Ferric maltol is an iron replacement product that is used in adults used to treat iron deficiency.

Ferric maltol may also be used for purposes not listed in this medication guide.

You should not use ferric maltol if you are allergic to it, or if you have:

• hemochromatosis or iron overload (the buildup of excess iron); or
• if you have repeated blood transfusions.

Tell your doctor if you have ever had inflammatory bowel disease.

Tell your doctor if you are pregnant or plan to become pregnant.

Ferric maltol is absorbed in a way that is not likely to be harmful to an unborn baby. Having untreated iron deficiency during pregnancy may increase the risk of anemia (low red blood cells), premature birth, or low birth weight. The benefit of treating iron deficiency with ferric maltol may outweigh any risks to the baby.

Ferric maltol is not likely to pass into breast milk. Ask your doctor about using this medicine if you are breastfeeding.

Not approved for use by anyone younger than 18 years old.

Use Ferric Maltol (Oral) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop taking ferric maltol and call your doctor at once if you have inflammatory bowel disease and you have a flare of symptoms such as diarrhea, stomach cramps, blood in your stools, loss of appetite, or weight loss.

Common side effects may include:

• stomach pain, bloating, gas, nausea, vomiting;
• diarrhea, constipation; or
• changes in the color of your bowel movements.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Do not take dimercaprol or iron supplements or a vitamin/mineral supplement that your doctor has not prescribed or recommended.