Duroferon

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Duroferon

Medically reviewed

Marina Burgos

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 Duroferon

Duroferon's identity is rooted in its role as a fundamental iron supplement, designed with a specific delivery system to efficiently address mineral deficiencies.

Property Description
Active Ingredient Ferrous Sulfate (FeSO₄)
Form Modified-release tablet (slow-release)
Pharmacological Class Antianemic preparation, Hematinic agent
Common Use Iron replacement therapy
Origin Synthetic inorganic compound (Iron salt)

What is Duroferon and Its Primary Classification?

Duroferon is classified as an antianemic preparation and a hematinic agent, functioning as a vital mineral supplement that supplies the body with iron. Its sole active ingredient is Ferrous Sulfate (FeSO₄), an elemental iron salt of synthetic inorganic origin. This pharmaceutical entity belongs to the broader category of medicines used for iron replacement therapy, a method recognized for its efficacy in restoring iron balance. Ferrous Sulfate is an established and effective compound for increasing iron levels in the body.


Modified-Release: The Duroferon Formulation Type

Duroferon is presented as a modified-release tablet specifically designed for oral administration. This is a technologically advanced slow-release or controlled-release formulation, a key differentiating factor from immediate-release iron supplements. The design ensures the Ferrous Sulfate is released gradually over several hours within the gastrointestinal tract. Controlled-release formulations are developed to enhance the consistency of absorption. This particular modified-release form is often recommended for situations where a sustained supply of iron is beneficial.


General Benefit: Supporting the Body’s Iron Supply

The general purpose of Duroferon is to correct or prevent physiological states related to insufficient iron, such as iron deficiency. By supplying the required mineral, the medicine supports hemoglobin synthesis and erythropoiesis, which is the production of new red blood cells. Ultimately, the use of this antianemic preparation reinforces the body’s fundamental ability to carry and transfer oxygen efficiently to tissues. This iron replacement is a typical use scenario when dietary intake alone is insufficient.

Regulatory References

  1. Iron - Health Professional Fact Sheet - NIH ODS

What side effects are possible with Duroferon?

Possible Side Effects and Safety Information

This section outlines the officially documented adverse reactions and safety restrictions for Duroferon, based strictly on government regulatory documents.

Frequency-Classified Adverse Reactions

The most common adverse effects associated with Duroferon involve the gastrointestinal system.

Classification Examples of Documented Reactions
Common (May affect up to 1 in 10 people) Nausea, stomach pain, constipation, or sluggish bowel movements.
Rare (May affect up to 1 in 1,000 people) Skin rashes, allergic reactions, ulceration of the esophagus (food pipe).
Frequency Not Known Mouth ulceration (if tablets are chewed or sucked), discoloration of the teeth.

Serious Safety Considerations

Safety documents highlight several serious and clinically significant concerns:

  • Localized Injury: The prolonged-release tablets carry a risk of irritation, leading to ulceration of the esophagus or bronchus (airway) if the tablet becomes stuck, is swallowed incorrectly, or is retained in the throat. This risk is elevated in patients with swallowing difficulties.
  • Overdose Hazard: Accidental overdose of iron-containing products is cited as a leading cause of fatal poisoning in young children (under 6 years old). The medicine must be kept out of their reach.
  • Hypersensitivity: Rare, severe allergic reactions are possible, requiring immediate medical attention.

Restrictions and Limitations

Regulatory documents list situations in which Duroferon should not be used (contraindications), including documented hypersensitivity to its components, diagnosed iron storage diseases (such as hemochromatosis), existing active gastrointestinal ulcers, ulcerative colitis, regional enteritis, or when the patient is already receiving repeated blood transfusions or other iron supplements.

Overdose and Emergency Response

Overdose and when to seek help

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6 years of age. Due to this critical risk, regulatory authorities mandate that individuals who have ingested an excessive amount of iron-containing product must seek emergency medical attention immediately and call a doctor or Poison Control Center.

