Retafer

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Retafer

Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Retafer

Quick Facts

Feature Detail
Active Ingredient Ferrous sulfate (Iron) and Ascorbic Acid (Vitamin C)
Therapeutic Class Iron supplement, Anti-anemic agent
Primary Use Prevention and treatment of iron deficiency anemia
Formulation Prolonged-release tablet (depot tablet)

Retafer is a medication used to treat and prevent conditions related to iron deficiency, particularly iron deficiency anemia. Its active ingredients are ferrous sulfate (a form of iron) and ascorbic acid (Vitamin C). Iron is an essential mineral required by the body to produce red blood cells and for the proper function of hemoglobin, which carries oxygen from the lungs to the rest of the body.

Iron deficiency is a condition where the body does not have enough iron to produce sufficient healthy red blood cells, which can lead to symptoms like fatigue, weakness, and shortness of breath. Ferrous sulfate, the key component, works by replenishing the body's iron stores, thereby aiding in the formation of new red blood cells. The inclusion of ascorbic acid is intended to enhance the intestinal absorption of iron.

Retafer is often formulated as a prolonged-release or depot tablet. This design allows the iron to be released slowly in the digestive tract, a feature intended to potentially minimize gastrointestinal side effects sometimes associated with immediate-release iron supplements.

What side effects are possible with Retafer?

Possible Side Effects and Safety Information

The safety characteristics of this iron supplement are officially categorized primarily by gastrointestinal adverse reactions and specific regulatory constraints.


Adverse Reaction Scope

Classification Adverse Reactions (Official Documentation)
Common (ge 1/100) Nausea, constipation, diarrhea, and abdominal discomfort.
Expected Darkening or black discoloration of the stools (a normal physiological change).
Rare Hypersensitivity reactions and gastrointestinal ulceration, including esophageal stricture.

Adverse reactions are mainly classified under the System-Organ-Class of Gastrointestinal disorders.


Serious Safety Considerations and Constraints

The official label highlights the severe, life-threatening risk of Acute Iron Poisoning, which is a leading cause of fatal poisoning in children under six years old. The product is contraindicated (should not be used) in individuals with known conditions of iron overload, such as hemochromatosis or hemosiderosis, or in cases of anemia not caused by iron deficiency.

Safety documentation also indicates that gastrointestinal side effects are often more frequently observed at the start of treatment and may lessen with continued use.


Connection to the Overall Safety Profile

The regulatory safety profile is structured by the high frequency of minor, expected digestive side effects and the critical, though rare, safety constraint regarding the life-threatening toxicity of iron in overdose. The explicit contraindications define the strict medical conditions for which the medicine is officially intended.

Overdose and Emergency Response

Overdose and When to Seek Help

The information regarding Retafer overdose is derived from regulatory documents for its active ingredient, Iron (III)-Hydroxide Polymaltose Complex (IPC). This compound has a distinct overdose profile compared to simple iron salts.

Overdose Component Official Regulatory Statement (IPC)
Documented Presentations No intoxication or iron overload reported to date following overdosage.
Physiological Risk Iron is not present in the gastrointestinal tract as free iron and is not taken up by the body by passive diffusion.
Severity Classification Overdosage has not resulted in intoxication or iron overload.

When Emergency Medical Help Is Required

While the specific iron complex has a low intrinsic risk of acute toxicity, all iron preparations carry a general caution that overdose may be fatal, especially in children.

If you, or particularly a child, have taken more than the prescribed amount, or if an overdose of any size is suspected, you must promptly consult a physician or contact a poison control center/emergency services immediately. Do not wait for symptoms to appear, as the potential for severe toxicity, especially with large amounts of elemental iron, always necessitates immediate professional assessment. Medical management would focus on supportive and symptomatic measures, as specific interventions are generally not required for this complex type of iron, according to regulatory data.

Therapeutic Uses of Retafer

Retafer, which contains an iron salt, is commonly used to help with iron deficiency anemia (IDA) and to prevent this condition when dietary intake is insufficient. This is the main therapeutic domain for oral iron supplements.

As an iron replacement, the product is applied in addressing the deficiency that may affect the body's ability to maintain healthy iron levels. It contributes to easing the overall symptom load associated with IDA by providing supportive relief during periods of heightened symptoms. The product may assist with the management of symptoms related to physical discomfort and symptoms that interfere with daily functioning, such as fatigue, weakness, and shortness of breath. This makes it relevant in conditions characterized by periods of heightened symptoms.

