Ferrous Sulphate

Pharmacologic Category

Iron Preparations

Dosing: Adult

Note: Multiple concentrations of ferrous sulfate oral liquid exist; close attention must be paid to the concentration when ordering and administering ferrous sulfate; incorrect selection or substitution of one ferrous sulfate liquid for another without proper dosage volume adjustment may result in serious over- or underdosing. 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). Doses are expressed in terms of elemental iron; ferrous sulfate contains ~20% elemental iron; ferrous sulfate exsiccated (dried) contains ~30% 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; Schrier 2019; Stoltzfus 1998; WHO 2001); may administer in up to 3 divided doses (depending on formulation). Note: Alternate-day dosing (eg, every other day or Monday, Wednesday, Friday) has been shown to result in greater absorption of iron; some experts recommend this dosing schedule in patients who can maintain adherence (Schrier 2019; Stoffel 2017).

Restless legs syndrome (off-label use): Oral: 65 mg elemental iron (325 mg ferrous sulfate) twice daily in combination with vitamin C in patients with a ferritin level ≤75 ng/mL (AAN [Winkelman 2016]).

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: Multiple concentrations of ferrous sulfate oral liquid exist; close attention must be paid to the concentration when ordering and administering ferrous sulfate; incorrect selection or substitution of one ferrous sulfate liquid for another without proper dosage volume adjustment may result in serious over- or underdosing.

Note: Doses expressed in terms of elemental iron; Ferrous sulfate contains ~20% elemental iron; ferrous sulfate exsiccated (dried) contains ~30% elemental iron

Iron deficiency anemia; prevention: Oral:

Infants ≥4 months (receiving human milk as only nutritional source or >50% as source of nutrition without iron fortified food): 1 mg iron/kg/day (Baker 2010); Note: In healthy, term infants, AAP does not recommend routine additional supplementation of iron be considered until at least 4 to 6 months of age if breastfed (full or partial) (Baker 2010; Schanler 2011)

Infants ≥6 months and Children <2 years in areas where anemia prevalence is >40%: 10 to 12.5 mg daily for 3 consecutive months in a year (WHO 2016b)

Children 2 years to <5 years in areas where anemia prevalence is >40%: 30 mg daily for 3 consecutive months in a year (WHO 2016b)

Children ≥5 to 12 years in areas where anemia prevalence is >40%: 30 to 60 mg daily for 3 consecutive months in a year (WHO 2016b)

Adolescent menstruating females (nonpregnant females of reproductive potential) in areas where anemia prevalence is >40%: 30 to 60 mg daily for 3 consecutive months in a year (WHO 2016a)

Treatment of iron deficiency: Infants, Children, and Adolescents: 3 to 6 mg/kg/day in 3 divided doses; suggested maximum daily dose: 200 mg/day (ASPEN [Corkins 2015]; Kliegman 2016)

Use: Labeled Indications

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

Use: Off-Label: Adult

Restless legs syndromeLevel of Evidence [C, G]

Data from a limited number of patients studied suggest that ferrous sulfate may be beneficial for improving symptoms of restless legs syndrome (RLS) in patients with low to low-normal serum ferritin (between 15 and 75 ng/mL) Ref.

Based on the American Academy of Neurology guidelines for the treatment of restless legs syndrome in adults, it is likely that ferrous sulfate improves RLS symptoms in patients with serum ferritin ≤ 75 ng/mL Ref. Based on the guidelines from the International Restless Legs Syndrome Study Group, the European Restless Legs Syndrome Study Group and the Restless Legs Syndrome Foundation, iron supplementation is recommended for RLS patients with low iron stores Ref. Access Full Off-Label Monograph

Level of Evidence Definitions

Level of Evidence Scale

Clinical Practice Guidelines

Iron Supplementation:

WHO, “Guideline: Daily Iron Supplementation in Adult Women and Adolescent Girls,” 2016

WHO, “Guideline: Daily Iron Supplementation in Infants and Children,” 2016

Restless Legs Syndrome:

