Zinc Sulfate

Mechanism-of-action classes: Acid-Base Activity; Electrolyte Activity; Enzyme Interactions.

• Zinc Sulfate Injection is indicated in adult and pediatric patients as a source of zinc for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. Zinc Sulfate Injection is a trace element indicated in adult and pediatric patients as a source of zinc for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.

• Zinc Sulfate Injection is contraindicated in patients with known hypersensitivity to zinc [ see Warnings and Precautions ( 5.6 ) ]. ​Known hypersensitivity to zinc ( 4 , 5.6 ).contraindicated

• Pharmacy Bulk Package. Not for direct intravenous infusion. ( 2.1 ) • See full prescribing information for information on preparation, administration, and general dosing considerations. ( 2.1 , 2.2 , 2.3 , 2.4 ) Recommended Dosage and Monitoring ( 2.5 ) • Zinc Sulfate Injection provides 1 mg/mL of zinc. • Zinc Sulfate Injection in a concentration of 1 mg/mL is recommended for use in pediatric patients, particularly those weighing less than 12 kg. • Individualize the dosage based upon the patient's clinical condition, nutritional requirements, and the contribution of oral or enteral zinc intake. • The dosage of Zinc Sulfate Injection should be individualized based on the patient’s clinical condition, nutritional requirements, and the contribution of oral or enteral zinc intake. • Adults : The recommended adult dosage is 3 mg/day for metabolically stable patients, with potential need for a higher daily dosage in monitored patients with small bowel fluid loss or excess stool or ileostomy output. • Pediatrics: The recommended dosage in pediatric patients is shown by age and estimated weight. The dosages in the table are general recommendations intended for most pediatric patients. However, based on clinical requirements, some patients may require a higher dosage.

• Pulmonary Embolism due to Pulmonary Vascular Precipitates : If signs of pulmonary distress occur, stop the infusion and initiate a medical evaluation. ( 5.1 ) • Vein Damage and Thrombosis : Solutions with osmolarity of 900 mOsmol/L or more must be infused through a central catheter. ( 2.1 , 5.2 ) • Aluminum Toxicity : Increase risk in patients with renal impairment, including preterm infants ( 5.3 , 8.4 ) • Monitoring and Laboratory Tests : Monitor fluid and electrolyte status, serum osmolarity, blood glucose, liver and kidney function, blood count and coagulation parameters throughout treatment. ( 5.4 , 2.4 ) • Copper Deficiency : If signs and symptoms develop, interrupt treatment with Zinc Sulfate Injection and check zinc, copper, and ceruloplasmin levels. ( 5.5 ) • Hypersensitivity Reactions : If reactions occur, discontinue Zinc Sulfate Injection and initiate appropriate medical treatment. ( 5.6 ) 5.1 Pulmonary Embolism due to Pulmonary Vascular Precipitates Pulmonary vascular precipitates causing pulmonary vascular emboli and pulmonary distress have been reported in patients receiving parenteral nutrition. The cause of precipitate formation has not been determined in all cases; however, in some fatal cases, pulmonary emboli occurred as a result of calcium phosphate precipitates. Precipitation has occurred following passage through an in-line filter; in vivo precipitate formation may also have occurred. If signs of pulmonary distress occur, stop the parenteral nutrition infusion and initiate a medical evaluation.

No zinc-related adverse reactions have been reported in clinical studies or post-marketing reports in patients receiving intravenously administered parenteral nutrition solutions containing zinc sulfate within the recommended dosage range. The following were identified in clinical studies or post-marketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: Adverse reactions with other components of parenteral nutrition solutions: • Pulmonary embolism due to pulmonary vascular precipitates [see Warnings and Precautions ( 5.1 )] • Vein damage and thrombosis [see Warnings and Precautions ( 5.2 )] • Aluminum toxicity [see Warnings and Precautions ( 5.3 )] Adverse reactions with the use of zinc-containing products administered by other routes of administration: • Copper deficiency [ see Warnings and Precautions ( 5.5 ) ] • Hypersensitivity reactions [ see Warnings and Precautions ( 5.6 ) ] No zinc-related adverse reactions in patients receiving intravenously administered parenteral nutrition solutions containing zinc within the recommended dosage range. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Piramal Critical Care at 1-888-822-8431 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . See 17 for PATIENT COUNSELING INFORMATION. Revised: 06/2023

