Ferric Maltol: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: May 20, 2026🚩 Report this page

Ferric Maltol

Iron Trivalent, Oral Preparations

Sold as Feraccru

EU EMAGB MHRA

Drug class: Iron Trivalent, Oral Preparations
Availability: See label
Markets covered: 2
Products on record: 2

Overview

Ferric Maltol is an active pharmaceutical ingredient in the Iron Trivalent, Oral Preparations group (B03AB). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
EU European Union	EMA	1	May 20, 2026
GB United Kingdom	MHRA	1	April 10, 2026

EUEuropean Union· EMA

1 product

Uses

EUOfficial regulatory label· revised May 20, 2026[1]

Feraccru is indicated in adults for the treatment of iron deficiency.

How to take

EUOfficial regulatory label

GBUnited Kingdom· MHRA

1 product

Uses

GBOfficial regulatory label· revised April 10, 2026[2]

Feraccru is indicated in adults for the treatment of iron deficiency.

How to take

GBOfficial regulatory label

Sources & citations

[1]European Medicines Agency · EMEA/H/C/002733 · revised May 20, 2026
[2]MHRA (UK) · PLGB200110063 · revised April 10, 2026

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Side effects & warnings

EUOfficial regulatory label· Adverse reactions· revised May 20, 2026[1]

Summary of the safety profile The most frequently reported adverse reactions were gastrointestinal symptoms (abdominal pain [8%], flatulence [4%], constipation [4%], abdominal discomfort [2%]/distension [2%] and diarrhoea [3%]) and these were mainly mild to moderate in severity.
9%]. Tabulated list of adverse reactions Table 1 presents all adverse reactions occurring clinical studies to date with Feraccru. Adverse reaction frequencies are defined as: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1,000, <1/100), rare (≥1/10,000, <1/1,000) or very rare (<1/10000).
5 Table 1: Adverse reactions observed during clinical studies to date. System organ class Common Uncommon Nervous system disorders Headache Gastrointestinal disorders Abdominal pain (including upper abdomen) Flatulence Constipation Abdominal discomfort/ distension Diarrhoea Discoloured faeces Nausea Small intestinal bacterial overgrowth Vomiting Skin and subcutaneous tissue disorders Acne Erythema Musculoskeletal and connective tissue disorders Joint stiffness Pain in extremity General disorders and administration site conditions Thirst Investigations Blood alkaline phosphatase increased Blood thyroid stimulating hormone increased Gamma-glutamyltransferase increased Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

EUOfficial regulatory label· Warnings and precautions· revised May 20, 2026[1]

Iron deficiency or iron deficiency anaemia (IDA) diagnosis should be made based on blood tests; it is important to investigate the cause of the iron deficiency and to exclude underlying causes of anaemia other than iron deficiency.
5 g/dl. 5) This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. This medicinal product also contains Allura Red AC (E 129) and Sunset Yellow FCF (E 110): these may cause allergic reactions.
This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.

This is not medical advice. Consult a qualified healthcare professional.

Side effects & warnings

GBOfficial regulatory label· Adverse reactions· revised April 10, 2026[2]

Summary of the safety profile The most frequently reported adverse reactions were gastrointestinal symptoms (abdominal pain [8%], flatulence [4%], constipation [4%], abdominal discomfort [2%]/distension [2%] and diarrhoea [3%]) and these were mainly mild to moderate in severity.
9%]. Tabulated list of adverse reactions Table 1 presents all adverse reactions occurring during clinical studies to date with Feraccru. Adverse reaction frequencies are defined as: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1,000, <1/100), rare (≥1/10,000, <1/1,000) or very rare (<1/10000) Table 1: Adverse reactions observed during clinical studies to date.
System organ class Common Uncommon Nervous system disorders Headache Gastrointestinal disorders Abdominal pain (including upper abdomen) Flatulence Constipation Abdominal discomfort/ distension Diarrhoea Discoloured faeces Nausea Small intestinal bacterial overgrowth Vomiting Skin and subcutaneous tissue disorders Acne Erythema Musculoskeletal and connective tissue disorders Joint stiffness Pain in extremity General disorders and administration site conditions Thirst Investigations Blood alkaline phosphatase increased Blood thyroid stimulating hormone increased Gamma- glutamyltransferase Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

GBOfficial regulatory label· Warnings and precautions· revised April 10, 2026[2]

Iron deficiency or iron deficiency anaemia (IDA) diagnosis should be made based on blood tests; it is important to investigate the cause of the iron deficiency and to exclude underlying causes of anaemia other than iron deficiency.
5 g/dl. 5) This medicinal product contains lactose: patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. This medicinal product also contains Allura Red AC (E129) and Sunset Yellow FCF (E110): these may cause allergic reactions.
This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.

This is not medical advice. Consult a qualified healthcare professional.