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What the label lists and what reports show

Calcium acetate side effects

Calcium acetate's FDA label: “The most common (>10%) adverse reactions are hypercalcemia, nausea, and vomiting.” FAERS holds 5,355 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is renal failure (484 reports).

  • Generic listed

Check it at the source: the calcium acetate FDA label on DailyMed (effective July 1, 2025, Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

The most common (>10%) adverse reactions are hypercalcemia, nausea, and vomiting.

From the label: adverse reactions, continued

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 Avet Pharmaceuticals Inc. at 1-866-901-DRUG (3784) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Hypercalcemia is discussed elsewhere [see Warnings and Precautions (5.1) ]. 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 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.

Source: FDA drug label, Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., effective July 1, 2025 (SPL set d48c66a9-26fe-4e1a-a68a-88afe83fb51d), via openFDA; the full label on DailyMed

What do FAERS reports show?

5,355 reports list calcium acetate among the medicines taken, each a report of something that happened, not proof the medicine caused it; 685 are coded as a death and 2,269 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 21 reactions below, 5 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

  • Renal Failure (named in the label)484
  • Chronic Kidney Disease464
  • End Stage Renal Disease (a use or a product term, not a reaction)436
  • Acute Kidney Injury378
  • Diarrhoea333
  • Nausea (named in the label)268
  • Fatigue255
  • Death (an outcome recorded in the report)243
  • Dyspnoea231
  • Nephrogenic Anaemia213
  • Pain187
  • Asthenia178
  • Vomiting (named in the label)172
  • Drug Ineffective (a use or a product term, not a reaction)171
  • Pneumonia169
  • Pruritus (named in the label)168
  • Off Label Use (a use or a product term, not a reaction)155
  • Dizziness (named in the label)154
  • Anaemia153
  • Headache147
  • Flushing144
  • Anxiety140
  • Hypotension135
  • Fall134
  • Malaise131

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Calcium acetate: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions