Drug · FAERS side-effect profile with label screen

Ferric side effects: what 2,193 FDA adverse event reports show

Ferric Citrate · 22 reaction terms · 556 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Label matched

Ferric Citrate (Ferric Citrate)

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

Who reports

2,193 reports · 35% serious · 260 with death outcome · 45% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Ferric citrate tablets are a phosphate binder indicated for the control of serum phosphorus levels in adult patients with chronic kidney disease on dialysis. ( 1 ) Ferric citrate tablets are an iron replacement product indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease not on dialysis.

FDA label, Indications and Usage

What it is

Ferric citrate, a phosphate binder and iron replacement product, is known chemically as iron (+3), x (1, 2, 3-propanetricarboxylic acid, 2-hydroxy-), y (H2O). Ferric citrate 210 mg ferric iron.

FDA label, Description section

Boxed warning

None in the current 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 17 strongest signals

Labeled (related wording) 1Likely indication confounding 2Reporting / coding artifact 4Not in label — unassessed 10

What the badges mean

Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
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.

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. 5 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
Faeces discoloured	118	52.3 43.9–62.4ROR 55.2 · χ² 5,861 / p <1e-300	51.6 EB05 44.3 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	serious PRR 16.4	no trial data cached
End stage renal disease	58	30.2 23.4–38.9ROR 31.0 · χ² 1,604 / p <1e-300	29.8 EB05 23.9 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious PRR 49.2	no trial data cached
Prescribed overdose	45	22.3 16.7–29.8ROR 22.7 · χ² 892 / p 3e-196	22.0 EB05 17.1 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 4.1	no trial data cached
Dialysis	21	14.1 9.2–21.6ROR 14.3 · χ² 243 / p 4e-55	13.5 EB05 8.9 · IC025 +2.7 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 20.7	no trial data cached
Blood potassium increased	15	8.8 5.3–14.6ROR 8.9 · χ² 97 / p 4e-23	7.5 EB05 4.6 · IC025 +1.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 10.0	no trial data cached
Peritonitis bacterial	9	8.6 4.5–16.4ROR 8.6 · χ² 53 / p 2e-13	6.5 EB05 3.5 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 14.0	no trial data cached
Chronic kidney disease	59	7.4 5.7–9.5ROR 7.5 · χ² 319 / p 1e-71	7.0 EB05 5.6 · IC025 +2.4 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 12.2	no trial data cached
Fluid overload	11	7.1 4.0–12.9ROR 7.2 · χ² 52 / p 3e-13	5.7 EB05 3.4 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 13.7	no trial data cached
Nephropathy	6	6.1 2.7–13.6ROR 6.1 · χ² 21 / p 3e-6	4.4 EB05 2.2 · IC025 +0.7 3/3 methods agree	Not in label — unassessed	serious PRR 10.7	no trial data cached
Peritonitis	13	6.0 3.5–10.3ROR 6.0 · χ² 49 / p 1e-12	5.0 EB05 3.1 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 7.6	no trial data cached
Economic problem	9	5.6 2.9–10.7ROR 5.6 · χ² 29 / p 3e-8	4.5 EB05 2.5 · IC025 +1.0 3/3 methods agree	Reporting / coding artifact	serious PRR 10.0	no trial data cached
Gastrointestinal haemorrhage	48	5.5 4.1–7.2ROR 5.6 · χ² 171 / p 2e-39	5.2 EB05 4.1 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 9.0	no trial data cached
Anhedonia	15	5.4 3.3–9.0ROR 5.4 · χ² 50 / p 9e-13	4.7 EB05 3.0 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 9.8	no trial data cached
Renal injury	14	4.5 2.6–7.5ROR 4.5 · χ² 34 / p 2e-9	3.9 EB05 2.5 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious PRR 7.3	no trial data cached