Common clinical scenarios for its use involve recurrent or episodic manifestations of the deficiency, and it is commonly used in settings marked by temporary physiological imbalance. This support helps patients cope more steadily with symptom fluctuations.

“This supportive relief supports general well-being during symptomatic phases.”

Quick Fact: Support for symptoms related to physical discomfort

Regulatory References

  1. NIH MedlinePlus Drug Information on Iron Supplements

Eligibility and Restrictions for Use

Retafer (Ferrous Sulfate/Ascorbic Acid) is officially indicated for use in adults and older adults for the prevention and treatment of confirmed iron deficiency anemia. Eligibility for this medicine is strictly defined by regulatory documents, focusing on conditions that may lead to iron toxicity or severe gastrointestinal complications.

The medicine is contraindicated and must not be used in specific populations. This includes patients diagnosed with iron overload disorders such as haemochromatosis or haemosiderosis. Use is also prohibited for those with active peptic ulcers, ulcerative colitis, or regional enteritis (forms of inflammatory bowel disease), and in individuals receiving repeated blood transfusions or taking any other oral or injectable iron preparations.

Regulatory documents advise special caution or place restrictions on other groups. The prolonged-release tablet formulation is not recommended for children. Older adults may use the medicine but require caution due to potential difficulty swallowing. During pregnancy, use is generally acceptable after the first trimester. Use is restricted to cases where the anemia is confirmed to be due to iron deficiency and other non-iron deficiency anemias have been ruled out.

What should I know about interactions with other medicines?

Interactions with Other Medicines and Products

The interaction profile for Retafer, which contains ferrous sulfate and ascorbic acid, is defined by numerous absorption-based pharmacokinetic interactions documented in regulatory labeling. These effects primarily require the mandatory separation of administration timing to manage reduced drug exposure.

The co-administration of Retafer with certain medicines may result in a decrease in the concentration of either Retafer or the co-administered drug:

  • Reduced Iron Exposure: Substances such as antacids, cimetidine, and cholestyramine are documented to reduce the absorption of the ferrous sulfate component.
  • Reduced Co-Drug Exposure: Iron binding may significantly reduce the absorption of medicines like L-thyroxine, Penicillamine, Levodopa, and drugs from the Quinolone and Tetracycline antibiotic classes.

Interaction Type Specific Regulatory Restriction
Mandatory Timing Rule Administration must be separated by at least two hours for L-thyroxine and Penicillamine. Tetracycline antibiotics require a two to four hour gap.
Pharmacodynamic Effect Ascorbic Acid is officially noted to enhance the intestinal absorption of iron. Chloramphenicol may increase the patient’s response to iron therapy.
Food Restriction Absorption of oral iron is impaired by consumption of foods including cereals, coffee, eggs, milk, and tea.
Population Note The ascorbic acid component may increase the risk of acute hemolysis in patients with Glucose-6-Phosphate Dehydrogenase (G6PD) Deficiency and may raise the risk of stone precipitation in patients predisposed to renal stones.

Mechanism of Action

Retafer is a brand name for a preparation containing ferrous sulfate, a source of elemental iron Fe^2+.

Biological Targets and Pathway

Following gastrointestinal absorption, the ferrous iron is primarily transported in the plasma bound to the protein transferrin ( Tf), forming the Fe^3+-transferrin complex. This complex interacts with transferrin receptors ( TfR1) located on the surface of target cells, particularly erythroid progenitor cells in the bone marrow, which express high levels of TfR1. This interaction triggers receptor-mediated endocytosis, internalizing the iron-transferrin complex within an endosome.

Intracellular and System-Level Effects

Within the acidic endosome, iron is released from transferrin and is subsequently transported into the cell's labile iron pool via the divalent metal transporter 1 ( DMT1). This intracellular iron is then incorporated into heme molecules by the enzyme ferrochelatase within the mitochondria, a critical step in the final stage of protoporphyrin synthesis. Heme then binds to globin chains to form hemoglobin ( Hb). This process drives the maturation of erythroid cells, ultimately modulating the total systemic capacity for oxygen transport.

Dosage and Administration Information

How to Use Retafer: Official Administration Guidelines

Retafer (Ferrous Sulfate and Ascorbic Acid) is a prolonged-release tablet used for iron supplementation. The official administration guidelines define the standard procedures for using this medicine, ensuring it is taken correctly as intended.

