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Accrufer

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Accrufer

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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 Accrufer

Property Description
Active ingredient Ferric maltol (Ferric trimaltol)
Form Oral capsules
Pharmacological class Iron replacement agent / Hematinic
General purpose Systematic iron repletion
Origin Synthetic coordination complex

What Type of Medicine is Accrufer (Ferric Maltol)?

The medicinal entity known as Ferric maltol is a prescription-only medicine indicated for the treatment of iron deficiency in adults. This drug is clinically classified as an iron replacement agent and belongs to the broader pharmacological category of hematinics, which are substances that support the formation of blood. It is administered via the oral route, with the active ingredient contained within a hard oral capsule, positioning it distinctly from intravenous preparations. Ferric maltol represents a specialized third-generation oral iron complex.

Composition: A Unique Iron Coordination Complex

The defining structural feature of the active ingredient is its synthetic coordination complex, which means it is a non-salt iron compound where ferric iron (Fe^3+) is tightly bound to the organic ligand maltol. This specific composition is designed to ensure the iron is delivered in a stable, pre-formed complex, a structural characteristic that differentiates it from older, inorganic iron salts like ferrous sulfate. This single-ingredient product is engineered to optimize the presentation of iron for absorption, contained within the capsule along with standard pharmaceutical excipients.

General Purpose and Iron Delivery Mechanism

The overall therapeutic purpose of Ferric maltol is the restoration of the body's iron stores and the correction of iron deficiency anemia (IDA). The medication is utilized when a patient requires sustained and efficient iron supplementation to address documented deficiency. It works through a targeted iron delivery mechanism, leveraging its unique structure to allow for efficient gastrointestinal absorption of the iron complex. By supplying utilizable iron, the medication supports the body's ability to synthesize hemoglobin and form healthy red blood cells, thereby providing the necessary foundation for systemic iron repletion.

Regulatory References

  1. DrugBank Entry

What side effects are possible with Accrufer?

Possible Side Effects and Safety Information

The official safety profile for ferric maltol, the active ingredient in Accrufer, is primarily defined by its effects on the gastrointestinal system and specific contraindications documented in regulatory labeling. The majority of reported adverse reactions are related to the digestive tract.

Frequency-Classified Adverse Reactions

Adverse reactions are classified according to incidence observed in clinical trials, using regulatory frequency bands. The most common effects are centered in the gastrointestinal tract, while others are classified as uncommon.

Classification Examples of Adverse Reactions (by System-Organ Class)
Common (1% to 10%) Flatulence, Diarrhea, Constipation, Abdominal pain, Nausea, Vomiting, Feces discoloration (dark stools)
Uncommon (0.1% to 1%) Headache, Small intestinal bacterial overgrowth, Acne, Joint stiffness, Increased blood alkaline phosphatase

Serious Safety Considerations

Ferric maltol is strictly contraindicated for use in individuals with conditions of iron overload, such as hereditary hemochromatosis, or in those who require repeated blood transfusions, as these situations increase the risk of iron accumulation. The drug is also contraindicated in cases of known hypersensitivity to the active substance or excipients. Regulatory warnings emphasize the serious risk of accidental iron poisoning in children and advise caution regarding the potential for an Inflammatory Bowel Disease (IBD) flare; use should be avoided during an active flare.

Population and Duration Notes

Official documents indicate that no dose adjustment is typically needed for older adults or patients with mild to moderate renal impairment (eGFR ge 15 mL/min/1.73 m^2). Regarding exposure, studies note that abdominal pain was the most common adverse reaction leading to the discontinuation of treatment. Warnings also exist regarding the excipients Allura Red AC (E129) and Sunset Yellow FCF (E110), due to their potential to cause allergic reactions.

Overdose and Emergency Response

Overdose Manifestations and Risks

Accidental overdose of iron-containing products, including ferric maltol, is documented by regulatory authorities as a leading cause of fatal poisoning in children under six years of age. This risk mandates that the product must be kept out of the reach of children.

