Feraccru

Selected form

There is no image.

Ferric Maltol

Treatment option: Iron Deficiency

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 Feraccru

Property	Description
Active ingredient	Ferric Maltol (INN)
Form	Hard capsule
Pharmacological Class	Oral Iron Replacement Therapy / Hematopoietic agent
General Purpose	To supplement and restore the body's iron reserves
Origin	Synthetic coordination complex

Feraccru is the trade name for the prescription-only medication containing the active ingredient Ferric Maltol, which is categorized as an oral iron replacement therapy and functions as a hematopoietic agent. The drug is prepared as a hard capsule intended exclusively for oral administration, designed to efficiently supply elemental iron to the body.

What Type of Medicine is Feraccru?

Feraccru belongs to the class of iron trivalent, oral preparations and is considered a non-salt based iron compound. The active ingredient, Ferric Maltol, is a synthetic coordination complex distinct from older, traditional iron salts like ferrous sulfate. This specific formulation utilizes trivalent iron (Fe^3+) bound to the organic ligand Maltol, creating a stable, non-ionic structure that represents a modern method in oral iron delivery. The unique structure is clinically recognized for its potential to reduce some of the gastrointestinal challenges often associated with conventional iron forms.

Composition and General Purpose

The capsule delivers the active ingredient in a stable compound, which facilitates absorption through a different route than standard iron salts, aiming to maximize the utility of the delivered iron. The fundamental purpose of Ferric Maltol supplementation is to provide a readily available source of iron to the systemic circulation to support critical physiological processes. By supplying elemental iron, the medication supports the creation of hemoglobin, the essential protein that carries oxygen in the red blood cells to all tissues and organs. The ultimate goal is to restore the body's iron reserves which are depleted in iron-deficient states.

What side effects are possible with Feraccru?

Possible Side Effects and Safety Information

The official safety profile for Ferric Maltol (Feraccru/Accrufer) details adverse reactions primarily within the Gastrointestinal disorders System-Organ Class (SOC). These effects are classified according to regulatory standards based on frequency observed in clinical studies.

Frequency-Classified Adverse Reactions

The most frequently documented reactions are classified as Common (affecting 1 to 10 users in 100). These typically involve a cluster of gastrointestinal events such as abdominal pain, flatulence, nausea, diarrhea, constipation, and vomiting. Additionally, discoloured faeces is a common and expected finding. Reactions classified as Uncommon (affecting 1 to 10 users in 1,000) extend to other systems, including headache (Nervous system disorders), acne and erythema (Skin and subcutaneous tissue disorders), and joint stiffness (Musculoskeletal disorders).

Safety Constraints and Special Populations

Official regulatory documents define specific contraindications (situations where the medicine should not be used). These include conditions of pre-existing iron overload (such as hemochromatosis or hemosiderosis) and a known history of hypersensitivity to the medication. The medicine is also contraindicated in patients receiving repeated blood transfusions.

Safety notes for specific populations state that use must be avoided in patients experiencing an active flare of Inflammatory Bowel Disease (IBD). Furthermore, the safety and effectiveness of Ferric Maltol have not been established for use in pediatric patients (17 years and younger).

Overdose and Emergency Response

Overdose and When to Seek Help

Immediate Medical Attention is Required for Overdose

Accidental overdose with iron-containing products, including ferric maltol, is a leading cause of fatal poisoning in children under six. Due to the severe and potentially life-threatening nature of iron toxicity in children, all cases of suspected accidental ingestion require immediate emergency medical help.

Overdose Symptoms and Presentations

Initial signs of an acute iron overdose typically occur within six hours of ingestion and involve significant gastrointestinal distress. These early symptoms may include:

Nausea and repeated vomiting
Severe abdominal pain or cramps
Diarrhea, which may be bloody or black

As the overdose progresses and iron is absorbed into the bloodstream, it can lead to systemic toxicity, potentially causing serious complications. More severe presentations that require critical care include signs of shock, such as low blood pressure (hypotension) and evidence of poor tissue perfusion (hypoperfusion), along with metabolic acidosis and organ damage, notably to the liver and kidneys. In rare, late-stage cases of severe poisoning, scarring or stricture of the stomach or bowels may occur.