Documented Overdose Profile

Feature Official Regulatory Statements for Ferrous Sulfate Overdose
Documented Overdose Presentations Initial severe gastrointestinal distress (nausea, vomiting, severe abdominal pain, bloody diarrhea). Progression to systemic signs, including hypotension, tachycardia, lethargy, and ultimately seizures or coma.
Physiological Systems Affected Gastrointestinal System, Central Nervous System, Cardiovascular System, Liver (acute hepatic necrosis), and Kidneys (renal failure).
Severe Outcomes Classified as potentially fatal poisoning and associated with shock, severe metabolic acidosis, and multi-organ failure.

The official management of systemic iron toxicity is symptomatic and supportive. It involves specialized procedures like monitoring serum iron concentrations and, if required, the administration of the specific iron-chelating agent, Deferoxamine. The regulatory guidance emphasizes immediate action, especially if a child has accidentally swallowed any iron-containing tablet.

Therapeutic Uses of Duroferon

What Duroferon Treats: Main Uses and Benefits

The primary therapeutic use of Duroferon is generally considered relevant for Iron Deficiency Anemia (IDA) and may assist with addressing states of low iron stores. Addressing this deficiency is important for health.

Alleviating Fatigue and Improving Physical Capacity

The medication is commonly used to help manage symptoms related to physical discomfort and systemic imbalance, including debilitating fatigue, generalized tiredness, and a marked reduction in physical endurance. Addressing the iron deficit helps patients cope more steadily with these manifestations, contributing to improved comfort during symptomatic periods, which supports day-to-day functional stability.

Supporting High-Demand Clinical Scenarios

This therapy is relevant for managing conditions characterized by periods of heightened systemic burden, notably IDA, low iron stores, chronic blood loss (like menorrhagia), and anemia during pregnancy. Duroferon's therapeutic relevance is generally in managing the symptomatic load caused by deficiency. This use may be part of symptomatic management during periods of acute physiological need or chronic loss, supporting the maintenance of adequate iron stores.


Quick Fact: Managing Tiredness
Duroferon is relevant for easing symptoms that create noticeable physiological strain, particularly the pervasive tiredness.

Regulatory References

  1. NIH MedlinePlus overview

Eligibility and Restrictions for Use

Duroferon, which contains ferrous sulfate, is an oral iron supplement used to treat and prevent iron-deficiency anemia.

It is typically prescribed for adults and can also be used as a preventive measure for individuals with increased iron needs, such as during pregnancy or after blood donation.


Contraindications

Certain conditions make the use of Duroferon unsuitable due to the risk of iron overload or complications. Individuals should not take this medication if they have:

  • Iron Overload Disorders: Such as hemochromatosis or hemosiderosis, where the body stores too much iron.
  • Hemolytic Anemia: A type of anemia where red blood cells are destroyed faster than they are made, which is not caused by iron deficiency.
  • Severe Gastrointestinal Conditions: Including active peptic ulcers, ulcerative colitis, or other inflammatory bowel diseases, as iron can sometimes irritate the lining.
  • Known Allergy: A hypersensitivity or allergic reaction to ferrous sulfate or any component of the tablet.

Patients who are receiving repeated blood transfusions should also typically avoid oral iron supplements.

It is crucial to consult a healthcare provider before starting Duroferon, especially if you have an existing health condition or are taking other medications.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Regulatory documentation outlines specific pharmacokinetic and pharmacodynamic interactions for Duroferon, a ferrous sulfate product.

Contraindicated Combinations

Co-administration of oral iron, such as Duroferon, with parenteral (injectable) iron preparations is explicitly contraindicated due to the risk of systemic iron accumulation. Concomitant use with Dimercaprol is also advised against in official prescribing information.

