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Oral iron (sodium iron edetate) Pregnancy: §4.6 verbatim: 'Administration of drugs during the first trimester of pregnancy requires careful assessment of potential risks versus benefits to be gained. No adverse events associated with Sytron administration during pregnancy and lactation have been reported.' §4.1 additionally lists pregnancy as an indication setting — 'In pregnancy when other forms of oral iron may not be well tolerated'.

Sodium feredetate

Brand names: Sytron

Sodium feredetate is an oral iron preparation (iron sodium edetate) used to treat and prevent iron-deficiency anaemia, particularly in children where a liquid formulation is useful.

Adult dose

Dose: Iron deficiency anaemia: 5 ml, increasing gradually to 10 ml, three times daily (Sytron oral solution, 27.5 mg iron per 5 ml)
Route: Oral (solution). §4.2 method of administration: 'Oral'. For instructions on dilution before administration the SPC refers to its §6.6, which was not fetched into this bundle.
Frequency: Three times daily
Max: 10 ml per dose — §4.4 twice refers to '10 ml' as 'the maximum dose' ('less than 100 mg [ethanol] in the maximum dose of 10 ml'; 'approximately 23 mg sodium in the maximum dose of 10 ml'), and 10 ml is the top of the range stated in §4.2. No higher dose appears anywhere in this SPC. The SPC prints no maximum DAILY total, so none is stated here.
§4.1 verbatim: 'Sytron is indicated in adults, children and infants for iron deficiency anaemia: • Notably in paediatrics; • In pregnancy when other forms of oral iron may not be well tolerated; • In anaemias secondary to rheumatoid arthritis.' §4.2 adult posology verbatim: 'Adults and the elderly (over 65 years): 5 ml increasing gradually to 10 ml three times daily.' The dose is stated in millilitres of Sytron; the product strength is 27.5 mg iron per 5 ml. Elderly (over 65) take the same dose as adults — the SPC gives no separate geriatric regimen. §4.4 carries the label warning that must accompany this product: 'Important warning: Contains iron. Keep out of the sight and reach of children, as overdose may be fatal.' Iron preparations colour the faeces black, which may interfere with tests for faecal occult blood. Each 5 ml contains 1400 mg sorbitol (280 mg/ml) — patients with hereditary fructose intolerance must not be given this medicine — plus methyl hydroxybenzoate (E218), Ponceau 4R (E124) and propyl hydroxybenzoate (E216), which may cause allergic reactions (possibly delayed).

Paediatric dose

Dose: 3 mg/kg/day
Route: Oral
Frequency: Daily total given in 2-3 divided doses
Max: Maximum 200 mg of elemental iron daily
ELEMENTAL IRON, NOT MILLILITRES OF SYTRON. §4.2 verbatim: 'Treatment of iron-deficiency anaemia in all paediatric age groups is 3-6 mg/kg (max 200 mg) of elemental iron daily given in 2-3 divided doses.' The calculator is deliberately set to the LOWER end of the label's own 3-6 mg/kg/day band; titrate upward within 3-6 mg/kg/day against response, and note that the label's 200 mg maximum applies to the DAILY total, which is why the calculated figure is capped there. The product strength is 27.5 mg iron per 5 ml; the concentration field is left unset because the SPC does not print a mg/ml figure, so no volume in ml is calculated here — convert against the 27.5 mg per 5 ml strength on the label. || PROPHYLAXIS IS A DIFFERENT REGIMEN FROM THE TREATMENT DOSE SHOWN ABOVE. §4.2 verbatim: 'Babies of low birth weight who are solely breast-fed: A daily dose of 5 mg of elemental iron as prophylactic iron supplementation for babies of low birth weight who are solely breast-fed is recommended. Higher doses up to 2 mg/kg of elemental iron per day might be needed to cover the needs of growing exclusively breastfed infants. Supplementation is started 4-6 weeks after birth and continued until mixed feeding is established. Other children (elemental iron per day): Age 6 - 24 months: 12.5 mg; Age 2 - 5 years: 20-30 mg; Age 6 - 11 years: 30 - 60 mg; Adolescents: 60 mg.' || §4.4: prolonged or excessive use in children may lead to toxic accumulation.

