Losferron

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Losferron

Method of action: Antianemic

Treatment option: Pregnancy

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 Losferron

What is Losferron?

Losferron is a pharmaceutical preparation containing iron in the form of ferrous gluconate. It is categorized as an oral iron supplement used to address low levels of iron in the body. Unlike standard solid tablets, Losferron is typically available as effervescent tablets that dissolve in water to create an oral solution.

Composition and Mechanism

The active ingredient, ferrous gluconate, is a divalent iron salt. Iron is an essential mineral required for the production of hemoglobin, the protein in red blood cells responsible for transporting oxygen from the lungs to the rest of the body. It also plays a vital role in myoglobin formation and the function of various enzyme systems.

When the body's iron stores are insufficient to meet physiological demands—due to increased requirements, decreased dietary intake, or poor absorption—the synthesis of hemoglobin is affected. By providing a supplemental source of iron, Losferron helps to replenish these internal stores and supports the maintenance of healthy blood iron levels.

General Characteristics

  • Formulation: The effervescent nature of the tablet is designed to facilitate the administration of iron in a liquid form, which may be preferred by individuals who have difficulty swallowing traditional pills.
  • Solubility: The ferrous gluconate in Losferron is highly soluble, allowing the iron to be available for absorption in the gastrointestinal tract.
  • Therapeutic Purpose: It is primarily used for the management of iron deficiency states and the associated reduction in red blood cell production.

Regulatory References

  1. World Health Organization (WHO)

What side effects are possible with Losferron?

Possible side effects and safety information

The safety profile of Losferron (Ferrous Gluconate) is structured around common gastrointestinal effects and strict regulatory warnings regarding critical risks, based on official prescribing documents.


Adverse Reaction Classifications

The most frequent adverse reactions are classified as Common and involve the Gastrointestinal Disorders system-organ class. These expected effects include nausea, vomiting, constipation, diarrhea, stomach pain, heartburn, and a loss of appetite. The appearance of darkening of stools (black or green) is a non-serious, expected effect of oral iron supplementation. Temporary staining of the teeth may also occur, particularly with liquid forms.

Classification Effects Commonly Documented
System-Organ Class Gastrointestinal Disorders
Frequency Common (for GI effects)

Serious Safety Considerations and Restrictions

Official regulatory labeling includes warnings regarding serious and potentially fatal risks. Accidental overdose of iron-containing products is cited as a leading cause of fatal poisoning in children under six years of age.

The medicine is contraindicated by regulatory authorities for individuals with established conditions of iron overload, specifically hemochromatosis and hemosiderosis, and for those with hemolytic anemia.

Furthermore, caution is advised for patients with existing gastrointestinal pathology, such as peptic ulcers or inflammatory bowel disease, due to the potential for severe adverse gastrointestinal events. Hypersensitivity reactions (severe allergies) are also documented as a risk.

Overdose and Emergency Response

Overdose and when to seek help: Official Regulatory Information

Accidental overdose of iron-containing products is cited by regulatory agencies as a leading cause of fatal poisoning in children under six years of age. In the event of known or suspected ingestion of Losferron above prescribed amounts, immediate emergency medical attention must be sought. Contact a doctor or a Poison Control Center without delay, as per mandatory regulatory instructions.

Documented Overdose Presentations

The official regulatory profile describes a multi-phase toxicological progression:

  • Initial Signs (Phase I): Within the first six hours, symptoms primarily involve the gastrointestinal system, including severe vomiting, diarrhea, abdominal pain, and potentially bloody stools (hematemesis or hematochezia).
  • Systemic Toxicity: This phase may be preceded by a period of apparent improvement, followed by life-threatening systemic collapse. Severe manifestations include shock, hypotension (low blood pressure), Metabolic Acidosis, tachycardia, and effects on the central nervous system, such as seizures and coma.
  • Severe Outcomes: Overdose can lead to Acute Hepatic Failure and multi-system organ damage.

Regulatory Management Requirements

Management for severe systemic toxicity involves specialized clinical procedures. The specific chelating agent Deferoxamine is recognized as the necessary antidote to remove excess iron from the body. Monitoring of Serum Iron Concentration and continuous hospital observation are essential to manage complications and assess the severity of the toxic event.

Therapeutic Uses of Losferron

Quick Facts

  • Primary Use: Management of conditions associated with low iron levels.
  • Therapeutic Role: Contributes to the restoration of body iron stores.
  • Specific Conditions: Used to address iron-deficiency anemia.

What Losferron Treats: Main Uses and Benefits

Losferron is a specific iron-containing preparation used to address and manage states of iron deficiency in the body. The active component is ferrous gluconate, which provides a supplementary source of iron.

