Boxed warningThe FDA label of this medicine carries a boxed warning, the strongest warning the FDA gives. Read it under warnings and precautions.
Indications
Edetate calcium disodium is indicated for the reduction of blood levels and depot stores of lead in lead poisoning (acute and chronic) and lead encephalopathy, in both pediatric populations and adults. Chelation therapy should not replace effective measures to eliminate or reduce further exposure to lead.
Contraindications
Edetate calcium disodium should not be given during periods of anuria, nor to patients with active renal disease or hepatitis.
Warnings and precautions
See Boxed Warning.
Interactions
Drug Interactions There is no known drug interference with standard clinical laboratory tests. Steroids enhance the renal toxicity of edetate calcium disodium in animals. 7 Edetate calcium disodium interferes with the action of zinc insulin preparations by chelating the zinc. 7
Pregnancy and breastfeeding
Pregnancy One reproduction study was performed in rats at doses up to 13 times the human dose and revealed no evidence of impaired fertility or harm to the fetus due to edetate calcium disodium. 10 Another reproduction study performed in rats at doses up to about 25 to 40 times the human dose revealed evidence of fetal malformations due to edetate calcium disodium, which were prevented by simultaneous supplementation of dietary zinc. 11 There are, however, no adequate and well-controlled studies in pregnant women.
Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
At a glance
- Brand name
- Edetate Calcium Disodium
- Route
- Injection
- Dosage form
- Injectable
- Applicant
- Casper Pharma LLC
- Status
- Prescription
- FDA approval
- 3 May 2023
- Application
- ANDA216435-001
- RxCUI
- 1903



