Tandem F Side Effects

Please note - some side effects for Tandem F 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 Tandem F - for the Consumer

Tandem F

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 Tandem F:

Constipation; diarrhea; heartburn; loss of appetite; nausea; stomach upset; vomiting.

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 stools; fever; severe or persistent vomiting with continuing 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

Hypersensitivity

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.

Gastrointestinal

Gastrointestinal side effects associated with ferrous fumarate have included anorexia, nausea, diarrhea, constipation, heartburn, vomiting, and discoloration of stools.

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.

Immunologic

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.

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.

Other

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

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.

Nervous system

Nervous system side effects have been reported in some patients receiving folic acid in daily dosages of 15 mg.

Daily doses of folic acid greater than 100 mcg can obscure pernicious anemia in that hematologic remission can occur while neurologic signs and symptoms progress.

Nervous system side effects associated with folic acid have included sleep disturbances, concentration problems, irritability, anxiety, depression, confusion, and impaired judgment.

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