Drug · FAERS side-effect profile with label screen

Ferrous Asparto Glycinate side effects: what 601 FDA adverse event reports show

Ferrous Asparto Glycinate, Iron, Ascorbic Acid, Folic Acid, Cyanocobalamin, Zinc, And Succinic Acid · 23 reaction terms · 236 drug–reaction co-reports · data 2026-09-14

Drug class

No validated FDA label found

closest label found was a multi-ingredient product (Ferrous Asparto Glycinate, Iron, Ascorbic Acid, Folic Acid, Cyanocobalamin, Zinc, And Succinic Acid) and was not used

Who reports

601 reports · 85% serious · 82 with death outcome · 61% female

openFDA FAERS counts, all years, deduplication not applied

Used for

—

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 19 strongest signals

Reporting / coding artifact 2No label text to screen 17

What the badges mean

Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
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.
No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.

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. 4 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
Peritonitis bacterial	12	41.6 23.8–72.9ROR 42.5 · χ² 436 / p 4e-97	39.2 EB05 23.9 · IC025 +3.0 3/3 methods agree	No label text to screen	serious PRR 25.8	no trial data cached
Mitral valve incompetence	9	27.8 14.5–53.1ROR 28.2 · χ² 206 / p 5e-47	26.2 EB05 14.4 · IC025 +2.4 3/3 methods agree	No label text to screen	serious PRR 18.9	no trial data cached
Joint range of motion decreased	10	26.1 14.1–48.3ROR 26.5 · χ² 217 / p 2e-49	24.8 EB05 14.1 · IC025 +2.5 3/3 methods agree	No label text to screen	serious PRR 22.5	no trial data cached
Cardiomegaly	9	25.3 13.2–48.5ROR 25.7 · χ² 187 / p 9e-43	23.8 EB05 12.9 · IC025 +2.3 3/3 methods agree	No label text to screen	serious PRR 17.6	no trial data cached
End stage renal disease	13	24.6 14.4–42.2ROR 25.2 · χ² 272 / p 2e-61	23.8 EB05 14.6 · IC025 +2.8 3/3 methods agree	No label text to screen	serious PRR 16.7	no trial data cached
Iron deficiency anaemia	6	22.8 10.3–50.6ROR 23.0 · χ² 104 / p 9e-25	19.8 EB05 7.6 · IC025 +1.7 3/3 methods agree	No label text to screen	serious PRR 16.3	no trial data cached
Melaena (black stool)	12	19.0 10.8–33.2ROR 19.4 · χ² 187 / p 7e-43	18.1 EB05 10.3 · IC025 +2.5 3/3 methods agree	No label text to screen	serious PRR 13.1	no trial data cached
Anhedonia	14	18.4 11.0–31.0ROR 18.9 · χ² 214 / p 9e-49	17.7 EB05 10.7 · IC025 +2.6 3/3 methods agree	No label text to screen	serious PRR 14.8	no trial data cached
Multi-organ failure	9	17.9 9.4–34.2ROR 18.2 · χ² 127 / p 8e-30	16.3 EB05 7.8 · IC025 +2.1 3/3 methods agree	No label text to screen	serious PRR 13.5	no trial data cached
Cardiac failure congestive	36	15.5 11.3–21.3ROR 16.4 · χ² 475 / p 1e-105	15.3 EB05 11.4 · IC025 +3.1 3/3 methods agree	No label text to screen	serious PRR 10.6	no trial data cached
Fear	12	15.5 8.8–27.1ROR 15.7 · χ² 148 / p 2e-34	14.2 EB05 7.7 · IC025 +2.3 3/3 methods agree	No label text to screen	serious PRR 15.4	no trial data cached
Coronary artery disease	12	13.7 7.8–24.0ROR 14.0 · χ² 129 / p 3e-30	12.3 EB05 6.6 · IC025 +2.2 3/3 methods agree	No label text to screen	serious PRR 9.4	no trial data cached
Economic problem	6	13.6 6.1–30.1ROR 13.7 · χ² 58 / p 1e-14	10.0 EB05 3.9 · IC025 +1.4 3/3 methods agree	Reporting / coding artifact	serious PRR 10.0	no trial data cached
Renal injury	10	11.6 6.3–21.5ROR 11.8 · χ² 87 / p 6e-21	9.5 EB05 4.9 · IC025 +1.9 3/3 methods agree	No label text to screen	serious PRR 8.7	no trial data cached
Pharmaceutical product complaint	7	9.3 4.4–19.4ROR 9.4 · χ² 44 / p 2e-11	6.6 EB05 3.2 · IC025 +1.3 3/3 methods agree	No label text to screen	serious PRR 5.8	no trial data cached
Drug exposure during pregnancy	9	9.1 4.8–17.4ROR 9.2 · χ² 57 / p 2e-14	6.9 EB05 3.7 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	serious PRR 6.9	no trial data cached
Peritonitis	5	8.4 3.5–20.2ROR 8.5 · χ² 26 / p 2e-7	5.4 EB05 2.4 · IC025 +0.8 3/3 methods agree	No label text to screen	serious PRR 4.6	no trial data cached
