Ferric carboxymaltose is an iron replacement product that is used in adults used to treat iron deficiency anemia (IDA), which is low red blood cells caused by a lack of iron in the body.

Ferric carboxymaltose is given to adults with IDA and chronic kidney disease (not on dialysis), or to adults with IDA when iron taken by mouth is not effective.

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

You should not use ferric carboxymaltose if you are allergic to it.

Tell your doctor if you have ever had:

• high blood pressure; or
• an allergic reaction to iron injected into a vein.

Tell your doctor if you are pregnant or plan to become pregnant. It is not known if ferric carboxymaltose will harm an unborn baby, but this medicine may cause severe reactions in the mother that could affect the baby's heartbeat.

Having iron deficiency anemia during pregnancy may increase the risk of premature birth or low birth weight. The benefit of treating this condition with ferric carboxymaltose may outweigh any risks to the baby.

If you are breastfeeding, tell your doctor if you notice diarrhea or constipation in the nursing baby.

Use Ferric Carboxymaltose (Injectafer) 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; feeling like you might pass out; wheezing, difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• increased blood pressure--dizziness, nausea, sudden warmth or redness in your face, severe headache, pounding in your neck or ears;
• low levels of phosphorus in your blood--confusion, bone pain, muscle weakness; or
• high levels of iron stored in your body--feeling weak or tired, joint pain, finger pain, stomach pain, weight loss, irregular heartbeats, fluttering in your chest.

Common side effects may include:

• nausea;
• dizziness;
• high blood pressure;
• flushing (warmth, redness, or tingly feeling); or
• low phosphorus levels.

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