Applies to heme iron polypeptide: oral capsule, oral tablet.

Other

Iron overload (i.e., hemosiderosis) has been reported in patients genetically predisposed, or have underlying disorders, that augment the absorption of iron. It has also occurred following administration of excessive parenteral iron therapy, combination of oral and parenteral iron, or in patients with hemoglobinopathies that were erroneously diagnosed as iron deficiency anemia. Hemosiderosis is treated with repeated phlebotomy or long-term administration of deferoxamine. The liver is particularly susceptible to toxicity in iron-overload states.^[Ref]

Other side effects associated with iron therapy have included iron overload (hemosiderosis).^[Ref]

Gastrointestinal

Gastrointestinal side effects have rarely included queasiness, dark green stool, and Hemoccult-positive stools.^[Ref]

Doses of heme iron polypeptide exceeding 56 mg of elemental iron have been reported to cause queasiness and dark green stool.

Patients who receive therapy with heme iron polypeptide and have a positive reaction to an occult stool test may require further work-up.^[Ref]

Immunologic

It has been hypothesized that gastroenteritis is caused by bacteria that become virulent in the presence of iron overload resulting in a systemic infection. Treatment consists of discontinuing deferoxamine and initiating appropriate antimicrobial therapy.^[Ref]

Immunologic side effects associated with iron therapy have rarely included gastroenteritis associated with Yersinia enterocolitica and Listeria monocytogenes in patients with iron overload status receiving treatment with deferoxamine.^[Ref]