Interactions Affecting Absorption

The most common class of interaction involves the reduction of absorption for either the iron product or the co-administered drug, often due to chelation or pH alteration. These include:

  • Antibiotics: Exposure to Tetracycline and Quinolone antibiotics is reduced.
  • Levothyroxine (Thyroid Hormone): Decreased L-thyroxine absorption is documented.
  • Antacids, Calcium, and Zinc Supplements: These substances decrease the absorption of iron itself.

Timing and Substance Restrictions

Official labeling mandates specific timing separation for certain combinations. For example, iron supplements should not be taken within two hours of Tetracycline antibiotics or Levothyroxine. Similarly, ingestion must be separated by at least one to two hours from antacids and mineral-containing preparations. The risk of iron toxicity is increased when co-administered with alcohol, as it may enhance iron absorption and hepatic storage. Furthermore, the absorption of iron is documented to be decreased by substances found in coffee, tea, milk, and certain foods.

Mechanism of Action

Duroferon is a formulation containing ferrous sulfate, which dissociates into the essential nutrient elemental iron (Fe^2+). This iron is primarily absorbed in the duodenum and proximal jejunum of the small intestine via the DMT1 transporter (Divalent Metal Transporter 1) on the enterocyte membrane. Once inside the cell, a portion of the absorbed iron is stored as ferritin, while the remainder is transported across the basolateral membrane by ferroportin and immediately oxidized to the ferric state (Fe^3+) by hephaestin.

In the bloodstream, Fe^3+ binds to the plasma protein transferrin (Tf). The Tf-Fe complex travels to the bone marrow, where it is endocytosed by developing erythroid cells through the transferrin receptor 1 (TfR1). Inside the erythroid precursor, the iron is released and incorporated into the protoporphyrin ring within the mitochondria to form heme. Heme is then incorporated into globin chains to synthesize functional hemoglobin (Hb). This process facilitates the formation of mature red blood cells, thus maintaining systemic oxygen transport capacity.

Dosage and Administration Information

Duroferon is administered exclusively via the oral route in the form of a modified-release tablet. This formulation necessitates specific procedural instructions for intake, as the tablet's integrity is essential for the controlled release of the active ingredient. The tablet must be swallowed whole with water and must not be chewed, crushed, or sucked before ingestion, a common constraint for extended-release formulations.

The dosing schedule for therapeutic use, such as correcting iron deficiency, often involves a divided dose, typically two or three times daily when using 200 mg Ferrous Sulfate equivalents, or a morning and evening regimen for the 100 mg elemental iron strength, depending on the regulatory context. For prophylactic use, a once-daily administration is generally followed. The medicine may be taken before meals to potentially maximize absorption, or it can be taken during meals if necessary to improve gastrointestinal tolerance.

Administration is typically extended over a long-term duration. Use is continued for several months until the iron deficiency has been corrected, and then for an additional three to six months to ensure that the body’s iron stores are fully replenished. Regarding specific populations, the usual adult dose may be administered to older adults, but this modified-release tablet is generally not recommended for children under 12 years in some regulatory contexts.

Recent Clinical Evidence

Research evidence / Overview of studies for Duroferon

The research base for this ferrous sulfate formulation includes studies exploring its use in individuals with diagnosed low iron status, including Iron Deficiency Anemia (IDA). Researchers have primarily used Randomized Controlled Trials (RCTs) and comprehensive Systematic Reviews to investigate this type of supplementation.

The main focus of these studies has been on whether the formulation is associated with changes in key measures of iron status. Research examined outcomes related to Hemoglobin (Hb) concentration and Serum Ferritin levels, which reflect the body’s iron stores. Additionally, studies monitored the incidence of clinical anemia and used patient-reported outcomes to measure changes in subjective physical symptoms, such as fatigue and general tiredness, over time. Research so far indicates that studies monitored measurable changes in these biomarkers, reporting patterns where Hemoglobin and Ferritin levels were observed to change during the study period.