Treatment noncompliance	24	4.2 2.8–6.3ROR 4.3 · χ² 56 / p 4e-14	3.9 EB05 2.8 · IC025 +1.3 3/3 methods agree	Reporting / coding artifact	serious PRR 7.6	no trial data cached
Hospitalisation	51	3.2 2.4–4.2ROR 3.3 · χ² 75 / p 2e-18	3.1 EB05 2.5 · IC025 +1.2 3/3 methods agree	Reporting / coding artifact	serious PRR 5.4	no trial data cached
Therapy interrupted	18	2.5 1.6–4.0ROR 2.5 · χ² 15 / p 6e-5	2.4 EB05 1.6 · IC025 +0.5	Reporting / coding artifact	serious PRR 4.1	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
Faeces discoloured	118	52.3 43.9–62.4ROR 55.2 · χ² 5,861 / p <1e-300	51.6 EB05 44.3 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	serious PRR 16.4	no trial data cached
Chronic kidney disease	59	7.4 5.7–9.5ROR 7.5 · χ² 319 / p 1e-71	7.0 EB05 5.6 · IC025 +2.4 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 12.2	no trial data cached
End stage renal disease	58	30.2 23.4–38.9ROR 31.0 · χ² 1,604 / p <1e-300	29.8 EB05 23.9 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious PRR 49.2	no trial data cached
Hospitalisation	51	3.2 2.4–4.2ROR 3.3 · χ² 75 / p 2e-18	3.1 EB05 2.5 · IC025 +1.2 3/3 methods agree	Reporting / coding artifact	serious PRR 5.4	no trial data cached
Gastrointestinal haemorrhage	48	5.5 4.1–7.2ROR 5.6 · χ² 171 / p 2e-39	5.2 EB05 4.1 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 9.0	no trial data cached
Prescribed overdose	45	22.3 16.7–29.8ROR 22.7 · χ² 892 / p 3e-196	22.0 EB05 17.1 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 4.1	no trial data cached
Treatment noncompliance	24	4.2 2.8–6.3ROR 4.3 · χ² 56 / p 4e-14	3.9 EB05 2.8 · IC025 +1.3 3/3 methods agree	Reporting / coding artifact	serious PRR 7.6	no trial data cached
Dialysis	21	14.1 9.2–21.6ROR 14.3 · χ² 243 / p 4e-55	13.5 EB05 8.9 · IC025 +2.7 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 20.7	no trial data cached
Therapy interrupted	18	2.5 1.6–4.0ROR 2.5 · χ² 15 / p 6e-5	2.4 EB05 1.6 · IC025 +0.5	Reporting / coding artifact	serious PRR 4.1	no trial data cached
Anhedonia	15	5.4 3.3–9.0ROR 5.4 · χ² 50 / p 9e-13	4.7 EB05 3.0 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 9.8	no trial data cached
Blood potassium increased	15	8.8 5.3–14.6ROR 8.9 · χ² 97 / p 4e-23	7.5 EB05 4.6 · IC025 +1.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 10.0	no trial data cached
Renal injury	14	4.5 2.6–7.5ROR 4.5 · χ² 34 / p 2e-9	3.9 EB05 2.5 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious PRR 7.3	no trial data cached
Peritonitis	13	6.0 3.5–10.3ROR 6.0 · χ² 49 / p 1e-12	5.0 EB05 3.1 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 7.6	no trial data cached
Fluid overload	11	7.1 4.0–12.9ROR 7.2 · χ² 52 / p 3e-13	5.7 EB05 3.4 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 13.7	no trial data cached
Economic problem	9	5.6 2.9–10.7ROR 5.6 · χ² 29 / p 3e-8	4.5 EB05 2.5 · IC025 +1.0 3/3 methods agree	Reporting / coding artifact	serious PRR 10.0	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.

Faeces discoloured — n=118, PRR 52.3
End stage renal disease — n=58, PRR 30.2
Prescribed overdose — n=45, PRR 22.3
Gastrointestinal haemorrhage — n=48, PRR 5.5

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 Ferric?

In FDA FAERS, the most frequently co-reported reaction terms for Ferric are faeces discoloured, chronic kidney disease, end stage renal disease, gastrointestinal haemorrhage, prescribed overdose, dialysis. 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 Ferric have an FDA boxed warning?

No. The FDA label retrieved for Ferric has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Ferric 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 8e8396fa-288b-402e-82b0-b1007d1b571f, effective 20240623; matched on openfda.generic_name.exact:"FERRIC CITRATE")
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, 22 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.