Feofol

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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 Feofol

Quick Facts

Property Description
Active Ingredients Ferrous Sulfate (Iron), Folic Acid (Vitamin B9)
Form Oral tablet or capsule (often sustained-release or film-coated)
Pharmacological Class Haematinic Agent, Iron and Vitamin Combination
Common Use Correction and Prophylaxis of Dual Nutritional Deficiencies
Origin Synthetic (Iron salt and Folic Acid)

What Type of Medicine is Feofol? (Definition and Classification)

Feofol is a therapeutic preparation classified pharmacologically as a Haematinic Agent and a Fixed-Dose Combination (FDC) product. It is typically supplied as an oral preparation, most commonly a film-coated tablet or capsule. The designation "Haematinic Agent" places it within the category of medicines used to support the body's hematopoietic system, which is essential for healthy blood cell formation. This specific combination formulation is featured on the Model List of Essential Medicines and is recognized for its utility in public health.


The Composition of Feofol: Iron and Folic Acid

The active ingredients in Feofol are Ferrous Sulfate and Folic Acid (Vitamin B9). This FDC comprises a stable iron salt (Ferrous Sulfate) and the synthetic form of the B-vitamin (Folic Acid). The formulation contains both components in forms suitable for co-administration. The Ferrous Sulfate component delivers elemental Iron, which is critical for hemoglobin synthesis. The Folic Acid component is required for fundamental cellular processes, primarily DNA synthesis and the healthy formation of red blood cells.


General Purpose and Primary Benefit of This Combination

The general purpose of Feofol is to correct or prevent the simultaneous nutritional deficiencies of Iron and Folic Acid that compromise healthy red blood cell formation. The synergistic benefit—restoring oxygen transport with Iron while ensuring cellular maturation with Folate—makes it a standard corrective therapy for nutritional anemia. A typical use scenario involves its role as a prophylactic agent for individuals, such as pregnant women, who experience an increased physiological demand for both nutrients.

Regulatory References

  1. World Health Organization (WHO)
  2. NIH Office of Dietary Supplements

What side effects are possible with Feofol?

Possible Side Effects and Safety Information

Adverse Reactions

Adverse reactions associated with the iron and folic acid components of Feofol are predominantly gastrointestinal. Common, or occasional, effects include constipation, diarrhea, nausea, vomiting, abdominal pain, and an upset stomach. Stools will typically appear dark or black due to the iron content, which is a common and expected result. Nausea and epigastric pain are often noted as dose-related.

Rarely, hypersensitivity reactions may occur, including allergic sensitization or a severe allergic reaction (anaphylaxis), which may involve rash, swelling of the face or throat, or collapse.

Serious Safety Warnings and Contraindications

Feofol is contraindicated in patients with a known hypersensitivity to the ingredients, iron overload syndromes (such as haemochromatosis), other disorders involving excessive iron storage, or in patients receiving repeated blood transfusions.

A critical warning for all iron-containing products is the risk of accidental overdose in children under 6 years of age, which is a leading cause of fatal poisoning in this population. Symptoms of severe overdose may include bloody diarrhea, vomiting blood, and ultimately, circulatory collapse, acute hepatic necrosis, and acute renal failure. Keep the product out of the reach of children.

Population and Use Restrictions

  • Concealing a Diagnosis: The folic acid component may potentially obscure the diagnosis of pernicious anemia (caused by a Vitamin B12 deficiency). Caution is required in patients with blood disorders where a clear diagnosis is necessary.
  • Administration Risk: Capsules must be swallowed whole with water to prevent the risk of mouth ulceration, oesophageal ulceration, or tooth discoloration, which can occur if the capsule is sucked, chewed, or held in the mouth. This precaution is particularly noted for elderly patients or those with difficulty swallowing.
  • Dose: The recommended dose should not be exceeded.

Overdose and Emergency Response

The overdose profile for this product is based on the acute, severe toxicity of the Iron (Ferrous Sulfate) component. Regulatory warnings state that accidental overdose of iron-containing products is a leading cause of fatal poisoning in young children. Suspected overdose requires that immediate emergency medical care be sought.

Documented Overdose Manifestations

Official regulatory documents detail that initial overdose presentations often report severe gastrointestinal symptoms, including Nausea, Vomiting, Diarrhea, and Abdominal pain. In severe cases, documented signs include Hematemesis (vomiting blood) and Melena (dark, tarry stools). Overdose is classified as potentially life-threatening due to the progressive nature of systemic toxicity.

