Medically reviewed by Drugs.com. Last updated on Nov 18, 2024.

Pronunciation

(FER us GLOO koe nate)

Index Terms

• Iron Gluconate

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Generic: 240 mg [elemental iron 27 mg], 324 mg [elemental iron 38 mg]

Tablet, Oral [preservative free]:

Ferate: 240 mg [elemental iron 27 mg] [corn free, dairy free, egg free, fragrance free, gluten free, no artificial flavor(s), sodium free, soy free, starch free, sugar free, wheat free, yeast free; contains fd&c blue #1 aluminum lake, fd&c yellow #6 aluminum lake]

Generic: 324 mg [elemental iron 37.5 mg]

Related/similar drugs

ferrous sulfate, ergocalciferol, folic acid, thiamine, Zinc, pyridoxine, FeroSul, Revlimid, lenalidomide, epoetin alfa

Brand Names: U.S.

• Ferate [OTC]

Pharmacologic Category

• Iron Preparations

Pharmacology

Replaces iron found in hemoglobin, myoglobin, and enzymes; allows the transportation of oxygen via hemoglobin

Onset of Action

Hematologic response: Oral: 3 to 10 days; peak reticulocytosis occurs in 5 to 10 days, and hemoglobin values increase in ∼2 to 4 weeks

Use: Labeled Indications

Iron-deficiency anemia: Prevention and treatment of iron-deficiency anemias

Contraindications

Hypersensitivity to iron salts or any component of the formulation; hemochromatosis, hemolytic anemia

Dosing: Adult

Note: Immediate release oral iron products are preferred for treatment of iron deficiency anemia; enteric coated and slow/sustained release preparations are not desired due to poor absorption (Hershko 2014; Liu 2012). Dose expressed in terms of elemental iron; ferrous gluconate contains ~12% elemental iron.

Iron-deficiency anemia, prevention in areas where anemia prevalence is ≥40% (off-label use): Oral: Menstruating women (nonpregnant females of reproductive potential): 30 to 60 mg elemental iron/day for 3 consecutive months in a year (WHO 2016a).

Iron-deficiency anemia, treatment: Oral: 65 to 200 mg elemental iron/day (Liu 2012; Stoltzfus 1998; WHO 2001); may administer in up to 3 divided doses. Note: Alternate-day dosing (eg, every other day or Monday, Wednesday, Friday) has been shown to result in greater absorption of iron (Stoffel 2017).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Geriatric

Lower doses (15 to 50 mg elemental iron/day) may have similar efficacy and less GI adverse events (eg, nausea, constipation) as compared to higher doses (eg, 150 mg elemental iron/day) (Rimon 2005).

Dosing: Pediatric

Note: Doses expressed as elemental iron. Ferrous gluconate contains ~12% elemental iron.

Iron deficiency, prevention in areas where anemia prevalence is >40%: Oral:

Infants ≥6 months and Children <2 years: 10 to 12.5 mg daily for 3 consecutive months in a year (WHO 2016b)

Children 2 years to <5 years: 30 mg daily for 3 consecutive months in a year (WHO 2016b)

Children ≥5 to 12 years: 30 to 60 mg daily for 3 consecutive months in a year (WHO 2016b)

Adolescent menstruating females (non-pregnant females of reproductive potential): 30 to 60 mg daily for 3 consecutive months in a year (WHO 2016a)

Iron deficiency, treatment: Oral: Children and Adolescents: 3 to 6 mg/kg/day in 3 divided doses; suggested maximum daily dose: 200 mg/day (ASPEN Pediatric Nutrition Support Core Curriculum [Corkins 2015]; Kliegman 2016)

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Administration

Oral: Should be administered with water or juice on an empty stomach (Liu 2012).

Dietary Considerations

May be administered with food to prevent irritation; however, not with cereals, dietary fiber, tea, coffee, eggs, or milk.

