Immediate Hypersensitivity Reaction to Ferric Carboxymaltose (FCM)
You experienced an immediate hypersensitivity reaction (infusion reaction) to ferric carboxymaltose, characterized by facial flushing, headache, chest tightness, and skin redness occurring within minutes of IV administration. 1, 2
What This Reaction Represents
This constellation of symptoms—red face, headache, chest tightness, and skin redness occurring immediately after FCM administration—represents a mild to moderate infusion-related hypersensitivity reaction, not anaphylaxis. 1, 2 Your symptoms do not meet criteria for anaphylaxis because you lack two or more of the following: skin/mucosal involvement PLUS respiratory compromise, PLUS hypotension with end-organ dysfunction, or PLUS severe persistent gastrointestinal symptoms. 3
- Facial flushing and skin redness indicate histamine-mediated vasodilation and skin/mucosal involvement. 3, 1
- Chest tightness without frank bronchospasm or dyspnea suggests mild respiratory symptoms but not true respiratory compromise. 3, 2
- Headache is consistent with vasodilation and increased blood flow. 3
Immediate Management That Should Have Been Provided
The infusion should have been stopped immediately when symptoms began, and you should have received antihistamines (diphenhydramine 25-50 mg IV) with close monitoring for progression. 3, 4, 1
- If symptoms were moderate to severe, corticosteroids (hydrocortisone 200 mg IV slowly) should have been added. 4
- You should have been observed for at least 30 minutes after symptom resolution to ensure no progression. 3, 2
- Vital signs including blood pressure should have been monitored to rule out hypotension. 4, 1
Why This Happened
FCM can cause immediate hypersensitivity reactions in a small percentage of patients (≥0.1% to <1.0%), though true anaphylaxis is extremely rare. 1, 2 These reactions are typically:
- Non-IgE mediated (not true allergic reactions) but rather direct histamine release or complement activation. 3, 1
- Related to infusion rate—rapid administration increases risk of these reactions. 3, 2
- Unpredictable on first exposure—you cannot predict who will react without prior exposure history. 1, 2
Critical Next Steps and Future Management
You should NOT receive FCM again without specific precautions, and alternative IV iron formulations should be strongly considered. 3, 1
If FCM Must Be Used Again:
- Mandatory premedication with antihistamines (diphenhydramine 50 mg IV) and corticosteroids (dexamethasone or hydrocortisone) 30 minutes before infusion. 4, 1
- Slower infusion rate—dilute in 100 mL normal saline and infuse over 30 minutes minimum (not the rapid 15-minute infusion). 3, 2
- Hospital setting with rapid response team available with personnel, equipment, and supplies to treat anaphylaxis. 3, 1
- Extended observation period of at least 60 minutes post-infusion. 3, 2
Preferred Alternative Approach:
Switch to a different IV iron formulation such as ferric derisomaltose (FDI) or iron sucrose, which have different carbohydrate complexes and may not trigger the same reaction. 3, 2
- Ferric derisomaltose has similar dosing convenience (1000 mg single infusion) with potentially different reactivity profile. 3
- Iron sucrose requires multiple smaller doses (200 mg maximum per dose) but has an excellent safety profile. 3, 2
Documentation Requirements
This reaction must be documented in your medical record as "hypersensitivity reaction to ferric carboxymaltose" with detailed description of symptoms, timing, and severity. 4, 1
- Document exact timing of symptom onset relative to infusion start. 4
- Record all vital signs during the reaction. 4
- Note specific symptoms and their progression or resolution. 4
- This documentation prevents inadvertent re-exposure without appropriate precautions. 1
Important Caveats
Do not confuse this reaction with the separate issue of FCM-induced hypophosphatemia, which is a delayed metabolic complication occurring days to weeks after infusion. 1, 2, 5 Your immediate symptoms are unrelated to phosphate levels but FCM carries a 47-75% risk of causing significant hypophosphatemia with repeat dosing, which is another reason to consider alternative formulations. 1, 5
This reaction is NOT related to "iodine allergy" or shellfish allergy—FCM contains iron and carbohydrate, not iodine. 3 Any mention of contrast media allergy in your records is irrelevant to this FCM reaction. 3