Ferrous fumarate
Pronunciation: FAIR-us FEW-mah-rayt.
- Generic name
- ferrous fumarate
- Drug class
- Oral iron salt (haematinic)
- Form
- Tablet (commonly 200-325 mg, providing roughly 65-106 mg elemental iron depending on product and market) or oral powder sachet (e.g. 100 mg ferrous fumarate/1 g powder, 33 mg elemental iron, in some markets)
- Route
- Oral (tablet, or powder for oral solution in infant/pregnancy presentations)
- Legal status
- Regulatory status varies genuinely by market: OTC/dietary-supplement-category product in the United States; MHRA-licensed pharmacy/prescription medicine in the United Kingdom; ANSM-authorised medicine in France/EU; marketed in Canada today as a Health-Canada-licensed Natural Health Product (NPN) rather than a standard DIN drug (no active DIN product found); TGA ARTG-listed and PBS-subsidised in Australia; Medsafe-authorised medicine in New Zealand, with plain Ferro-Tab Pharmac-funded. Always check your own country and product label.
Availability and supply rules vary by country
Trade names by country: United States · United Kingdom · Canada · Australia · New Zealand
Australia: Ferro Tab (6), FerroVEN Iron (6), APOHealth Iron Tablets (6) · Full directory
What ferrous fumarate is and how it works
Ferrous fumarate is an oral iron salt used to prevent or treat iron-deficiency anaemia by replenishing the body's iron stores. As with any oral iron product, gastrointestinal side effects can occur. (1) (4)
Regulatory treatment genuinely differs by market: in the United States it is sold as an OTC/dietary-supplement product; in the United Kingdom and France it is a real authorised medicine with its own contraindications and dosing rules; in Canada it is marketed today as a Health-Canada-licensed Natural Health Product rather than a standard prescription/OTC drug; and in New Zealand it is a genuinely Medsafe-authorised medicine, with a plain tablet form (Ferro-Tab) funded by Pharmac as one of only two government-funded oral iron tablets. Whatever the regulatory category, the single most important safety fact to know is that accidental overdose of iron-containing products is a leading, real, documented cause of fatal poisoning in young children -- French regulatory sources specifically describe severe gastrointestinal necrosis, shock, and organ damage in children under 2 requiring emergency treatment. Always store it like any other medicine, out of children's reach.
Mechanism of action: how ferrous fumarate works
Ferrous fumarate provides ferrous (Fe2+) iron, replenishing iron stores needed for haemoglobin synthesis and correcting iron-deficiency anaemia. This dossier's sources did not detail the specific site of gastrointestinal absorption. (4)
What ferrous fumarate is used for
Iron-deficiency anaemia (treatment)
Used to treat iron-deficiency anaemia in adults and, in some markets, children, by replenishing low iron stores. (2) (3)
Iron deficiency prevention
Used to prevent iron deficiency in pregnant women, premature infants, twins, and infants born to iron-deficient mothers in some markets (e.g. France's infant/pregnancy oral-powder presentation), and to support recommended daily iron intake more generally in OTC/supplement formulations. (4) (1)
Before taking ferrous fumarate
Do not take / not appropriate for
- Do not take if you have haemochromatosis, an active peptic ulcer, paroxysmal nocturnal haemoglobinuria, or inflammatory bowel disease (ulcerative colitis, regional enteritis). (United Kingdom) (2)
- Do not take if you have an iron-overload condition such as thalassaemia, refractory anaemia, or a bone-marrow condition requiring repeated transfusion, or if you are hypersensitive to ferrous fumarate or its excipients. (France (European Union)) (4)
Tell your clinician about
- Any history of iron-overload conditions (haemochromatosis, thalassaemia) or a bone-marrow condition requiring repeated transfusion.
- Any history of active peptic ulcer or inflammatory bowel disease.
- If you are pregnant or breastfeeding.
- Any other oral medicines you take, particularly tetracycline antibiotics, fluoroquinolones, levothyroxine, or bisphosphonates.
- If there are young children in the household -- discuss safe storage given the real risk of accidental childhood iron poisoning.
