Precautions for the use of parenteral iron preparations

Safety warnings | messages in brief | 01/08/2023

10 years after the review of iron-containing drugs for intravenous use in connection with allergic reactions (see link ), we would like to remind you of the following:

  • Iron-containing drugs for intravenous use are contraindicated in patients with hypersensitivity to the active ingredient or other ingredients. Parenteral iron preparations must also not be used in patients with severe hypersensitivity to other iron-containing drugs for intravenous use.
  • Because data indicate that allergic reactions may still occur in patients who have not responded to a test dose, test doses are no longer recommended. Instead, caution is advised with any dose of intravenous iron, even if previous administrations have been well tolerated.
  • The risk of hypersensitivity with parenteral administration of iron preparations is increased in patient:s with known allergies, including drug allergies, and those with a history of severe asthma, eczema, or other atopic allergy.
  • There is also an increased risk of hypersensitivity reactions in patients with immunologic or inflammatory diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis).
  • Since allergic reactions can be dangerous for the unborn child, especially during pregnancy, iron-containing parenteral drugs should not be used during pregnancy, if possible, unless clearly necessary. Treatment should be limited to the second and third trimesters if the benefits of treatment clearly outweigh the potential serious risks to the fetus, such as anoxia and fetal distress. During pregnancy, parenteral administration of iron preparations may result in associated fetal bradycardia.
  • Iron preparations for intravenous use should be given only if staff:in trained in the recognition and treatment of anaphylactic and anaphylactoid reactions and equipment for resuscitation are immediately available. Patients should be closely monitored for signs and symptoms of hypersensitivity reactions during the injection and for at least 30 minutes thereafter.
  • In the event of a hypersensitivity reaction, the healthcare professional should immediately discontinue iron administration and consider appropriate treatment for the hypersensitivity reaction.
  • All prescribing physicians should educate their patients about the risk and severity of a hypersensitivity reaction and the importance of seeking medical attention in the event of a reaction.
  • Hypotensive episodes may occur if intravenous injection is too rapid. Possible paravenous leakage at the injection site may cause irritation of the skin and potentially long-lasting brown discoloration around the injection site. Thus, iron-containing parenterals should be administered cautiously to avoid paravenous leakage. In the event of paravenous leakage, administration must be discontinued immediately.

Other important precautions and warnings, such as the risk of hypophosphatemic osteomalacia occurring, can be found in the Instructions for Use and Specialty Information.

If you become aware of any adverse reactions to parenteral iron preparations, we request that you report them to the Federal Office for Safety in Health Care, regardless of whether they are known according to the expert information or not:

Online: E-mail:

Or by paper form to fax: +43 (0) 50 555 - 36207

or Department Blood, Tissue and Vigilance Institute Monitoring BASG - Federal Office for Safety in Health Care AGES - Austrian Agency for Health and Food Safety GmbH Traisengasse 5 A-1200 Vienna


Further inquiry note