Elemental iron content of ferrous gluconate: 12%

Dietary sources of iron include beans, cereal (enriched), clams, beef, lentils, liver, oysters, shrimp, and turkey. Foods that enhance dietary absorption of iron include broccoli, grapefruit, orange juice, peppers and strawberries. Foods that decrease dietary absorption of iron include coffee, dairy products, soy products, spinach, and tea.

Dietary reference intake (IOM 2001): Note: Dose expressed in terms of elemental iron; ferrous gluconate contains ~12% elemental iron.

0 to 6 months: 0.27 mg/day (adequate intake)

7 to 12 months: 11 mg/day

1 to 3 years: 7 mg/day

4 to 8 years: 10 mg/day

9 to 13 years: 8 mg/day

14 to 18 years: Males: 11 mg/day; Females: 15 mg/day; Pregnant females: 27 mg/day; Lactating females: 10 mg/day

19 to 50 years: Males: 8 mg/day; Females: 18 mg/day; Pregnant females: 27 mg/day; Lactating females: 9 mg/day

≥50 years: 8 mg/day

Storage

Store at 20°C to 25°C (68°F to 77°F). Iron is a leading cause of fatal poisoning in children. Store out of children's reach and in child-resistant containers.

Drug Interactions

Alpha-Lipoic Acid: Iron Preparations may decrease the absorption of Alpha-Lipoic Acid. Alpha-Lipoic Acid may decrease the absorption of Iron Preparations. Management: Separate administration of alpha-lipoic acid from that of any iron-containing compounds by several hours. If alpha-lipoic acid is given 30 minutes before breakfast, then administer oral iron-containing products at lunch or dinner. Consider therapy modification

Antacids: May decrease the absorption of Iron Preparations. Management: Separate dosing of oral iron preparations and antacids as much as possible to avoid decreased efficacy of iron preparation. If coadministered with antacids, monitor for decreased therapeutic effects of iron preparations. Consider therapy modification

Baloxavir Marboxil: Polyvalent Cation Containing Products may decrease the serum concentration of Baloxavir Marboxil. Avoid combination

Bictegravir: Iron Preparations may decrease the serum concentration of Bictegravir. Management: Bictegravir, emtricitabine, and tenofovir alafenamide can be administered with iron preparations under fed conditions, but coadministration with or 2 hours after an iron preparation is not recommended under fasting conditions. Consider therapy modification

Bisphosphonate Derivatives: Polyvalent Cation Containing Products may decrease the serum concentration of Bisphosphonate Derivatives. Management: Avoid administration of oral medications containing polyvalent cations within: 2 hours before or after tiludronate/clodronate/etidronate; 60 minutes after oral ibandronate; or 30 minutes after alendronate/risedronate. Consider therapy modification

Cefdinir: Iron Preparations may decrease the serum concentration of Cefdinir. Red-appearing, non-bloody stools may also develop due to the formation of an insoluble iron-cefdinir complex. Management: Avoid concurrent cefdinir and oral iron when possible. Separate doses by at least 2 hours if combined. Iron-containing infant formulas do not appear alter cefdinir pharmacokinetics, but red-appearing, non-bloody stools may develop when combined. Consider therapy modification

Deferiprone: Polyvalent Cation Containing Products may decrease the serum concentration of Deferiprone. Management: Separate administration of deferiprone and oral medications or supplements that contain polyvalent cations by at least 4 hours. Consider therapy modification

Dimercaprol: May enhance the nephrotoxic effect of Iron Preparations. Avoid combination

Dolutegravir: Iron Preparations may decrease the serum concentration of Dolutegravir. Management: Administer dolutegravir at least 2 hours before or 6 hours after oral iron. Administer dolutegravir/rilpivirine at least 4 hours before or 6 hours after oral iron. Alternatively, dolutegravir and oral iron can be taken together with food. Consider therapy modification