8.1 Pregnancy Risk Summary Administration of the approved recommended dose of Zinc Sulfate Injection in parenteral nutrition is not expected to cause major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with intravenous zinc sulfate. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Disease-associated Maternal and/or Embryo-Fetal Risk Deficiency of trace elements, including zinc, is associated with adverse pregnancy and fetal outcomes. Pregnant women have an increased metabolic demand for trace elements, including zinc. Parenteral nutrition with zinc should be considered if a pregnant woman’s nutritional requirements cannot be fulfilled by oral or enteral intake. 8.2 Lactation Risk summary Zinc is present in human milk. Administration of the approved recommended dose of Zinc Sulfate Injection in parenteral nutrition is not expected to cause harm to a breastfed infant. There is no information on the effects of zinc sulfate on milk production.

There are reported cases of overdosage with intravenous zinc in parenteral nutrition: • Seven adult patients received an inadvertent overdosage of 50 mg to 75 mg elemental zinc per day in parenteral nutrition solution for 26 to 60 days; 6 of the 7 patients developed hyperamylasemia (peak amylase values of 557 to 1850 Klein units; normal: 130 to 310). Amylase was not reported in one patient. Serum zinc concentrations ranged from 310 to 670 mcg/dL. None of the patients developed clinical signs of pancreatitis. Five of the 7 patients died of septic complications. • One adult patient died of infectious complications after receiving an inadvertent overdosage of 7.4 grams of zinc sulfate (equivalent to 1.2 grams of elemental zinc per day for 2.5 days) in parenteral nutrition solution over 60 hours. The serum zinc concentration was 4184 mcg/dL. Symptoms of zinc overdosage also included hyperamylasemia, thrombocytopenia, anemia, vomiting and diarrhea. • One preterm infant born at 26 weeks gestation died of cardiac failure following a medication error in which the parenteral nutrition solution contained 330 mg/100 mL instead of 330 mcg/100 mL of zinc sulfate (overdosage of 1000-fold).

• Jul 18, 2019NDANDA209377Am Regent
• May 3, 2022ANDAANDA216249Gland
• Dec 27, 2022ANDAANDA216145Fresenius Kabi Usa
• Aug 22, 2023ANDAANDA217074Zydus Pharms
• Jun 10, 2024ANDAANDA218059Apotex
• Jul 17, 2024ANDAANDA216135Somerset Theraps Llc
• May 1, 2025ANDAANDA219585Aspiro

1. 1Diarrhoea2237.9%
2. 2Fatigue1776.3%
3. 3Nausea1716.0%
4. 4Death1565.5%
5. 5Off Label Use1545.4%
6. 6Pain1485.2%
7. 7Vomiting1415.0%
8. 8Dyspnoea1384.9%
9. 9Pyrexia1294.6%
10. 10Headache1043.7%
11. 11Asthenia1003.5%
12. 12Pneumonia973.4%
13. 13Anaemia953.4%
14. 14Drug Ineffective943.3%
15. 15Back Pain933.3%

Recent PubMed references pinned to Zinc Sulfate as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Comparative evaluation of zinc hydroxychloride and zinc sulphate on growth performance, antioxidant status, immune function, and zinc bioavailability in growing crossbred calves.
  Veterinary research communications · 2026 · Pal RP, Mani V, Mir SH, et al.
  PMID 42142145DOI 10.1007/s11259-026-11257-6
• Zn-based seed priming enhances drought resistance during germination of Lespedeza potaninii: physiological and transcriptomic insights.
  PeerJ · 2026 · Huo XW, Li JW, Chen Q, et al.
  PMID 41970271DOI 10.7717/peerj.21054
• Zinc Sulfate-Mediated Modulation of Growth, Physiology, Yield, and Metabolome in Capsicum annuum L. Under Salinity Stress.
  Physiologia plantarum · 2026 · Singh A, Choudhary KK
  PMID 41808264DOI 10.1111/ppl.70833
• Machine learning-based evaluation of seed priming and biostimulant applications in rainfed wheat.
  PeerJ · 2026 · Sharifi L, Ghiyasi M, Talebian B, et al.
  PMID 41800132DOI 10.7717/peerj.20578
• Additive effect of free-choice olfactory training combined with pharmacotherapy: A retrospective analysis of post-viral olfactory dysfunction.
  Auris, nasus, larynx · 2026 · Morishita H, Kobayashi M, Nishida K, et al.
  PMID 41763121DOI 10.1016/j.anl.2026.02.011
• Enhancing rapeseed germination by nano zinc oxide and zinc sulfate particles under interrupted irrigation.
  Scientific reports · 2025 · Alavifard SD, Taghvaei M, Naderi R, et al.
  PMID 41449218DOI 10.1038/s41598-025-31616-8
• Dietary zinc-di-tripeptide enhances zinc relative bioavailability and reduces fecal zinc losses compared to zinc sulfate, without compromising performance of growing pigs.
  Journal of animal science · 2025 · Careli PS, Dalto DB, Nunes RA, et al.
  PMID 41288969DOI 10.1093/jas/skaf409
• Zinc improves meat quality by modulating lipid metabolism in necrotic enteritis challenged broilers.
  Poultry science · 2025 · Xiao C, Pan X, Sun P, et al.
  PMID 41240704DOI 10.1016/j.psj.2025.106086

