ferrous gluconate

Ferrous gluconate is an oral iron product used to prevent and treat iron deficiency anemia. Ferrous gluconate is taken as a supplemental source of iron when dietary sources are inadequate to maintain adequate iron levels. Dietary sources of iron include lean meat, poultry, seafood, kidney beans, lentils, spinach, peas, nuts and certain fortified foods. Ferrous gluconate is available over the counter (OTC) in the U.S.

Iron is an important component of hemoglobin, the protein in red blood cells that delivers oxygen to all the tissues, and myoglobin, the muscle protein that stores oxygen and releases it to the muscle cells when oxygen saturation drops. In addition to oxygen transport and storage, iron is essential for many cellular processes, synthesis of enzymes and hormones, DNA synthesis and repair, electron transport and energy metabolism.

In general, women relatively need more iron intake because of loss of iron with menstrual bleeding, and pregnant women often need iron supplements because their requirement goes up during pregnancy and breastfeeding. Iron overdose can be extremely toxic and particularly lethal for children below 6 years of age.

• Do not take ferrous gluconate if you are hypersensitive to any component of the formulation.
• Do not take ferrous gluconate if you have disorders that cause iron build up in the body such as:
  • Hemochromatosis,
  • Hemosiderosis
• Do not take ferrous gluconate if you have anemia due to:
  • Premature destruction of red blood cells (hemolysis)
  • Any reason other than iron deficiency
• Avoid taking iron supplements if you have peptic ulcer, colon inflammation (enteritis) or ulcerative colitis.
• Absorption of iron from oral products may be variable in different individuals, and can be incomplete.
• Avoid taking ferrous gluconate if you receive frequent blood transfusions.
• Do not administer ferrous gluconate to premature infants with vitamin E deficiency. It may cause hemolysis and hemolytic anemia.
• Use iron supplements with caution in elderly persons. Elderly individuals usually have adequate iron stores, but may have anemia of chronic disease because of inability to use available iron stores.

Common side effects of ferrous gluconate include:

• Nausea
• Vomiting
• Gastrointestinal irritation
• Stomach cramping
• Heartburn
• Diarrhea
• Constipation
• Dark color stools
• Discoloration of urine
• Staining of teeth

Call your doctor immediately if you experience any of the following symptoms or serious side effects while using this drug:

• Serious heart symptoms include fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness;
• Severe headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady;
• Severe nervous system reaction with very stiff muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, and feeling like you might pass out; or
• Serious eye symptoms include blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.

This is not a complete list of all side effects or adverse reactions that may occur from the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may also report side effects or health problems to the FDA at 1-800-FDA-1088.

Tablet (Ferate, generic)

• 240 mg (27 mg elemental iron)
• 324 mg (38 mg elemental iron)

Adult:

Iron Deficiency Anemia

• Treatment: 60 mg elemental Fe orally once every 6-12 hours
• Prophylaxis: 60 mg elemental Fe orally once daily

Recommended Daily Intake

• Men: 8 mg elemental Fe orally once daily
• Women: 18 mg elemental Fe orally once daily
• Pregnant women: 27 mg elemental Fe orally once daily
• Lactating women: 9 mg elemental Fe orally once daily

Geriatric:

• Lower doses of 10-50 mg elemental iron/day recommended may cause fewer gastrointestinal (GI) adverse events

Pediatric:

Iron Deficiency Anemia

• Treatment: 3-6 mg elemental Fe/kg/day orally  
• Prophylaxis: 1-2 mg elemental Fe/kg/day orally; not to exceed 15 mg/day

Recommended Daily Intake

• Children 0-6 months: 0.27 mg elemental Fe orally once daily
• Children 7-12 months: 11 mg elemental Fe orally once daily
• Children 1-3 years: 7 mg elemental Fe orally once daily
• Children 4-8 years: 10 mg elemental Fe orally once daily
• Children 9-13 years: 8 mg elemental Fe orally once daily
• Children 14-18 years
  • Males: 11 mg elemental Fe orally once daily
  • Females: 15 mg elemental Fe orally once daily
  • Pregnant females: 27 mg elemental Fe orally once daily
  • Lactating females: 10 mg elemental Fe orally once daily

Overdose

• The symptoms of acute iron overdose include abdominal pain, nausea, vomiting, diarrhea, low blood pressure (hypotension), rapid heart rate (tachycardia), excessive acidity of body fluids (metabolic acidosis), liver damage, jaundice, low blood sugar (hypoglycemia), kidney failure, fluid in lungs (pulmonary edema), lethargy, shock and coma.
• Iron overdose can be lethal for children younger than 6 years of age.
• Overdose may be treated with symptomatic and supportive care.

Inform your doctor of all medications you are currently taking, who can advise you on any possible drug interactions. Never begin taking, suddenly discontinue, or change the dosage of any medication without your doctor’s recommendation.

• Ferrous gluconate has no listed severe interaction with other drugs.
• Serious interactions of ferrous gluconate include:
  • baloxavir marboxil
  • demeclocycline
  • doxycycline
  • eltrombopag
  • fleroxacin
  • gemifloxacin
  • levofloxacin
  • minocycline
  • moxifloxacin
  • mycophenolate
  • ofloxacin
  • oxytetracycline
  • tetracycline
• Ferrous gluconate has moderate interactions with at least 38 different drugs.
• Mild interactions of ferrous gluconate include:
  • acetohydroxamic acid
  • calcium acetate
  • calcium carbonate
  • calcium chloride
  • calcium citrate
  • calcium gluconate
  • carbidopa
  • didanosine
  • gymnema
  • manganese
  • vitamin E

The drug interactions listed above are not all of the possible interactions or adverse effects. For more information on drug interactions, visit the RxList Drug Interaction Checker.

It is important to always tell your doctor, pharmacist, or health care provider of all prescription and over-the-counter medications you use, as well as the dosage for each, and keep a list of the information. Check with your doctor or health care provider if you have any questions about the medication.

• Iron requirement increases during pregnancy, and untreated iron deficiency and anemia can increase the risk for low birth weight, preterm birth, or newborn mortality.
• Supplemental ferrous gluconate intake in recommended doses during pregnancy is acceptable in order to prevent iron deficiency.
• Iron is present in breast milk and is considered safe for breastfeeding. Iron is a beneficial mineral nutrient for the breastfeeding baby and breastmilk provides enough iron to meet the infant’s iron requirement. Iron content in breastmilk is typically not influenced by the mother’s iron status.
• Do not take any OTC products, including ferrous gluconate, without first checking with your healthcare provider if you are pregnant or breastfeeding.

• Take ferrous gluconate exactly as per instructions. Do not exceed recommended dosages. Iron overdose can result in severe consequences.
• Store ferrous gluconate safely out of reach of children, in children-resistant containers. Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children below 6 years of age.
• In case of overdose, seek immediate medical help or contact Poison Control.