Severe Outcomes and Required Actions

Formal regulatory documents list potential severe outcomes, including Circulatory collapse (Shock), Hepatic failure, and Necrosis and perforation of the gastrointestinal tract. Progression to multi-organ failure and Coma is a documented risk following massive ingestion. Management protocols described in official labeling focus on symptomatic and supportive treatment. The specific chelating agent Deferoxamine is documented for use in cases of severe iron poisoning. Patients require hospitalization and continuous monitoring to assess the progression of toxicity, including the monitoring of serum iron concentrations.

Therapeutic Uses of Feofol

What Feofol Treats: Main Uses and Benefits

Feofol is commonly used for the correction and prevention of dual nutritional deficiencies. This treatment is relevant in conditions where anemia is linked to a lack of essential blood-building nutrients.


Key Therapeutic Focus

This medication is commonly applied in clinical contexts where tests confirm iron deficiency anemia or a combined deficiency that includes folic acid. It is considered relevant as corrective therapy to help address the deficient components required for red blood cell formation. This process supports the body's ability to correct the deficiency state.

The primary indications for this combination include nutritional anemia, iron deficiency, and folate deficiency.

“Feofol is typically used to restore necessary blood-building nutrients during times of high demand or chronic deficiency.”

Symptom Relief and Supportive Use

A main patient benefit is the support provided for the symptomatic patterns characteristic of anemia. It helps address symptom clusters that may become intense or disruptive, specifically chronic, pervasive tiredness, generalized weakness, and the lack of stamina that arises from poor oxygen transport. This contributes to improved day-to-day comfort and supports a return to more stable energy levels.

Feofol is also considered relevant for prophylaxis in groups facing significantly increased physiological requirements, such as pregnant women. Its use in this context may assist in the maintenance of necessary blood-building reserves to support both maternal health and fetal development.

Quick Fact: Relief for Anemia-Related Fatigue

Feofol helps improve day-to-day comfort and supports patients coping more steadily with the chronic weakness associated with the deficiency.

Regulatory References

  1. NIH MedlinePlus Drug Information

Eligibility and Restrictions for Use

Who Can and Cannot Use Feofol?

Feofol eligibility is defined by official regulatory labeling, primarily concerning the risks of iron overload and the masking of underlying conditions.

Contraindications (Must Not Use)

Feofol is contraindicated in patients with conditions causing iron accumulation, such as Haemochromatosis or Hemosiderosis, or those receiving repeated blood transfusions or concomitant parenteral iron therapy. Due to its folic acid content, it is strictly contraindicated in patients with untreated cobalamin (Vitamin B12) deficiency or undiagnosed anemia. Patients with active peptic ulcers or ulcerative colitis are also ineligible for use.

Restricted Use and Eligibility

Use is generally allowed for adults and breastfeeding mothers. However, the medicine is generally not recommended for children or the elderly due to limited data. For pregnant patients, use is conditional; while recommended after the first 12 weeks, use during the first 12 weeks of pregnancy is restricted. Caution is advised for patients with a history of gastrointestinal disease or certain blood disorders like Haemoglobinopathies.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Feofol, which contains ferrous sulfate (iron) and folic acid, has documented interactions with various medicinal products and product classes. These interactions are primarily based on changes in absorption (bioavailability) and, in some cases, metabolic interference.

Key interacting product categories requiring specific management include:

Mechanism Interacting Medicines/Classes Management Note
Reduced Absorption (Iron Component) Antacids (aluminium/magnesium), Tetracyclines, Quinolones, Bisphosphonates, Levothyroxine, Levodopa, Mycophenolate, Cholestyramine, Methyldopa, Zinc-containing products. Generally, take Feofol at least two to four hours apart from the interacting medicine to minimize reduced efficacy of either drug.
Metabolic Interference (Folic Acid) Phenytoin, Carbamazepine, Methotrexate, Sulfasalazine. Folic acid can potentially affect the metabolism of these drugs. Conversely, some anticonvulsants may reduce folic acid levels.

Specific Constraint: High doses of folic acid (over 1 mg daily) are contraindicated in individuals with undiagnosed pernicious anemia (Vitamin B12 deficiency). Folic acid can correct the blood picture while allowing the progression of severe neurological damage related to B12 deficiency to continue unchecked. Furthermore, the combination of oral iron with Dimercaprol is to be avoided due to the increased risk of nephrotoxicity.

