Table 4 presents the adverse drug reactions (ADRs) reported during clinical studies in which >8,000 subjects received 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 Ferinject treatment. The most serious ADR is anaphylactoid/anaphylactic reactions (rare); fatalities have been reported. See Precautions for further details. (See Table 4.)
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