American Academy of Neurology, “Treatment of Restless Legs Syndrome in Adults,” 2016

American Academy of Sleep Medicine, "The treatment of restless legs syndrome and periodic limb movement disorder in adults - An update for 2012: Practice parameters with an evidence-based systematic review and meta-analysis," 2012

European Federation of Neurological Societies, the European Neurological Society and the European Sleep Research Society, “European guidelines on management of restless legs syndrome: Report of a joint task force by the European Federation of Neurological Societies, the European Neurological Society and the European Sleep Research Society,” November 2012

International Restless Legs Syndrome Study Group (IRLSSG), European Restless Legs Syndrome Study Group (ERLSSG), and Restless Legs Syndrome Foundation, “Guidelines for the first-line treatment of restless legs syndrome/Willis-Ekbom disease, prevention and treatment of dopaminergic augmentation: A combined task force of the IRLSSG, ERLSSG and the RLS Foundation," May 2016

Administration: Oral

Do not chew or crush extended-release preparations; administer with water or juice on an empty stomach.

Administration: Pediatric

Oral: Do not chew or crush extended release preparations; administer with water or juice between meals for maximum absorption; may administer with food if GI upset occurs; do not administer with milk or milk products

Dietary Considerations

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

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: 0.27 mg daily (adequate intake)

7 to 12 months: 11 mg daily

1 to 3 years: 7 mg daily

4 to 8 years: 10 mg daily

9 to 13 years: 8 mg daily

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

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

≥50 years: 8 mg daily

Storage/Stability

Iron is a leading cause of fatal poisoning in children. Store out of children's reach and in child-resistant containers.

Medication Patient Education with HCAHPS Considerations

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.

Frequently reported side effects of this drug

• Diarrhea

• Constipation

• Stool discoloration

• Lack of appetite

• Abdominal cramps

• Staining of mouth, teeth, or fillings

Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:

• Black, tarry, or bloody stools

• Severe nausea

• Severe vomiting

• Severe abdominal pain

• Vomiting blood

• Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of 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 brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Medication Safety Issues

Sound-alike/look-alike issues:

Administration issues:

Contraindications

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

Warnings/Precautions

Disease-related concerns:

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

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

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).

• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer's labeling.

• Propylene glycol: Some dosage forms may contain propylene glycol; large amounts are potentially toxic and have been associated hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Zar 2007).

Other warnings/precautions:

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

Geriatric Considerations

Anemia in the elderly is often caused by “anemia of chronic disease,” a result of aging changes in the bone marrow, 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 is not secondary to iron deficiency but the inability of the reticuloendothelial system to use available iron stores. Timed release iron preparations should be avoided due to their erratic absorption. Products combined with a laxative or stool softener should not be used unless the need for the combination is demonstrated.

Warnings: Additional Pediatric Considerations

Consider all iron sources when evaluating the dose of iron, including combination products, infant formulas, and liquid nutritional supplements. Some liquid preparations may temporarily stain the teeth.

Some dosage forms may contain propylene glycol; in neonates large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Shehab 2009).

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; IOM 2001; Pavord 2012).

In general, treatment of iron deficiency or IDA in pregnancy is the same as in non-pregnant females. The majority of studies note iron therapy improves maternal hematologic parameters; however, information related to clinical outcomes in the mother and neonate is limited (Peña-Rosas 2015; Reveiz 2011; 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; Pavord 2012). Ferrous sulfate 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 (ACOG 95 2008).

Breast-Feeding Considerations

Iron is present in breast milk (IOM 2001).

Maternal iron requirements are increased in breastfeeding women (IOM 2001). Breast milk levels of iron are maintained in females with mild to moderate iron deficiency anemia (IDA), but concentrations decrease if IDA is severe (El-Farrash 2012; Kumar 2008).