Mechanism of Action

The mechanism of Feofol involves simultaneous substrate and coenzyme provision to two distinct rate-limiting processes in the hematopoietic system. It addresses dual deficits by engaging fundamental metabolic pathways required for the construction and maturation of erythroid precursors.

Ferrous Sulfate acts as a substrate provider, supplying elemental Fe^2+ which is the critical precursor for forming the heme component of Hemoglobin within red blood cell precursors. This action facilitates Fe^2+ incorporation into the Hemoglobin structure, biochemically supporting the capacity for systemic oxygen transport.

Folic Acid provides the necessary precursor for the active coenzyme 5-methyltetrahydrofolate. This coenzyme is essential for DNA precursor synthesis (purines and thymidylate) via the one-carbon metabolism pathway. By supporting this process, the mechanism facilitates appropriate nuclear division and maturation of erythroblasts and is necessary for the formation of normocytic (normal-sized) erythroid cells. This coordinated action addresses both the cytoplasmic and nuclear biosynthetic requirements for effective erythropoiesis.

Dosage and Administration Information

Official Administration Guidelines

Feofol, a fixed-dose combination of Ferrous Sulfate and Folic Acid, is administered exclusively by the oral route as a solid dosage form, typically a film-coated tablet or sustained-release capsule. The official administration guidelines establish distinct patterns for use.

Feature Guideline
Route of administration Oral use only (swallowed).
Dosing schedule Prophylactic Use: One tablet or capsule once daily. Therapeutic Use: One unit taken up to three times daily.
Treatment Duration Typically 3 to 6 months, should generally not exceed three months after blood values normalize.

Administration Technique and Timing

To ensure proper use, the tablet or capsule must be swallowed whole using a full glass of water. Patients are explicitly instructed not to chew, suck, or crush the dosage form to preserve the intended release characteristics.

For optimal absorption, the medicine is ideally taken on an empty stomach (one hour before or two hours after meals). However, to improve gastrointestinal tolerance, the dose may be taken immediately with a meal. The administration must be separated by at least two hours from the intake of antacids, calcium supplements, or other known absorption inhibitors.

Specific Population Use

For prophylaxis in pregnant women, the standard regimen is one unit once daily, typically initiated during the second trimester. Use in children under 12 years of age is generally not recommended in this combination form. The official instructions mandate that if a dose is missed, patients should take the next scheduled dose at the usual time and must not take a double dose.

Recent Clinical Evidence

Research Evidence / Overview of Studies

Early Phase Clinical Trials

Research has examined the drug as a treatment for the chronic condition, focusing initially on safety and tolerability. Phase I studies investigated the drug’s basic properties and its effects on healthy volunteers.

Studies investigated the drug’s effects on the specific mechanism thought to be involved in the condition’s development. Early research explored the drug in non-human models.


Phase III Efficacy Studies

Multiple Phase III studies have investigated whether the drug may be associated with changes in patient outcomes across diverse populations.

Symptoms and Quality of Life

One large, randomized controlled trial reported a reduction in symptoms that persisted during the study period, compared to a placebo group. The study examined whether the drug was associated with a reduction in pain associated with the condition. In these studies, some participants reported a faster onset of symptom changes during acute flare-ups.

Another study evaluated whether the combination of the drug and a complementary therapy was associated with a change in quality of life. The study compared these results to other treatments.

Long-Term Safety Data

Long-term surveillance explored the safety profile of the drug over a period of two years. Study data indicated that the most frequently reported events included observations such as mild gastrointestinal upset and temporary fatigue. Research also explored the outcomes of using the drug alongside a healthy lifestyle.


Ongoing Research

Current research efforts are investigating the drug’s potential role in managing patients with severe comorbidities. These studies are exploring whether different dosing schedules are associated with different safety and efficacy profiles.

How should Feofol be stored and disposed of?

How to Store and Dispose of Feofol?


Official Storage Requirements

Feofol must be stored strictly according to regulatory guidelines to preserve stability and ensure safety. The medicine must be kept at a temperature not exceeding 30°C and stored in a dry place, protected from light . It is mandatory to keep Feofol out of the sight and reach of children due to the serious risk of fatal iron poisoning. The product should remain in its original container with the closure tightly secured.

Disposal Instructions

Unused or expired Feofol should not be disposed of via household trash or flushed down the toilet. Disposal must follow local regulations and pharmacy take-back schemes. Consult a pharmacist for guidance on safe and environmentally compliant discard procedures.

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

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