Official Administration Protocol

Administration Scope Official Instruction
Route of Administration The medicine is strictly for oral administration.
Standard Adult Dosing The typical regimen is one prolonged-release tablet daily. In cases of severe deficiency, some labels permit one tablet twice daily.
Tablet Integrity The tablets must be swallowed whole with water. They must not be crushed, chewed, or sucked, as this action compromises the prolonged-release mechanism.
Timing Relative to Meals For optimal absorption, the tablet may be taken on an empty stomach (one hour before or two hours after a meal). If gastrointestinal upset occurs, it may be taken with food.
Use with Other Items Do not take Retafer within two hours of consuming antacids, dairy products, tea, or coffee, as these can interfere with iron absorption.

Procedural and Time Constraints

For most cases of iron deficiency anemia, the course of treatment should generally not exceed six months, or three months after the body's iron stores have been normalized. If a dose is missed, instructions advise taking the next dose at the regular scheduled time; do not double the dose to make up for the missed one.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Retafer

This section provides an objective overview of the scientific studies and research patterns available for the components of Retafer (ferrous sulfate and ascorbic acid), focusing on what the research examined and what findings were reported.

Evidence for Treating Iron Deficiency Anemia (IDA)

The volume of research exploring the use of oral ferrous iron salts to address iron deficiency anemia (IDA) is considerable. Researchers have conducted numerous Randomized Controlled Trials (RCTs) and comprehensive systematic reviews to evaluate this application. Studies monitored changes in key hematologic biomarkers, such as Hemoglobin (Hb) and Serum Ferritin (iron storage levels), in adult populations diagnosed with IDA. Studies monitored changes in both Hemoglobin and Ferritin concentrations in the observed populations, and findings describe patterns observed in the studies. Research also explored changes in outcomes related to systemic or functional imbalance, such as the reporting of fatigue or weakness. This research contributes to understanding symptom patterns but does not determine whether an individual will respond similarly.

Research on the Role of Ascorbic Acid (Vitamin C) Co-Supplementation

Specific research, including bioavailability studies, has explored the impact of combining ascorbic acid (Vitamin C) with oral iron supplements. Laboratory studies examined the addition of Vitamin C and reported findings related to conditions that may influence iron absorption in the digestive tract. However, when examining clinical results, findings were mixed across various trials regarding the extent to which the Vitamin C combination contributes to a faster or significantly greater change in Hemoglobin recovery compared to taking iron alone. For this reason, the evidence level for the overall research findings related to IDA correction is described as Moderate, and certainty remains low in certain contexts.

Evidence in Specific Patient Groups, Including Pregnancy

Clinical research has also focused on the use of iron supplementation, including ferrous iron salts, in specific patient groups, most notably pregnant women. Studies consistently monitored measurements indicating that oral iron supplementation was associated with an increase in maternal Hemoglobin and Ferritin levels during pregnancy. The evidence level for this specific hematologic effect is considered High. However, when research examined whether the supplementation was associated with a change in certain adverse infant outcomes, such as low birthweight, findings were mixed, and some official reviews indicate that the research describes limited information regarding the effect on severe maternal or adverse infant outcomes.

Key Studies & References

  1. Daily Iron and Folic Acid Supplementation in Pregnant Women (WHO Guideline)

Frequently Asked Questions (FAQ)

Common questions about Retafer (FAQ)

Q: How quickly does Retafer start to work for its main purpose?

A: Official guidance describes that an initial improvement associated with taking ferrous sulfate may be reported within 3 to 4 weeks. However, the medicine may take up to 2 to 4 months to fully contribute to the intended changes by building up the body's iron stores.

Q: Is Retafer the same type of medicine as other treatments for this condition?

A: Retafer is a brand name for a supplement containing ferrous sulfate, which is one common form of oral iron salt used for iron deficiency, alongside other forms like ferrous fumarate and ferrous gluconate.

Q: Can Retafer be taken by people with kidney issues?

A: Official product information indicates that the Ascorbic Acid (Vitamin C) component of Retafer may present a risk of stone precipitation in individuals predisposed to renal stones (kidney stones). Regulatory information describes that caution is generally necessary regarding the Vitamin C component for those with existing kidney conditions.

Q: Are there known interactions between Retafer and vitamins or supplements?

A: Official information indicates that the Ascorbic Acid component may interact with other supplements, including those containing Aluminum. Additionally, official documents describe that Ascorbic Acid may affect the action of certain drugs like Statins/Niacin and certain hormone therapies.

