Calcium Gluconate

Intravenous administration of calcium gluconate increases serum ionized calcium level. Calcium gluconate dissociates into ionized calcium in plasma.

• Calcium Gluconate in Sodium Chloride Injection is indicated for pediatric and adult patients for the treatment of acute symptomatic hypocalcemia. Limitations of Use The safety of Calcium Gluconate in Sodium Chloride Injection for long term use has not been established.

• Calcium Gluconate in Sodium Chloride Injection is contraindicated in: •Hyperca lcemia • Neonates (28 days of age or younger) receiving ceftriaxone [see Warnings and Precautions (5.2)] • Hypercalcemia (4) • Neonates (28 days of age or younger) receiving ceftriaxone (4)contraindicated

• Administer intravenously (bolus or continuous infusion) via a secure intravenous line (2.1) • See Full Prescribing Information (FPI) for administration rates, and appropriate monitoring (2.1) • Do not dilute Calcium Gluconate in Sodium Chloride Injection prior to use. Any unused portion should be discarded (2.1) • Individualize the dose within the recommended range in adults and pediatric patients depending on the severity of symptoms of hypocalcemia, the serum calcium level, and the acuity of onset of hypocalcemia. See Table 1 in the FPI for dosing recommendations in mg of calcium gluconate for neonates, pediatric and adult patients. (2.2) • Measure serum calcium during intermittent infusions every 4 to 6 hours and during continuous infusion every 1 to 4 hours. (2.3) • Calcium Gluconate Injection is not physically compatible with fluids containing phosphate or bicarbonate. Precipitation may result if mixed. See FPI for all drug incompatibilities. (2.5) 2.1 Important Administration Instructions See Table 1 for amounts of elemental calcium in Calcium Gluconate in Sodium Chloride Injection. Table 1.

• Arrhythmias with Concomitant Cardiac Glycoside Use: If concomitant therapy is necessary, Calcium Gluconate in Sodium Chloride Injection should be given slowly in small amounts and close ECG monitoring is recommended (5.1) • End-Organ Damage due to Intravascular Ceftriaxone-Calcium Precipitates: Concurrent use of intravenous ceftriaxone may cause life-threatening precipitates. Do not administer ceftriaxone simultaneously with Calcium Gluconate in Sodium Chloride Injection via a Y-site in any age group. Cases of fatal outcomes in neonates have occurred. (4, 5.2) • Tissue Necrosis and Calcinosis: Calcinosis cutis can occur with or without extravasation of Calcium Gluconate in Sodium Chloride Injection. Tissue necrosis, ulceration, and secondary infection are the most serious complications. If extravasation occurs or clinical manifestations of calcinosis cutis are noted, immediately discontinue intravenous administration at that site and treat as needed. (5.3) • Hypotension, Bradycardia, and Cardiac Arrhythmias with Rapid Administration: To avoid adverse reactions that may follow rapid intravenous administration, Calcium Gluconate in Sodium Chloride Injection should be infused slowly, with careful ECG monitoring for cardiac arrhythmias. (5.4) • Aluminum Toxicity: This product contains aluminum, up to 25 mcg per liter, that may be toxic. (5.5) 5.1 Arrhythmias with Concomitant Cardiac Glycoside Use Cardiac arrhythmias may occur if calcium and cardiac glycosides are administered together. Hypercalcemia increases the risk of digoxin toxicity.

The following serious adverse reactions are also described elsewhere in the labeling: • Arrhythmias with Concomitant Cardiac Glycoside Use [see Warnings and Precautions (5.1)] • End-Organ Damage due to Intravascular Ceftriaxone-Calcium Precipitates [see Warnings and Precautions (5.2)] • Tissue Necrosis and Calcinosis [see Warnings and Precautions (5.3)] • Hypotension, Bradycardia, and Cardiac Arrhythmias [see Warnings and Precautions (5.4)] • Aluminum toxicity [see Warnings and Precautions (5.5)] The following adverse reactions associated with the use of calcium gluconate were identified in the literature. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure. Cardiovascular : Vasodilation, decreased blood pressure, bradycardia, cardiac arrhythmia, syncope, cardiac arrest Administration site reactions : Local soft tissue inflammation, local necrosis, calcinosis cutis and calcification due to extravasation The most common adverse events with Calcium Gluconate Injection are local soft tissue inflammation and necrosis, calcinosis cutis and calcification that are related to extravasation. Other adverse events include vasodilation, decreased blood pressure, bradycardia, cardiac arrhythmia, syncope, and cardiac arrest. (6) To report SUSPECTED ADVERSE REACTIONS, contact WG Critical Care, LLC at 1-866-562-4708 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