What to Do in Case of Overdose

If you suspect an overdose has occurred, or if a child accidentally ingests this medicine, contact a poison control center or seek help from an emergency room right away. Do not wait for symptoms to appear before calling for help.

Therapeutic Uses of Feraccru

Quick Facts

Primary Therapeutic Domain: Management of low iron levels in the body.
Approved Use: Treatment for iron deficiency in adults.
Potential Benefit: May support the restoration of the body's iron stores and help address symptoms associated with deficiency.

Feraccru is a medicinal product approved for the treatment of iron deficiency in adults. This condition is characterized by low levels of iron in the body, which can affect physiological processes and overall well-being. The use of Feraccru is intended to help the body restore its iron stores, which is a key process for the production of hemoglobin and addressing related concerns.

In clinical practice, this medication is used to manage confirmed iron deficiency, with or without anemia. The duration of the treatment course depends on the individual's specific requirements, aiming to maintain iron levels within an appropriate range. Healthcare professionals determine if this therapeutic option is suitable for the patient's condition after appropriate diagnostic testing.

The medication may contribute to the maintenance of appropriate iron status in the body, supporting a patient’s well-being and management of their condition.

Eligibility and Restrictions for Use

Official Eligibility for Feraccru (Ferric Maltol)

Feraccru is primarily approved for the treatment of iron deficiency in adults aged 18 and older. The official label explicitly defines populations who must not use the medicine and those who require conditional consideration based on health status.

Prohibited Use (Contraindications)

The medicine is contraindicated in patients with conditions that increase the risk of excess iron, including known Iron Overload Syndromes (such as hemochromatosis) and those receiving repeated blood transfusions. It must also not be used by individuals with a documented Hypersensitivity to ferric maltol or any excipient, or those with specific rare hereditary issues like galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption.

Eligibility Restrictions and Status

Age-Group: Use is not recommended in children and adolescents (under 18) because safety and efficacy have not been established by regulatory authorities.
Inflammatory Bowel Disease (IBD): Use should be avoided during an active IBD flare. Furthermore, it is not recommended for IBD patients with haemoglobin below 9.5 g/dl.
Physiological Status: Use may be considered during pregnancy and breastfeeding if clinically necessary.
Organ Function: Data is insufficient to guide dose adjustment in patients with severe renal or hepatic impairment, meaning use is not established for these populations.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official regulatory profile for Ferric Maltol establishes two primary types of interaction constraints: mandated prohibitions and specific timing requirements.

Contraindicated and Avoided Combinations

Co-administration with certain products must be avoided based on formal regulatory statements outlining specific risks:

Intravenous Iron Salts: Avoided combination due to the risk of inducing hypotension or collapse from rapid iron release into the circulation.
Dimercaprol: Avoided due to documented risk of nephrotoxicity when combined with oral iron preparations.
Chloramphenicol: Avoided because it is documented to interfere with erythropoiesis and delay plasma iron clearance.
Methyldopa: Concomitant use should be avoided as oral iron may antagonise the hypotensive effect of Methyldopa.

Exposure-Altering Interactions and Timing Rules

Numerous oral medicinal products are subject to separation rules due to a chelation or binding interaction that reduces their absorption and bioavailability.

Mandatory Separation: Drugs such as Fluoroquinolone antibiotics (e.g., Ciprofloxacin, Levofloxacin), Levothyroxine, Bisphosphonates, and Penicillamine must be administered at least 2 hours apart from Feraccru.
Tetracycline antibiotics require a separation of 2 to 3 hours to reduce the loss of both agents' absorption.
Food: Food is documented to significantly inhibit uptake of Ferric Maltol, necessitating administration on an empty stomach.

Mechanism of Action

Intestinal Iron Delivery and Stability

Feraccru (ferric maltol) exerts its action through the targeted delivery and absorption of ferric iron in the small intestine. The ferric ( Fe^3+) iron is tightly bound to a trimaltol ligand, forming a stable coordination complex. This stable complex resists degradation in the acidic gastric environment, thereby maintaining the iron in a soluble form and preventing the formation of insoluble precipitates in the gut lumen.