Eltrombopag: Polyvalent Cation Containing Products may decrease the serum concentration of Eltrombopag. Management: Administer eltrombopag at least 2 hours before or 4 hours after oral administration of any polyvalent cation containing product. Consider therapy modification

Elvitegravir: Polyvalent Cation Containing Products may decrease the serum concentration of Elvitegravir. Management: Administer elvitegravir 2 hours before or 6 hours after the administration of polyvalent cation containing products. Consider therapy modification

Entacapone: Iron Preparations may decrease the serum concentration of Entacapone. Management: Consider separating doses of the agents by 2 or more hours to minimize the effects of this interaction. Monitor for decreased therapeutic effects of levodopa during concomitant therapy, particularly if doses cannot be separated. Consider therapy modification

Ferric Hydroxide Polymaltose Complex: May decrease the serum concentration of Iron Preparations. Specifically, the absorption of oral iron salts may be reduced. Management: Do not administer intravenous (IV) ferric hydroxide polymaltose complex with other oral iron preparations. Therapy with oral iron preparations should begin 1 week after the last dose of IV ferric hydroxide polymaltose complex. Consider therapy modification

Histamine H2 Receptor Antagonists: May decrease the absorption of Iron Preparations. Monitor therapy

Levodopa: Iron Preparations may decrease the serum concentration of Levodopa. Only applies to oral iron preparations. Management: Consider separating doses of the agents by 2 or more hours to minimize the effects of this interaction. Monitor for decreased therapeutic effects of levodopa during concomitant therapy, particularly if doses cannot be separated. Consider therapy modification

Levothyroxine: Iron Preparations may decrease the serum concentration of Levothyroxine. Management: Separate oral administration of iron preparations and levothyroxine by at least 4 hours. Separation of doses is not required with parenterally administered iron preparations or levothyroxine. Consider therapy modification

Methyldopa: Iron Preparations may decrease the serum concentration of Methyldopa. Management: Consider separating doses of methyldopa and orally administered iron preparation by 2 or more hours. Monitor for decreased efficacy of methyldopa if an oral iron preparation is initiated/dose increase, or increased efficacy if discontinued/dose decreased. Consider therapy modification

PenicillAMINE: Polyvalent Cation Containing Products may decrease the serum concentration of PenicillAMINE. Management: Separate the administration of penicillamine and oral polyvalent cation containing products by at least 1 hour. Consider therapy modification

Phosphate Supplements: Iron Preparations may decrease the absorption of Phosphate Supplements. Management: Administer oral phosphate supplements as far apart from the administration of an oral iron preparation as possible to minimize the significance of this interaction. Consider therapy modification

Proton Pump Inhibitors: May decrease the absorption of Iron Preparations. Monitor therapy

Quinolones: Iron Preparations may decrease the serum concentration of Quinolones. Management: Give oral quinolones at least several hours before (4 h for moxi- and sparfloxacin, 2 h for others) or after (8 h for moxi-, 6 h for cipro/dela-, 4 h for lome-, 3 h for gemi-, and 2 h for enox-, levo-, nor-, oflox-, peflox, or nalidixic acid) oral iron. Consider therapy modification

Raltegravir: Polyvalent Cation Containing Products may decrease the serum concentration of Raltegravir. Management: Administer raltegravir 2 hours before or 6 hours after administration of the polyvalent cations. Dose separation may not adequately minimize the significance of this interaction. Consider therapy modification

Tetracyclines: May decrease the absorption of Iron Preparations. Iron Preparations may decrease the serum concentration of Tetracyclines. Management: Avoid this combination if possible. Administer oral iron preparations at least 2 hours before, or 4 hours after, the dose of the oral tetracycline derivative. Monitor for decreased therapeutic effect of oral tetracycline derivatives. Consider therapy modification

Trientine: Polyvalent Cation Containing Products may decrease the serum concentration of Trientine. Management: Avoid concomitant administration of trientine and oral products that contain polyvalent cations. If oral iron supplements are required, separate the administration by 2 hours. If other oral polyvalent cations are needed, separate administration by 1 hour. Consider therapy modification

Test Interactions

False-positive for blood in stool by the guaiac test

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

Frequency not defined.

