Acetate

Calcium acetate, when taken with meals, combines with dietary phosphate to form an insoluble calcium phosphate complex, which is excreted in the feces, resulting in decreased serum phosphorus concentration.

• Calcium acetate is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (ESRD). Calcium acetate is a phosphate binder indicated for the reduction of serum phosphorus in patients with end stage renal disease.

• Patients with hypercalcemia. Hypercalcemia.contraindicated

The recommended initial dose of calcium acetate for the adult dialysis patient is 2 capsules with each meal. Increase the dose gradually to lower serum phosphorus levels to the target range, as long as hypercalcemia does not develop. Most patients require 3-4 capsules with each meal. Starting dose is 2 capsules with each meal. (2) Titrate the dose every 2-3 weeks until acceptable serum phosphorus level is reached. Most patients require 3-4 capsules with each meal. (2)

Treat mild hypercalcemia by reducing or interrupting calcium acetate capsules and Vitamin D. Severe hypercalcemia may require hemodialysis and discontinuation of calcium acetate capsules. ( 5.1 ) Hypercalcemia may aggravate digitalis toxicity. ( 5.2 ) 5.1 Hypercalcemia Patients with end stage renal disease may develop hypercalcemia when treated with calcium, including calcium acetate. Avoid the use of calcium supplements, including calcium based nonprescription antacids, concurrently with calcium acetate. An overdose of calcium acetate may lead to progressive hypercalcemia, which may require emergency measures. Therefore, early in the treatment phase during the dosage adjustment period, monitor serum calcium levels twice weekly. Should hypercalcemia develop, reduce the calcium acetate dosage, or discontinue the treatment, depending on the severity of hypercalcemia. More severe hypercalcemia (Ca >12 mg/dL) is associated with confusion, delirium, stupor and coma. Severe hypercalcemia can be treated by acute hemodialysis and discontinuing calcium acetate therapy. Mild hypercalcemia (10.5 to 11.9 mg/dL) may be asymptomatic or manifest as constipation, anorexia, nausea, and vomiting. Mild hypercalcemia is usually controlled by reducing the calcium acetate dose or temporarily discontinuing therapy. Decreasing or discontinuing Vitamin D therapy is recommended as well. Chronic hypercalcemia may lead to vascular calcification and other soft-tissue calcification. Radiographic evaluation of suspected anatomical regions may be helpful in early detection of soft tissue calcification.

Hypercalcemia is discussed elsewhere [see Warnings and Precautions (5.1) ]. The most common (>10%) adverse reactions are hypercalcemia, nausea and vomiting. ( 6.1 ) In clinical studies, patients have occasionally experienced nausea during calcium acetate therapy. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Cipla Ltd. at 1-866-604-3268 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In clinical studies, calcium acetate has been generally well tolerated. Calcium acetate was studied in a 3-month, open-label, non-randomized study of 98 enrolled ESRD hemodialysis patients and an alternate liquid formulation of calcium acetate was studied in a two week double-blind, placebo-controlled, cross-over study with 69 enrolled ESRD hemodialysis patients. Adverse reactions (>2% on treatment) from these trials are presented in Table 1.

8.1 Pregnancy Pregnancy Category C Calcium acetate capsules contain calcium acetate. Animal reproduction studies have not been conducted with calcium acetate, and there are no adequate and well controlled studies of calcium acetate use in pregnant women. Patients with end stage renal disease may develop hypercalcemia with calcium acetate treatment [see Warnings and Precautions (5.1) ] . Maintenance of normal serum calcium levels is important for maternal and fetal well being. Hypercalcemia during pregnancy may increase the risk for maternal and neonatal complications such as stillbirth, preterm delivery, and neonatal hypocalcemia and hypoparathyroidism. Calcium acetate treatment, as recommended, is not expected to harm a fetus if maternal calcium levels are properly monitored during and following treatment. 8.2 Labor and Delivery The effects of calcium acetate on labor and delivery are unknown. 8.3 Nursing Mothers A calcium acetate capsule contains calcium acetate and is excreted in human milk. Human milk feeding by a mother receiving calcium acetate is not expected to harm an infant, provided maternal serum calcium levels are appropriately monitored. 8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established.

Administration of calcium acetate in excess of the appropriate daily dosage may result in hypercalcemia [see Warnings and Precautions (5.1) ].

• May 27, 1959NDANDA011757Pfizer
• May 17, 1962NDANDA050356Ph Health
• Jan 24, 1969NDANDA016763Rising
• Nov 10, 1972NDANDA017100Abbvie
• Jul 10, 1973NDANDA017469Sandoz
• Aug 13, 1975NDANDA017586Otsuka Icu Medcl
• Feb 2, 1979NDANDA017378Baxter Hlthcare
• May 4, 1983NDANDA018893Hospira

1. 1Drug Ineffective30,6357.4%
2. 2Fatigue30,4737.4%
3. 3Off Label Use24,1595.8%
4. 4Death24,0275.8%
5. 5Pain21,9915.3%
6. 6Nausea19,6224.7%
7. 7Diarrhoea17,9124.3%
8. 8Headache17,6844.3%
9. 9Dyspnoea15,6423.8%
10. 10Dizziness14,5893.5%
11. 11Injection Site Pain14,5253.5%
12. 12Arthralgia14,3483.5%
13. 13Malaise13,7963.3%
14. 14Rash13,7803.3%
15. 15Asthenia13,5793.3%

