Heme iron polypeptide Side Effects

Some side effects of heme iron polypeptide may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to heme iron polypeptide: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking heme iron polypeptide: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor if you have a serious side effect such as:

  • bright red blood in your stools; or

  • pain in your chest or throat when swallowing a heme iron polypeptide tablet.

Less serious side effects of heme iron polypeptide may include:

  • constipation, diarrhea;

  • nausea, stomach pain, upset stomach; or

  • black or dark-colored stools or urine.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

For Healthcare Professionals

Applies to heme iron polypeptide: 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.

Other side effects associated with iron therapy have included iron overload (hemosiderosis).

Gastrointestinal

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

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.

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.

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.

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