• Geriatric use : Dosing in elderly patients should be cautious, usually starting at the low end of the dosage range. (8.5) • Renal impairment: Initiate with the lower limit of the dosage range and monitor serum calcium levels every 4 hours. (8.6, 2.4) 8.1 Pregnancy Risk summary Limited available data with Calcium Gluconate Injection use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. There are risks to the mother and the fetus associated with hypocalcemia in pregnancy [see Clinical Considerations] . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Disease-associated maternal risk Maternal hypocalcemia can result in an increased rate of spontaneous abortion, premature and dysfunctional labor, and possibly preeclampsia. Fetal/Neonatal adverse reactions Infants born to mothers with hypocalcemia can have associated fetal and neonatal hyperparathyroidism, which in turn can cause fetal and neonatal skeletal demineralization, subperiosteal bone resorption, osteitis fibrosa cystica and neonatal seizures.

Metabolism

Absorption Calcium Gluconate Injection is 100% bioavailable following intravenous injection. Metabolism Calcium itself does not undergo direct metabolism.

Overdosage of Calcium Gluconate in Sodium Chloride Injection may result in hypercalcemia. Symptoms of hypercalcemia typically develop when the total serum calcium concentration is ≥12 mg/dL. Neurologic symptoms include depression, weakness, fatigue, and confusion at lower levels, with patients experiencing hallucinations, disorientation, hypotonicity, seizures, and coma. Effects on the kidney include diminished ability to concentrate urine and diuresis. If overdose of Calcium Gluconate in Sodium Chloride Injection occurs immediately discontinue administration and provide supportive treatments to restore intravascular volume as well as promote calcium excretion in the urine if necessary.

• Jun 15, 2017NDANDA208418Fresenius Kabi Usa
• Oct 29, 2018NDANDA210906Hq Spclt Pharma
• Oct 14, 2022ANDAANDA213071Nivagen Pharms Inc
• Aug 21, 2023ANDAANDA216541B Braun Medical
• Sep 5, 2023ANDAANDA217174Amneal
• Oct 19, 2023ANDAANDA217689Somerset
• May 10, 2024ANDAANDA216611Amneal
• May 4, 2026ANDAANDA218840Caplin

1. 1Drug Ineffective2,11518%
2. 2Pain1,68214%
3. 3Fatigue1,66114%
4. 4Off Label Use1,57013%
5. 5Rheumatoid Arthritis1,37312%
6. 6Nausea1,34711%
7. 7Alopecia1,31811%
8. 8Arthropathy1,24211%
9. 9Vomiting1,24011%
10. 10Pemphigus1,23911%
11. 11Psoriatic Arthropathy1,23110%
12. 12Abdominal Discomfort1,22910%
13. 13Systemic Lupus Erythematosus1,21210%
14. 14Diarrhoea1,18610%
15. 15Glossodynia1,1699.9%

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

• Simulated Y-Site Compatibility of Calcium Gluconate and Benzylpenicillin With Maintenance Fluid Used in Neonatal Intensive Care Unit.
  Clinical and translational science · 2026 · Allahham A, Pulbrook R, Lo B, et al.
  PMID 42168135DOI 10.1111/cts.70603
• Risk-based strategy for evaluating and controlling residual protein impurities in enzymatically synthesized calcium gluconate: Bridging analytical detection to safety assessment.
  Regulatory toxicology and pharmacology : RTP · 2026 · Jin Z, Huang Q, Sun X, et al.
  PMID 42000024DOI 10.1016/j.yrtph.2026.106102
• Hydrogenated fat-embedded calcium gluconate improves apparent total tract digestibility in lactating dairy cows in a dose-dependent manner.
  Animal : an international journal of animal bioscience · 2026 · Seymour DJ, Sanz-Fernandez MV, Nichols K, et al.
  PMID 41934948DOI 10.1016/j.animal.2026.101802
• Mapping ionized calcium levels and evaluating the outcome of prehospital calcium supplementation in acute trauma and hemorrhagic shock.
  Transfusion · 2026 · Walsh RW, Meledeo MA, Nicolson SE, et al.
  PMID 41906379DOI 10.1111/trf.70176
• Multiple Subcutaneous Calcifications in a Neonate after Intravenous Calcium Gluconate: A Case Report.
  JNMA; journal of the Nepal Medical Association · 2025 · Ghimire A
  PMID 41783629DOI 10.31729/jnma.v63i290.9197
• Calcium and vitamin D reduce hypoparathyroidism and hospital stay after thyroidectomy: A randomized controlled trial.
  Surgery · 2026 · Gkanis V, Nastos K, Ntalaperas K, et al.
  PMID 41604835DOI 10.1016/j.surg.2025.110071
• Individualised Wound Treatment Strategies for Skin Lesions Caused by Calcium Gluconate Extravasation in Neonates: A Case Report.
  Nursing in critical care · 2026 · Li X, Yan J, Liu Y, et al.
  PMID 41416416DOI 10.1111/nicc.70297
• Bedside mixing of calcium gels for dermal hydrofluoric acid treatment leads to precipitate formation and loss of dissolved calcium.
  Clinical toxicology (Philadelphia, Pa.) · 2025 · Cowdery CP, Kazmierczak SC, Thompson JA, et al.
  PMID 40587120DOI 10.1080/15563650.2025.2519323