Overdose manifestations relate primarily to the effects of excess iron on the body. Early clinical signs of overdose may include acute gastrointestinal symptoms such as nausea, vomiting, abdominal pain, and diarrhea. Chronic exposure beyond therapeutic necessity carries the separate risk of iron overload, which can result in the excessive storage of iron, known as iatrogenic hemosiderosis.

When to Seek Urgent Medical Help

Accidental overdose is classified as a medical emergency. Regulators explicitly require that in case of overdose, immediate action must be taken to seek emergency medical attention or call a doctor or a Poison Control center immediately.

Management of iron overdose is generally based on providing symptomatic and supportive treatment. Because of the potential for iron accumulation, monitoring of iron parameters is necessary to assess the risk of chronic iron overload resulting from excessive exposure.

Therapeutic Uses of Accrufer

Main Uses of Accrufer

Accrufer (ferric maltol) is an oral iron replacement product primarily used to treat iron deficiency in adults. It is specifically formulated to increase iron levels in individuals who have low iron stores, regardless of whether they have also developed anemia.

Iron deficiency occurs when the body lacks sufficient iron to function properly. This condition is common in individuals with various underlying health issues, including:

  • Inflammatory Bowel Disease (IBD): Such as Crohn's disease or ulcerative colitis.
  • Chronic Kidney Disease (CKD): Where iron absorption or utilization may be impaired.
  • Other Chronic Conditions: Various long-term health issues that can interfere with iron balance or lead to blood loss.

How Accrufer Works

Accrufer utilizes a unique chemical complex consisting of iron (ferric iron) bound to maltol. This formulation is designed to keep the iron stable and soluble within the gastrointestinal tract. This stability allows the iron to be available for absorption in the small intestine, from where it enters the bloodstream and is transported to the bone marrow for red blood cell production or stored for future use.

Because the iron is tightly bound to the maltol ligand until it reaches the site of absorption, less "free iron" is released into the gut environment. This mechanism is intended to provide an effective way to replenish iron levels while being managed by the body's natural uptake processes.

Expected Benefits

The primary goal of Accrufer treatment is to restore healthy iron levels. The benefits associated with successful iron replacement include:

  • Increased Hemoglobin Levels: For those who have progressed to iron deficiency anemia, treatment can help raise hemoglobin levels, improving the blood's oxygen-carrying capacity.
  • Replenishment of Iron Stores: Accrufer helps build up ferritin levels, which represents the body's stored iron reserves.
  • Improvement in Symptoms: Addressing iron deficiency may help alleviate common symptoms such as fatigue, weakness, and shortness of breath, which often occur when iron levels are insufficient for the body's needs.

Eligibility and Restrictions for Use

Who Can and Cannot Use Accrufer (Ferric Maltol)

Official regulatory information strictly defines the population eligible to use Accrufer as adults (age 18 years and older) with iron deficiency. Use in pediatric patients (under 18) is officially not established due to insufficient safety and effectiveness data.

Absolute Contraindications

Accrufer is contraindicated and must not be used in the following populations:

  • Patients with a known history of Hypersensitivity to ferric maltol or any product excipient.
  • Individuals with Hemochromatosis or other iron overload syndromes.
  • Patients receiving repeated blood transfusions.

Restricted and Conditional Use

Eligibility is conditional based on certain clinical statuses:

  • Inflammatory Bowel Disease (IBD): Use should be avoided in patients experiencing an active IBD flare.
  • Organ Impairment: No dose adjustment is needed for non-severe renal impairment. However, no clinical data is available for use in patients with impaired hepatic function or severe renal impairment.

Pregnancy and Lactation

Use is permitted if clinically needed during both pregnancy and lactation, as the drug’s limited systemic absorption is not expected to result in exposure to the fetus or breastfed child.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Ferric maltol's official interaction profile is characterized primarily by its potential for cation binding and the risk of iron accumulation, as documented in regulatory information.

Contraindicated and Restricted Combinations

Co-administration with Intravenous Iron is prohibited due to the risk of iron overload. Concomitant use with Dimercaprol must be avoided due to the documented increase in the risk of nephrotoxicity. Additionally, co-administration with other oral iron supplements is restricted to minimize the potential for excessive iron intake. Regulatory documents also advise against combining ferric maltol with Chloramphenicol and Methyldopa due to documented interference with iron incorporation and potential antagonism of therapeutic effects, respectively.

