Ferrous fumarate/folic acid/iron polysaccharide Side Effects
Hypersensitivity side effects associated with folic acid have been reported rarely. They have included erythema, rash, pruritus, malaise, dyspnea with bronchospasm, and a single case of apparent anaphylaxis.[Ref]
Cases of gastrointestinal discomfort are typically mild and subside with continuation of therapy. According to the manufacturer, ferrous fumarate-folic acid-iron polysaccharide is best absorbed when administered at bedtime; however, gastrointestinal side effects in may be minimized when administered with a meal.
Constipation may be relieved by increased fiber in the diet.
Discoloration of stools is a harmless effect resulting from unabsorbed iron.[Ref]
Immunologic side effects associated with oral iron products have rarely included gastroenteritis associated with Yersinia enterocolitica and Listeria monocytogenes in patients with iron overload status receiving treatment with deferoxamine.[Ref]
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]
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]
Nervous system side effects have been reported in some patients receiving folic acid in daily dosages of 15 mg.
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Related treatment guides
1. "Product Information. Tandem F (ferrous fumarate/FA/iron polysaccharide)." US Pharmaceutical Corporation (2022):
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Some side effects may not be reported. You may report them to the FDA.