Note: Doses expressed as elemental iron. Ferrous fumarate contains 33% elemental iron.
Iron deficiency, prevention:
AAP recommendations:
Infants ≥4 months (exclusively fed human milk or human milk provides >50% of nutrition without iron fortified food): Oral: 1 mg elemental iron/kg/day; supplementation should be continued until sufficient iron is provided in complementary foods (Ref).
WHO recommendations:
Areas where anemia prevalence is ≥40%:
Infants ≥6 months and Children <2 years: Oral: 10 to 12.5 mg elemental iron daily for 3 consecutive months in a year (Ref).
Children 2 to <5 years: Oral: 30 mg elemental iron daily for 3 consecutive months in a year (Ref).
Children 5 to 12 years: Oral: 30 to 60 mg elemental iron daily for 3 consecutive months in a year (Ref).
Adolescent menstruating patients (nonpregnant patients of reproductive potential): Oral: 30 to 60 mg elemental iron daily for 3 consecutive months in a year (Ref).
Areas where anemia prevalence 20% to <40%: Weekly intermittent dosing:
Children 2 to <5 years: Oral: 25 mg elemental iron once weekly for 3 consecutive months, then alternating 3 months off supplementation, 3 months on supplementation (Ref).
Children 5 to 12 years: Oral: 45 mg elemental iron once weekly for 3 consecutive months, then alternating 3 months off supplementation, 3 months on supplementation (Ref).
Iron deficiency, treatment: Infants, Children, and Adolescents: Oral: Initial: 3 mg elemental iron/kg/day as a single daily dose (Ref) up to 60 to 120 mg elemental iron once daily (Ref); higher doses may be needed in select patients; dosage range: 3 to 6 mg elemental iron/kg/day in 1 to 3 divided doses; usual maximum daily dose: 150 to 200 mg elemental iron/day (Ref); once-daily administration may be preferred for ease of administration and adherence (Ref). Studies in iron-depleted adults suggest that iron absorption may be improved by less frequent dosing (alternate-day dosing, or once daily versus multiple daily doses) (Ref).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
(For additional information see "Ferrous fumarate: Drug information")
Note: Dosage expression: Dose is expressed in terms of elemental iron; ferrous fumarate contains 33% elemental iron per mg of mineral salt (eg, each 325 mg tablet contains ~106 mg elemental iron). Formulation: Enteric-coated and slow/sustained-release preparations are generally not preferred due to poor absorption (Ref). Route of administration: IV iron replacement is preferred over oral replacement in several clinical situations (eg, poor GI absorption, lack of response to or poor tolerability of oral iron, chronic kidney disease, active inflammatory bowel disease, cancer, chronic or extensive blood loss) (Ref).
Iron deficiency or iron-deficiency anemia: Oral: 29 to 150 mg of elemental iron (1 tablet) once every other day or on Monday, Wednesday, and Friday. Note: Daily dosing has been shown to result in reduced absorption but may be reasonable in some individuals to improve adherence (Ref).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
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: Local irritation
Hemochromatosis, hemolytic anemia.
Disease-related concerns:
• Gastrointestinal disease: Avoid in patients with peptic ulcer, enteritis, or ulcerative colitis.
• Porphyria: Use with caution in patients with porphyria.
Special populations:
• Blood transfusion recipients: Avoid in patients receiving frequent blood transfusions.
• Older adult: 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.
Consider all iron sources when evaluating the dose of iron, including combination products, infant formulas, and liquid nutritional supplements.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Tablet, Oral:
Ferretts: 325 mg (106 mg elemental iron) [scored]
Ferrimin 150: Elemental iron 150 mg
Hemocyte: 324 mg (106 mg elemental iron) [DSC]
Generic: 324 mg (106 mg elemental iron), 324 mg (106 mg elemental iron), Elemental iron 29 mg
Yes
Tablets (Ferrimin 150 Oral)
150 mg (per each): $0.13
Tablets (Ferrocite Oral)
324 mg (per each): $0.22
Tablets (Ferrous Fumarate Oral)
324 (106 Fe) mg (per each): $0.35
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
When treating iron deficiency anemias, treat for 3 to 4 months after hemoglobin/hematocrit return to normal in order to replenish total body stores.
