Zinc: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: December 4, 2025🚩 Report this page

Zinc

Active ingredient

Sold as Wilzin · Prostatone · Leg Pain Relief · MICRO ZN · MICRO+ TE PEDIATRIC

CA Health CanadaUS FDAEU EMA

Drug class: -
Availability: Over-the-counter
Routes: Intravenous, Oral
Markets covered: 3
Products on record: 14
FDA reports (12 mo): 2,853

Overview

Zinc is an active pharmaceutical ingredient. 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
CA Canada	Health Canada	10	December 4, 2025
US United States	FDA	3	October 29, 2024
EU European Union	EMA	1	December 18, 2024

CACanada· Health Canada

10 products

Uses

CAOfficial regulatory label· revised December 4, 2025[1]

MICRO +4 REGULAR STRENGTH (4 Trace Elements Injection USP) is indicated for: • use as a supplement to intravenous solutions given for TPN. Its administration in TPN solutions helps to maintain plasma zinc, copper, manganese and chromium levels and to prevent depletion of endogenous stores of these elements and development of subsequent deficiency symptoms.
2 Recommended Dose and Dose Adjustments). 2 Geriatrics (≥ 65 years of age): MICRO +4 REGULAR STRENGTH is indicated for use in geriatric patients. No dosage adjustments are required.

How to take

USUnited States· FDA

3 products

Uses

USOfficial regulatory label· revised October 4, 2023[2]

Uses* temporarily relieves symptoms of leg pain such as: restless legs, leg cramps, shooting pain

How to take

EUEuropean Union· EMA

1 product

Uses

EUOfficial regulatory label· revised December 18, 2024[3]

Treatment of Wilson’s disease.

How to take

EUOfficial regulatory label

Sources & citations

[1]Health Canada (DPD) · 02091135 · revised December 4, 2025
[2]FDA DailyMed · 07f85300-bf90-11… · revised October 4, 2023 [PDF]
[3]European Medicines Agency · EMEA/H/C/000535 · revised December 18, 2024
[4]OpenFDA adverse-event reports (US), 12 months ending June 4, 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

CAOfficial regulatory label· Adverse reactions· revised December 4, 2025[1]

1 Adverse Reaction Overview MICRO +4 REGULAR STRENGTH (4 Trace Elements Injection USP) Page 9 of 17 Protected B / Protégé B No adverse reactions have been reported for the amount of zinc, copper, manganese, or chromium present in this product.
The amounts are small and toxicity symptoms are not likely to occur at the suggested dosage level.

CAOfficial regulatory label· Warnings and precautions· revised December 4, 2025[1]

, General 05/2021 TABLE OF CONTENTS Sections and Subsections that are not applicable at the time of authorization are not listed.
PART I:
HEALTH PROFESSIONAL INFORMATION .................................................................................. 4 1 INDICATIONS.......................................................................................................................................
1 PEDIATRICS ( ≤ 18 YEARS OF AGE) .................................................................................................. 2 GERIATRICS (≥ 65 YEARS OF AGE) ..................................................................................................
4 2 CONTRAINDICATIONS ....................................................................................................................... 4 4 DOSAGE AND ADMINISTRATION .....................................................................................................
1 DOSING CONSIDERATIONS ..................................................................................................................... 2 RECOMMENDED DOSE AND DOSAGE ADJUSTMENT .................................................................................
3 RECONSTITUTION .................................................................................................................................. 4 ADMINISTRATION ...................................................................................................................................
6 5 OVERDOSAGE .................................................................................................................................... 6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ............................................
7 7 WARNINGS AND PRECAUTIONS ...................................................................................................... 1 SPECIAL POPULATIONS ..................................................................................................................
1 PREGNANT WOMEN ................................................................................................................. 2 BREAST-FEEDING .....................................................................................................................
8 8 ADVERSE REACTIONS ...................................................................................................................... 1 ADVERSE REACTION OVERVIEW.............................................................................................................
8 9 DRUG INTERACTIONS ....................................................................................................................... 2 DRUG INTERACTIONS OVERVIEW ............................................................................................................
4 DRUG-DRUG INTERACTIONS................................................................................................................... 5 DRUG-FOOD INTERACTIONS ...................................................................................................................
6 DRUG-HERB INTERACTIONS ................................................................................................................... 7 DRUG-LABORATORY TEST INTERACTIONS ..............................................................................................
9 10 CLINICAL PHARMACOLOGY ............................................................................................................. 1 MECHANISM OF ACTION .......................................................................................................................
2 PHARMACODYNAMICS........................................................................................................................ 3 PHARMACOKINETICS..........................................................................................................................
11 11 STORAGE, STABILITY AND DISPOSAL ......................................................................................... 13 12 SPECIAL HANDLING INSTRUCTIONS ............................................................................................
13 PART II: SCIENTIFIC INFORMATION ....................................................................................................... 14 13 PHARMACEUTICAL INFORMATION ...............................................................................................
14 14 CLINICAL TRIALS ............................................................................................................................. 15 15 MICROBIOLOGY ...............................................................................................................................
15 MICRO +4 REGULAR STRENGTH (4 Trace Elements Injection USP) Page 3 of 17 Protected B / Protégé B 16 NON-CLINICAL TOXICOLOGY .........................................................................................................
15 PATIENT MEDICATION INFORMATION ................................................................................................... 16 MICRO +4 REGULAR STRENGTH (4 Trace Elements Injection USP) Page 4 of 17 Protected B / Protégé B PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS MICRO +4 REGULAR STRENGTH (4 Trace Elements Injection USP) is indicated for: • use as a supplement to intravenous solutions given for TPN.
Its administration in TPN solutions helps to maintain plasma zinc, copper, manganese and chromium levels and to prevent depletion of endogenous stores of these elements and development of subsequent deficiency symptoms. 2 Recommended Dose and Dose Adjustments).
2 Geriatrics (≥ 65 years of age): MICRO +4 REGULAR STRENGTH is indicated for use in geriatric patients. No […]

