There was no increased risk of infections with IV iron .
Gastrointestinal AEs were reduced with IV iron .
CONCLUSION Intravenous iron therapy is not associated with an increased risk of SAEs or infections .
Infusion reactions are more pronounced with IV iron
OBJECTIVE To amass all available evidence regarding the safety of intravenous ( IV ) iron preparations to provide a true balance of efficacy and safety .
Safety and tolerability of intravenous ferric carboxymaltose in patients with iron deficiency anemia
There is limited safety information about ferric carboxymaltose ( FCM ) , a new intravenous iron preparation . This r and omized , crossover study compared the safety and tolerability of double‐blinded intravenous doses of FCM or placebo in patients with iron deficiency anemia . Subjects ( 559 ) with iron deficiency anemia received a dose of either FCM ( 15 mg/kg , maximum 1000 mg ) over 15 minutes or placebo on day 0 . On day 7 , subjects received the other agent . Safety evaluations were performed on days 7 and 14 . The primary endpoint was the incidence of treatment‐emergent adverse events during each 7‐day study period . During the first 24 hours and during the 7‐day treatment period , at least one treatment‐emergent adverse event was experienced by 15.0 % and 29.3 % of subjects after FCM and 11.4 % and 19.7 % after placebo , respectively . Most were classified as Grade 1 or 2 . Six subjects had Grade 3 treatment‐emergent adverse events  after FCM and 9 subjects after placebo . One subject had a Grade 4 , and 1 subject had a Grade 5 treatment‐emergent adverse event , but neither was considered study drug‐related . During the first 24 hours of the treatment period , drug‐related adverse events were reported in 9.3 % of subjects receiving FCM and 4.8 % receiving placebo . Of drug‐related Grade 3 events , 4 subjects received FCM and 5 subjects received placebo . Administration of FCM ( 15 mg/kg , maximum of 1000 mg ) over 15 minutes was well tolerated and associated with minimal risk of adverse reactions in patients with iron deficiency anemia
There was no increased risk of infections with IV iron .
Gastrointestinal AEs were reduced with IV iron .
CONCLUSION Intravenous iron therapy is not associated with an increased risk of SAEs or infections .
Infusion reactions are more pronounced with IV iron
OBJECTIVE To amass all available evidence regarding the safety of intravenous ( IV ) iron preparations to provide a true balance of efficacy and safety .