>10%: Gastrointestinal: Constipation, darkening of stools, nausea, stomach cramps, vomiting

1% to 10%:

Gastrointestinal: Dental discoloration, diarrhea, heartburn

Genitourinary: Urine discoloration

<1%, postmarketing, and/or case reports: Contact dermatitis

Warnings/Precautions

Disease-related concerns:

• Gastrointestinal disease: Avoid in patients with peptic ulcer, enteritis, or ulcerative colitis.

Special populations:

• Blood transfusion recipients: Avoid in patients receiving frequent blood transfusions.

• Elderly: Anemia in the elderly is often caused by “anemia of chronic disease” or associated with inflammation rather than blood loss. Iron stores are usually normal or increased, with a serum ferritin >50 ng/mL and a decreased total iron binding capacity. Hence, the “anemia of chronic disease” is not secondary to iron deficiency but the inability of the reticuloendothelial system to reclaim available iron stores.

• Pediatric: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6 years of age. Keep this product out of the reach of children. In case of accidental overdose call the poison control center immediately.

• Premature infants: Avoid use in premature infants until the vitamin E stores, deficient at birth, are replenished.

Dosage form specific issues:

• Oral iron formulations: Immediate release oral iron products are preferred for treatment of iron deficiency anemia; enteric coated and slow/sustained release preparations are not desired due to poor absorption (Hershko 2014; Liu 2012).

Other warnings/precautions:

• Duration of therapy: Administration of iron for >6 months should be avoided except in patients with continuous bleeding or menorrhagia.

Monitoring Parameters

Serum iron, total iron binding capacity, reticulocyte count, hemoglobin

Pregnancy Considerations

Maternal iron requirements increase during pregnancy. Adequate iron concentrations to the fetus can be maintained regardless of maternal iron status, except in severe cases of anemia (IOM 2001). Untreated iron deficiency and iron deficiency anemia (IDA) in a pregnant female may be associated with adverse events, including low birth weight, preterm birth, or increased perinatal mortality (ACOG 95 2008; BSH [Pavord 2020]; IOM 2001).

In general, treatment of iron deficiency or IDA in pregnancy is the same as in nonpregnant females (USPSTF [Siu 2015]). Ferrous salts are preferred for oral management of IDA in pregnancy (BSH [Pavord 2020]). Continued supplementation is recommended for 3 months once Hb is within the normal range, and for at least 6 months postpartum to replenish maternal iron stores (BSH [Pavord 2020]; FIGO 2019). The majority of studies note iron therapy improves maternal hematologic parameters; however, information related to clinical outcomes in the mother and neonate is limited (FIGO 2019; Peña-Rosas 2015; Reveiz 2011; USPSTF [Siu 2015]). Oral preparations are generally sufficient; however, parenteral iron therapy may be used in females who cannot tolerate or will not take oral iron, in cases of severe iron deficiency, or when malabsorption is present (ACOG 95 2008; BSH [Pavord 2020]). Ferrous gluconate has been evaluated in multiple studies as an iron supplement or for the treatment of IDA in pregnancy (Peña-Rosas 2015; Reveiz 2011). Enteric-coated and slow/sustained-release preparations may be less effective and use should be avoided (ACOG 95 2008; BSH [Pavord 2020]).

Patient Education

What is this drug used for?

• It is used to aid diet needs.

• It is used to treat or prevent low iron in the body.

• It may be given to you for other reasons. Talk with the doctor.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Upset stomach

• Throwing up

• Stomach pain

• Diarrhea

• Constipation

• Change in color of stool to green

• Not hungry

• Stomach cramps

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Black, tarry, or bloody stools

• Throwing up blood

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

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