Drug · FAERS side-effect profile with label screen

Edetate side effects: what 40 FDA adverse event reports show

Edetate Calcium Disodium · 11 reaction terms · 319 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Label matched

Edetate Calcium Disodium (Edetate Calcium Disodium)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

40 reports · 92% serious · 0 with death outcome · 11% female

openFDA FAERS counts, all years, deduplication not applied

Used for

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.

FDA label, Indications and Usage

What it is

DESCRIPTION Edetate Calcium Disodium injection, USP is a sterile, injectable, chelating agent in concentrated solution for intravenous infusion or intramuscular injection. Each 5 mL single-dos.

FDA label, Description section

Boxed warning

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.

FDA label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 11 strongest signals

Labeled — boxed warning 1Labeled (related wording) 2Not in label — unassessed 8

What the badges mean

Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 0 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Obstructive airways disorder	29	1,365.4 1,127.2–1,654.1ROR 4,962.6 · χ² 38,107 / p <1e-300	714.8 EB05 522.0 · IC025 +5.2 3/3 methods agree	Not in label — unassessed	serious PRR 881.4	no trial data cached
Nodule	29	1,167.3 963.7–1,413.9ROR 4,242.1 · χ² 32,584 / p <1e-300	656.6 EB05 479.5 · IC025 +5.2 3/3 methods agree	Not in label — unassessed	serious PRR 1,122.9	no trial data cached
Lymphopenia	29	1,082.7 893.9–1,311.4ROR 3,934.5 · χ² 30,226 / p <1e-300	629.1 EB05 459.4 · IC025 +5.2 3/3 methods agree	Not in label — unassessed	serious PRR 726.3	no trial data cached
Obesity	29	954.5 788.1–1,155.9ROR 3,468.1 · χ² 26,647 / p <1e-300	583.6 EB05 426.2 · IC025 +5.2 3/3 methods agree	Not in label — unassessed	serious PRR 688.4	no trial data cached
Respiratory tract infection	29	586.1 484.1–709.6ROR 2,128.6 · χ² 16,360 / p <1e-300	421.9 EB05 308.1 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	serious PRR 445.7	no trial data cached
Lacrimation increased	29	509.3 420.7–616.6ROR 1,849.3 · χ² 14,214 / p <1e-300	380.7 EB05 278.0 · IC025 +5.1 3/3 methods agree	Labeled (related wording) related wording	serious PRR 823.2	no trial data cached
Viral infection	29	457.7 378.0–554.1ROR 1,661.7 · χ² 12,771 / p <1e-300	351.2 EB05 256.4 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	serious PRR 399.6	no trial data cached
Haematuria (blood in urine)	29	443.6 366.4–537.0ROR 1,610.3 · χ² 12,376 / p <1e-300	342.8 EB05 250.3 · IC025 +5.1 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 304.2	no trial data cached
Renal disorder	29	325.8 269.1–394.4ROR 1,182.1 · χ² 9,083 / p <1e-300	268.1 EB05 195.8 · IC025 +5.0 3/3 methods agree	Labeled (related wording) related wording	serious PRR 248.4	no trial data cached
Productive cough (cough with phlegm)	29	321.3 265.5–389.0ROR 1,165.9 · χ² 8,958 / p <1e-300	265.1 EB05 193.6 · IC025 +5.0 3/3 methods agree	Not in label — unassessed	serious PRR 297.4	no trial data cached
Prostate cancer	29	187.3 154.7–226.7ROR 678.3 · χ² 5,206 / p <1e-300	166.8 EB05 121.8 · IC025 +4.9 3/3 methods agree	Not in label — unassessed	serious PRR 116.6	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Prostate cancer	29	187.3 154.7–226.7ROR 678.3 · χ² 5,206 / p <1e-300	166.8 EB05 121.8 · IC025 +4.9 3/3 methods agree	Not in label — unassessed	serious PRR 116.6	no trial data cached
Productive cough (cough with phlegm)	29	321.3 265.5–389.0ROR 1,165.9 · χ² 8,958 / p <1e-300	265.1 EB05 193.6 · IC025 +5.0 3/3 methods agree	Not in label — unassessed	serious PRR 297.4	no trial data cached
Renal disorder	29	325.8 269.1–394.4ROR 1,182.1 · χ² 9,083 / p <1e-300	268.1 EB05 195.8 · IC025 +5.0 3/3 methods agree	Labeled (related wording) related wording	serious PRR 248.4	no trial data cached
Haematuria (blood in urine)	29	443.6 366.4–537.0ROR 1,610.3 · χ² 12,376 / p <1e-300	342.8 EB05 250.3 · IC025 +5.1 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 304.2	no trial data cached
Viral infection	29	457.7 378.0–554.1ROR 1,661.7 · χ² 12,771 / p <1e-300	351.2 EB05 256.4 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	serious PRR 399.6	no trial data cached
Lacrimation increased	29	509.3 420.7–616.6ROR 1,849.3 · χ² 14,214 / p <1e-300	380.7 EB05 278.0 · IC025 +5.1 3/3 methods agree	Labeled (related wording) related wording	serious PRR 823.2	no trial data cached
Respiratory tract infection	29	586.1 484.1–709.6ROR 2,128.6 · χ² 16,360 / p <1e-300	421.9 EB05 308.1 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	serious PRR 445.7	no trial data cached
Obesity	29	954.5 788.1–1,155.9ROR 3,468.1 · χ² 26,647 / p <1e-300	583.6 EB05 426.2 · IC025 +5.2 3/3 methods agree	Not in label — unassessed	serious PRR 688.4	no trial data cached
Lymphopenia	29	1,082.7 893.9–1,311.4ROR 3,934.5 · χ² 30,226 / p <1e-300	629.1 EB05 459.4 · IC025 +5.2 3/3 methods agree	Not in label — unassessed	serious PRR 726.3	no trial data cached
Nodule	29	1,167.3 963.7–1,413.9ROR 4,242.1 · χ² 32,584 / p <1e-300	656.6 EB05 479.5 · IC025 +5.2 3/3 methods agree	Not in label — unassessed	serious PRR 1,122.9	no trial data cached
Obstructive airways disorder	29	1,365.4 1,127.2–1,654.1ROR 4,962.6 · χ² 38,107 / p <1e-300	714.8 EB05 522.0 · IC025 +5.2 3/3 methods agree	Not in label — unassessed	serious PRR 881.4	no trial data cached

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

Obstructive airways disorder — n=29, PRR 1,365.4
Nodule — n=29, PRR 1,167.3
Lymphopenia — n=29, PRR 1,082.7
Obesity — n=29, PRR 954.5
Respiratory tract infection — n=29, PRR 586.1
Viral infection — n=29, PRR 457.7
Productive cough — n=29, PRR 321.3
Prostate cancer — n=29, PRR 187.3

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Edetate?

In FDA FAERS, the most frequently co-reported reaction terms for Edetate are prostate cancer, productive cough, renal disorder, haematuria, viral infection, lacrimation increased. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Edetate have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: 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.

Do FAERS signals prove that Edetate causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

FDA label via openFDA (set ID 710a2c8c-3620-4f6f-b8fc-fb19ab9e9f22, effective 20250213; matched on openfda.generic_name.exact:"EDETATE CALCIUM DISODIUM")
Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA count= aggregation, field patient.drug.openfda.generic_name.exact, 11 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath

Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.