Ferinject Adverse Reactions

Table 4 presents the adverse drug reactions (ADRs) reported during clinical studies in which >9,000 subjects (including >100 children and adolescents 1 to 17 years) received Ferric carboxymaltose (Ferinject), as well as those reported from the post-marketing experience (see table footnotes for details).
The most commonly reported ADR is nausea (occurring in 2.9% of the subjects), followed by injection/infusion site reactions, hypophosphataemia, headache, flushing, dizziness and hypertension. Injection/infusion site reactions comprise several ADRs which individually are either uncommon or rare.
For subjects in clinical trials that showed a decrease in serum phosphorous, the minimum values were obtained after approximately 2 weeks, and in most cases returned to baseline values by 12 weeks following Ferric carboxymaltose (Ferinject) treatment. The most serious ADR is anaphylactic reactions (rare); fatalities have been reported. See Precautions for further details. (See Table 4.)

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Pediatric population: The safety profile of children and adolescents aged 1 to 17 years is comparable with that of adults. 110 paediatric patients received Ferric carboxymaltose (Ferinject) in 7 clinical studies. No serious ADRs were reported. The reported non-serious ADRs were hypophosphataemia (n=5), urticaria (n=5), injection/infusion site reactions (n=4), abdominal pain (n=2), flushing (n=2), headache (n=2), pyrexia (n=2), liver enzymes increased (n=2), and rash (n=2). Constipation, gastritis, hypertension, pruritus and thirst were reported only once.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions.