Adverse Effects of Intravenous Ferric Carboxymaltose in Pediatric Patients
Ferric carboxymaltose is generally well-tolerated in pediatric patients, with most children (84-92%) experiencing no adverse effects during or after infusion, and serious adverse events being extremely rare. 1, 2
Common Adverse Effects (≥1% to <10%)
The most frequently reported adverse effects during injection and immediate post-infusion period include:
- Hypophosphatemia (13% in pediatric trials): Transient decreases in blood phosphorus levels are common but typically asymptomatic 3
- Injection site reactions (8%): Including pain, hematoma, hypoesthesia, extravasation, discoloration, bruising, erythema, and swelling 3
- Rash/skin reactions (8%): Including urticaria, exanthema, and pruritic rash 3
- Headache (5%): May include migraine-type symptoms 3
- Vomiting (5%): Gastrointestinal upset during or shortly after infusion 3
- Flushing (3%): Transient sensation during injection 3
- Dizziness (2.1%): Including balance disorder and vertigo 3
- Nausea (7.2% in some studies): More common with higher doses 3
Serious but Rare Adverse Effects (<1%)
- Hypersensitivity reactions (≥0.1% to <1%): Risk is low but includes potential for anaphylaxis, though no test dose is required unlike iron dextran 4, 3
- Hypotension (1%): Can occur during rapid infusion 3
- Hypertension (4%): Paradoxical blood pressure elevation 3
- Hepatic enzyme elevation (1.2%): Transient increases in ALT/AST 3
Critical Safety Considerations
Extravasation risk: Skin staining and discoloration can occur if IV iron leaks outside the vein; administration must be stopped immediately if paravenous leakage occurs 4. This was the only adverse event reported in one pediatric CKD study of 79 patients 5.
Systemic iron toxicity: Hepatocellular damage has been documented in pediatric patients receiving excessive doses (e.g., 16 mg/kg of iron sucrose), emphasizing the importance of proper weight-based dosing 4, 6
Fetal bradycardia: In pregnant adolescents, severe hypersensitivity reactions may cause fetal bradycardia, particularly in second and third trimesters 3
Administration Factors Affecting Adverse Events
- No test dose required: Unlike iron dextran, ferric carboxymaltose does not require pre-administration testing 4, 7
- Infusion rate matters: Minimum administration time is 6 minutes for 500 mg and 15 minutes for 1000 mg when properly diluted 4
- Dose-related effects: Most adverse effects are mild and self-limited, with severe reactions more common with larger single doses 4
Real-World Pediatric Safety Data
Multiple studies confirm excellent tolerability:
- In 144 children aged 18 months to <18 years, 92% had uneventful infusions with only 5 patients reporting potentially related symptoms during 96-hour follow-up 1
- In 79 pediatric CKD patients, only one adverse event (extravasation) occurred, with no hypersensitivity or anaphylactic reactions 5
- In 72 children receiving 116 infusions, 84% experienced no adverse effects, with only minor transient complications in 7 infusions 2
- In 39 children with RLS/PLMD, only 7 (14.3%) experienced mild adverse events 8
Monitoring Recommendations
During infusion: Watch for flushing, chest discomfort, dyspnea, or signs of hypersensitivity 3
Post-infusion: Monitor phosphate levels as hypophosphatemia occurs in approximately 27% of patients, though rarely symptomatic 3, 9
Avoid premature iron status reassessment: Ferritin levels increase markedly after IV iron and cannot be used to assess iron status for at least 4 weeks post-administration 4