Pharmacokinetic and Timing Constraints

Ferric maltol may decrease the bioavailability of several co-administered oral medications by forming complexes in the gastrointestinal tract. This effect is specifically noted for quinolone and tetracycline antibiotics, as well as drugs such as Mycophenolate and Levothyroxine.

To mitigate this reduction in exposure, regulatory labels mandate specific timing separation rules. Administration of ferric maltol must be separated by at least 2 to 4 hours from these affected oral medicines. Furthermore, ferric maltol should be taken on an empty stomach, separated from antacids, to avoid reduced iron absorption.

Mechanism of Action

️ Targeted Iron Delivery by Chelation

Ferric maltol's mechanism of action is based on its unique chemical structure: a stable ferric trimaltol coordination complex. This structure facilitates the controlled delivery of iron for incorporation into systemic metabolic pathways. The chelation maintains the iron atom in a protected state, reducing its availability for non-specific binding as it passes through the acidic stomach environment. Upon reaching the alkaline duodenum and jejunum, the complex undergoes dissociation to donate the Fe^3+ atom directly to the intestinal enterocytes . This mechanism dictates the rate and proportion of iron presented for absorption, contributing to the bioavailability of ferric iron.

Systemic Transport and Substrate Provision for Hemoglobin Synthesis

Following donation, the iron is absorbed and immediately binds to the transport protein Transferrin in the bloodstream, which is the major protein responsible for the transport and distribution of iron throughout the body. The mechanism enables the delivery of the iron substrate to the bone marrow, the site of erythropoiesis (red blood cell production). This availability allows the iron to be efficiently incorporated into the Hemoglobin molecule, while simultaneously facilitating the deposition of iron into long-term reserves bound to the storage protein Ferritin.

Dosage and Administration Information

How to Use Accrufer (Ferric Maltol)

Accrufer (ferric maltol) is an iron replacement agent administered via the oral route as a 30 mg hard capsule. The standardized regimen for adults requires a total daily dose of 60 mg, achieved by taking one capsule twice daily (BID).

Proper use is strictly governed by timing relative to meals. To ensure optimal absorption, the capsule must be taken on an empty stomach, defined as 1 hour before or 2 hours after a meal. The medicine should be swallowed whole with water; patients are specifically instructed not to open, break, or chew the capsule to maintain its intended delivery mechanism. Administration must also be separated by at least two hours from compounds like oral calcium or magnesium salts.

The duration of use is not fixed but is guided by the clinical goal of replenishing the body's iron stores. Treatment typically requires a minimum of 12 weeks and continues until serum ferritin levels are normalized.

Population-Specific Usage

Patient Group Official Administration Guidance
Older Adults No dose adjustment is typically needed.
Renal Impairment No dose adjustment is needed for patients with eGFR ge 15 mL/min/1.73 m^2.
Pediatric Patients Safety and efficacy are not established for use in individuals under 17 years of age.

Recent Clinical Evidence

Accrufer: Recent Clinical Evidence

Clinical evidence for ferric maltol (Accrufer) is based primarily on three pivotal Phase 3 randomized, double-blind, placebo-controlled trials. These studies investigated the compound's use in adult patients with iron deficiency anemia (IDA), particularly in populations associated with chronic inflammation or underlying conditions like inflammatory bowel disease (IBD) or chronic kidney disease (CKD).

Key Findings in Iron Indices

Research evaluated changes in hematological parameters following the administration of ferric maltol versus a placebo.

  • Hemoglobin (Hb) Concentration: In one study involving patients with IDA associated with IBD, the mean change in Hb concentration from baseline to Week 12 was numerically higher in the ferric maltol group compared to the placebo group. A statistically significant difference in mean Hb change was observed between the two groups at Week 12.
  • Iron Stores: Studies also assessed changes in iron storage and transport. Mean serum ferritin concentrations and transferrin saturation (TSAT) were observed to increase steadily in the ferric maltol groups across the primary 12 to 16-week study periods.