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

Side effects & warnings

EUOfficial regulatory label· Adverse reactions· revised December 18, 2024[3]

Reported adverse reactions are listed below, by system organ class and by frequency. 5 Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. System organ class Adverse drug reactions Blood and lymphatic system disorders uncommon: sideroblastic anaemia, leukopenia Gastrointestinal disorders common: gastric irritation Investigations common: blood amylase, lipase and alkaline phosphatase increased Anaemia may be micro-, normo- or macrocytic and is often associated with leukopenia.
e. developing red blood cells containing iron-engorged paranuclear mitochondria). They may be early manifestations of copper deficiency and may recover rapidly following reduction of zinc dosage. However, they must be distinguished from haemolytic anaemia which commonly occurs where there is elevated serum free copper in uncontrolled Wilson’s disease.
The most common undesirable effect is gastric irritation. This is usually worst with the first morning dose and disappears after the first days of treatment. Delaying the first dose to mid-morning or taking the dose with a little protein may usually relieve the symptoms.
Elevations of serum alkaline phosphatase, amylase and lipase may occur after a few weeks of treatment, with levels usually returning to high normal within the first one or two years of treatment. 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 December 18, 2024[3]

Zinc acetate dihydrate is not recommended for the initial therapy of symptomatic patients because of its slow onset of action. Symptomatic patients must be initially treated with a chelating agent; once copper levels are below toxic thresholds and patients are clinically stable, maintenance treatment with Wilzin can be considered.
Nevertheless, while awaiting zinc induced duodenal metallothionein production and consequential effective inhibition of copper absorption, zinc acetate dehydrate could be administered initially in symptomatic patients in combination with a chelating agent.
Although rare, clinical deterioration may occur at the beginning of the treatment, as has also been reported with chelating agents. Whether this is related to mobilisation of copper stores or to natural history of the disease remains unclear.
A change of therapy is recommended in this situation. Caution should be exercised when switching patients with portal hypertension from a chelating agent to Wilzin, when such patients are doing well and the treatment is tolerated. Two patients of a series of 16 died from hepatic decompensation and advanced portal hypertension after being changed from penicillamine to zinc therapy.
Therapeutic monitoring The aim of the treatment is to maintain the plasma free copper (also known as non-ceruloplasmin plasma copper) below 250 microgram/l (normal: 100-150 microgram/l) and the urinary copper excretion below 125 microgram/24 h (normal: < 50 microgram/24 h).
The non-ceruloplasmin plasma copper is calculated by subtracting the ceruloplasmin-bound copper from the total plasma copper, given that each milligram of ceruloplasmin contains 3 micrograms of copper. The urinary excretion of copper is an accurate reflection of body loading with excess copper only when patients are not on chelation therapy.
Urinary copper levels are usually increased with chelation therapy such as penicillamine or trientine. The level of hepatic copper cannot be used to manage therapy since it does not differentiate between potentially toxic free copper and metallothionein bound copper.
In treated patients, assays of urinary and/or plasma zinc may be a useful measure of treatment compliance. Values of urinary zinc above 2 mg/24 h and of plasma zinc above 1250 microgram/l generally indicate adequate compliance. Like with all anti-copper agents overtreatment carries the risk of copper deficiency, which is especially harmful for children and pregnant women since copper is required for proper growth and mental development.

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