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Polysaccharide Iron Side Effects

Generic Name: iron polysaccharide

Note: This document contains side effect information about iron polysaccharide. Some of the dosage forms listed on this page may not apply to the brand name Polysaccharide Iron.

For the Consumer

Applies to iron polysaccharide: oral capsule, oral tablet

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Black, tarry, or bloody stools.
  • Fever.
  • Very upset stomach or throwing up.
  • Very bad belly pain.
  • Throwing up blood or throw up that looks like coffee grounds.
  • Stomach cramps.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Upset stomach or throwing up.
  • Hard stools (constipation).
  • Change in color of stool to green.
  • Loose stools (diarrhea).
  • Belly pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

For Healthcare Professionals

Applies to iron polysaccharide: oral capsule, oral elixir, oral liquid, oral tablet

Gastrointestinal

Gastrointestinal side effects have been reported the most frequently. They have included nausea, vomiting, diarrhea, constipation, abdominal pain, flatulence, and heartburn.[Ref]

Constipation may be relieved by administering docusate sodium 100 mg to 200 mg per day in addition to increasing the intake of oral fluids, such as water.[Ref]

Other

Other side effects have included iron overload (hemosiderosis). Secondary hemochromatosis due to prolonged iron ingestion has been reported rarely.[Ref]

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]

References

1. Wingard RL, Parker RA, Ismail N, Hakim RM "Efficacy of oral iron therapy in patients receiving recombinant human erythropoietin." Am J Kidney Dis 25 (1995): 433-9

2. KleinSchwartz W "Toxicity of polysaccharid-iron complex exposures reported to poison control centers." Ann Pharmacother 34 (2000): 165-9

3. Glassman E "Oral iron therapy with ferrous fumarate and polysaccharide iron complex." ANNA J 19 (1992): 277-8,323

4. "Multum Information Services, Inc. Expert Review Panel"

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

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