Ferrous gluconate

Pronunciation: FAIR-us GLOO-koh-nayt.

Generic name
ferrous gluconate
Drug class
Oral iron salt (haematinic)
Form
Tablet (commonly 300-324 mg, providing about 35-38 mg elemental iron) or oral solution/ampoule (e.g. 50 mg elemental iron per 10 mL in some markets)
Route
Oral (tablet or liquid solution, depending on product and market)
Legal status
Regulatory status varies genuinely by market: OTC/dietary-supplement-category product in the United States; ANSM-authorised medicine in France; UK EMC-confirmed only in an IV trace-element product; DIN-listed/marketed in Canada; TGA ARTG-registered in Australia; not regulated as a medicine at all in New Zealand (regulated instead as a dietary supplement). 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: Ferrous+C (6) · Full directory

What ferrous gluconate is and how it works

Ferrous gluconate 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) (7)

Regulatory treatment genuinely differs by market: in the United States it is sold as an OTC/dietary-supplement product rather than an individually FDA-approved new drug; in France it is a real ANSM-authorised medicine (TOT'HEMA); and in New Zealand, iron and mineral supplements including ferrous gluconate are not registered as medicines and are not Medsafe-approved at all -- New Zealand's own funded iron tablets are ferrous sulfate and ferrous fumarate instead. 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 children under 6 -- always store it like any other medicine, out of children's reach.

Mechanism of action: how ferrous gluconate works

Ferrous gluconate 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.

What ferrous gluconate is used for

Iron-deficiency anaemia (treatment)

Used to treat iron-deficiency anaemia in adults, children, and infants, by replenishing low iron stores. (4)

Iron deficiency prevention

Used to prevent iron deficiency in pregnant women and infants when dietary iron intake is insufficient, and to support recommended daily iron intake more generally in some OTC/supplement formulations. (4) (1)

Before taking ferrous gluconate

Do not take / not appropriate for

  • Do not take if you have a condition involving iron overload, such as haemochromatosis or thalassaemia, unless specifically directed by a clinician. (all countries) (4)
  • Do not take if you have Wilson's disease. (all countries) (4)
  • Liquid formulations: do not use for anything other than swallowing -- accidental inhalation into the airways can cause serious lung damage. (markets with liquid/ampoule products) (4)

Tell your clinician about

  • Any history of iron-overload conditions (haemochromatosis, thalassaemia) or Wilson's disease.
  • If you have an inflammatory condition, since iron supplements are generally not effective for anaemia caused by inflammation.
  • If you are pregnant or breastfeeding.
  • Any other oral medicines you take, particularly tetracycline antibiotics.
  • If there are young children in the household -- discuss safe storage given the real risk of accidental childhood iron poisoning.
(1) (4)

How to take ferrous gluconate

  • 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; do not crush or chew.
  • Liquid/ampoule products: swallow directly, ideally diluted as directed; never inject or use other than as an oral product.
  • Avoid taking within 2 hours of oral tetracycline antibiotics, as iron reduces tetracycline 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.
(1) (4)

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 gluconate. 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 children under 6 years old. 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, seizures or shock. (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. (1)

Constipation or diarrhoea.

What to notice: Constipation or diarrhoea.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

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. (1)

Serious warnings

Accidental childhood iron poisoning — high caution

Symptoms: This is a real, mandatory, FDA-documented warning: accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6.

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. (1)

Iron overload / contraindicated conditions — 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, or Wilson's disease unless specifically directed and monitored by a clinician; iron supplementation can worsen these conditions. (4)

Aspiration/inhalation of liquid iron formulations — high caution

Symptoms: Persistent cough, coughing up blood, or breathing difficulty after taking a liquid iron product.

Action: Liquid iron products must be swallowed, never inhaled into the airway. Seek urgent medical review if these symptoms occur after taking a liquid iron formulation -- real bronchial damage can result from accidental aspiration. (4)

Interactions

  • Oral tetracycline antibiotics: avoid taking within 2 hours of ferrous gluconate, as iron reduces tetracycline absorption and effectiveness. (1)

Pregnancy, breastfeeding, kidney/liver function, age

Pregnancy

Used in some markets specifically to prevent/treat iron deficiency in pregnancy (e.g. France's TOT'HEMA); in the US OTC/supplement context, seek advice from a health professional before use if pregnant. (1) (2) (3) (4) (5) (6) (7)

Breastfeeding

Seek advice from a health professional before use if breastfeeding, per the US OTC label reviewed. (1) (2) (3) (4) (5) (6) (7)

Children

Used to treat/prevent iron deficiency in children and infants under clinician direction in some markets (e.g. France); in the US OTC/supplement context, consult a physician before giving to children. Accidental overdose is a real, serious risk in young children -- always store safely out of reach. (1) (2) (3) (4) (5) (6) (7)

Elderly

No specific age-based dose adjustment described in the sources reviewed for this dossier beyond individualised clinical dosing. (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)

Monitoring

Before starting

  • Confirm no iron-overload condition (haemochromatosis, thalassaemia) or Wilson's disease.
  • Confirm the cause of anaemia is genuinely iron deficiency, since iron supplements are not effective for anaemia caused by inflammatory conditions.

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.
(1) (4)

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, France's ANSM database entry for TOT'HEMA, UK EMC, Canada's Health Canada DIN listing, Australia's TGA ARTG entry, and New Zealand's Medsafe dietary-supplement policy reviewed for this dossier; verify against the current full label for the specific product before recommending.

United States

Indication: OTC/supplement iron repletion

Dose summary: Adults: 1 tablet (324 mg/38 mg elemental iron) 3-4 times daily; children: consult a physician.