How to take ferrous fumarate
- Take exactly as directed on your product's label or by your clinician -- strength and dosing schedules vary by product and market.
- Tablets: swallow whole; adult use only unless a paediatric presentation and clinician direction specifically apply.
- Oral-powder/infant presentations: mix and dose exactly as directed, since these are formulated for a different strength (elemental iron per gram) than tablets.
- Separate dosing from tetracycline antibiotics, fluoroquinolones, levothyroxine, and bisphosphonates by at least 2 hours, as iron reduces their absorption.
- ALWAYS store out of reach and sight of children, in child-resistant packaging where available -- accidental childhood overdose is a real, leading cause of fatal poisoning.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5) (6) (7)
Missed dose
This dossier's sources did not cover missed-dose instructions specific to ferrous fumarate. Follow the missed-dose guidance printed on your own product's label, or ask your pharmacist or clinician if unsure -- do not double up doses without checking first.
Overdose
Accidental overdose of iron-containing products is a leading cause of fatal poisoning in young children. French regulatory sources specifically describe that overdose in children under 2 years can cause severe gastrointestinal necrosis, shock, and organ damage, requiring immediate emergency treatment (gastric lavage and chelation therapy). If an overdose is suspected in a child or adult, call a doctor or poison control centre immediately -- do not wait for symptoms to appear, as early treatment saves lives. Keep the product's packaging or label available to show emergency responders. Symptoms of iron overdose can include severe nausea, vomiting, stomach pain, bloody diarrhoea, drowsiness, pale or clammy skin, rapid weak pulse, and, in severe cases, shock, organ damage, or seizures. (1) (4)
Side effects
Side effects and their urgency vary; report severe, persistent, or concerning symptoms.
Nausea, stomach discomfort.
What to notice: Nausea, stomach discomfort.
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (2)
Constipation or diarrhoea.
What to notice: Constipation or diarrhoea.
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (2)
Dark or black-coloured stools -- a normal, expected effect of iron and not itself a cause for concern.
What to notice: Dark or black-coloured stools -- a normal, expected effect of iron and not itself a cause for concern.
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (3)
Serious warnings
Accidental childhood iron poisoning — high caution
Symptoms: This is a real, mandatory warning across multiple regulator sources: accidental overdose of iron-containing products is a leading cause of fatal poisoning in young children. French regulatory sources specifically document severe gastrointestinal necrosis, shock, and organ damage in children under 2.
Action: Keep this product out of reach and sight of children at all times, and use child-resistant packaging where available. If a child may have taken any amount, call a doctor or poison control centre immediately, even without symptoms -- do not wait. Emergency treatment may include gastric lavage and chelation therapy. (1) (4)
Contraindicated conditions (iron overload, GI, or blood disorders) — high caution
Symptoms: Not applicable for a first dose -- this is a pre-treatment contraindication check.
Action: Do not take if you have haemochromatosis, thalassaemia, refractory anaemia, an active peptic ulcer, paroxysmal nocturnal haemoglobinuria, or inflammatory bowel disease, unless specifically directed and monitored by a clinician. (2) (4)
Interactions
Pregnancy, breastfeeding, kidney/liver function, age
Pregnancy
Used in some markets specifically to prevent/treat iron deficiency in pregnancy (e.g. France's infant/pregnancy oral-powder presentation, dosed at approximately 50 mg iron/day in the final two trimesters); UK sources state it may be used during pregnancy when clinically indicated. In the US OTC/supplement context, seek advice from a health professional before use if pregnant. (1) (2) (3) (4) (5) (6) (7)
Breastfeeding
UK sources report no reported adverse effects in nursing infants; France's sources note passage into breast milk has not been formally evaluated but is considered compatible given the molecule's nature. In the US OTC/supplement context, seek advice from a health professional before use if breastfeeding. (1) (2) (3) (4) (5) (6) (7)
Children
Not suitable for paediatric use in the standard UK tablet form. France offers a distinct, lower-strength oral-powder presentation specifically formulated and dosed for infants under clinician direction. Accidental overdose is a real, serious risk in young children of any market -- always store safely out of reach. (1) (2) (3) (4) (5) (6) (7)
Elderly
UK sources include elderly patients in the same standard adult dosing as other adults, with no separate age-based adjustment described. (1) (2) (3) (4) (5) (6) (7)
Hepatic_impairment
No specific restriction described in the sources reviewed for this dossier. (1) (2) (3) (4) (5) (6) (7)
Renal_impairment
No specific restriction described in the sources reviewed for this dossier. (1) (2) (3) (4) (5) (6) (7)
Source_ids
UK-EMC-FERROUS-FUMARATE-322MG-2026,EU-FRANCE-ANSM-FUMAFER-POWDER-PEDIATRIC-OVERDOSE-2026 (1) (2) (3) (4) (5) (6) (7)
Monitoring
Before starting
- Confirm no iron-overload condition (haemochromatosis, thalassaemia, refractory anaemia) or contraindicated GI/blood condition.