Studies on Iron Status Prevention in High-Demand Scenarios

The research has explored this ferrous sulfate formulation for preventative strategies in populations where the physiological need for iron is heightened, notably during pregnancy. These studies were conducted to assess whether supplementation was associated with a lower risk of developing maternal Iron Deficiency (ID) and Iron Deficiency Anemia (IDA) by the end of the pregnancy period. Findings from systematic reviews describe patterns where studies reported a lower incidence of maternal iron deficiency and anemia in the observed populations.


Comparative Research on the Modified-Release Formulation

Duroferon's design as a modified-release tablet has been the subject of specific comparative research. Comparative Randomized Controlled Trials (RCTs) tracked the incidence of gastrointestinal (GI) symptoms like nausea and abdominal pain, and monitored treatment discontinuation rates. Some studies reported a lower incidence of specific GI symptoms for the modified-release formulation compared to the conventional form. However, findings on overall adherence were mixed, and certainty remains low regarding the full context of long-term developmental benefits in certain pediatric groups.


Key Research Gaps and Areas of Uncertainty

A major limitation is the heterogeneity across studies, meaning that the specific results and reported symptom patterns varied widely depending on the research setting and patient population. Furthermore, while the short-term effects on iron biomarkers are well-documented, the long-term effects and the sustained durability of the iron status correction after the treatment period are not fully established.

Key Studies & References

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

Frequently Asked Questions (FAQ)

Common questions about Duroferon (FAQ)

Q: Is Duroferon the same as regular iron tablets?

Official product information describes Duroferon as a modified-release or slow-release formulation of iron, which is a key difference from standard immediate-release iron tablets. This specialized design ensures the active ingredient is released gradually over several hours in the gastrointestinal tract.

Q: Is Duroferon used for all types of anemia?

According to official documents, this medicine is specifically indicated for the treatment and prevention of anemia caused by iron deficiency. It is typically contraindicated for other types of anemia, such as hemolytic anemia, which are not caused by low iron levels.

Q: Can Duroferon be taken at the same time as other vitamins?

Regulatory documents show that certain mineral supplements, like those containing Calcium or Zinc, can reduce the body’s absorption of iron. Official information indicates that separating the administration of iron from these other supplements may be advised to manage potential interactions. A healthcare provider can offer guidance on the timing needed for specific multivitamin components.

Q: Can children or adolescents use Duroferon?

Official prescribing information notes that this formulation is generally not recommended for children under 12 years old in some regions. However, dosing guidelines for adolescents are provided in official materials, indicating appropriate use in this older age group under the direction of a healthcare professional.

Q: Do studies support the long-term use of Duroferon?

Treatment with iron is typically extended over several months to correct the deficiency and replenish iron stores. Official guidance suggests caution regarding iron administration for longer than six months, except in cases of continuous iron loss, as the long-term durability of the iron status correction is not fully established by all studies.

Q: Why is Duroferon sometimes recommended over other iron supplements?

Comparative research has examined this modified-release formulation against conventional iron tablets. Studies indicated that the modified-release form may be associated with a lower incidence of specific gastrointestinal side effects. This finding may be a consideration in its selection.

Q: Can Duroferon cause constipation or diarrhea?

Constipation is noted as a common side effect in the frequency-classified adverse reactions for this medicine. Diarrhea is also documented in official product information as a possible adverse effect of ferrous sulfate products.

Q: Do you need a prescription to get Duroferon?

Ferrous sulfate products are marketed in various regulatory environments as both prescription drugs and over-the-counter (OTC) supplements, depending on the dosage and specific formulation strength. The precise legal status of the branded Duroferon product may depend on local regulatory confirmation.

Q: Is it normal to have dark stool when taking Duroferon?

Regulatory safety information indicates that black or dark discoloration of the stools is a common and expected effect of taking oral iron supplements. This change is due to the unabsorbed iron and is a documented physiological change that occurs with unabsorbed iron.

Q: How long does it typically take to feel an effect from Duroferon?