Maternal use of ferrous sulfate increases the iron content of breast milk (Marin 2012). Adverse events were not observed in breastfeeding infants following maternal use of ferrous sulfate in supplemental doses (Baykan 2006). Ferrous sulfate has been evaluated in multiple studies for the treatment of postpartum IDA (Markova 2015). The World Health Organization considers ferrous salts used for anemia to be compatible with breastfeeding (WHO 2002). All postpartum women at risk of gestational anemia (regardless of breastfeeding status) may be given oral iron with or without folic acid for 6 to 12 weeks postpartum to reduce the risk of anemia (WHO 2016c).

Adverse Reactions

>10%: Gastrointestinal: Darkening of stools (≤80%; Tolkien 2015), abdominal pain (≤70%; Tolkien 2015), heartburn (1% to 68%; Tolkien 2015), nausea (≤63%; Tolkien 2015), constipation (≤39%; Tolkien 2015), flatulence (≤36%; Tolkien 2015), vomiting (≤34%; Tolkien 2015), diarrhea (≤23%; Tolkien 2015)

<1%, postmarketing, and/or case reports: Abdominal discomfort (Tolkien 2015)

Allergy and Idiosyncratic Reactions

• Iron Preparation Allergy

Toxicology

• Iron

Metabolism/Transport Effects

None known.

Drug Interactions Open Interactions

Alpha-Lipoic Acid: Iron Preparations may decrease the absorption of Alpha-Lipoic Acid. Alpha-Lipoic Acid may decrease the absorption of Iron Preparations. Risk D: 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. 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, 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. 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. Exceptions: Pamidronate; Zoledronic Acid. 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. Separating doses by several hours may minimize interaction. Iron-containing infant formulas do not appear to interact with cefdinir. 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

Histamine H2 Receptor Antagonists: May decrease the absorption of Iron Preparations. Risk C: 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. Risk D: 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. 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. Exceptions: Sodium Glycerophosphate Pentahydrate. Risk D: Consider therapy modification

Proton Pump Inhibitors: May decrease the absorption of Iron Preparations. Risk C: 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 levo-, nor-, oflox-, pefloxacin, or nalidixic acid) oral iron. Exceptions: LevoFLOXacin (Oral Inhalation). 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

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. Exceptions: Eravacycline. Risk D: 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. Risk D: Consider therapy modification

Food Interactions

Cereals, dietary fiber, tea, coffee, eggs, and milk may decrease absorption.

Test Interactions

False-positive for blood in stool by the guaiac test

Monitoring Parameters

Iron deficient anemia: 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)

Cancer and chemotherapy-induced anemia: Serum iron, total iron-binding capacity, transferrin saturation, or ferritin levels (baseline and periodic) (Rizzo 2010)

CKD associated anemia (patients not on dialysis): To monitor response to iron therapy: Hemoglobin, serum ferritin, transferrin saturation (KDIGO 2013)

Reference Range

Serum iron:

Males: 75 to 175 mcg/dL (SI: 13.4 to 31.3 micromole/L)

Females: 65 to 165 mcg/dL (SI: 11.6 to 29.5 micromole/L)

Serum ferritin (Ineck 2008):

Males: 15 to 200 ng/mL

Females: 12 to 150 ng/mL

Total iron binding capacity: 230 to 430 mcg/dL

Transferrin: 204 to 360 mg/dL

Percent transferrin saturation: 20% to 50%

Advanced Practitioners Physical Assessment/Monitoring

May cause GI irritation. Monitor GI function (observe for epigastric pain, nausea, dark stools, vomiting, stomach cramping, constipation).

Nursing Physical Assessment/Monitoring

May cause GI irritation. Monitor GI function (observe for epigastric pain, nausea, dark stools, vomiting, stomach cramping, constipation).