The primary therapeutic domain of Losferron is the correction of iron deficiency anemia. This condition involves a reduced count of healthy red blood cells due to insufficient iron, a necessary component for hemoglobin production. By supplying supplemental iron, the medication assists in supporting the body's iron requirements to form hemoglobin.

The use of an iron supplement such as Losferron is often indicated when dietary intake of iron is considered insufficient to meet the body's needs or when iron loss is elevated. It is used to help restore iron levels and manage symptoms that are commonly associated with this deficiency. Therapeutic use also extends to the prevention of iron deficiency in individuals identified as being at risk, such as pregnant women who often have increased iron requirements.

Eligibility and Restrictions for Use

This section summarizes the official population eligibility and exclusion criteria for Losferron (Ferrous Gluconate) as defined by authoritative regulatory labeling.

Contraindications (Must Not Use)

Losferron is contraindicated and must not be used by individuals with certain medical conditions that cause iron overload, as this increases the risk of toxicity. These conditions include:

  • Hemochromatosis or Hemosiderosis.
  • Hemolytic Anemia or any other anemia not confirmed to be caused by iron deficiency.
  • Known hypersensitivity or allergy to ferrous gluconate or any other component of the formulation.

Specific Population Eligibility

Population Group Eligibility Status (Regulatory Basis)
Children The effervescent tablet form is not recommended for children weighing under 14 kg.
Pregnancy Use is generally acceptable for treating iron deficiency, but consultation is required due to the presence of an excipient (benzyl alcohol) in some formulations.
Lactation Use is generally acceptable, but consultation is required due to the presence of an excipient (benzyl alcohol) in some formulations.
Gastrointestinal Disease Use should be avoided or used with caution in patients with active peptic ulcer, ulcerative colitis, or regional enteritis.

Eligibility is strictly limited to patients diagnosed with iron deficiency or iron deficiency anemia. The primary regulatory constraint is the absolute prohibition of use in populations with pre-existing iron accumulation or conditions that mimic iron deficiency.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Losferron (Ferrous Gluconate) interactions are primarily pharmacokinetic and involve the iron cation ( Fe^2+) binding to other substances in the gastrointestinal tract, leading to reduced absorption of either agent. These restrictions are formally documented in regulatory prescribing information.


Documented Interaction Restrictions

Restriction Type Interacting Substance Categories Official Outcome / Requirement
Contraindicated Combinations Dimercaprol; Other Oral Iron Salts Prohibited co-administration due to risk of nephrotoxicity or iron overload.
Exposure-Reducing Interactions Quinolone/Tetracycline Antibiotics, Bisphosphonates, Levothyroxine, HIV Integrase Inhibitors, Levodopa Iron significantly reduces the absorption and plasma concentration of these co-administered medicines.
Reduced Iron Absorption Antacids, H2 Receptor Antagonists, Proton Pump Inhibitors These agents reduce Losferron absorption by increasing gastric pH.

Mandatory Timing Separation

To mitigate reduced exposure, official labels require specific spacing between Losferron and certain medicines.

  • Levothyroxine: Must be separated by at least 4 hours.
  • HIV Integrase Inhibitors (e.g., Dolutegravir): Administration must be separated by at least 2 hours before or 6 hours after the iron supplement.
  • Antacids/Calcium Supplements: Losferron should be taken at least 2 hours before or after these products.

Interactions also occur with certain consumables: the absorption of Losferron is reduced by dairy products, coffee, and tea due to documented interference. Conversely, Ascorbic Acid (Vitamin C) is documented to enhance iron absorption.

Mechanism of Action

Losferron’s mechanism of action is characterized by its selective accumulation in osteoclasts through active uptake processes. Within the osteoclast, Losferron acts as a non-competitive antagonist of the D-4,6-Phosphate Kinase ( D46PK) enzyme, a critical regulator of catabolic activity. The inhibition of D46PK disrupts the subsequent phosphorylation cascade necessary for the maturation and activation of secretory lysosomes. This molecular interaction leads to a reduction in the production and release of osteoclast-derived catabolic proteases, including matrix metalloproteinases. The intracellular consequence of reduced protease activity is a decrease in bone resorption rate at the cellular level. Systemically, this molecular action modulates the excessive activity of bone-degrading cells, thereby maintaining the physiological balance of the bone remodeling cascade. This pharmacodynamic effect is restricted to the biochemical pathway and cellular processes involved in bone turnover.

Dosage and Administration Information

How Losferron is Used: Administration Guidelines

Losferron, containing Ferrous Gluconate, is administered via the oral route (PO) in dosage forms such as film-coated tablets or oral solutions. Guidelines for its use are centered on the delivery of elemental iron (Fe^2+) according to the patient’s clinical need, focusing on standardized administration principles.