Emotional distress	27	7.8 5.4–11.2ROR 8.1 · χ² 153 / p 2e-35	7.0 EB05 5.0 · IC025 +2.1 3/3 methods agree	No label text to screen	serious PRR 5.9	no trial data cached
Osteonecrosis of jaw (jawbone death)	5	7.0 2.9–16.8ROR 7.1 · χ² 20 / p 4e-6	4.6 EB05 2.1 · IC025 +0.6 3/3 methods agree	No label text to screen	serious PRR 4.8	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
Cardiac failure congestive	36	15.5 11.3–21.3ROR 16.4 · χ² 475 / p 1e-105	15.3 EB05 11.4 · IC025 +3.1 3/3 methods agree	No label text to screen	serious PRR 10.6	no trial data cached
Emotional distress	27	7.8 5.4–11.2ROR 8.1 · χ² 153 / p 2e-35	7.0 EB05 5.0 · IC025 +2.1 3/3 methods agree	No label text to screen	serious PRR 5.9	no trial data cached
Anhedonia	14	18.4 11.0–31.0ROR 18.9 · χ² 214 / p 9e-49	17.7 EB05 10.7 · IC025 +2.6 3/3 methods agree	No label text to screen	serious PRR 14.8	no trial data cached
End stage renal disease	13	24.6 14.4–42.2ROR 25.2 · χ² 272 / p 2e-61	23.8 EB05 14.6 · IC025 +2.8 3/3 methods agree	No label text to screen	serious PRR 16.7	no trial data cached
Coronary artery disease	12	13.7 7.8–24.0ROR 14.0 · χ² 129 / p 3e-30	12.3 EB05 6.6 · IC025 +2.2 3/3 methods agree	No label text to screen	serious PRR 9.4	no trial data cached
Fear	12	15.5 8.8–27.1ROR 15.7 · χ² 148 / p 2e-34	14.2 EB05 7.7 · IC025 +2.3 3/3 methods agree	No label text to screen	serious PRR 15.4	no trial data cached
Melaena (black stool)	12	19.0 10.8–33.2ROR 19.4 · χ² 187 / p 7e-43	18.1 EB05 10.3 · IC025 +2.5 3/3 methods agree	No label text to screen	serious PRR 13.1	no trial data cached
Peritonitis bacterial	12	41.6 23.8–72.9ROR 42.5 · χ² 436 / p 4e-97	39.2 EB05 23.9 · IC025 +3.0 3/3 methods agree	No label text to screen	serious PRR 25.8	no trial data cached
Renal injury	10	11.6 6.3–21.5ROR 11.8 · χ² 87 / p 6e-21	9.5 EB05 4.9 · IC025 +1.9 3/3 methods agree	No label text to screen	serious PRR 8.7	no trial data cached
Joint range of motion decreased	10	26.1 14.1–48.3ROR 26.5 · χ² 217 / p 2e-49	24.8 EB05 14.1 · IC025 +2.5 3/3 methods agree	No label text to screen	serious PRR 22.5	no trial data cached
Drug exposure during pregnancy	9	9.1 4.8–17.4ROR 9.2 · χ² 57 / p 2e-14	6.9 EB05 3.7 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	serious PRR 6.9	no trial data cached
Multi-organ failure	9	17.9 9.4–34.2ROR 18.2 · χ² 127 / p 8e-30	16.3 EB05 7.8 · IC025 +2.1 3/3 methods agree	No label text to screen	serious PRR 13.5	no trial data cached
Cardiomegaly	9	25.3 13.2–48.5ROR 25.7 · χ² 187 / p 9e-43	23.8 EB05 12.9 · IC025 +2.3 3/3 methods agree	No label text to screen	serious PRR 17.6	no trial data cached
Mitral valve incompetence	9	27.8 14.5–53.1ROR 28.2 · χ² 206 / p 5e-47	26.2 EB05 14.4 · IC025 +2.4 3/3 methods agree	No label text to screen	serious PRR 18.9	no trial data cached
Pharmaceutical product complaint	7	9.3 4.4–19.4ROR 9.4 · χ² 44 / p 2e-11	6.6 EB05 3.2 · IC025 +1.3 3/3 methods agree	No label text to screen	serious PRR 5.8	no trial data cached

Unlabeled candidate signals

Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.

✓ A hand-written Bradford Hill causality assessment exists for this drug: Zoledronic acid (bisphosphonates) ↔ Osteonecrosis of the jaw.

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 Ferrous Asparto Glycinate?

In FDA FAERS, the most frequently co-reported reaction terms for Ferrous Asparto Glycinate are cardiac failure congestive, emotional distress, anhedonia, end stage renal disease, coronary artery disease, fear. 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 Ferrous Asparto Glycinate have an FDA boxed warning?

No validated FDA label could be retrieved for this product name, so this page cannot say.

Do FAERS signals prove that Ferrous Asparto Glycinate 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

No FDA label passed the name-validation check for this product string, so label-based screening was skipped
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, 23 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.