Official guidance states that a measurable change in blood components, known as a hematologic response, typically begins within 3 to 10 days of starting therapy. Increases in hemoglobin levels (the protein that carries oxygen) are generally observed within 2 to 4 weeks.

Q: What happens if I forget to take a dose of Duroferon?

The official patient leaflet states that if a dose is missed, it should be taken as soon as it is remembered, unless it is almost time for the next scheduled dose. The leaflet specifies that a double dose should not be taken to make up for the forgotten dose.

Q: What are the signs of an iron overdose?

Official medical resources warn that symptoms of acute iron overdose can initially include severe gastrointestinal upset, such as nausea, vomiting blood, and diarrhea. Later, more serious effects, including organ damage or shock, can occur, and regulatory documents contain a specific warning regarding the need to keep iron products out of the reach of children.

Q: Is it safe to stop taking Duroferon suddenly?

Iron supplementation is typically intended to be continued until the body’s iron stores are fully replenished. Clinical guidance indicates that a sudden cessation of oral iron supplementation may be advised in rare situations where blood tests show signs of iron overload (elevated ferritin).

Q: Is Duroferon safe for people with kidney problems?

The treatment of iron deficiency in people with Chronic Kidney Disease (CKD) is complex and often requires intravenous (IV) iron. While Duroferon (oral iron) may be referenced in this population, official information indicates that the determination of safety and appropriateness in this population requires an assessment by a healthcare provider.

Q: Do I need regular blood tests while using Duroferon?

Official guidelines describe the need for periodic blood monitoring during the treatment of iron deficiency anemia. This monitoring includes checking a full blood count and measuring serum ferritin levels, which indicate the status of the body’s iron stores.

Q: Does Duroferon contain gluten, lactose, or other common allergens?

Regulatory labels for ferrous sulfate products sometimes list excipients (inactive ingredients) such as lactose or sucrose. For specific excipients, including potential allergens like lactose or sucrose, patients are advised to refer to the official package leaflet for the formulation they are using.

Q: Can I take pain relievers at the same time as Duroferon?

Regulatory and clinical resources often suggest that separating the administration time of iron supplements from other medicines, including common pain relievers like ibuprofen or acetaminophen, is considered. This separation helps to ensure proper absorption of both the iron and the pain reliever.

Q: Can Duroferon affect the results of lab tests?

Clinical research referenced in guidance indicates that oral iron does not typically interfere with the results of a fecal occult blood test (FOBT), which checks for blood in stool. However, the medicine can cause the stool itself to become darker.

Q: Does Duroferon have any known interactions with herbal supplements?

Regulatory resources caution that combining iron with herbal remedies or supplements should be discussed with a healthcare provider, as some herbal products can interfere with iron absorption or have documented interactions.

Q: Does Duroferon contain ascorbic acid (Vitamin C)?

Some formulations of Duroferon contain ascorbic acid, commonly known as Vitamin C. This ingredient is often included in iron supplements because it is known to help enhance the absorption of iron in the body. The specific ingredients for the formulation being used can be confirmed by referring to the local product label.

How should Duroferon be stored and disposed of?

How to Store and Dispose of Duroferon?

Detail Official Regulatory Requirement
Labeled storage temperature requirements Store at room temperature, typically defined as between 15 C and 30 C, and avoid excess heat.
Light/moisture protection requirements The container must be protected from moisture and direct sunlight.
Packaging-related storage rules Keep the medicine in its original container, ensuring the container is tightly closed.
Child-protection storage requirements The product must be kept out of the sight and reach of children due to the serious risk of accidental iron overdose.
Disposal instructions The preferred method for discarding unused or expired medicine is a drug take-back program.
Environmental or controlled-waste disposal requirements The medicine should not be flushed down the toilet or disposed of via household wastewater.

Official regulatory documents define storage conditions as requiring room temperature and protection from moisture to maintain product stability. Disposal instructions prioritize take-back programs and mandate that medicine not be poured down the drain, with specific steps provided for preparing the product for household trash if take-back is unavailable.

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

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