Enterocyte Uptake and Release

Upon reaching the small intestine, the change to a mildly alkaline pH facilitates the dissociation of the ferric-trimaltol complex. The released ferric iron is then made available for uptake across the apical membrane of the intestinal wall (enterocytes). This uptake pathway is believed to involve specific transport mechanisms, potentially including the divalent metal transporter 1 (DMT1) or integrin beta-3. The pathway is subject to feedback regulation corresponding to the body's physiological iron requirements.

Systemic Distribution and Storage

Following transepithelial absorption, the iron is released into the bloodstream. Here, it rapidly binds to the transport protein transferrin for systemic distribution to various tissues, including the bone marrow for erythropoiesis. Excess iron is subsequently taken up and incorporated into the storage protein ferritin. This process mediates the homeostatic allocation of absorbed iron within the systemic circulation and storage pools.

Dosage and Administration Information

How to Use Feraccru (Ferric Maltol)

Feraccru is a hard capsule intended for oral use only, administered according to specific instructions.

Official Administration Guidelines

Administration Scope	Instruction
Recommended Dose	One 30 mg capsule, twice daily (morning and evening).
Administration Method	Swallow the capsule whole with half a glass of water. Do not open, break, or chew the capsule.
Timing Restriction	Take on an empty stomach. This is typically defined as 1 hour before or 2 hours after a meal, as absorption is reduced by food.
Treatment Duration	Treatment requires a minimum of 12 weeks and should be continued as long as necessary to replenish the body's iron stores, as determined by blood tests.
Age Restriction	Indicated for adults only. Safety and efficacy in children 17 years and under have not been established.
Drug Separation	Certain medications, including tetracycline antibiotics and specific quinolones, must be separated from Feraccru by at least two hours to prevent reduced absorption of either medication.
Missed Dose	If a dose is missed, skip the missed dose and take the next dose at the regular scheduled time. Do not take a double dose to make up for a missed one.

These instructions define the precise delivery of the medication to maximize its effectiveness. The requirements for twice-daily dosing on an empty stomach and the separation from certain other oral medications are critical procedural steps for correct use.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Feraccru

The research base for Ferric Maltol (Feraccru) is built upon official clinical trials and regulatory reviews. This summary describes the structure of that evidence, focusing on what was studied and what the research findings describe, without offering clinical advice or recommendations.

Evidence for Use in Iron Deficiency Anemia (IDA) in Adults with Chronic Conditions

Key research was conducted through Phase III Randomized, Double-Blind, Placebo-Controlled Trials (RCTs). These short-term trials were conducted primarily to see what patterns in iron levels and blood biomarkers were observed when the compound was evaluated against an inactive pill (placebo).

Research examined adults who had confirmed IDA associated with specific conditions, such as Inflammatory Bowel Disease (IBD) or Chronic Kidney Disease (CKD) that did not require dialysis. These studies monitored key outcomes related to systemic or functional imbalance, specifically looking at measurement of Hemoglobin (Hb) concentration, which carries oxygen, and iron storage and transport markers like ferritin and Transferrin Saturation (TSAT).

Findings describe patterns observed in the studies where the measurements of Hemoglobin, ferritin, and TSAT showed changes from the initial baseline measurements compared to the placebo groups over the study period. Studies also explored outcomes reflecting daily functioning or activity level, using patient-reported outcomes describing perceived discomfort. These findings help contextualize how patients reported their experience during the short-term trials.

Comparative Studies Against Other Iron Therapies

Research examined how the compound was evaluated against other iron treatments for IDA. Randomized trials were observed in comparison to either traditional oral iron salts (like ferrous sulfate) or to intravenous (IV) iron.

These comparison studies monitored similar outcomes, including the measurement of Hb concentration and iron status markers. The research provides insight into short-term patterns that were observed when comparing the compound on iron indices against these other treatment methods. Comparative evidence is lacking for many other specific forms of iron and the follow-up durations were limited, meaning the data available reflect specific, short-term research scenarios.

Long-Term Studies and Follow-Up Data

Studies were designed to monitor participants for longer periods after the initial, controlled research phase was complete. These open-label extension studies were observed in adult populations who completed the primary trials, primarily those with IBD.

