Drug · FAERS side-effect profile with label screen
Iron Sucrose side effects: what 9,470 FDA adverse event reports show
Drug class
Parenteral Iron Replacement
FDA label (Established Pharmacologic Class)
Who reports
9,470 reports · 79% serious · 921 with death outcome · 67% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Iron Sucrose Injection is indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD). Iron Sucrose Injection is an iron replacement product indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD).
FDA label, Indications and Usage
What it is
Iron Sucrose Injection, USP, an iron replacement product, is a brown, sterile, aqueous, complex of polynuclear iron (III)-hydroxide in sucrose for intravenous use. Iron Sucrose Injection, USP .
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 40 strongest signals
Labeled adverse reaction 2Labeled (related wording) 5Likely indication confounding 1Reporting / coding artifact 1Lab value / disease marker 5Not in label — unassessed 26
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- 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.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- 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. 997 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Shunt stenosis | 23 | 197.6 129.0–302.7ROR 198.1 · χ² 3,947 / p <1e-300 | 157.8 EB05 110.7 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=23 · 100% clinician | no trial data cached |
| Haemodialysis complication | 10 | 139.9 73.8–265.0ROR 140.0 · χ² 1,169 / p 2e-256 | 105.6 EB05 61.3 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious n=10 | no trial data cached |
| Anti-erythropoietin antibody positive | 14 | 128.9 75.2–220.9ROR 129.1 · χ² 1,559 / p <1e-300 | 104.8 EB05 66.3 · IC025 +3.7 3/3 methods agree | Lab value / disease marker | serious n=13 | no trial data cached |
| Shunt occlusion | 24 | 110.0 73.1–165.7ROR 110.3 · χ² 2,366 / p <1e-300 | 96.9 EB05 68.5 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=24 · 100% clinician | no trial data cached |
| Granuloma skin | 39 | 109.3 79.3–150.6ROR 109.7 · χ² 3,881 / p <1e-300 | 99.2 EB05 75.7 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=39 · ♀ 100% (drug 67%) · 92% clinician | no trial data cached |
| Agonal respiration | 11 | 92.3 50.5–168.7ROR 92.4 · χ² 868 / p 5e-191 | 77.2 EB05 46.0 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Extravasation | 149 | 82.6 70.2–97.1ROR 83.9 · χ² 11,495 / p <1e-300 | 78.8 EB05 68.8 · IC025 +5.7 3/3 methods agree | Labeled adverse reaction exact term | serious n=49 | no trial data cached |
| Superficial vein thrombosis | 27 | 76.7 52.3–112.6ROR 76.9 · χ² 1,877 / p <1e-300 | 70.6 EB05 51.0 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=27 · 100% clinician | no trial data cached |
| Transferrin saturation increased | 11 | 72.3 39.7–131.8ROR 72.4 · χ² 681 / p 2e-150 | 62.8 EB05 37.4 · IC025 +3.1 3/3 methods agree | Lab value / disease marker | – | no trial data cached |
| Loss of employment | 94 | 70.4 57.4–86.4ROR 71.1 · χ² 6,163 / p <1e-300 | 67.3 EB05 56.7 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=94 · ♀ 100% (drug 67%) | no trial data cached |
| Infusion site discolouration | 26 | 68.9 46.6–101.7ROR 69.0 · χ² 1,620 / p <1e-300 | 63.8 EB05 45.8 · IC025 +4.2 3/3 methods agree | Labeled (related wording) related wording | serious n=14 · 100% clinician | no trial data cached |
| Nephrogenic systemic fibrosis | 88 | 65.5 53.0–80.9ROR 66.1 · χ² 5,363 / p <1e-300 | 62.8 EB05 52.5 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=88 | no trial data cached |
| Blood parathyroid hormone decreased | 42 | 64.1 47.2–87.1ROR 64.4 · χ² 2,473 / p <1e-300 | 60.7 EB05 46.8 · IC025 +4.7 3/3 methods agree | Lab value / disease marker | serious n=41 · ♀ 100% (drug 67%) · 90% clinician | no trial data cached |
| Chronic kidney disease-mineral and bone disorder | 29 | 61.3 42.4–88.6ROR 61.4 · χ² 1,614 / p <1e-300 | 57.5 EB05 42.0 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=29 · ♀ 36% (drug 67%) | no trial data cached |
