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The most commonly reported ADR is nausea (occurring in 3.2% 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.
The most serious ADR is anaphylactic reactions (rare); fatalities have been reported. See Precautions for further details. (See Table 4.)
Click on icon to see table/diagram/imagePaediatric population: The safety profile for children and adolescents aged 1 to 17 years is comparable with that of adults. 110 paediatric patients received 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 via E-mail: THZP-PV-Contact@zuelligpharma.com.
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