Research describes the patterns related to iron status—specifically the levels of Hemoglobin and ferritin—for time intervals extending up to approximately one year (52 to 64 weeks). These studies contribute to the broader evidence landscape by providing data on longer periods of observation, but they do not compare the compound use against a placebo or alternative treatment over that full extended period.

Evidence in Special Populations

Research has explored the compound's use outside of the core adult groups with chronic conditions. Specifically, ferric maltol was evaluated in adolescents and children.

Studies monitored young patients in different age ranges (from infants to 17 years old) with confirmed iron deficiency or IDA. These research scenarios sometimes involved an oral suspension formulation of the compound rather than the adult capsule. Research describes patterns related to iron uptake in these younger populations, alongside the measurement of Hb and iron biomarkers over defined time intervals, providing context on how changes were measured in these groups.

What Is Still Uncertain About Feraccru Research

While the research base is supported by Phase III RCTs, several areas remain where evidence is limited or ongoing:

Generalizability: The results apply only to the populations studied, meaning that the full long-term effects are not fully established in the general adult population with IDA who do not have IBD or CKD.
Severity of Anemia: Data for certain groups remain insufficient, particularly for patients presenting with very low Hemoglobin levels (severe anemia), as these individuals were often excluded from the core pivotal trials.
Duration and Comparison: Follow-up durations were limited for the comparative studies, meaning limited information for long-term outcomes when stacked against different oral or IV iron products is available.
Subgroup Data: Certainty remains low regarding outcomes in highly specific subgroups, as data for these groups remain insufficient to draw strong conclusions outside the main IBD and CKD cohorts.

Key Studies & References

Study With Oral Ferric Maltol for the Treatment of Iron Deficiency Anemia in Subjects With Chronic Kidney Disease (AEGIS-CKD)

Frequently Asked Questions (FAQ)

Common questions about Feraccru (FAQ)

Q: What is Feraccru used for?

Feraccru is a medicine prescribed to treat iron deficiency anemia in adults with Chronic Kidney Disease (CKD) who are not on dialysis, or in adults with Inflammatory Bowel Disease (IBD). It is a prescription-only treatment.

Q: How should I take Feraccru capsules?

The official prescribing information for Feraccru provides guidance on how it should be taken. It is generally advised to swallow the capsules whole with water. You should always follow the specific instructions given by your healthcare provider regarding timing and whether to take it with or without food.

Q: What are the most common side effects of Feraccru?

Like most medicines, Feraccru may cause side effects. The most commonly reported side effects include gas (flatulence), diarrhea, constipation, abdominal pain, and nausea. It is important to discuss any persistent or bothersome side effects with your doctor.

Q: Can I stop taking Feraccru if I start feeling better?

Iron deficiency treatment is often long-term, even after symptoms improve. Stopping the medication early could result in your iron levels dropping again. Do not stop taking Feraccru without consulting your healthcare provider, as they will determine the duration of treatment based on your individual lab results and medical condition.

Q: What should I do if I miss a dose of Feraccru?

If you miss a dose, it is generally advised to take the missed dose as soon as you remember, unless it is almost time for your next scheduled dose. If that is the case, you should skip the missed dose and continue with your regular schedule. Do not take a double dose to make up for a missed one. Specific guidance may vary, so always refer to the instructions provided by your pharmacist or doctor.

How should Feraccru be stored and disposed of?

Feraccru (ferric maltol) capsules must be stored and handled according to specific conditions mandated by regulatory labeling to maintain stability and ensure safety.

Storage Requirements

Condition	Regulatory Statement
Temperature	Store at controlled room temperature, specifically 20, C to 25, C (68, F to 77, F). Store below 25, C (European labeling).
Protection	Must be stored in the original container and protected from heat and moisture.
Stability Limit	The product must be used or discarded within 45 days of first opening the bottle.
Child Safety	Keep out of the sight and reach of children. The risk of accidental overdose from iron-containing products is cited in regulatory warnings.

Disposal Instructions

Official labeling states that there are no special requirements for disposal of the unused product or waste material. Disposal must be conducted in accordance with local requirements.

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