Iron Salt |
Elemental Iron Content (% of salt form) |
Approximate Equivalent Doses (mg of iron salt) |
---|---|---|
Ferrous fumarate |
33 |
197 |
Ferrous gluconate |
11.6 |
560 |
Ferrous sulfate |
20 |
324 |
Ferrous sulfate, exsiccated |
30 |
217 |
Oral: Administer with water or juice prior to breakfast and/or between meals for maximum absorption (Ref); may administer with food if GI upset occurs; do not administer with milk or milk products.
Administer with a full glass of water. Do not lie down for 30 minutes after administration.
Store at 15°C to 30°C (59°F to 86°F). Iron is a leading cause of fatal poisoning in children. Store out of children's reach and in child-resistant containers.
Prevention and treatment of iron deficiency anemias (OTC: FDA approved in adults; see product-specific labeling for pediatric approval ages).
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program
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. Risk D: Consider therapy modification
Antacids: May decrease the absorption of Iron Preparations. Management: No action is likely necessary for the majority of patients who only use antacids intermittently or occasionally. Consider separating doses of oral iron and antacids in patients who require chronic use of both agents and monitor for reduced iron efficacy. Risk D: Consider therapy modification
Baloxavir Marboxil: Polyvalent Cation Containing Products may decrease the serum concentration of Baloxavir Marboxil. Risk X: Avoid combination
Bictegravir: Iron Preparations may decrease the serum concentration of Bictegravir. Management: Bictegravir can be given with iron under fed conditions. Under fasting conditions, coadministration with, or 2 hours after, iron is not recommended. In pregnancy, bictegravir can be given 2 hours before or 6 hours after iron under fasting conditions. Risk D: 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. Risk D: Consider therapy modification
Cabotegravir: Polyvalent Cation Containing Products may decrease the serum concentration of Cabotegravir. Management: Administer polyvalent cation containing products at least 2 hours before or 4 hours after oral cabotegravir. Risk D: 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. Risk D: 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. Risk D: Consider therapy modification
Dimercaprol: May enhance the nephrotoxic effect of Iron Preparations. Risk X: 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. Risk D: 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. Risk D: 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. Risk D: 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. Risk D: 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. Risk D: Consider therapy modification
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. Risk D: Consider therapy modification
Levonadifloxacin: Iron Preparations may decrease the serum concentration of Levonadifloxacin. Risk X: Avoid combination
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. Risk D: 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. Risk D: 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. Risk D: 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. Risk D: Consider therapy modification
Polyethylene Glycol-Electrolyte Solution: May decrease the absorption of Iron Preparations. Management: Give oral iron products at least 2 hours before or at least 6 hours after polyethylene glycol-electrolyte solutions that contain magnesium sulfate (Suflave brand). Other products without magnesium do not require dose separation. Risk D: Consider therapy modification
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. Risk D: 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. Risk D: Consider therapy modification
Roxadustat: Polyvalent Cation Containing Products may decrease the serum concentration of Roxadustat. Management: Administer roxadustat at least 1 hour after the administration of oral polyvalent cation containing products. Risk D: 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. Risk D: Consider therapy modification
Trientine: Polyvalent Cation Containing Products may decrease the serum concentration of Trientine. Management: Avoid concomitant use of trientine and polyvalent cations. If oral iron supplements are required, separate the administration by 2 hours. For other oral polyvalent cations, give trientine 1 hour before, or 1 to 2 hours after the polyvalent cation. Risk D: Consider therapy modification
Unithiol: May diminish the therapeutic effect of Polyvalent Cation Containing Products. Risk X: Avoid combination
Vadadustat: Iron Preparations may decrease the serum concentration of Vadadustat. Management: Administer vadadustat at least 1 hour before oral iron supplements. Risk D: Consider therapy modification
Cereals, dietary fiber, tea, coffee, eggs, and milk may decrease absorption.
May be administered with food to prevent irritation; however, not with cereals, dietary fiber, tea, coffee, eggs, or milk.
Elemental iron content of ferrous fumarate: 33%
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):
0 to 6 months: Adequate intake: 0.27 mg elemental iron/day.
7 to 12 months: RDA: 11 mg elemental iron/day.
1 to 3 years: RDA: 7 mg elemental iron/day.
4 to 8 years: RDA: 10 mg elemental iron/day.
9 to 13 years: RDA: 8 mg elemental iron/day.