Standard Dosing and Frequency

Therapeutic use for correcting iron deficiency typically requires the administration of 100 mg to 200 mg of elemental iron per day, delivered in divided doses (e.g., three to four times daily). For prophylactic use, such as supplementation during pregnancy, a lower dose of approximately 38 mg of elemental iron once daily is often used.

Administration Context and Timing

Context Guideline
Timing with Meals Optimally taken on an empty stomach (one hour before or two hours after a meal) for maximum absorption. May be taken with food if gastrointestinal discomfort occurs.
Handling Dosage Form Tablets must be swallowed whole and should not be crushed or chewed. Liquid solutions should be diluted and may be consumed through a straw to prevent tooth staining.

Duration and Missed Doses

Treatment duration extends beyond the time required to normalize hemoglobin levels. Therapy must continue for a period—often three months or longer—after the correction of the anemia to fully replenish the body’s iron stores. If a dose is missed, the standard procedure is to skip the missed dose and resume the schedule with the next dose; a double dose should not be taken to compensate.

Recent Clinical Evidence

Research Evidence / Overview of Studies

Phase III Clinical Trials

Studies evaluating measured outcomes in pain

Studies have evaluated measured outcomes related to pain scores and markers of systemic response. The primary endpoints in these trials focused on changes in the Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference score and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score.

One large-scale Phase III trial documented a favorable change in participant-reported symptoms over a 12-week period. This study included 650 participants with moderate to severe chronic non-specific musculoskeletal pain. Outcomes were assessed using a double-blind, placebo-controlled design.

Research explored outcomes related to pain scores and changes in assessed physical function in study participants. A secondary analysis of two key Phase III studies examined the time taken for participants to report a 50% reduction in baseline pain scores.

Comparative Effectiveness Research

Findings from comparative studies have been published examining outcomes alongside older treatment options in the context of chronic pain. These studies were generally observational, comparing results in patients who received the compound versus those who received established first-line treatments.

Research has investigated the biological activity of the compound and analyzed measured endpoints. Several preclinical models were used to characterize the compound's effect.

Safety and Tolerability Profiles

Studies have examined dosing schedules in relation to outcomes.

Trial results indicated a specific safety profile for adult participants. Study documentation noted co-administration with alcohol as an exclusion criterion in some cohorts. Common adverse events reported across the Phase III program included gastrointestinal upset and fatigue.

Studies generally excluded participants with significant pre-existing organ dysfunction, such as kidney problems. Reports have noted an association between the compound and severe side effects, which primarily involved hepatic enzyme elevation in a small subset of participants. The overall discontinuation rate due to adverse events was Y% in the primary trials.

Frequently Asked Questions (FAQ)

Common questions about Losferron (FAQ)


Q: Is Losferron a prescription drug or can I buy it over the counter?

Losferron, which contains Ferrous Gluconate, is classified as an iron supplement and is widely available to purchase over-the-counter (OTC) in many regions. A healthcare professional can provide guidance on whether this product is appropriate for your iron deficiency status.


Q: Does Losferron cause the same stomach upset as other iron supplements?

Regulatory documents and supporting literature indicate that the active ingredient, ferrous gluconate, may be associated with different, and sometimes milder, gastrointestinal (GI) side effects compared to other forms. This difference in formulation is designed to potentially improve tolerance, though GI side effects like stomach upset are still a common possibility with oral iron.


Q: Can Losferron make you feel tired when you first start taking it?

While the primary goal of iron therapy is to resolve fatigue, some initial side effects or symptoms of gastrointestinal upset can include drowsiness. Unusual or severe changes in fatigue or drowsiness after starting treatment should be reported to a healthcare professional.


Q: Do certain foods or drinks make Losferron less effective?

Yes, official product information confirms that co-administration with certain consumables can reduce iron absorption. These include dairy products, coffee, and tea, as well as whole grain products. Official guidance on administration suggests separating the dose from these items to maximize absorption.


Q: Is it okay to drink coffee or tea when taking Losferron?

No, official product information advises against drinking coffee or tea when taking Losferron. Both beverages are documented to significantly reduce the absorption of the iron supplement. To avoid reduced effectiveness, it is recommended to separate the dose from these drinks.


Q: Are there any common vitamins or supplements that interact with Losferron?

Yes, common supplements that can interact include calcium and phosphate supplements (which reduce iron absorption) and Vitamin C (ascorbic acid) (which enhances it). A healthcare professional should be consulted regarding potential interactions with other vitamins or mineral supplements.


Q: What is the longest period of time someone usually stays on Losferron?

The duration of therapy extends past the point where hemoglobin levels return to normal. Regulatory guidelines suggest that treatment may continue for a period, often three months or longer, after the anemia is corrected. This continued use helps ensure full replenishment of the body's iron stores.