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via the eMC — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Paediatric weight-based calculator

ELEMENTAL IRON, NOT MILLILITRES OF SYTRON. §4.2 verbatim: 'Treatment of iron-deficiency anaemia in all paediatric age groups is 3-6 mg/kg (max 200 mg) of elemental iron daily given in 2-3 divided doses.' The calculator is deliberately set to the LOWER end of the label's own 3-6 mg/kg/day band; titrate upward within 3-6 mg/kg/day against response, and note that the label's 200 mg maximum applies to the DAILY total, which is why the calculated figure is capped there. The product strength is 27.5 mg iron per 5 ml; the concentration field is left unset because the SPC does not print a mg/ml figure, so no volume in ml is calculated here — convert against the 27.5 mg per 5 ml strength on the label. || PROPHYLAXIS IS A DIFFERENT REGIMEN FROM THE TREATMENT DOSE SHOWN ABOVE. §4.2 verbatim: 'Babies of low birth weight who are solely breast-fed: A daily dose of 5 mg of elemental iron as prophylactic iron supplementation for babies of low birth weight who are solely breast-fed is recommended. Higher doses up to 2 mg/kg of elemental iron per day might be needed to cover the needs of growing exclusively breastfed infants. Supplementation is started 4-6 weeks after birth and continued until mixed feeding is established. Other children (elemental iron per day): Age 6 - 24 months: 12.5 mg; Age 2 - 5 years: 20-30 mg; Age 6 - 11 years: 30 - 60 mg; Adolescents: 60 mg.' || §4.4: prolonged or excessive use in children may lead to toxic accumulation.

Verify in a children's formulary

Contraindications

  • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
  • Haemochromatosis and haemosiderosis (iron preparations are contraindicated)
  • Patients receiving repeated blood transfusions
  • Patients receiving parenteral iron therapy
  • Hereditary fructose intolerance — each 5 ml contains 1400 mg sorbitol (§4.4)

Side effects

  • Hypersensitivity (frequency unknown)
  • Nausea (frequency unknown)
  • Mild diarrhoea (frequency unknown)
  • Black discoloration of the faeces (§4.4 — may interfere with tests for faecal occult blood)

Monitoring

  • Take care in patients with haemolytic anaemia, iron-storage or iron-absorption diseases, or existing gastrointestinal disease
  • Be aware that iron colours the faeces black and may interfere with tests used to detect occult blood in the stools
  • Avoid prolonged or excessive use in children — it may lead to toxic accumulation
  • Separate interacting oral medicines: iron reduces the absorption of penicillamine, mycophenolate, fluoroquinolones, levodopa, carbidopa, thyroxine and bisphosphonates; iron and tetracyclines, and iron and zinc, reduce each other's absorption
  • Avoid concomitant oral iron with dimercaprol (formation of toxic compounds)
  • Expect reduced iron absorption with entacapone, proton pump inhibitors, bicarbonates, carbonates, calcium, zinc, magnesium and other mineral supplements, trientine, antacids, cholestyramine, tea, eggs, milk and coffee; ascorbic acid and/or citric acid may increase it
  • Oral iron may reduce the hypotensive effect of methyldopa; oral chloramphenicol delays plasma iron clearance and interferes with erythropoiesis
  • Sorbitol content (1400 mg per 5 ml) may cause gastrointestinal discomfort and a mild laxative effect at or above 140 mg/kg/day, and may affect the bioavailability of other oral medicines given at the same time

Clinical monograph

How it works

It provides elemental iron in a chelated form that is absorbed from the gut and incorporated into haemoglobin, replenishing iron stores required for erythropoiesis.

Prescribing in practice

  • Iron preparations are a leading cause of accidental poisoning in young children, so containers must be stored securely out of reach.
  • Absorption is reduced by tea, antacids and some other drugs, so timing relative to meals and interacting medicines should be considered.
  • Anaemia should be confirmed as iron-deficient before treatment, and an underlying cause sought.

Monitoring

Check haemoglobin and other iron indices to confirm response and decide when to stop, continuing for a period after normalisation to replenish stores.

Counselling the patient

  • It may turn the stools dark and can cause stomach upset, constipation or diarrhoea.
  • Keep well out of reach of children, as overdose can be very harmful.
  • Take as directed and complete the course to rebuild iron stores.

Evidence & guidelines

Oral iron salts are long-established first-line therapy for uncomplicated iron-deficiency anaemia as reflected in NICE guidance.

Reference: NICE NG8; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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