14 to 18 years: RDA:
Males: 11 mg elemental iron/day.
Females: 15 mg elemental iron/day.
Pregnant patients: 27 mg elemental iron/day.
Lactating patients: 10 mg elemental iron/day.
19 to 50 years: RDA:
Males: 8 mg elemental iron/day.
Females: 18 mg elemental iron/day.
Pregnant patients: 27 mg elemental iron/day.
Lactating patients: 9 mg elemental iron/day.
≥50 years: 8 mg elemental iron/day.
Iron transfer to the fetus is regulated by the placenta (BSH [Pavord 2020]; NAS 2020).
Maternal iron requirements increase during pregnancy. Untreated iron deficiency and iron deficiency anemia (IDA) in pregnant patients are associated with adverse pregnancy outcomes, including low birth weight, preterm birth, and increased perinatal mortality (ACOG 2021; BSH [Pavord 2020]). Maternal iron deficiency is also associated with fatigue, increased risk of postpartum depression, and possibly postpartum hemorrhage (BSH [Pavord 2020]).
Oral and parenteral iron are effective at replacing iron stores in pregnant patients (ACOG 2021). Most studies note iron therapy improves maternal hematologic parameters; however, data related to clinical outcomes in the mother and neonate are limited (FIGO 2019; NAS 2020; USPSTF [Siu 2015]). Use of low-dose supplemental iron is recommended for all pregnant patients beginning in the first trimester or first prenatal visit to prevent anemia at term (ACOG 2021).
Ferrous fumarate has been evaluated in multiple studies as an iron supplement or for the treatment of IDA in pregnancy (Abdel Moety 2017; Govindappagari 2019; Karakoc 2022; Lewkowitz 2019; Peña-Rosas 2015; Reveiz 2011; Rogozińska 2021). Ferrous salts are preferred over ferric salts for the oral management of IDA in pregnancy due to better absorption and bioavailability (BSH [Pavord 2020]). Iron supplementation is recommended for 3 months once hemoglobin is within the normal range and at least 6 weeks postpartum to replenish maternal iron stores (BSH [Pavord 2020]; FIGO 2019). Iron supplementation is recommended in addition to use of prenatal vitamins in pregnant patients diagnosed with IDA (ACOG 2021). Enteric-coated and slow/sustained-release preparations may be less effective due to decreased absorption, and use should be avoided (ACOG 2021; BSH [Pavord 2020]).
Hemoglobin and hematocrit; consider additional tests such as RBC count, RBC indices, serum ferritin, transferrin saturation, total iron-binding capacity, serum iron concentration, and erythrocyte protoporphyrin concentration (CDC 1998).
Serum iron (AAP [Kleinman 2019]):
≤6 weeks: 100 to 250 mcg/dL (SI: 17.9 to 44.8 micromole/L).
7 weeks to 11 months: 40 to 100 mcg/dL (SI: 7.2 to 17.9 micromole/L).
1 to 10 years: 50 to 120 mcg/dL (SI: 9 to 21.5 micromole/L).
≥11 years:
Female: 30 to 160 mcg/dL (SI: 5.4 to 28.6 micromole/L).
Male: 50 to 170 mcg/dL (SI: 9 to 30.4 micromole/L).
Total iron binding capacity (AAP [Kleinman 2019]):
≤2 months: 59 to 175 mcg/dL (SI: 10.6 to 31.3 micromole/L).
3 months to 17 years: 250 to 400 mcg/dL (SI: 44.8 to 71.6 micromole/L).
≥18 years: 240 to 450 mcg/dL (SI: 43 to 80.6 micromole/L).
Replaces iron found in hemoglobin, myoglobin, and enzymes; allows the transportation of oxygen via hemoglobin
Onset of action: Hematologic response: Oral, parenteral iron salts: ~3 to 10 days
Peak effect: Reticulocytosis: 5 to 10 days; hemoglobin values increase within 2 to 4 weeks
Absorption: Iron is absorbed in the duodenum and upper jejunum; in persons with normal serum iron stores, 10% of an oral dose is absorbed, this is increased to 20% to 30% in persons with inadequate iron stores. Food and achlorhydria will decrease absorption.
Protein binding: To serum transferrin
Excretion: Urine, sweat, sloughing of intestinal mucosa, and menses
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