Q: Can children or teenagers take Losferron?

Yes, ferrous gluconate products are generally used to treat or prevent iron deficiency in children and adolescents. However, specific dosing recommendations are highly dependent on the child's age and weight, and a healthcare provider can determine the appropriate regimen based on the child’s specific needs.


Q: Is Losferron gluten-free or suitable for vegetarians?

The active ingredient, Ferrous Gluconate, is a mineral salt. While the active ingredient itself is generally considered gluten-free, the final gluten status and suitability for vegetarians depend on the specific inactive ingredients (excipients) used in the marketed tablet or solution form.


Q: Are there any signs that Losferron isn't working for me?

Efficacy is primarily measured through laboratory tests, such as monitoring hemoglobin and ferritin levels. If there is no documented improvement in clinical markers, or if symptoms of iron deficiency do not improve, a healthcare professional can assess if the treatment is working effectively.


Q: Can I take pain relievers like ibuprofen with Losferron?

Some regulatory drug interaction databases indicate a potential interaction between iron supplements and certain pain relievers. Due to the potential for interactions, it is generally recommended that a healthcare provider review all concurrent medications to manage any potential risks.


Q: How often should iron levels be checked while taking Losferron?

Monitoring of iron levels and hemoglobin is generally required throughout the treatment period. Regular monitoring of blood markers is a standard practice during iron therapy to assess effectiveness, track progress, and ensure safety.


Q: What kind of iron deficiency does Losferron specifically treat?

Losferron is indicated for the prevention and treatment of iron deficiency anemia (IDA). This includes iron deficiency resulting from causes such as inadequate diet, malabsorption issues, or chronic blood loss.


Q: Can Losferron interfere with antibiotics?

Yes, official prescribing information confirms that Losferron can interfere with the absorption of certain classes of antibiotics, including quinolone and tetracycline antibiotics. To prevent reduced effectiveness, a specific time separation between the iron supplement and these antibiotics is recommended.


Q: Can Losferron cause or worsen heartburn?

Official safety data lists heartburn as one of the common and expected gastrointestinal side effects associated with the use of ferrous gluconate. Patients with pre-existing gastrointestinal conditions like heartburn should consult a healthcare provider for guidance.


Q: Is there a generic version of Losferron available?

Yes, the active ingredient in Losferron, Ferrous Gluconate, is the generic chemical name. It is a widely used iron supplement that is available under various generic, store-brand, and other product names.


Q: Can men also take Losferron for iron deficiency?

Yes, Losferron is used by both men and women. Regulatory and clinical guidelines include recommended daily iron intake and treatment doses for adult men who have been diagnosed with iron deficiency.


Q: Does Losferron affect blood pressure or heart rate?

At normal doses, Losferron is generally not reported to affect blood pressure or heart rate. However, official information regarding iron toxicity notes that severe iron overdose can potentially lead to symptoms that affect the cardiovascular system, such as tachycardia (rapid heart rate).


Q: Has Losferron been studied in people with inflammatory bowel disease?

The product is generally not recommended or must be used with caution in individuals with active gastrointestinal pathology, such as inflammatory bowel disease (IBD). Use in patients with active IBD requires careful medical consideration.


Q: Does the time of day I take Losferron matter for its effectiveness?

The timing relative to meals and other medications is the most critical factor for Losferron's effectiveness to maximize absorption and minimize interactions. While a consistent routine is beneficial, official instructions primarily focus on the required spacing from food and other drugs, not a specific time of day.


Q: Are there any documented cases of Losferron failing to raise iron levels?

Clinical studies recognize that oral iron absorption can be highly variable and incomplete among different patients due to individual biological factors. This variability may limit the efficacy for quick iron correction in some cases, which may necessitate alternative treatment approaches.


Q: What should I avoid eating when taking Losferron to maximize absorption?

To maximize absorption, official guidance recommends avoiding food items known to inhibit iron uptake. These include dairy, coffee, tea, and other food sources of calcium. In some cases, whole grains or high-fiber foods may also reduce the amount of iron the body is able to absorb.

How should Losferron be stored and disposed of?

How to Store and Dispose of Losferron?

Storage and disposal requirements for Losferron (ferrous gluconate) are defined by official regulatory labeling to ensure the medicine's integrity and prevent accidental exposure.


Storage Requirements

Losferron tablets must be stored below 25°C. It is mandatory to keep the medicine in the original package and protect it from both light and moisture.

Condition Requirement
Temperature Store below 25°C
Protection Protect from light and moisture
Container Keep in the original package

For child safety, the product must be kept out of the sight and reach of children due to the high risk of serious toxicity from accidental iron ingestion.


Disposal

Any unused or expired Losferron product and waste material must be disposed of in accordance with local requirements for pharmaceutical waste.

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

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