| Iron overload | 29 | 61.0 42.2–88.2ROR 61.2 · χ² 1,608 / p <1e-300 | 57.3 EB05 41.8 · IC025 +4.3 3/3 methods agree | Labeled adverse reaction exact term | serious n=29 | no trial data cached |
| Gastrointestinal vascular malformation haemorrhagic | 10 | 60.3 32.2–113.0ROR 60.3 · χ² 511 / p 2e-113 | 53.1 EB05 30.8 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious n=10 | no trial data cached |
| Skin fibrosis | 12 | 56.4 31.8–100.1ROR 56.5 · χ² 584 / p 2e-129 | 50.9 EB05 31.0 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Hyperparathyroidism secondary | 57 | 50.9 39.2–66.2ROR 51.2 · χ² 2,679 / p <1e-300 | 49.0 EB05 39.2 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=57 · ♀ 40% (drug 67%) | no trial data cached |
| Extremity contracture | 14 | 49.4 29.1–83.8ROR 49.4 · χ² 602 / p 3e-133 | 45.5 EB05 28.8 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Intravascular haemolysis | 12 | 48.7 27.5–86.2ROR 48.7 · χ² 502 / p 1e-111 | 44.5 EB05 27.1 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Joint contracture | 21 | 44.1 28.6–67.9ROR 44.2 · χ² 825 / p 8e-182 | 41.7 EB05 28.8 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=21 · ♀ 43% (drug 67%) | no trial data cached |
| C-reactive protein decreased | 12 | 41.5 23.5–73.4ROR 41.6 · χ² 427 / p 5e-95 | 38.5 EB05 23.4 · IC025 +3.0 3/3 methods agree | Lab value / disease marker | serious n=12 | no trial data cached |
| Skin induration | 38 | 41.5 30.1–57.1ROR 41.6 · χ² 1,433 / p <1e-300 | 40.0 EB05 30.4 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=38 | no trial data cached |
| Infusion site oedema | 15 | 40.8 24.5–67.9ROR 40.8 · χ² 533 / p 3e-118 | 38.3 EB05 24.6 · IC025 +3.3 3/3 methods agree | Labeled (related wording) related wording | serious n=14 | no trial data cached |
| Serum ferritin decreased | 29 | 38.0 26.4–54.9ROR 38.1 · χ² 992 / p 6e-218 | 36.6 EB05 26.7 · IC025 +3.9 3/3 methods agree | Lab value / disease marker | serious n=26 | no trial data cached |
| Panniculitis | 40 | 37.3 27.3–51.0ROR 37.5 · χ² 1,354 / p 1e-296 | 36.1 EB05 27.7 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=40 · ♀ 100% (drug 67%) · 90% clinician | no trial data cached |
| Nephrogenic anaemia | 74 | 35.6 28.3–44.7ROR 35.8 · χ² 2,413 / p <1e-300 | 34.7 EB05 28.6 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=74 · ♀ 43% (drug 67%) | no trial data cached |
| Livedo reticularis | 32 | 34.5 24.3–48.8ROR 34.6 · χ² 991 / p 1e-217 | 33.3 EB05 24.7 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=30 · ♀ 100% (drug 67%) · 91% clinician | no trial data cached |
| Aplasia pure red cell | 52 | 33.9 25.8–44.6ROR 34.1 · χ² 1,605 / p <1e-300 | 33.1 EB05 26.2 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=51 · ♀ 44% (drug 67%) · 92% clinician | no trial data cached |
| Skin hypertrophy | 41 | 32.8 24.1–44.7ROR 33.0 · χ² 1,216 / p 1e-266 | 31.9 EB05 24.5 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=41 | no trial data cached |
| Rheumatoid nodule | 40 | 32.2 23.6–44.0ROR 32.4 · χ² 1,162 / p 5e-255 | 31.3 EB05 24.0 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=40 · ♀ 100% (drug 67%) · 90% clinician | no trial data cached |
| Thrombophlebitis superficial | 43 | 31.3 23.2–42.3ROR 31.4 · χ² 1,214 / p 2e-266 | 30.5 EB05 23.6 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=40 · ♀ 90% (drug 67%) · 100% clinician | no trial data cached |
| Drug tolerance decreased | 39 | 31.2 22.8–42.8ROR 31.4 · χ² 1,096 / p 1e-240 | 30.4 EB05 23.2 · IC025 +4.0 3/3 methods agree | Labeled (related wording) related wording | serious n=39 · ♀ 100% (drug 67%) · 92% clinician | no trial data cached |
| Anaphylactoid reaction | 48 | 26.2 19.7–34.8ROR 26.3 · χ² 1,126 / p 4e-247 | 25.7 EB05 20.1 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=48 · ♀ 91% (drug 67%) · 92% clinician | no trial data cached |
| Discoloured vomit | 10 | 23.6 12.7–44.0ROR 23.6 · χ² 192 / p 5e-44 | 22.2 EB05 12.4 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial data cached |
