FDA label 3b438f47-8fd9-4892-8f13-eabc362427da
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- SPL set ID
- b921a0da-4642-4b8b-ac44-7e0d278722d0
- SPL ID
- 3b438f47-8fd9-4892-8f13-eabc362427da
- Version
- 3
- Effective date
- 2019-11-22
- Source export date
- 2026-09-28
- Source partition
- 8
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:51:27
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| spl id | 3b438f47-8fd9-4892-8f13-eabc362427da | id | |
| spl set id | b921a0da-4642-4b8b-ac44-7e0d278722d0 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings: Patients with end stage renal failure may develop hypercalcemia when given calcium with meals. No other calcium supplements should be given concurrently with Calcium Acetate Tablets, USP. Progressive hypercalcemia due to overdose of Calcium Acetate Tablets, USP may be severe as to require emergency measures. Chronic hypercalcemia may lead to vascular calcification, and other soft-tissue calcification. The serum calcium level should be monitored twice weekly during the early dose adjustment period. The serum calcium times phosphate (CaXP) product should not be allowed to exceed 66. Radiographic evaluation of suspect anatomical region may be helpful in early detection of soft tissue calcification.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
Adverse Reactions: In clinical studies, patients have occasionally experienced nausea during calcium acetate tablet therapy. Hypercalcemia may occur during treatment with Calcium Acetate Tablets, USP. Mild hypercalcemia (Ca >10.5 mg/dl) may be asymptomatic or manifest itself as constipation, anorexia, nausea and vomiting. More severe hypercalcemia (Ca >12 mg/dl) is associated with confusion, delirium, stupor and coma. Mild hypercalcemia is easily controlled by reducing the Calcium Acetate Tablets, USP dose or temporarily discontinuing therapy. Severe hypercalcemia can be treated by acute hemodialysis and discontinuing calcium acetate tablets therapy. Decreasing dialysate calcium concentration could reduce the incidence and severity of Calcium Acetate Tablets, USP induced hypercalcemia. The long-term effect of calcium acetate tablets on the progression of vascular or soft tissue calcification has not been determined. Isolated cases of pruritus have been reported which may represent allergic reactions.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.