Research in Specific Populations

Specific trials focused on populations where iron deficiency is often complicated by inflammation or absorption issues:

  • IBD and CKD: Two of the pivotal studies examined adults with IDA and underlying IBD, and one studied patients with non-dialysis-dependent Stage 3 or 4 CKD. These studies provided the core data used by regulatory bodies to evaluate the compound's clinical profile.
  • Long-Term Data: Open-label extension phases of these trials provided long-term data for up to 64 weeks, during which participants maintained observed improvements in Hb concentration and iron indices.

Key Studies & References

  1. Oral ferric maltol for treatment of iron deficiency anemia in adults with or without inflammatory bowel disease: a phase 3 randomized, controlled trial (AEGIS-II)

Frequently Asked Questions (FAQ)

Common questions about Accrufer (FAQ)

Q: Why is Accrufer considered an effective treatment for iron deficiency?

A: Accrufer (ferric maltol) is an iron replacement agent that is indicated for the treatment of iron deficiency in adults, according to regulatory documents. Its specific formulation is designed to provide iron for the body to use in restoring iron levels.

Q: How quickly can a person generally expect to see an increase in their iron levels after starting Accrufer?

A: Clinical studies have examined the response to treatment over several weeks. Official information indicates that increases in iron stores (ferritin) and red blood cell components (hemoglobin) are typically observed during the primary study periods, which ranged from 12 to 16 weeks.

Q: How long is the typical course of treatment with Accrufer for iron deficiency?

A: The exact duration of use is determined by a healthcare provider. According to official prescribing information, treatment generally requires a duration of at least 12 weeks. It is intended to continue until the body's iron stores, monitored through blood tests like ferritin levels, are assessed to be within the normal range.

Q: Are there any specific foods or drinks that should be avoided while taking Accrufer?

A: The official guidance does not list specific foods or drinks that must be avoided. However, the medicine must be taken on an empty stomach (separated from meals) to promote optimal absorption.

Q: Do certain antibiotics need to be spaced out from the time Accrufer is taken?

A: Yes, official documents specify that the medicine should be administered separately from certain oral medications. To reduce the risk of decreased bioavailability, Accrufer must be separated by at least four hours from antibiotics such as those in the quinolone and tetracycline classes.

Q: Is it safe to take multivitamins or other supplements that contain iron while also on Accrufer?

A: Official product information indicates that co-administration with other oral iron supplements is restricted. This restriction is in place to minimize the potential for excessive iron intake.

Q: Is Accrufer a treatment for general anemia or specifically for iron deficiency anemia?

A: Accrufer is specifically indicated and approved for the treatment of iron deficiency and the resulting condition known as iron deficiency anemia (IDA). It is utilized to restore the iron that the body is missing.

Q: Can individuals with celiac disease or gluten sensitivity use Accrufer capsules?

A: Official ingredient lists do not specifically mention gluten. However, the inactive ingredients in the capsule may contain substances like lactose, which should be considered by individuals with known sensitivities or intolerances.

Q: Is there any information about using Accrufer during pregnancy or while breastfeeding?

A: Official information indicates that, due to limited systemic absorption, maternal use is not anticipated to result in exposure to the unborn fetus during pregnancy or to a breastfed child.

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

A: The inactive components of the capsules do include lactose. Additionally, the medicine may contain coloring agents (like E129 and E110) that have the potential to cause allergic reactions in some individuals.

Q: What kind of monitoring (like blood tests) is typically required while a person is taking Accrufer?

A: To manage the risk of iron accumulation and to assess the body's response, a healthcare provider will typically check the level of iron in the blood before starting treatment and continue monitoring these levels during the course of therapy.

Q: Is Accrufer available as a generic medicine, or only as a brand name?

A: Ferric maltol, the active ingredient in Accrufer, is currently available only as the brand-name medicine, Accrufer, in the United States.

Q: Are there any known long-term side effects associated with using Accrufer for an extended period?

A: Clinical trials included studies with long-term data, with some extension phases running for up to 64 weeks. During these studies, the side effect profile, which is predominantly gastrointestinal, was continuously monitored.