The 10 most recently updated of 173 ClinicalTrials.gov registrations naming Zinc Sulfate as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Zinc Therapy in Critical Illness
  Completed · Phase 1 · Interventional · 55 enrolled · University of Vermont
  NCT01162109updated 2026-06-01
• Zinc Supplementation and Infections in Older Medical Patients
  Recruiting · Interventional · 8,000 enrolled · Herlev Hospital
  NCT07367412updated 2026-05-29
• 0.2% Chlorhexidine vs MicroRepair ABX in Gingivitis
  Completed · Interventional · 40 enrolled · University of Pavia
  NCT07088666updated 2026-04-29
• Assessing the Effect of a Mineral-enriched Powder on Iron Deficiency in Women of Reproductive Age
  Completed · Phase 2 · Interventional · 150 enrolled · Carleton University
  NCT05990166updated 2026-04-27
• Comparative Evaluation of Three Different Pulpotomy Agents in Primary Molars
  Active not recruiting · Phase 2 · Interventional · 165 enrolled · Al-Mustansiriyah University
  NCT07541976updated 2026-04-24
• MicroRepair® ABX vs Chlorhexidine 0.12% in Gingivitis Patients
  Completed · Interventional · 40 enrolled · University of Pavia
  NCT07088653updated 2026-04-23
• Comparison of Efficacy and Safety of Vita 6 Versus Zinc Along With Applied Behavioural Therapy
  Completed · Interventional · 64 enrolled · Muhammad Aamir Latif
  NCT07383363updated 2026-04-15
• Topical Application of Engineered Lactobacillus Reuteri With a Zinc Sulfate-Tannic Acid MPN Coating for Acne
  Recruiting · Phase 2 · Interventional · 196 enrolled · Shenzhen People's Hospital
  NCT07366229updated 2026-04-06
• Efficacy & Safety of Oral Adjuvants to Phototherapy in Neonatal Hyperbilirubinemia
  Recruiting · Phase 4 · Interventional · 80 enrolled · Amira Adel Fouly
  NCT06517862updated 2026-03-18
• Assessing the Impact of Herbal Supplement on Fatigue and Disease Activity in SLE: Results From an 8-Week Randomized Trial
  Completed · Interventional · 59 enrolled · University Tunis El Manar
  NCT07398885updated 2026-02-10

Frequently asked questions

How does Zinc Sulfate work?

Mechanism-of-action classes: Acid-Base Activity; Electrolyte Activity; Enzyme Interactions.

What is Zinc Sulfate used for?

According to FDA labeling, Zinc Sulfate carries indications including: Zinc Sulfate Injection is indicated in adult and pediatric patients as a source of zinc for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. Zinc Sulfate Injection is a trace element indicated in adult and pediatric patients as a source of zinc for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Zinc Sulfate?

Zinc Sulfate is classified as Electrolyte solutions, Zinc, Acid-Base Activity, Electrolyte Activity, Enzyme Interactions, Astringent Activity.

What are the brand names for Zinc Sulfate?

Zinc Sulfate is marketed under brand names including Concept OB, Eldertonic, Ellis Tonic, Hemocyte Plus, Lactocal, Multitrace-4, Multitrace-5, Multrys.

What are the contraindications for Zinc Sulfate?

Zinc Sulfate labeling lists contraindications including: Zinc Sulfate Injection is contraindicated in patients with known hypersensitivity to zinc [ see Warnings and Precautions ( 5.6 ) ]. ​Known hypersensitivity to zinc ( 4 , 5.6 ).. Always consult the full prescribing information and a clinician.