- Confirm the cause of anaemia is genuinely iron deficiency.
During treatment
- Watch for gastrointestinal side effects.
- Watch for any signs of accidental ingestion by children in the household.
- Follow up with your clinician to confirm anaemia is improving as expected.
Storage
Store at room temperature, away from moisture. ALWAYS keep out of reach and sight of children, ideally in original child-resistant packaging, and properly resecure the closure after every use.
Professional information
Clinician-facing context only, sourced from the current US DailyMed OTC label, UK EMC SmPC, France's ANSM database entries for FUMAFER (tablet and oral-powder), Canada's Health Canada NPN/LNHPD framework, Australia's TGA ARTG entries, and New Zealand's Medsafe CMI/data sheets and Pharmac funding documentation reviewed for this dossier; verify against the current full label for the specific product before recommending.
United Kingdom
Indication: Prophylaxis and treatment of iron-deficiency states
Dose summary: Adults/elderly: 1 tablet (322 mg/approx. 100 mg elemental iron) daily, up to twice daily for severe/resistant deficiency; not suitable for paediatric use.
Renal context: No specific renal dose adjustment described in the sources reviewed. (2)
France (European Union)
Indication: Iron-deficiency anaemia treatment/prevention
Dose summary: Adults/children 10+: 100-200 mg elemental iron/day; infants (5-12 kg): 6-10 mg iron/kg/day; pregnancy (final two trimesters): approx. 50 mg iron/day; typical course 3-6 months.
Renal context: No specific renal dose adjustment described in the sources reviewed. (3) (4)
Hepatic guidance
No specific hepatic caution described in the sources reviewed for this dossier.
Overdose note
Iron overdose is a genuine medical emergency, with French regulatory sources specifically documenting severe gastrointestinal necrosis, shock, and organ damage in children under 2, requiring immediate gastric lavage and chelation therapy. Always call poison control or emergency services immediately for a suspected overdose and follow their direction. (4)
Frequently asked questions
Is ferrous fumarate available in the US, UK, EU, Canada, Australia, and New Zealand?
Yes, but under genuinely different regulatory categories. It is sold as an OTC/dietary-supplement product in the United States, a real MHRA-licensed pharmacy/prescription medicine in the United Kingdom, and an ANSM-authorised medicine in France (both tablet and infant/pregnancy oral-powder presentations). In Canada, no currently active DIN drug product was found this session -- it is marketed today as a Health-Canada-licensed Natural Health Product (NPN) instead. Australia confirms multiple real TGA ARTG-listed, PBS-subsidised products. New Zealand confirms real Medsafe-authorised combination products (Ferro-F-Tab, Ferodan) and a Pharmac-funded plain tablet (Ferro-Tab). (1) (2) (3) (5) (6) (7)
Why does ferrous fumarate carry a warning about children?
Accidental overdose of iron-containing products, including ferrous fumarate, is a real, documented, leading cause of fatal poisoning in young children. French regulatory sources specifically describe that overdose in children under 2 can cause severe gastrointestinal necrosis, shock, and organ damage requiring emergency gastric lavage and chelation therapy. Always store iron products out of reach and sight of children and call a doctor or poison control centre immediately if a child may have taken any amount. (1) (4)
Is ferrous fumarate the same as other iron supplements like ferrous gluconate or ferrous sulfate?
