Prescription medicine
Edetate First approved as Calcium Disodium Versenate
Edetate (Calcium Disodium Versenate) is a prescription medicine with an FDA approval on record since 1953. FDA's NDC Directory lists it from 1 generic labeler.
- Generic listed
- Boxed warning
Check it at the source: the edetate FDA label on DailyMed (effective February 13, 2025, Rising Pharma Holdings, Inc.); the NDA 8922 record on Drugs@FDA; every edetate label on DailyMed.
Highlights of the record
FDA label of February 13, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Edetate calcium disodium injection is capable of producing toxic effects which can be fatal. Lead encephalopathy is relatively rare in adults, but occurs more often in pediatric patients in whom it may be incipient and thus overlooked. The mortality rate in pediatric patients has been high. Patients with lead encephalopathy and cerebral edema may experience a lethal increase in intracranial pressure following intravenous infusion; the intramuscular route is preferred for these patients. In cases where the intravenous route is necessary, avoid rapid infusion. The dosage schedule should be followed and at no time should the recommended daily dose be exceeded.
Used for
From the label: indications and usageEdetate 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.
Forms and strengths
- 200 mg/ml
Injection.
On the market
- Earliest approval on file
- July 16, 1953 Calcium Disodium Versenate, Bausch; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 1 first May 3, 2023; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 1 of which 1 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 4 since 2013 0 Class I among all firms' recalls; latest December 22, 2022; 6 more by firms not listed as its makers
- FAERS reports
- 40 through July 30, 2026
What is edetate used for?
From the label: indications and usageEdetate 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.
FDA pharmacologic class: Anti-coagulant and Lead Chelator.
Source: FDA drug label (Edetate Calcium Disodium), Rising Pharma Holdings, Inc., effective February 13, 2025 (SPL set 710a2c8c-3620-4f6f-b8fc-fb19ab9e9f22), via openFDA; the full label on DailyMed
Is there a generic for edetate (Calcium Disodium Versenate)?
The FDA approved the first generic edetate on May 3, 2023. 1 generic application is approved; 1 of it carries a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists edetate from 1 labeler under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1953 earliest approval on file
- 2023 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has edetate been recalled?
The FDA's Enforcement Report lists 10 recalls naming edetate since 2013: 0 Class I (the most serious), 10 Class II, 0 Class III; 0 still ongoing. 6 of them are by firms that FDA's NDC Directory does not list as a maker of edetate and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| December 22, 2022 | Class II | Pharmacy Innovations | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. |
| December 6, 2021 | Class II | Edge Pharma, LLC | Lack of Assurance of Sterility. |
| December 6, 2021 | Class II | Edge Pharma, LLC | Lack of Assurance of Sterility |
| June 19, 2019 | Class II | RXQ Compounding LLC not a listed maker | Lack of Assurance of Sterility |
| July 24, 2015 | Class II | JD & SN Inc., dba Moses Lake Professional Pharmacy not a listed maker | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry |
| October 19, 2013 | Class II | Specialty Medicine Compounding Pharmacy not a listed maker | Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same … |
| July 26, 2013 | Class II | Beacon Hill Medical Pharmacy, P.C. not a listed maker | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance |
| April 10, 2013 | Class II | FVS Holdings, Inc. dba. Green Valley Drugs not a listed maker | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the edetate label say about other medicines?
The edetate label names no other medicine on this site. The labels of 2 other medicines name edetate. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
Other labels that name edetate
Source: FDA drug label (Edetate Calcium Disodium), Rising Pharma Holdings, Inc., effective February 13, 2025 (SPL set 710a2c8c-3620-4f6f-b8fc-fb19ab9e9f22), via openFDA; the full label on DailyMed
What do FAERS reports show for edetate?
The FDA Adverse Event Reporting System holds 40 reports that list edetate among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 32 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.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other anti-coagulants
- the pharmacologic class, with prices and generics
- Edetate side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other