Ferric Maltol

• ACCRUFER is indicated for the treatment of iron deficiency in adult and pediatric patients 10 years of age and older. ACCRUFER is an iron replacement product indicated for the treatment of iron deficiency in adult and pediatric patients 10 years of age and older.ICD-10: E61.1

• ACCRUFER is contraindicated in patients with a history of: Hypersensitivity to the active substance or to any of the excipients [see Description ( 11 )] . Reactions could include shock, clinically significant hypotension, loss of consciousness, and/or collapse.contraindicated

30 mg orally twice daily on an empty stomach 1 hour before or 2 hours after meals ( 2.1 ) Swallow capsules whole. Do not open, break, or chew capsules. ( 2.1 ) Continue as long as necessary to replenish body iron stores ( 2.1 ) 2.1 Recommended Dosage Adults and Children Aged 10 Years and Above ​ The recommended dosage of ACCRUFER is 30 mg orally twice daily, on an empty stomach 1 hour before or 2 hours after meals. Swallow capsules whole. Do not open, break, or chew capsules. Treatment duration will depend on the severity of iron deficiency but generally at least 12 weeks of treatment is required. The treatment should be continued as long as necessary until ferritin levels are within the normal range.

IBD Flare: Avoid use in patients with IBD flare ( 5.1 ) Iron Overload: Do not administer to patients with iron overload or those receiving intravenous iron. ( 5.2 ) Risk of Overdosage in Children Due to Accidental Ingestion: Keep out of reach of children. ( 5.3 ) 5.1 Increased Risk of Inflammatory Bowel Disease (IBD) Flare Avoid use of ACCRUFER in patients with an active inflammatory bowel disease (IBD) flare, as there is potential risk of increased inflammation in the gastrointestinal tract. 5.2 Iron Overload Excessive therapy with iron products can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis. Do not administer ACCRUFER to patients with evidence of iron overload or patients receiving intravenous iron [see Contraindications ( 4 )] . Assess iron parameters prior to initiating ACCRUFER and monitor iron parameters while on therapy [see Overdosage ( 10 ) and Clinical Pharmacology ( 12.2 )] . 5.3 Risk of Overdosage in Children Due to Accidental Ingestion Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

The following clinically significant adverse reactions are described elsewhere in the labeling: Increased Risk of Inflammatory Bowel Disease Flare [see Warnings and Precautions ( 5.1 )] Iron Overload [see Warnings and Precautions ( 5.2 )] Most common adverse reactions (incidence > 1%) are flatulence, diarrhea, constipation, feces discolored, abdominal pain, nausea, vomiting and abdominal discomfort/distension. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Shield Therapeutics Inc at 1-888-963-6267 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described below reflect exposure to ACCRUFER in 175 adult patients in the placebo-controlled phase of three randomized studies conducted in patients with anemia and quiescent inflammatory bowel disease (IBD) (Studies AEGIS 1 & 2) or non-dialysis dependent chronic kidney disease (CKD) (AEGIS 3). The pooled patient population had a mean age of 58 years, 67.4% were female (n=118), and 81.7% (n=143) were Caucasian. Table 1 presents all adverse reactions occurring in the placebo-controlled period of the pooled randomized studies [see Clinical Studies ( 14 )] occurring at a rate of > 1% in the treated group, and for which the rate for ACCRUFER exceeds the rate for placebo. Table 1.

8.1 Pregnancy Risk Summary ACCRUFER is not absorbed systemically as an intact complex following oral administration, and maternal use is not expected to result in fetal exposure to the drug [see Clinical Pharmacology ( 12.3 )] . In animal reproduction studies, oral administration of ferric or ferrous compounds to gravid CD1-mice and Wistar-rats during organogenesis at doses 13 to 32 times the recommended human dose resulted in no adverse developmental outcomes. An overdose of iron in pregnant women may carry a risk for spontaneous abortion, gestational diabetes and fetal malformation (see Data) . In animal reproduction studies, oral administration of maltol to pregnant Crl: COBS-CD (SD) BR rats during organogenesis at doses 6 times the recommended human dose resulted in no adverse developmental outcomes (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

No data are available regarding overdose of ACCRUFER in patients. Acute iron ingestion of 20 mg/kg elemental iron is potentially toxic and 200- 250 mg/kg is potentially fatal. Early signs and symptoms of iron overdose may include nausea, vomiting, abdominal pain and diarrhea. In more serious cases there may be evidence of hypoperfusion, metabolic acidosis and systemic toxicity. Dosages of ACCRUFER in excess of iron needs may lead to accumulation of iron in storage sites leading to hemosiderosis. Periodic monitoring of iron parameters such as serum ferritin and transferrin saturation may assist in recognizing iron accumulation. Do not administer ACCRUFER to patients with iron overload [ see Contraindications ( 4 ) ] . Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.