No -- these are different iron salts with different elemental iron content per tablet and sometimes different regulatory status. In New Zealand, for example, ferrous fumarate is a genuinely Medsafe-authorised, Pharmac-funded medicine, whereas ferrous gluconate is not regulated as a medicine there at all. All iron salts carry the same fundamental accidental-overdose risk in children. (7)
What is the mechanism of action of ferrous fumarate?
Ferrous fumarate provides ferrous (Fe2+) iron, replenishing iron stores needed for haemoglobin synthesis and correcting iron-deficiency anaemia. This dossier's sources did not detail the specific site of gastrointestinal absorption. (4)
References
- FERRETTS - ferrous fumarate tablet, film coated - Drug Facts labelDailyMed (U.S. National Library of Medicine) -- OTC/supplement drug facts label · United States · accessed 2026-07-31 · source 1
- Ferrous Fumarate 322mg Tablets -- SmPCelectronic medicines compendium (emc), United Kingdom -- Summary of Product Characteristics · United Kingdom · accessed 2026-07-31 · source 2
- FUMAFER 66 mg, comprime pellicule -- medicine extract (CIS 64404201)Base de Donnees Publique des Medicaments (ANSM / French Ministry of Health) -- official French medicines database · European Union (France) · accessed 2026-07-31 · source 3
- FUMAFER 33 mg/1 g, poudre pour solution buvable -- RCP (R0271484)ANSM (Agence nationale de securite du medicament et des produits de sante), France -- RCP (Resume des Caracteristiques du Produit) · European Union (France) · accessed 2026-07-31 · source 4
- Ferrous fumarate historical DIN entries (all cancelled) and current Natural Health Product (NPN) licensingHealth Canada -- Drug Product Database (DPD, prescription/OTC drugs) and Licensed Natural Health Products Database (LNHPD) · Canada · accessed 2026-07-31 · source 5
- Ferro Tab and related ferrous fumarate ARTG entries (175706, 339241, 286619, 347752, 339242)Therapeutic Goods Administration (TGA), Australia -- ARTG entries · Australia · accessed 2026-07-31 · source 6
- Ferro-F-Tab (ferrous fumarate 310 mg + folic acid 350 mcg) and Ferodan -- Medsafe CMI/data sheets; Ferro-Tab Pharmac funding statusMedsafe (New Zealand Medicines and Medical Devices Safety Authority) -- Consumer Medicine Information; Pharmac funded-medicines consultation · New Zealand · accessed 2026-07-31 · source 7
Brand names by country
Single-ingredient ferrous fumarate names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.
Priority countries
United States
- Ferrum sulphuricum500 [hp_C], 30 [hp_C]/30[hp_C], 30 [hp_C], 6 [hp_C], 200 [hp_C], 1 [hp_Q], 12 [hp_C], 1 [hp_M] · hahnemann laboratories, inc.
- Schuessler Tissue Salts Ferr Phos First Aid 46 [hp_X]/30mL, 6 [hp_X] · martin & pleasance pty ltd
- Ferrum Carbonicum6 [hp_X]/23g · true botanica, llc
- Ferrum iodatum30 [hp_C]/30[hp_C] · boiron
United Kingdom
Canada
- Ferrous fumarate tablets (Natural Health Product, NPN-licensed) (5)Health Canada NPN licensed no active DIN found · 300 mg (approx. 100 mg elemental iron), varies by product · multiple NPN-licensed manufacturers (historical DIN entries all cancelled)
Australia
- Ferro Tab (6)TGA ARTG registered confirmed via search direct fetch timed out · not independently re-confirmed this session (ARTG 175706) · AFT Pharmaceuticals Pty Ltd
- FerroVEN Iron (6)TGA ARTG registered 2020-07-09 confirmed · 200 mg · Arrotex Pharmaceuticals Pty Ltd (ARTG 339241)
- APOHealth Iron Tablets (6)TGA ARTG registered 2017-03-10 confirmed · 200 mg · Arrotex Pharmaceuticals Pty Ltd (ARTG 286619)