Q: Does Retafer have any known long-term side effects that appear after many years of use?

A: Official safety information notes that long-term, repeated high exposure to iron supplements carries a risk of excessive iron build-up in the body, known as iron overload. Official documents indicate that this risk must be considered as iron build-up can potentially affect organs such as the liver.

Q: What should I look out for as a sign that Retafer is working?

A: The medicine works to improve the body's iron levels. Research has been conducted on functional outcomes like reports of reduced fatigue and weakness, which are the common symptoms associated with iron deficiency, and evidence gathered focuses on these areas of improvement.

Q: Are there special considerations for taking Retafer if I have a chronic condition?

A: Regulatory information notes specific interactions with medicines used to treat various chronic conditions. For example, interactions are listed with drugs used for high blood pressure (e.g., Methyldopa) and conditions requiring immunosuppression (e.g., Mycophenolate Mofetil).

Q: Is Retafer available over the counter?

A: Formulations containing ferrous sulfate are generally available both by prescription and for purchase over the counter at pharmacies, depending on the specific product strength and the local regulatory guidelines.

Q: Does Retafer have a generic equivalent?

A: Retafer is a brand name for a combination product containing ferrous sulfate and ascorbic acid, both of which are common ingredients. These ingredients are widely available in various generic and non-branded combination formulations.

Q: Does Retafer interact with common pain relievers like ibuprofen?

A: Official drug interaction information for ferrous sulfate does not currently list a direct pharmacokinetic interaction with ibuprofen. However, regulatory documentation highlights the need for caution, as Retafer is contraindicated in patients with pre-existing conditions like active peptic ulcers.

Q: Why does Retafer require a prescription?

A: The need for a prescription relates to the drug's classification and strength. Regulatory guidance emphasizes that the medicine is contraindicated (should not be used) for any anemia not caused by iron deficiency, meaning a medical diagnosis is required before use.

Q: Are there any specific laboratory tests required while using Retafer?

A: Official information describes the monitoring of key hematologic markers while using Retafer. These markers often include Hemoglobin and Serum Ferritin levels, which are used to confirm the diagnosis and assess the body's response to the iron supplementation.

Q: Does Retafer interact with blood thinners?

A: Ferrous sulfate is generally not contraindicated for co-administration with the blood thinner warfarin. However, some official sources note that high doses of the Ascorbic Acid component may potentially affect the body's response to blood thinners.

Q: Does Retafer affect blood sugar levels?

A: Ferrous sulfate is not generally recognized as causing increases in blood glucose levels. Official guidance may note that the effect of iron on blood sugar is subject to clinical discussion and is not listed as a common adverse reaction in the labeling.

Q: What does official guidance say about Retafer use during breastfeeding?

A: Official guidance states that iron supplements can typically be used during breastfeeding. Supplementing with iron is not expected to affect the natural concentration of iron found in breast milk or cause side effects in the infant.

Q: Is Retafer available in different strengths?

A: Ferrous sulfate, the active iron component in Retafer, is available in various strengths and formulations. These different formulations provide varying amounts of elemental iron depending on the specific product.

Q: Does Retafer interact with alcohol?

A: Official safety information describes the need to restrict or avoid alcohol intake, as consumption may interfere with iron absorption. Alcohol has also been associated with the potential to increase the risk of liver damage when combined with iron supplements.

Q: Can people with liver impairment use Retafer?

A: The medicine is contraindicated in conditions that cause iron overload, such as hemochromatosis, which is a condition that affects the liver. Official safety data also notes that iron may potentially affect the liver.

Q: How does Retafer differ from non-drug options for the same condition?

A: Retafer provides the mineral iron as a pharmaceutical supplement, which differs from dietary or non-drug sources of iron in that the dose and formulation are standardized.

How should Retafer be stored and disposed of?

Storage and Disposal Requirements

Storage Conditions

Retafer (ferrous sulfate/ascorbic acid) must be stored below 25 C in a dry place and protected from light. It is required to keep the medicine in its original container and ensure the container remains tightly closed to maintain product stability until the labeled expiry date. Due to the severe risk of poisoning, Retafer must be strictly kept out of the sight and reach of children.

Disposal Instructions

Expired or unused Retafer should not be disposed of using household garbage or by pouring into wastewater. Official instructions require that users consult a pharmacist on the proper method for disposal. This ensures the unused medicine is discarded in a manner that protects the environment.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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