Ferric citrate contains iron that binds to the phosphates you take in through food, which helps your body absorb fewer phosphates. This can lower the amount of phosphorus (a mineral) in your blood.

Ferric citrate is used to control phosphorus levels in adults with chronic kidney disease who are on dialysis.

Ferric citrate is also used to treat iron deficiency anemia in adults with chronic kidney disease who are not on dialysis.

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

Keep ferric citrate out of the reach of children. An accidental overdose of ferric citrate by a child can be fatal.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Ferric citrate works best if you take it with meals.

Do not crush or chew a ferric citrate tablet. The pill may discolor your teeth or mouth.

Ferric citrate contains iron, which is absorbed and stored by your body while you are taking ferric citrate. To make sure your body is not storing too much iron, you will need frequent blood tests to check your iron levels.

You may need to follow a special diet while using ferric citrate. Follow all instructions of your doctor or dietitian. Learn about the foods to eat or avoid to help control your condition.

Store at room temperature away from moisture and heat.

Keep the bottle tightly closed and out of the reach of children. Accidental iron overdose is a leading cause of death in children younger than 6 years old.

Usual Adult Dose for Hyperphosphatemia of Renal Failure:

Each tablet contains ferric iron 210 mg equivalent to ferric citrate 1 g

Initial dose: 2 tablets orally 3 times a day with meals
-Adjust dose in increments/decrements of 1 to 2 tablets per day per week or longer intervals to maintain serum phosphorous at target levels
Average dose: 8 to 9 tablets per day
Maximum dose: 12 tablets per day

Comments:
-Monitor serum phosphorous and titrate dose accordingly.
-Tablets should not be chewed or crushed because it may cause discoloration of mouth and teeth.

Use: Control of serum phosphorous levels in patients with chronic kidney disease on dialysis.

Usual Adult Dose for Anemia Associated with Chronic Renal Failure:

Each tablet contains ferric iron 210 mg equivalent to ferric citrate 1 g

Initial dose: 1 tablet orally 3 times a day with meals
-Adjust dose as needed to achieve and maintain target hemoglobin levels
Average dose: 5 tablets per day
Maximum dose: 12 tablets per day

Comments:
-Tablets should not be chewed or crushed because it may cause discoloration of mouth and teeth.

Use: Treatment of iron deficiency anemia in patients with chronic kidney disease not on dialysis.

Usual Adult Dose for Iron Deficiency Anemia:

Each tablet contains ferric iron 210 mg equivalent to ferric citrate 1 g

Initial dose: 1 tablet orally 3 times a day with meals
-Adjust dose as needed to achieve and maintain target hemoglobin levels
Average dose: 5 tablets per day
Maximum dose: 12 tablets per day

Comments:
-Tablets should not be chewed or crushed because it may cause discoloration of mouth and teeth.

Use: Treatment of iron deficiency anemia in patients with chronic kidney disease not on dialysis.

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

• iron overload disorder (hemochromatosis).

Tell your doctor if you have ever had:

• liver disease;

• a stomach or intestinal disorder;

• stomach bleeding; or

• stomach or intestinal surgery.

It is not known whether this medicine will harm an unborn baby. An overdose of iron can cause miscarriage, birth defects, or pregnancy-related diabetes. Tell your doctor if you are pregnant or plan to become pregnant.

It may not be safe to breast-feed a baby while you are using this medicine. Ask your doctor about any risks.

Your dose needs may be different during pregnancy or while you are nursing.

This medicine is not approved for use by anyone younger than 18 years old.

Take the medicine (with food) as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of iron can be fatal to a child who accidentally consumes ferric citrate.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

Do not take a vitamin or mineral supplement that contains iron while you are taking ferric citrate, unless your doctor tells you to.

Avoid taking other medicines at the same time of day with ferric citrate.

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

Ferric citrate may cause serious side effects. Call your doctor at once if you have:

• severe stomach problems (pain, vomiting, diarrhea); or

• high potassium--nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement.

Common side effects of ferric citrate may include:

• diarrhea, constipation;

• darker color in your bowel movements;

• nausea, vomiting, stomach pain; or

• cough.

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.

If you take any of the following medicines, take them separately from your dose of ferric citrate:

• An antibiotic called doxycycline: take ferric citrate at least 1 hour before you take ferric citrate.

• An antibiotic called ciprofloxacin: take it at least 2 hours before or 2 hours after you take ferric citrate.

Other drugs may affect ferric citrate, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to ferric citrate.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.