Ferrous fumarate

Ferrous fumarate

What is ferrous fumarate?

Ferrous fumarate is used to treat iron deficiency anemia (a lack of red blood cells caused by too little iron in the body).

Ferrous fumarate may also be used for purposes not listed in this medication guide.

Side effects of ferrous fumarate

If necessary, get emergency medical helpSigns of an allergic reaction:hives; difficulty breathing; Swelling of your face, lips, tongue, or throat.

Ferrous fumarate can cause serious side effects. Call your doctor immediately if you have:

• severe stomach pain;

• severe nausea or vomiting;

• Coughing up blood or vomit that looks like coffee grounds;

• blood or tarry stools; or

• bright red blood in the stool.

Common side effects of ferrous fumarate may include:

• constipation, diarrhea;

• abdominal cramps;

• loss of appetite; or

• black or dark stool or urine.

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

Warnings

You should not use ferrous fumarate if you have iron overload syndrome or other red blood cell disorders.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if a child accidentally ingests it.A ferrous fumarate overdose can be fatal to a child under 6 years old.

Before you take this medicine

You should not use ferrous fumarate if you are allergic to it or if you have:

• iron overload syndrome; or

• hemolytic anemia.

Ask a doctor or pharmacist whether it is safe to use ferrous fumarate if you have ever had:

• a stomach ulcer;

• an intestinal disease such as ulcerative colitis; or

• Blood transfusions.

Tell your doctor if you are pregnant or breastfeeding. Your dosage needs may be different during pregnancy or breastfeeding.

Do not give ferrous fumarate to a child without the advice of a doctor.

How should I take ferrous fumarate?

Use exactly as directed on the label or as prescribed by your doctor.

Take ferrous fumarate on an empty stomach, at least 1 hour before or 2 hours after a meal.

Take it with food if ferrous fumarate causes stomach upset.

Frequent medical examinations may be required.

You may need to follow a special diet while using ferrous fumarate. Follow all instructions from your doctor or nutritionist. Learn about the foods you should eat to ensure you're getting enough iron from both your diet and your medications.

Do not take this medicine for more than 6 months without medical advice.

Store at room temperature, protected from moisture, heat and light.

Ferrous fumarate dosage information

Usual adult dosage for iron deficiency anemia:

Initial dose: 360 mg/day ferrous fumarate (120 mg/day elemental iron) for 3 months
-Administer in multiple doses (1 to 3 times daily)

Usual adult dose for anemia associated with chronic kidney failure:

Initial dose: 600 mg/day ferrous fumarate (200 mg/day elemental iron) orally in multiple doses (1 to 3 times daily)

Comments:
-If goals are not met with oral iron after 1 to 3 months, consider intravenous iron supplementation.
-Smaller daily doses may be better tolerated.

Usual adult dosage for vitamin/mineral supplementation:

Initial dose: 1 tablet orally once daily

or

Initial dose: 18 to 54 mg/day ferrous fumarate (6 to 18 mg/day elemental iron) orally, in multiple doses (1 to 3 times daily)

51 years and older: 15 to 24 mg/day ferrous fumarate (5 to 8 mg/day elemental) orally, in multiple doses (1 to 3 times daily)

Usual Pediatric Dose for Iron Deficiency Anemia:

0 to 5 years: 9 to 18 mg/kg/day ferrous fumarate (3 to 6 mg/kg/day elemental iron)
5 to 12 years: 180 mg ferrous fumarate (60 mg/day elemental)
12-18 years, male: 360 mg ferrous fumarate (120 mg elemental) daily orally
12-18 years female: 180 to 360 mg/day ferrous fumarate (60 to 120 mg/day elemental)
-Administer in multiple doses (1 to 3 times daily)

Usual Pediatric Vitamin/Mineral Supplement Dose:

Preterm infant (less than 37 weeks of gestation), 0 to 12 months: 6 mg/kg/day ferrous fumarate (2 mg/kg/day elemental iron)
0 to 6 months: 0.6 to 0.81 mg/day ferrous fumarate (0.2 to 0.27 mg/day elemental)
7 to 12 months: 21 to 33 mg/day ferrous fumarate (7 to 11 mg/day elemental)
1 to 3 years: 12 to 27 mg/day ferrous fumarate (4 to 9 mg/day elemental)
4 to 8 years: 12 to 30 mg/day ferrous fumarate (4 to 10 mg/day elemental)
9 to 13 years: 18 to 24 mg/day ferrous fumarate (6 to 8 mg/day elemental)
14 to 18 years: 24 to 45 mg/day ferrous fumarate (8 to 15 mg/day elemental)
-Administer in multiple doses (1 to 3 times daily)

or

Tablets (324 to 325 mg ferrous fumarate, 106 mg elemental iron)
12 years and older: 1 tablet orally once daily

What happens if I miss a dose?

Take the medicine as soon as possible, but skip the missed dose if it is almost time for the next dose. Do not take two doses at the same time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help hotline at 1-800-222-1222 if you think you have used too much ferrous fumarate or if a child accidentally swallowed it.A ferrous fumarate overdose can be fatal to a child under 6 years old.

Symptoms of overdose may include stomach pain, nausea, vomiting, diarrhea, cold or clammy skin, blue lips, and loss of consciousness.

What should I avoid when taking ferrous fumarate?

Avoid eating high-fiber foods at the same time as you take your ferrous fumarate dose. Foods rich in fiber include whole grains, raw vegetables and bran.

Avoid milk or other dairy products at least 2 hours before or 2 hours after taking ferrous fumarate.

Do not take any vitamin or mineral supplements that your doctor has not prescribed or recommended.

What other drugs affect ferrous fumarate?

Some medications can affect the blood levels of other medications you are taking, which may increase side effects or make the medications less effective. Ask your doctor how much time should elapse between your ferrous fumarate dose and other medicines you are taking, especially:

• an antacid or stomach acid reducer;

• an antibiotic;

• thyroid medications;

• Medicines for the treatment of Parkinson's disease;

• osteoporosis medications; or

• Anti-seizure medication.

Other medications can affect ferrous fumarate, including prescription and over-the-counter medications, vitamins, and herbal products. Tell your doctor about all medications you are currently taking and any medications you are taking or stopping.

More information

Remember to keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medicine only for the prescribed indication.