The 10 most recently updated of 5,596 ClinicalTrials.gov registrations naming Calcium Gluconate as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Study to Compare Blinatumomab Alone to Blinatumomab With Nivolumab in Patients Diagnosed With First Relapse B-Cell Acute Lymphoblastic Leukemia (B-ALL)
  Recruiting · Phase 2 · Interventional · 461 enrolled · National Cancer Institute (NCI)
  NCT04546399updated 2026-06-12
• Phase I/II Study of Engineered T Cell Receptor-Modified NK Cells Targeting PRAME in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapse/Refractory Myeloid Malignancies
  Recruiting · Phase 1 · Phase 2 · Interventional · 44 enrolled · M.D. Anderson Cancer Center
  NCT06383572updated 2026-06-12
• Host-Diet-Gut Interaction Post Vegan Diet in Pediatric Autoimmune Hepatitis.
  Recruiting · Interventional · 40 enrolled · Institute of Liver and Biliary Sciences, India
  NCT07118657updated 2026-06-12
• Polygenic Risk-based Detection of Subclinical Coronary Atherosclerosis and Intervention With Statin and Colchicine
  Active not recruiting · Phase 4 · Interventional · 200 enrolled · Massachusetts General Hospital
  NCT05850091updated 2026-06-12
• Fermented Foods and Bone Health: Investigating the Gut-Bone Axis in Premenopausal Vegan Women
  Not yet recruiting · Interventional · 50 enrolled · Isabelle Herter-Aeberli
  NCT07645885updated 2026-06-12
• Biological, Radiographic and Clinical Evaluation of Various Inter-Visit Root Canal Dressings in Retreatment Cases
  Recruiting · Phase 1 · Interventional · 60 enrolled · Ain Shams University
  NCT07641933updated 2026-06-12
• A Prospective Registry Study to Assess Real-world Patient Characteristics, Treatment Patterns, and Longitudinal Outcomes in Patients Receiving Mavacamten and Other Treatments for Symptomatic Obstructive Hypertrophic Cardiomyopathy (Obstructive-HCM)
  Recruiting · Observational · 1,700 enrolled · Bristol-Myers Squibb
  NCT05489705updated 2026-06-12
• A Clinical Study of Enlicitide in Participants With High Cholesterol (MK-0616-037)
  Recruiting · Phase 3 · Interventional · 975 enrolled · Merck Sharp & Dohme LLC
  NCT07216482updated 2026-06-12
• Influence of Dermocorticoids on Bone Mineral Density in Patients With Bullous Pemphigoid
  Completed · Phase 4 · Interventional · 47 enrolled · Centre Hospitalier Universitaire, Amiens
  NCT03926377updated 2026-06-12
• Statins to Prevent Cancer Associated Blood Clots
  Recruiting · Phase 4 · Interventional · 4,000 enrolled · Brigham and Women's Hospital
  NCT07303816updated 2026-06-12

Frequently asked questions

How does Calcium Gluconate work?

Intravenous administration of calcium gluconate increases serum ionized calcium level. Calcium gluconate dissociates into ionized calcium in plasma.

What is Calcium Gluconate used for?

According to FDA labeling, Calcium Gluconate carries indications including: Calcium Gluconate in Sodium Chloride Injection is indicated for pediatric and adult patients for the treatment of acute symptomatic hypocalcemia. Limitations of Use The safety of Calcium Gluconate in Sodium Chloride Injection for long term use has not been established.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Calcium Gluconate?

Calcium Gluconate is classified as Calcium, Electrolyte solutions, Other dermatologicals, Bone Resorption Alteration.

What are the brand names for Calcium Gluconate?

Calcium Gluconate is marketed under brand names including Calgonate.

What are the contraindications for Calcium Gluconate?

Calcium Gluconate labeling lists contraindications including: Calcium Gluconate in Sodium Chloride Injection is contraindicated in: •Hyperca lcemia • Neonates (28 days of age or younger) receiving ceftriaxone [see Warnings and Precautions (5.2)] • Hypercalcemia (4) • Neonates (28 days of age or younger) receiving ceftriaxone (4). Always consult the full prescribing information and a clinician.