Ferric maltol is a parenteral iron replacement indicated for the treatment of iron deficiency in adult and pediatric patients 10 years of age and older. It is available as capsules for oral use. MedsAcross supplies Ferric maltol for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
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.
Source: US FDA prescribing information
ACCRUFER delivers iron for uptake across the intestinal wall and transfer to transferrin and ferritin.
Source: US FDA prescribing information
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. Continue as long as necessary to replenish body iron stores
Source: US FDA prescribing information
ACCRUFER is contraindicated in patients with a history of: Hypersensitivity to the active substance or to any of the excipients. Reactions could include shock, clinically significant hypotension, loss of consciousness, and/or collapse. Hemochromatosis and other iron overload syndromes. Use may result in iron overdose. Receiving repeated blood transfusions. Use may result in iron overload. Hypersensitivity to the active substance or any excipient. Patients receiving repeated blood transfusions
Source: US FDA prescribing information
IBD Flare: Avoid use in patients with IBD flare. Iron Overload: Do not administer to patients with iron overload or those receiving intravenous iron. Risk of Overdosage in Children Due to Accidental Ingestion: Keep out of reach of children.
Source: US FDA prescribing information
The following clinically significant adverse reactions are described elsewhere in the labeling: Increased Risk of Inflammatory Bowel Disease Flare Iron Overload Most common adverse reactions (incidence > 1%) are flatulence, diarrhea, constipation, feces discolored, abdominal pain, nausea, vomiting and abdominal discomfort/distension.
Source: US FDA prescribing information
Dimercaprol: Avoid concomitant use. Oral Medications: Separate administration of ACCRUFER from certain oral medications. Monitor clinical responses as appropriate.
Source: US FDA prescribing information
Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Ferric maltol, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Accrufer 30 mg capsuleOral | Shield TX (UK) | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 1 presentations of Ferric maltol and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Ferric maltol, including Accrufer.
Yes. The US FDA first approved Ferric maltol on 25 July 2019, according to Drugs@FDA.
Yes. Ferric maltol has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Ferric maltol is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Ferric maltol is classified under ATC code B03AB10 (Ferric maltol).
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