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

• Diphenylpiperazine attached to different triazole acetamide derivatives as a potent α-glucosidase inhibitor, new insight into the in silico study of an uncompetitive inhibitor.
  Journal of computer-aided molecular design · 2026 · Ghasemi M, Sepehri N, Biglar M, et al.
  PMID 42257774DOI 10.1007/s10822-026-00847-w
• New-onset erythrodermic psoriasis associated with antiepileptic drug use.
  Dermatology online journal · 2026 · Feng J, Shah P, Cloutier J, et al.
  PMID 42246351DOI 10.25251/5bv66v50
• Comparing the safety and efficacy of sodium valproate, levetiracetam, and phenytoin in attenuating the severity of agitation in patients with post-traumatic brain injury: An observational study.
  PloS one · 2026 · Singh S, Nayak R, Gangachannaiah S, et al.
  PMID 42234767DOI 10.1371/journal.pone.0350585
• Anti-asthma drug montelukast induces autistic behaviors via disrupting neuronal retinoic acid signaling.
  Signal transduction and targeted therapy · 2026 · Hao ZJ, Wu QH, Li YL, et al.
  PMID 42230569DOI 10.1038/s41392-026-02665-w
• Slow-inactivated sodium channels as a therapeutic target in trigeminal neuralgia: evidence from a systematic review and meta-analysis of lacosamide.
  Journal of oral & facial pain and headache · 2026 · Meechumnarn T, Phutinart S, Anukoolwittaya P, et al.
  PMID 42220289DOI 10.22514/jofph.2026.037
• In Situ pH Determination Using (1)H-MRS Acetate Chemical Shift for Noninvasive Postmortem Examinations.
  NMR in biomedicine · 2026 · Frese S, Gascho D, Thali MJ, et al.
  PMID 42219944DOI 10.1002/nbm.70323
• Valorization of bamboo vinegar through modified biochar for synergistic cadmium immobilization and phosphorus activation in saline alkaline soil.
  Bioresource technology · 2026 · Yang C, Xie Y, Wei L, et al.
  PMID 42219121DOI 10.1016/j.biortech.2026.135032
• Synergistic Effects of Acetic Acid and Ethanol on Offspring Production and Gallery Expansion by Fungus-Farming Ambrosia Beetles.
  Journal of chemical ecology · 2026 · Ranger CM, Baniszewski JA, Patwa N, et al.
  PMID 42216980DOI 10.1007/s10886-026-01725-3

The 10 most recently updated of 3,033 ClinicalTrials.gov registrations naming Acetate 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
• Intrauterine Stent Placement Following Hysteroscopic Septum Resection
  Recruiting · Interventional · 320 enrolled · Weill Medical College of Cornell University
  NCT07032506updated 2026-06-12
• A Study of Ocular Toxicity Evaluation and Mitigation During Treatment With Mirvetuximab Soravtansine in Participants With Recurrent Ovarian Cancer With High Folate Receptor-Alpha Expression
  Recruiting · Phase 2 · Interventional · 100 enrolled · AbbVie
  NCT06365853updated 2026-06-12
• A Drug-Drug Interaction Study of Itraconazole and Opevesostat (MK-5684) in Healthy Adult Male Participants (MK-5684-017)
  Active not recruiting · Phase 1 · Interventional · 14 enrolled · Merck Sharp & Dohme LLC
  NCT07548606updated 2026-06-12
• 177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer
  Not yet recruiting · Phase 1 · Phase 2 · Interventional · 18 enrolled · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  NCT06991738updated 2026-06-12
• The Effect of Medical Management Following Excisional Surgery for Endometriosis: A Randomized Controlled Trial
  Recruiting · Phase 3 · Interventional · 110 enrolled · Main Line Health
  NCT06439524updated 2026-06-12
• Presurgical Phase II Study of Talazoparib in Combination With Enzalutamide in Prostate Cancer
  Recruiting · Phase 2 · Interventional · 30 enrolled · M.D. Anderson Cancer Center
  NCT05873192updated 2026-06-12
• A Trial to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent Glioblastoma
  Recruiting · Phase 2 · Phase 3 · Interventional · 2,250 enrolled · Global Coalition for Adaptive Research
  NCT03970447updated 2026-06-12
• A Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer
  Recruiting · Phase 3 · Interventional · 750 enrolled · Amgen
  NCT07213674updated 2026-06-12
• Dexamethasone in Controlling Dyspnea in Patients With Cancer
  Active not recruiting · Phase 2 · Interventional · 135 enrolled · M.D. Anderson Cancer Center
  NCT03367156updated 2026-06-11

Frequently asked questions

How does Acetate work?

Calcium acetate, when taken with meals, combines with dietary phosphate to form an insoluble calcium phosphate complex, which is excreted in the feces, resulting in decreased serum phosphorus concentration.

What is Acetate used for?

According to FDA labeling, Acetate carries indications including: Calcium acetate is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (ESRD). Calcium acetate is a phosphate binder indicated for the reduction of serum phosphorus in patients with end stage renal disease.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What are the contraindications for Acetate?

Acetate labeling lists contraindications including: Patients with hypercalcemia. Hypercalcemia.. Always consult the full prescribing information and a clinician.