Fe Caps Side Effects

Please note - some side effects for Fe Caps may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Fe Caps - for the Consumer

Fe Caps Controlled-Release Capsules

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Fe Caps Controlled-Release Capsules:

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

Severe allergic reactions (rash; hives; itching; 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.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Side Effects by Body System - for Healthcare Professionals

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 sulfate.

Oral preparations of ferrous sulfate may rarely cause Hemoccult-positive stools, patients with positive tests generally require further work-up.

Gastrointestinal side effects are dose-related with approximately 25% of patients experiencing side effects at a dosage of 325 mg three times a day.

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

Administering each dose with food may also minimize gastrointestinal discomfort. However, concurrent administration of ferrous sulfate with food may decrease the amount of iron absorbed.

Due to the small amount of iron released and absorbed, the use of enteric-coated or delayed release ferrous sulfate preparations may reduce gastrointestinal side effects; however, these products are not recommended for use.

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.

Other

Other side effects have included stained teeth and iron overload (hemosiderosis). Secondary hemochromatosis due to prolonged iron ingestion has been reported rarely.

Stained teeth have primarily occurred following ingestion of ferrous sulfate 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.

Immunologic

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

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.

Local

Local side effects have included gangrene.

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

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

Metabolic

Metabolic side effects have included decreased absorption of thyroxine (T4).

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