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Zinc salt (Wilson's disease) Pregnancy: Data on a limited number of exposed pregnancies in Wilson's disease give no indication of harmful effects of zinc on embryo/foetus or mother (5 miscarriages and 2 birth defects — microcephaly and a correctable heart defect — reported in 42 pregnancies); animal studies with different zinc salts do not indicate direct or indirect harmful effects. It is extremely important that pregnant Wilson's disease patients continue therapy during pregnancy; whether zinc or a chelating agent is used should be decided by the physician. Dose adjustments to guarantee the foetus does not become copper deficient must be made and close monitoring is mandatory (usual effective pregnancy dose 25 mg three times daily). Breast-feeding: zinc is excreted in human breast milk and zinc-induced copper deficiency in the breast-fed baby may occur — breast-feeding should be avoided during therapy.

Zinc acetate

Brand names: Wilzin

Zinc acetate is licensed for the treatment of Wilson's disease, a disorder of copper accumulation, particularly as maintenance therapy.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 50 mg three times daily
Route: Oral
Frequency: Three times daily
Max: 50 mg five times daily
Wilson's disease (Wilzin, zinc acetate dihydrate; doses expressed as elemental zinc, available as 25 mg and 50 mg hard capsules). Treatment should be initiated under the supervision of a physician experienced in the treatment of Wilson's disease and is a LIFE-LONG therapy. There is no difference in dose between symptomatic and presymptomatic patients. In all cases the dose should be adjusted according to therapeutic monitoring. Administration: must be taken on an empty stomach, at least 1 hour before or 2–3 hours after meals. In case of gastric intolerance (often with the morning dose), that dose may be delayed to mid-morning, between breakfast and lunch; it may also be taken with a little protein, such as meat. Switching from a chelating agent to zinc for maintenance: the chelating treatment should be maintained and co-administered for 2 to 3 weeks (the time for zinc to induce maximum metallothionein induction and full blockade of copper absorption), and administration of the chelating agent and zinc should be separated by at least 1 hour. Zinc acetate dihydrate is NOT recommended for initial therapy of symptomatic patients because of its slow onset of action — symptomatic patients must first be treated with a chelating agent, with maintenance zinc considered once copper levels are below toxic thresholds and the patient is clinically stable. Caution when switching patients with portal hypertension from a chelating agent. PREGNANCY DOSE: 25 mg three times daily is usually effective, but the dose should be adjusted to copper levels. PAEDIATRIC (age/weight-banded fixed doses, not per-kg, so not held in paedDose): from 1 to 6 years — 25 mg twice daily; from 6 to 16 years if bodyweight under 57 kg — 25 mg three times daily; from 16 years or if bodyweight above 57 kg — 50 mg three times daily. Data are very limited in children under 6 years, but since the disease is fully penetrant, prophylactic treatment should be considered as early as possible. In children unable to swallow capsules, the capsules should be opened and the contents suspended in a little water (possibly sugar- or syrup-flavoured water). Verify all paediatric dosing against a children's formulary. Monitoring targets: plasma free (non-caeruloplasmin) copper below 250 microgram/L and urinary copper excretion below 125 microgram/24 h; urinary zinc above 2 mg/24 h and plasma zinc above 1250 microgram/L generally indicate adequate compliance; overtreatment risks copper deficiency, especially harmful in children and pregnant women, in whom urinary copper should be kept a little above the upper limit of normal or high-normal (40–50 microgram/24 h). Source: eMC SPC for Wilzin 25 mg hard capsules (§4.2). NOTE: the openFDA record fetched for "zinc acetate" is Equate Calaspray (Walmart), an unrelated topical calamine/zinc skin spray — it was NOT used and its directions must not be applied to this page.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to the active substance or to any of the excipients

Side effects

  • Gastric irritation — common; usually worst with the first morning dose and disappears after the first days of treatment (may be relieved by delaying the first dose to mid-morning or taking it with a little protein)
  • Increased blood amylase, lipase and alkaline phosphatase — common; may occur after a few weeks of treatment, usually returning to high normal within the first one or two years
  • Sideroblastic anaemia — uncommon; may be micro-, normo- or macrocytic and is often associated with leukopenia, and may be an early manifestation of copper deficiency (may recover rapidly on reducing the zinc dose)
  • Leukopenia — uncommon
  • Copper deficiency with overtreatment — monitor haematology and lipoproteins for early manifestations such as anaemia and/or leukopenia

Interactions

  • Food — must be taken on an empty stomach, at least 1 hour before or 2–3 hours after meals; may be taken with a little protein (e.g. meat) if gastric intolerance occurs (SPC §4.2, cross-referring to §4.5)
  • Chelating agents (e.g. penicillamine, trientine) — when switching to zinc for maintenance, co-administer for 2 to 3 weeks and separate the two administrations by at least 1 hour; urinary copper levels are usually increased by chelation therapy, which affects monitoring interpretation (SPC §4.2/§4.4)
  • NOTE: SPC §4.5 was not present in the fetched source — verify the full interactions section.

Clinical monograph

How it works

Zinc induces intestinal metallothionein, which binds dietary copper within enterocytes and prevents its absorption; the bound copper is then lost as cells are shed, producing a negative copper balance.

Prescribing in practice

  • Effective copper control is essential in Wilson's disease, so adherence and avoidance of treatment interruption must be emphasised to prevent disease progression.
  • Taking zinc on an empty stomach away from food improves absorption and copper-binding efficacy.
  • Zinc may cause gastric irritation, and prolonged high intake can itself lead to copper deficiency.

Monitoring

Monitoring of copper status (including urinary copper and relevant copper indices) and zinc levels is required to confirm adequate control and avoid over-treatment.

Counselling the patient

  • Take between meals, away from food, to help it work effectively.
  • Keep taking it as prescribed in Wilson's disease, even when you feel well.

Evidence & guidelines

Zinc maintenance therapy is an established option in the management of Wilson's disease.

Reference: NICE EAMS; EASL clinical practice guidelines for Wilson's disease; SmPC; 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.