Renal context: No specific renal dose adjustment described in the sources reviewed. (1)

France (European Union)

Indication: Iron-deficiency anaemia treatment/prevention

Dose summary: Individualised by age and indication (adult, child, infant, pregnancy) per the product's own label.

Renal context: No specific renal dose adjustment described in the sources reviewed. (4)

Mechanism of action

Hepatic guidance

No specific hepatic caution described in the sources reviewed for this dossier.

Overdose note

Iron overdose is a genuine medical emergency in children. This dossier's sources did not detail specific emergency antidote/chelation protocols -- always call poison control or emergency services immediately for a suspected overdose and follow their direction.

Frequently asked questions

Is ferrous gluconate available in the US, UK, EU, Canada, Australia, and New Zealand?

Regulatory treatment genuinely differs by market. It is sold as an OTC/dietary-supplement product in the United States, and as a real ANSM-authorised medicine in France (TOT'HEMA). Canada (Health Canada DIN) and Australia (TGA ARTG) confirm real, government-listed marketed products. In the UK, the only directly confirmed EMC-licensed product containing ferrous gluconate this session was an IV trace-element infusion, with oral-tablet NHS use referenced only via a search snippet whose direct page fetch failed. In New Zealand, iron and mineral supplements including ferrous gluconate are not registered as medicines and are not Medsafe-approved at all -- New Zealand's own funded iron tablets are ferrous sulfate and ferrous fumarate instead. (1) (2) (4) (5) (6) (7)

Why does ferrous gluconate carry a warning about children?

Accidental overdose of iron-containing products, including ferrous gluconate, is a real, documented, leading cause of fatal poisoning in children under 6. This is why US labelling carries a mandatory warning and why the US Consumer Product Safety Commission requires child-resistant packaging for iron-containing medicines and vitamins. 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)

Is ferrous gluconate the same as other iron supplements like ferrous sulfate or ferrous fumarate?

No -- these are different iron salts with different elemental iron content per tablet and sometimes different tolerability, though all carry the same fundamental accidental-overdose risk in children. New Zealand's funded iron tablets, for example, are ferrous sulfate and ferrous fumarate, not ferrous gluconate. (7)

What is the mechanism of action of ferrous gluconate?

Ferrous gluconate 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.

What is the generic name of Ferrous gluconate?

The generic name is ferrous gluconate. (1) (4)

What class of drug is ferrous gluconate?

Ferrous gluconate is classed as: Oral iron salt (haematinic). (1) (4)

References

  1. Ferrous Gluconate Tablets -- Drug Facts labelDailyMed (U.S. National Library of Medicine) -- OTC/supplement drug facts label · United States · accessed 2026-07-30 · source 1
  2. NUTRYELT concentrate for solution for infusion -- EMC search result (contains ferrous gluconate as one of nine trace elements)electronic medicines compendium (emc), United Kingdom -- product search · United Kingdom · accessed 2026-07-30 · source 2
  3. Iron-deficiency anaemias formulary guidance referencing ferrous gluconate tabletsNHS regional formulary guidance (Devon Formulary, referencing British Society of Gastroenterology 2021 guidelines) -- accessed via search-engine result synthesis, not a direct live page fetch · United Kingdom · accessed 2026-07-30 · source 3
  4. TOT'HEMA, solution buvable en ampoule -- medicine extract (CIS 65161713)Base de Donnees Publique des Medicaments (ANSM / French Ministry of Health) -- official French medicines database · European Union (France) · accessed 2026-07-30 · source 4
  5. Ferrous Gluconate Tablet 300mg -- DIN 02244532Health Canada Drug Product Database, as reflected in licensed Canadian retail pharmacy chain drug databases (Proxim, Guardian/I.D.A./Remedy'sRx) · Canada · accessed 2026-07-30 · source 5
  6. Ferrous+C (ARTG 339188) -- contains ferrous gluconate dihydrateTherapeutic Goods Administration (TGA), Australia -- ARTG entry · Australia · accessed 2026-07-30 · source 6
  7. Iron supplements (oral) -- Healthify medicines A-Z, and Medsafe dietary supplement regulationMedsafe (New Zealand Medicines and Medical Devices Safety Authority) -- Regulation of Dietary Supplements; Pharmac funded-medicines information; Healthify NZ · New Zealand · accessed 2026-07-30 · source 7

Brand names by country

Single-ingredient ferrous gluconate 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

  • Nutryelt (IV trace-element infusion containing ferrous gluconate) (2)MHRA licensed POM confirmed · 18 mg ferrous gluconate per 10 mL ampoule (trace element component) · Baxter Healthcare Ltd / Laboratoire Aguettant
  • Ferrous gluconate 300mg tablets (NHS formulary reference, oral) (3)NHS formulary referenced search snippet only direct fetch failed · 300 mg · not independently confirmed this session

Canada

  • Ferrous Gluconate Tablet 300mg (5)Health Canada DIN confirmed · 300 mg · multiple (DIN 02244532)

Australia

  • Ferrous+C (6)TGA ARTG registered 2020-07-08 confirmed · ferrous gluconate dihydrate (exact strength not independently re-confirmed this session) · not independently re-confirmed this session (ARTG 339188)

New Zealand

  • Not applicable -- regulated as a dietary supplement, not a Medsafe medicine (7)outside Medsafe medicine framework confirmed · not applicable · not applicable
View brands in additional countries.

European Union

TOT'HEMA (France) (4)

This page provides general reference information about ferrous gluconate and is not a substitute for advice from your pharmacist or clinician. Always keep iron-containing products out of reach of children -- accidental overdose is a real and serious poisoning risk -- and seek urgent medical help if an overdose is suspected.

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