Q: Does Accrufer interact with thyroid hormones or thyroid medication?

A: Yes, regulatory documents note that Accrufer may decrease the bioavailability, or absorption, of certain medicines. This effect is specifically noted for Levothyroxine, a commonly prescribed thyroid medicine.

Q: Is a metallic taste in the mouth a common side effect of Accrufer?

A: While the most frequently reported side effects are gastrointestinal, a metallic taste in the mouth has been reported in post-marketing experience with iron-containing products generally.

Q: Can Accrufer cause allergic reactions, and what are the signs to watch for?

A: Accrufer is contraindicated for patients with a known history of hypersensitivity to the active substance or any excipients. Serious allergic reactions are possible, and signs may include symptoms such as swelling of the face or throat or trouble breathing.

Q: What is the risk associated with accidental swallowing of Accrufer capsules by children?

A: Official warnings emphasize that accidental overdose of iron-containing products is a leading cause of death from poisoning in children under the age of six. For this reason, official warnings advise that the medicine should be kept safely out of the sight and reach of children.

Q: Have studies examined the efficacy of Accrufer in patients with conditions like heart failure and low iron?

A: While the primary studies focused on patients with conditions like IBD and CKD, research has also included studies, such as a Phase 4 trial, that examined the medicine's use in patients with heart failure who also have iron deficiency.

Q: Can a person stop taking Accrufer once their iron levels have returned to normal?

A: The duration of treatment is guided by the need to replenish iron stores and typically continues until blood tests confirm that ferritin levels are within the normal range. The decision to change or discontinue the medication is guided by the healthcare provider based on the results of monitoring.

Q: Is Accrufer ever prescribed in combination with intravenous (IV) iron treatments?

A: No. Official prescribing information states that co-administration with Intravenous Iron is strictly prohibited. This is because combining the two medicines has been associated with a risk of excessive iron levels in the body.

Q: Does Accrufer interact with calcium supplements?

A: Yes, official product information advises separating the administration of Accrufer from oral calcium supplements and magnesium salts. This separation is noted to help avoid a reduced absorption of the iron.

Q: Is it possible to have an allergic reaction to the ferric maltol ingredient itself?

A: Yes, the product information indicates that the medicine is contraindicated for patients who have a known history of hypersensitivity to the active substance (ferric maltol) or to any of the other excipients.

Q: How does a person know if their iron stores are fully replenished after taking Accrufer?

A: The state of the iron stores is confirmed by a healthcare provider, who uses ongoing blood tests to monitor key indicators. The goal of treatment is typically achieved when serum ferritin levels have normalized.

Q: Can taking Accrufer cause changes in appetite or lead to unexpected weight loss?

A: Changes in appetite or weight loss are not listed as common side effects. However, official warnings note that loss of appetite and weight loss can be symptoms of an underlying, serious condition, such as an inflammatory bowel disease (IBD) flare, which should be monitored.

Q: What happens if a person taking Accrufer misses a dose?

A: The official label does not provide specific instructions for a missed dose.

Q: Does Accrufer interact with common medications for Parkinson's disease, suchs as levodopa?

A: Official documents caution that iron products can interact with certain medications for Parkinson's disease, such as Levodopa. The iron can form a complex with the medicine, which may reduce the bioavailability (absorption) of the Parkinson's medication.

Q: Is it necessary to take Accrufer with food or should it be taken on an empty stomach?

A: The official product information specifies that Accrufer must be taken on an empty stomach. This separation from meals is advised to support optimal absorption of the medication.

How should Accrufer be stored and disposed of?

How to Store and Dispose of Accrufer?

Accrufer (ferric maltol) capsules must be stored at Controlled Room Temperature, which is 20 C to 25 C (68 F to 77 F), with permitted excursions up to 30 C (86 F). The medicine must be kept in its original container and the container must be tightly closed to provide protection from moisture.

Handling and Disposal

The product must be kept out of the sight and reach of children due to the serious risk of fatal iron poisoning from accidental overdose. Any unused or expired Accrufer should be managed as pharmaceutical waste and disposed of according to local regulatory requirements, and should not be discarded into household trash or wastewater.

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

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