Dosage Forms Considerations

Ferrous sulfate contains ~20% elemental iron (ie, 325 mg ferrous sulfate is equivalent to 65 mg elemental iron); ferrous sulfate exsiccated (dried) contains ~30% elemental iron.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Elixir, Oral:

FeroSul: 220 (44 Fe) MG/5ML (473 mL [DSC]) [contains alcohol, usp, fd&c yellow #6 (sunset yellow), propylene glycol, saccharin sodium, sodium benzoate; lemon flavor]

Iron Supplement: 220 (44 Fe) MG/5ML (473 mL) [contains fd&c yellow #6 (sunset yellow), sodium benzoate]

Generic: 220 (44 Fe) MG/5ML (473 mL)

Liquid, Oral:

Generic: 220 (44 Fe) MG/5ML (473 mL [DSC])

Solution, Oral:

BProtected Pedia Iron: 75 (15 Fe) MG/ML (50 mL) [alcohol free, gluten free; contains sodium metabisulfite; citrus flavor]

Fer-In-Sol: 75 (15 Fe) MG/ML (50 mL) [contains alcohol, usp, sodium bisulfite]

Fer-Iron: 75 (15 Fe) MG/ML (50 mL [DSC]) [contains sodium metabisulfite; lemon flavor]

Iron Supplement Childrens: 75 (15 Fe) MG/ML (50 mL) [alcohol free, dye free, gluten free, lactose free; contains sodium bisulfite]

Generic: 75 (15 Fe) MG/ML (50 mL)

Syrup, Oral:

Generic: 300 (60 Fe) MG/5ML (5 mL)

Tablet, Oral:

FeroSul: 325 (65 Fe) MG [contains fd&c blue #2 aluminum lake, fd&c red #40 aluminum lake]

FeroSul: 325 (65 Fe) MG [contains fd&c red #40 aluminum lake, fd&c yellow #6 aluminum lake]

Ferro-Bob: 325 (65 Fe) MG [DSC]

Generic: 325 (65 Fe) MG

Tablet, Oral [preservative free]:

FerrouSul: 325 (65 Fe) MG [gluten free, sodium free; contains brilliant blue fcf (fd&c blue #1), fd&c blue #2 (indigotine), fd&c red #40, fd&c yellow #6 (sunset yellow)]

Generic: 325 (65 Fe) MG

Tablet Delayed Release, Oral:

Generic: 324 (65 Fe) MG, 325 (65 Fe) MG

Tablet Extended Release, Oral:

Slow Fe: 142 (45 Fe) MG [contains fd&c blue #1 aluminum lake, fd&c red #40 aluminum lake, fd&c yellow #6 aluminum lake]

Tablet Extended Release, Oral [preservative free]:

Slow Iron: 160 (50 Fe) MG [gluten free]

Generic: 140 (45 Fe) MG [DSC]

Dosage Forms: Canada

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

Liquid, Oral:

Generic: 150 (30 Fe) MG/5ML (10 mL, 250 mL, 500 mL)

Anatomic Therapeutic Chemical (ATC) Classification

• B03AA07

Generic Available (US)

Yes

Pricing: US

Elixir (Ferrous Sulfate Oral)

220 (44 Fe) mg/5 mL (per mL): $0.01 - $0.04

Liquid (Ferrous Sulfate Oral)

220 (44 Fe) mg/5 mL (per mL): $0.01

Solution (BProtected Pedia Iron Oral)

75 (15 Fe) mg/mL (per mL): $0.17

Solution (Fer-In-Sol Oral)

75 (15 Fe) mg/mL (per mL): $0.21

Solution (Ferrous Sulfate Oral)

75 (15 Fe) mg/mL (per mL): $0.09 - $0.18

Syrup (Ferrous Sulfate Oral)

300 (60 Fe) mg/5 mL (per mL): $0.81

Tablet, controlled release (Slow Fe Oral)

142 (45 Fe) mg (per each): $0.23

Tablet, EC (Ferrous Sulfate Oral)

324 (65 Fe) mg (per each): $0.06 - $0.11

325 (65 Fe) mg (per each): $0.05 - $0.82

Tablets (FeroSul Oral)

325 (65 Fe) mg (per each): $0.02

Tablets (Ferrous Sulfate Oral)

325 (65 Fe) mg (per each): $0.01 - $0.11

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.

