Ferrous fumarate

Ferrous fumarate is a form of iron. You usually get iron from the foods you eat. In your body, iron becomes part of your hemoglobin (HEEM o glo bin) and myoglobin (MY o glo bin). Hemoglobin carries oxygen through your blood to your tissues and organs. Myoglobin helps your muscle cells store oxygen.

Ferrous fumarate is used to treat iron deficiency anemia (a condition where there aren’t enough red blood cells because of low iron levels in the body).

Ferrous fumarate may also be used for reasons not mentioned in this medication guide.

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 with food if ferrous fumarate upsets your stomach.

You may need frequent medical tests.

You may need to follow a special diet while using ferrous fumarate. Follow all instructions from your doctor or dietitian. Learn about the foods to eat to ensure you get enough iron from both your diet and your medication.

Do not take this medicine for longer than 6 months without a doctor's advice.

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

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

Seek emergency medical help or call the Poison Help line at 1-800-222-1222 if a child has accidentally swallowed it. An overdose of ferrous fumarate can be fatal to a child younger than 6 years old.

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 if ferrous fumarate is safe to use if you have ever had:

• a stomach ulcer;
• an intestinal disorder such as ulcerative colitis; or
• blood transfusions.

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

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

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

Ferrous fumarate may 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 your stools.

Common side effects of ferrous fumarate may include:

• constipation, diarrhea;
• stomach cramps;
• loss of appetite; or
• black or dark-colored stools 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 may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Iron Deficiency Anemia:

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

Usual Adult Dose for Anemia Associated with Chronic Renal Failure:

Initial dose: 600 mg/day ferrous fumarate (200 mg/day elemental iron) orally in divided doses (1 to 3 times daily)Comments:-If goals are not met with oral iron after 1 to 3 months, consider IV iron supplementation.-Smaller daily doses may be better tolerated.

Usual Adult Dose for Vitamin/Mineral Supplementation:

Initial dose: 1 tablet orally once a dayor Initial dose: 18 to 54 mg/day ferrous fumarate (6 to 18 mg/day elemental iron) orally, in divided doses (1 to 3 times daily)51 and over: 15 to 24 mg/day ferrous fumarate (5 to 8 mg/day elemental) orally, in divided 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) orally daily12-18 years female: 180 to 360 mg/day ferrous fumarate (60 to 120 mg/day elemental)-Give in divided doses (1 to 3 times daily)

Usual Pediatric Dose for Vitamin/Mineral Supplementation:

Preterm infant (less than 37 weeks 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)-Give in divided 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 a day

Take the medicine as soon as you remember, but skip the missed dose if it’s nearly time for your next dose. Do not take two doses at the same time.

Seek emergency medical help or call the Poison Help line at 1-800-222-1222 if you think you have taken too much ferrous fumarate, or if a child has accidentally swallowed it. An overdose of ferrous fumarate can be fatal to a child younger than 6 years old.

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

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

Avoid milk or other dairy products for at least 2 hours before or 2 hours after you take ferrous fumarate.

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

Some medications can change the levels of other drugs in your blood, which can increase side effects or make the medications work less effectively. Ask your doctor how long you should wait between taking your ferrous fumarate dose and other medicines you use, especially:

• an antacid or stomach acid reducer;
• an antibiotic;
• thyroid medication;
• medicine to treat Parkinson's disease;
• osteoporosis medication; or
• seizure medication.

Other medications may also affect ferrous fumarate, including both prescription and over-the-counter medicines, vitamins, and herbal products. Inform your doctor about all the medicines you are currently taking and any new medicine you start or stop using.