treatment of iron deficiency anemia: Two randomized, controlled trials. Anemia; 2012:2012.

Anemia K. Adverse Reactions of Ferric Carboxymaltose. 2014;8(10):8-9.

Milman N, Bergholt T, Byg KE, Eriksen L, Graudal N. Iron status and iron balance during pregnancy. A critical reappraisal of iron supplementation. Acta Obstet Gynecol Scand. 1999;78(9):749-57.

Koduru P, Abraham BP. The role of ferric carboxymaltose in the treatment of iron deficiency anemia in patients with gastrointestinal disease. Therap Adv Gastroenterol. 2016;9(1):76-85.

Favrat B, Balck K, Breymann C, Hedenus M, Keller T, Mezzacasa A, et al. Evaluation of a single dose of ferric carboxymaltose in fatigued, iron-deficient women - PREFER a randomized, placebo-controlled study. PLoS One. 2014;9(4):3-12.

Hussain I, Bhoyroo J, Butcher A, Koch TA, He A, Bregman DB. Direct comparison of the safety and efficacy of ferric carboxymaltose versus iron dextran in patients with iron deficiency anemia. Anemia; 2013:2013(Iv).

Srinivasan R, Ramya G. Adverse Drug Reaction-Causality Assessment. Int J Res Pharm Chem. 2011;1(3):606-12.

Raut AL, Patel P, Patel C, Pawar A. Preventability, Predictability and Seriousness of Adverse Drug Reactions amongst Medicine Inpatients in a Teaching Hospital: A Prospective Observational Study. Int J Pharm Chem Sci. 2012;1(3):1293-9.

Organization WH. The use of the WHO-UMC system for standardized case causality assessment. Uppsala Uppsala Monit Cent [Internet]. 2005;(3):2-7.

Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I, Roberts EA, et al. A method for estimating the probability of adverse drug reactions. Clinical Pharmacology & Therapeutics. 1981 Aug 1;30(2):239-45.

Meyboom RH, Lindquist M, Egberts AC. An ABC of drug-related problems. Drug Saf. 2000;22(6):415-23.