Mechanism of Action

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

Pharmacodynamics/Kinetics

Onset of action: Hematologic response: Oral: ~3 to 10 days

Peak effect: Reticulocytosis: 5 to 10 days; hemoglobin increases 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 transferrin

Excretion: Urine, sweat, sloughing of the intestinal mucosa, and menses

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

Do not prescribe tetracyclines simultaneously with iron since GI tract absorption of both tetracycline and iron may be inhibited. Liquid preparations may temporarily stain the teeth.

Effects on Bleeding

No information available to require special precautions

Related Information

• Oral Medications That Should Not Be Crushed or Altered

Index Terms

Feosol Original; Ferric Sulfate; Ferrous Sulphate; FeSO4; Iron Sulfate; Slow FE

References

Alade SL, Brown RE, Paquet A. Polysorbate 80 and E-Ferol toxicity. Pediatrics. 1986;77(4):593-597.[PubMed 3960626]

American Academy of Pediatrics, Committee on Nutrition, “Nutritional Needs of the Premature Infant,” In: Kleinman RE, ed, Pediatric Nutrition Handbook, 6th ed, Elk Grove Village, IL: American Academy of Pediatrics; 2009, 79-112.

American College of Obstetricians and Gynecologists, “ACOG Practice Bulletin No. 95: Anemia in Pregnancy,” Obstet Gynecol, 2008, 112(1):201-7.[PubMed 18591330]

Baker RD, Greer FR; Committee on Nutrition American Academy of Pediatrics. Diagnosis and prevention of iron deficiency and iron-deficiency anemia in infants and young children (0-3 years of age). Pediatrics. 2010;126(5):1040-1050.[PubMed 20923825]

Baykan A, Yalçin SS, Yurdakök K. Does maternal iron supplementation during the lactation period affect iron status of exclusively breast-fed infants? Turk J Pediatr. 2006;48(4):301-307.[PubMed 17290563]

Carney LN, Nepa A, Cohen SS, et al. Parenteral and Enteral Nutrition Support: Determining the Best Way to Feed. In: Corkins MR, Balint J, Bobo E, et al, eds. The A.S.P.E.N Pediatric Nutrition Support Core Curriculum. American Society of Parenteral and Enteral Nutrition. Silver Spring, MD: 2010; 440-441.

Centers for Disease Control (CDC). Unusual syndrome with fatalities among premature infants: association with a new intravenous vitamin E product. MMWR Morb Mortal Wkly Rep. 1984;33(14):198-199. http://www.cdc.gov/mmwr/preview/mmwrhtml/00000319.htm[PubMed 6423951]

Centers for Disease Control and Prevention (CDC), “Recommendations to Prevent and Control Iron Deficiency in the United States,” MMWR Recomm Rep, 1998, 47(RR-3):1-29.[PubMed 9563847]

Corkins MR, Balint J, Bobo E, et al, eds. The A.S.P.E.N Pediatric Nutrition Support Core Curriculum. 2nd ed. Silver Spring: MD: American Society of Parenteral and Enteral Nutrition, 2015.

El-Farrash RA, Ismail EA, Nada AS. Cord blood iron profile and breast milk micronutrients in maternal iron deficiency anemia. Pediatr Blood Cancer. 2012;58(2):233-238. doi: 10.1002/pbc.23184.[PubMed 21548016]

Fer-In-Sol (ferrous sulfate) [prescribing information]. Evansville, IN: Mead Johnson & Company; received December 2018.

