Ferrous fumarate Side Effects

For the Consumer

Applies to ferrous fumarate: chewable tablets, suspension

Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; darkened or green stools; diarrhea; nausea; stomach upset.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; blood or streaks of blood in the stool; fever; vomiting with continuing sharp stomach pain.

For Healthcare Professionals

Applies to ferrous fumarate: compounding powder, oral liquid, oral suspension, oral tablet, oral tablet chewable, oral tablet extended release

Gastrointestinal

Gastrointestinal side effects are generally dose-related and have included nausea, constipation, anorexia, heartburn, vomiting and diarrhea. In addition, stools may appear darker in color in patients taking ferrous fumarate.

Oral preparations may rarely cause Hemoccult-positive stools, patients with positive tests generally require further work-up.^[Ref]

Gastrointestinal discomfort may be minimized by initiating ferrous fumarate therapy at smaller doses and gradually titrating upwards until the desired dose is achieved.

Gastrointestinal discomfort may also be minimized by administering each dose with food. However, concurrent administration of ferrous fumarate with food may decrease the amount of iron absorbed.

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]

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

Local

Local side effects have included gangrene.^[Ref]

Localized corrosion has been reported in a pregnant woman taking ferrous sulfate (tablet) that lodged in a Meckel's diverticulum.

There have also been reports of wax-matrix ferrous sulfate tablets (delayed-release) lodging in the bowels of patients with strictures.^[Ref]

Other

Stained teeth have primarily occurred following ingestion of ferrous fumarate liquid preparation. Liquid dosage forms should be diluted in juice or water and sipped through a straw to aid in prevention of staining.

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 have included stained teeth and iron overload (hemosiderosis). Secondary hemochromatosis due to prolonged iron ingestion has been reported rarely.^[Ref]

Not all side effects for ferrous fumarate may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

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