• Jul 25, 2019NDANDA212320Shield Tx

1. 1Constipation15716%
2. 2Inappropriate Schedule Of Product Administration10310%
3. 3Diarrhoea10110%
4. 4Abdominal Discomfort1009.9%
5. 5Nausea979.6%
6. 6Abdominal Pain Upper747.3%
7. 7Maternal Exposure During Pregnancy706.9%
8. 8Treatment Noncompliance605.9%
9. 9Drug Ineffective494.9%
10. 10Off Label Use383.8%
11. 11Vomiting333.3%
12. 12Death303.0%
13. 13Dizziness252.5%
14. 14Fatigue232.3%
15. 15Abdominal Pain222.2%

The 10 most recently updated of 16 ClinicalTrials.gov registrations naming Ferric Maltol as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Efficacy and Tolerability of Sucrosomial® Iron vs Ferric Maltol in Iron Deficient Women
  Recruiting · Phase 4 · Interventional · 146 enrolled · Pharmanutra S.p.a.
  NCT07308769updated 2026-03-23
• Perioperative Iron for Colorectal Cancer (PICoC Study)
  Completed · Phase 3 · Interventional · 40 enrolled · The Royal Wolverhampton Hospitals NHS Trust
  NCT05177484updated 2026-01-30
• Evaluate the Safety and Efficacy of Ferric Maltol Oral Suspension vs. Ferrous Sulfate Oral Liquid in Children and Adolescents Aged 2 to 17 Years With Iron-deficiency Anaemia, With a Single Arm Study in Infants Aged 1 Month to Less Than 2 Years
  Completed · Phase 3 · Interventional · 65 enrolled · Shield Therapeutics
  NCT05126901updated 2025-11-10
• Four-Way Crossover Study to Compare Ferric Maltol Capsules and Oral Suspension in Healthy Volunteers
  Completed · Phase 1 · Interventional · 32 enrolled · Shield Therapeutics
  NCT04626414updated 2025-08-24
• Evaluating the Effectiveness of Various Iron Salts in Oral Iron Therapy for Iron Deficiency and Anemia in Healthy Adults
  Unknown · Interventional · 59 enrolled · Liaquat University of Medical & Health Sciences
  NCT05985070updated 2025-04-16
• ORal IrON Supplementation with Ferric Maltol in Treating Iron Deficiency and Anaemia in Patients with Heart Failure (ORION-HF)
  Completed · Phase 4 · Interventional · 50 enrolled · Hannover Medical School
  NCT05697211updated 2025-03-07
• Predicting Response to Iron Supplementation in Patients With Active Inflammatory Bowel Disease
  Unknown · Phase 4 · Interventional · 90 enrolled · Leiden University Medical Center
  NCT05456932updated 2023-03-31
• Evaluate the PK, Safety, Tolerability of Ferric Maltol at 3 Dosage Levels in Paediatric Subjects With Iron Deficiency
  Completed · Phase 1 · Interventional · 37 enrolled · Shield Therapeutics
  NCT03181451updated 2021-10-06
• Study With Oral Ferric Maltol for the Treatment of Iron Deficiency Anemia in Subjects With Chronic Kidney Disease
  Completed · Phase 3 · Interventional · 167 enrolled · Shield Therapeutics
  NCT02968368updated 2020-11-02
• Safety and Efficacy Study of Oral Ferric Maltol Compared to Intravenous Iron To Treat Iron Deficiency Anaemia in IBD
  Completed · Phase 3 · Interventional · 250 enrolled · Shield Therapeutics
  NCT02680756updated 2020-11-02

Frequently asked questions

What is Ferric Maltol used for?

According to FDA labeling, Ferric Maltol carries indications including: ACCRUFER is indicated for the treatment of iron deficiency in adult and pediatric patients 10 years of age and older. ACCRUFER is an iron replacement product indicated for the treatment of iron deficiency in adult and pediatric patients 10 years of age and older.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Ferric Maltol?

Ferric Maltol is classified as Iron trivalent, oral preparations.

What are the brand names for Ferric Maltol?

Ferric Maltol is marketed under brand names including Accrufer.

What are the contraindications for Ferric Maltol?

Ferric Maltol labeling lists contraindications including: ACCRUFER is contraindicated in patients with a history of: Hypersensitivity to the active substance or to any of the excipients [see Description ( 11 )] . Reactions could include shock, clinically significant hypotension, loss of consciousness, and/or collapse.. Always consult the full prescribing information and a clinician.