Garcia-Borreguero D, Silber MH, Winkelman JW, et al. Guidelines for the first-line treatment of restless legs syndrome/Willis-Ekbom disease, prevention and treatment of dopaminergic augmentation: a combined task force of the IRLSSG, EURLSSG, and the RLS-foundation. Sleep Med. 2016;21:1-11. doi: 10.1016/j.sleep.2016.01.017.[PubMed 27448465]

Haider BA, Olofin I, Wang M, et al, "Anaemia, Prenatal Iron Use, and Risk of Adverse Pregnancy Outcomes: Systematic Review and Meta-analysis," BMJ, 2013, 346:f3443.[PubMed 23794316]

Hershko C and Camaschella C. How I treat unexplained refractory iron deficiency anemia. Blood. 2014;123(3):326-333. doi: 10.1182/blood-2013-10-512624.[PubMed 24215034]

"Inactive" ingredients in pharmaceutical products: update (subject review). American Academy of Pediatrics Committee on Drugs. Pediatrics. 1997;99(2):268-278.[PubMed 9024461]

Ineck B, Mason BJ, Lyons W. Chapter 104. Anemias. Pharmacotherapy: A Pathophysiologic Approach. DiPiro JT, ed. New York, NY: McGraw-Hill Medical; 2008.

Institute of Medicine (IOM), “Nutrition During Lactation.” Washington, DC: National Academy Press, 1991. Available at http://www.nap.edu

IOM (Institute of Medicine), Dietary Reference Intakes for Vitamin A, Vitamin K, Arsenic, Boron, Chromium, Copper, Iodine, Iron, Manganese, Molybdenum, Nickel, Silicon, Vanadium, and Zinc, Washington, DC: National Academy Press, 2001.

Isaksson M, Jansson L. Contact allergy to Tween 80 in an inhalation suspension. Contact Dermatitis. 2002;47(5):312-313.[PubMed 12534540]

Kidney Disease: Improving Global Outcomes (KDIGO) CKD Work Group. KDIGO 2012 clinical practice guidelines for the evaluation and management of chronic kidney disease. Kidney Inter. 2013;3(suppl):1-150. Available at http://kdigo.org/clinical_practice_guidelines/pdf/KDIGO-Anemia%20GL.pdf

Kliegman RM, Stanton BMD, St. Geme J, Schor NF, eds. Nelson Textbook of Pediatrics. 20th ed. Philadelphia, PA: Saunders Elsevier; 2016.

Kumar A, Rai AK, Basu S, et al. Cord blood and breast milk iron status in maternal anemia. Pediatrics. 2008;121(3):e673-e677. doi: 10.1542/peds.2007-1986.[PubMed 18310187]

Lee CS, Lee SD, Kang SH, Park HY, Yoon IY. Comparison of the efficacies of oral iron and pramipexole for the treatment of restless legs syndrome patients with low serum ferritin. Eur J Neurol. 2014;21(2):260-266. doi: 10.1111/ene.12286.[PubMed 24267148]

Lipschitz DA, “The Anemia of Chronic Disease,” J Am Geriatr Soc, 1990, 38(11):1258-64.[PubMed 2123218]

Liu K, Kaffes AJ. Iron deficiency anaemia: a review of diagnosis, investigation and management. Eur J Gastroenterol Hepatol. 2012;24(2):109-116.[PubMed 22157204]

Lucente P, Iorizzo M, Pazzaglia M. Contact sensitivity to Tween 80 in a child. Contact Dermatitis. 2000;43(3):172.[PubMed 10985636]

Marin GH, Mestorino N, Errecalde J, et al. Personalised iron supply for prophylaxis and treatment of pregnant women as a way to ensure normal iron levels in their breast milk. J Med Life. 2012;5(1):29-32.[PubMed 22574084]

Markova V, Norgaard A, Jørgensen KJ, et al. Treatment for women with postpartum iron deficiency anaemia. Cochrane Database Syst Rev. 2015;(8):CD010861. doi: 10.1002/14651858.CD010861.pub2.[PubMed 26270434]

Marx JJM, “Normal Iron Absorption and Decreased Red Cell Iron Uptake in the Aged,” Blood, 1979, 53:204-11.[PubMed 760850]

McArdle HJ, Lang C, Hayes H, et al, "Role of the Placenta in Regulation of Fetal Iron Status," Nutr Rev, 2011, 69(Suppl 1):17-22.[PubMed 22043877]

Meyer MP, Haworth C, Meyer JH, et al, "A Comparison of Oral and Intravenous Iron Supplementation in Preterm Infants Receiving Recombinant Erythropoietin," J Pediatr, 1996, 129(2):258-63.[PubMed 8765624]

Pavord S, Myers B, Robinson S, et al; British Committee for Standards in Haematology. UK guidelines on the management of iron deficiency in pregnancy. Br J Haematol. 2012;156(5):588-600.[PubMed 22512001]

Peña-Rosas JP, De-Regil LM, Garcia-Casal MN, et al. Daily oral iron supplementation during pregnancy. Cochrane Database Syst Rev. 2015;7:CD004736. doi: 10.1002/14651858.CD004736.pub5.[PubMed 26198451]

Rao R and Georgieff MK, "Iron Therapy for Preterm Infants," Clin Perinatol, 2009, 36(1):27-42.[PubMed 19161863]

Reveiz L, Gyte GM, Cuervo LG, et al. Treatments for iron-deficiency anaemia in pregnancy. Cochrane Database Syst Rev. 2011;10:CD003094. doi: 10.1002/14651858.CD003094.pub3.[PubMed 21975735]

Rimon E, Kagansky N, Kagansky M, et al, “Are We Giving Too Much Iron? Low-Dose Iron Therapy is Effective in Octogenarians,” Am J Med, 2005, 118(10):1142-7.[PubMed 16194646]

Rizzo JD, Brouwers M, Hurley P, et al. American Society of Clinical Oncology/American Society of Hematology clinical practice guideline update on the use of epoetin and darbepoetin in adult patients with cancer. J Clin Oncol. 2010;28(33):4996-5010.[PubMed 20975064]

Schanler RJ, Feldman-Winter L, Landers S, et al. Concerns with early universal iron supplementation of breastfeeding infants. Pediatrics. 2011;127(4):e1097.[PubMed 21460097]

Schrier SL, Auerbach M. Treatment of iron deficiency anemia in adults. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed March 22, 2019.

Shehab N, Lewis CL, Streetman DD, Donn SM. Exposure to the pharmaceutical excipients benzyl alcohol and propylene glycol among critically ill neonates. Pediatr Crit Care Med. 2009;10(2):256-259.[PubMed 19188870]

Shelley WB, Talanin N, Shelley ED. Polysorbate 80 hypersensitivity. Lancet. 1995;345(8980):1312-1313.[PubMed 7746084]

Siu AL; U.S. Preventive Services Task Force. Screening for iron deficiency anemia and iron supplementation in pregnant women to improve maternal health and birth outcomes: U.S. Preventive Services Task Force Recommendation Statement. Ann Intern Med. 2015;163(7):529-36. doi: 10.7326/M15-1707.[PubMed 26344176]

Stoffel NU, Cercamondi CI, Brittenham G, et al. Iron absorption from oral iron supplements given on consecutive versus alternate days and as single morning doses versus twice-daily split dosing in iron-depleted women: two open-label, randomised controlled trials. Lancet Haematol. 2017;4(11):e524-e533. doi: 10.1016/S2352-3026(17)30182-5.[PubMed 29032957]

Stoltzfus RJ, Dreyfuess ML. Guidelines for the use of iron supplements to prevent and treat iron deficiency anemia. International Nutritional Anemia Consultative Group (INACG). 1998. Available at http://www.who.int/nutrition/publications/micronutrients/anaemia_iron_deficiency/1-57881-020-5/en/

Tolkien Z, Stecher L, Mander AP, Pereira DI, Powell JJ. Ferrous sulfate supplementation causes significant gastrointestinal side-effects in adults: a systematic review and meta-analysis. PLoS One. 2015;10(2):e0117383.[PubMed 25700159]

United Nations Children’s Fund, United Nations University, World Health Organization (WHO). Iron Deficiency Anaemia. Assessment, Prevention, and Control. A guide for programme managers. 2001. http://www.who.int/nutrition/publications/en/ida_assessment_prevention_control.pdf.

Wang J, O'Reilly B, Venkataraman R, Mysliwiec V, Mysliwiec A. Efficacy of oral iron in patients with restless legs syndrome and a low-normal ferritin: a randomized, double-blind, placebo-controlled study. Sleep Med. 2009;10(9):973-975.[PubMed 19230757]

Winkelman JW, Armstrong MJ, Allen RP, et al. Practice guideline summary: Treatment of restless legs syndrome in adults: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology. Neurology. 2016;87(24):2585-2593. doi: 10.1212/WNL.0000000000003388.[PubMed 27856776]

World Health Organization (WHO): Guideline: Daily Iron Supplementation in Adult Women and Adolescent Girls. Geneva, Switzerland: World Health Organization; 2016a. https://www.ncbi.nlm.nih.gov/books/NBK361888/.[PubMed 27195351]

World Health Organization (WHO): Guideline: Daily Iron Supplementation in Infants and Children. Geneva, Switzerland: World Health Organization; 2016b. https://www.ncbi.nlm.nih.gov/books/NBK362032/.[PubMed 27195348]

World Health Organization (WHO): Guideline: Iron supplementation in postpartum women. Geneva: World Health Organization; 2016c. http://www.who.int/nutrition/publications/micronutrients/guidelines/daily_iron_supp_postpartum_women/en/.[PubMed 27583315]

World Health Organization (WHO). Breastfeeding and maternal medication, recommendations for drugs in the eleventh WHO model list of essential drugs. 2002. Available at http://www.who.int/maternal_child_adolescent/documents/55732/en/.

Zar T, Graeber C, Perazella MA. Recognition, treatment, and prevention of propylene glycol toxicity. Semin Dial. 2007;20(3):217-219.[PubMed 17555487]

Brand Names: International

Aktiferrin (HU); Brisofer (PH); Conferon (HU); Duroferon (FI, NO, SE); Eribell (PY); Femas (JP); Feosol (PH); Feospan (AE, BF, BJ, CI, CY, EG, ET, GH, GM, GN, HK, IQ, IR, JO, KE, LB, LR, LY, MA, ML, MR, MU, MW, NE, NG, OM, SA, SC, SD, SL, SN, SY, TN, TZ, UG, YE, ZA, ZM, ZW); Feospan Z (AE); Fer-In-Sol (AR, BR, CL, CZ, GR, HK, PE, SA, VE); Ferglobin (PH); Ferlea (AR); Fero-Gradumet (BE, ES, LU, NL, PL); Feroba (KR); Feromin (BH, QA); Feromin Oral Drops (SA); Ferro Duretter (DK); Ferro-grad (IT); Ferro-Gradumet (AE, AT, AU, BG, CH, CY, EG, HU, ID, IL, IQ, IR, JO, LB, LY, OM, PT, SA, SY, YE); Ferro-Liquid (AU); Ferrogamma (DE); Ferrogard (JO); Ferrograd (GB, IE, MT); Ferrograd C (IE); Ferrogradumet (RO); Ferrophor (DE); Ferroplex ”Era” (DK); Ferrostatin (JP); Ferrosterol (UY); Fersulph (LK); Haemoprotect (DE); Hemobion (MX); Iberol Drops (LK); Inshel (TW); Irovit (BH); Kdiron (BH, QA); Kidiron (TH); Liquifer (NL); Microfer (GR); Mol-Iron (CO); Pediafer (LB); Pharmafer (LB); Plastufer (DE); Plexafer (BF, BJ, CI, ET, GH, GM, GN, KE, LR, MA, ML, MR, MU, MW, NE, NG, SC, SD, SL, SN, TN, TZ, UG, ZA, ZM, ZW); Retafer (FI, HR, MY); Slow-Fe (AE, BB, BM, BS, BZ, CY, EG, GY, IQ, IR, JM, JO, LB, LY, OM, SA, SR, SY, TT, YE); Sorbifer (HU); Tardyferon (AE, BH, CY, ES, FR, HU, IL, LU, QA); Valdefer (MX)

Last Updated 3/28/20