| Skin tightness | 49 | 23.4 17.6–30.9ROR 23.5 · χ² 1,015 / p 4e-223 | 22.9 EB05 18.0 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=47 | no trial data cached |
| Calciphylaxis | 18 | 22.0 13.8–34.9ROR 22.0 · χ² 336 / p 2e-75 | 21.3 EB05 14.1 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=18 | no trial data cached |
| Infusion site extravasation | 58 | 20.8 16.1–26.9ROR 20.9 · χ² 1,064 / p 9e-234 | 20.5 EB05 16.4 · IC025 +3.7 3/3 methods agree | Labeled (related wording) related wording | serious n=39 | no trial data cached |
| Iron deficiency | 40 | 20.1 14.7–27.4ROR 20.2 · χ² 700 / p 2e-154 | 19.7 EB05 15.1 · IC025 +3.5 3/3 methods agree | Likely indication confounding term in indications | serious n=38 | no trial data cached |
| Breath sounds abnormal | 44 | 19.9 14.8–26.8ROR 20.0 · χ² 764 / p 2e-168 | 19.6 EB05 15.2 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=44 · ♀ 100% (drug 67%) | 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 |
|---|---|---|---|---|---|---|
| Drug hypersensitivity | 1,159 | 13.3 12.6–14.0ROR 15.0 · χ² 13,188 / p <1e-300 | 13.2 EB05 12.6 · IC025 +3.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 14.7 · 93% clinician | no trial data cached |
| Nausea | 1,021 | 2.9 2.7–3.0ROR 3.1 · χ² 1,285 / p 1e-281 | 2.9 EB05 2.7 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.1 | no trial data cached |
| Dyspnoea (shortness of breath) | 988 | 3.9 3.6–4.1ROR 4.2 · χ² 2,154 / p <1e-300 | 3.9 EB05 3.7 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.3 | no trial data cached |
| Off label use (used outside approved label) | 640 | 1.6 1.5–1.8ROR 1.7 · χ² 163 / p 1e-37 | 1.6 EB05 1.5 · IC025 +0.6 | Reporting / coding artifact | serious PRR 1.9 | no trial data cached |
| Pruritus (itching) | 636 | 3.7 3.5–4.0ROR 3.9 · χ² 1,288 / p 3e-282 | 3.7 EB05 3.5 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.4 | no trial data cached |
| Vomiting | 632 | 3.0 2.8–3.2ROR 3.1 · χ² 850 / p 3e-187 | 3.0 EB05 2.8 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.4 | no trial data cached |
| Diarrhoea (diarrhea) | 547 | 1.9 1.7–2.0ROR 1.9 · χ² 232 / p 1e-52 | 1.9 EB05 1.8 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 2.1 | no trial data cached |
| Rash | 539 | 2.8 2.5–3.0ROR 2.9 · χ² 612 / p 3e-135 | 2.7 EB05 2.6 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 | no trial data cached |
| Hypotension (low blood pressure) | 520 | 5.8 5.3–6.3ROR 6.0 · χ² 2,053 / p <1e-300 | 5.7 EB05 5.3 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.4 | no trial data cached |
| Dizziness | 512 | 2.3 2.1–2.5ROR 2.3 · χ² 374 / p 1e-83 | 2.3 EB05 2.1 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.5 | no trial data cached |
| Headache | 468 | 1.7 1.5–1.8ROR 1.7 · χ² 124 / p 4e-29 | 1.7 EB05 1.5 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 2.0 · ♀ 87% (drug 67%) | no trial data cached |
| Urticaria (hives) | 464 | 6.2 5.7–6.8ROR 6.4 · χ² 2,021 / p <1e-300 | 6.1 EB05 5.7 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.1 · ♀ 88% (drug 67%) | no trial data cached |
| Malaise (feeling unwell) | 456 | 2.3 2.1–2.5ROR 2.4 · χ² 339 / p 5e-76 | 2.3 EB05 2.1 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 2.6 | no trial data cached |
| Arthralgia (joint pain) | 451 | 2.4 2.2–2.6ROR 2.5 · χ² 378 / p 2e-84 | 2.4 EB05 2.2 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.0 · ♀ 89% (drug 67%) | no trial data cached |
| Pain | 439 | 1.6 1.4–1.7ROR 1.6 · χ² 95 / p 8e-23 | 1.6 EB05 1.5 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 1.5 | 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.
- Shunt stenosis — n=23, PRR 197.6
- Shunt occlusion — n=24, PRR 110.0
- Granuloma skin — n=39, PRR 109.3
- Superficial vein thrombosis — n=27, PRR 76.7
- Loss of employment — n=94, PRR 70.4
- Nephrogenic systemic fibrosis — n=88, PRR 65.5
- Chronic kidney disease-mineral and bone disorder — n=29, PRR 61.3
- Hyperparathyroidism secondary — n=57, PRR 50.9
- Joint contracture — n=21, PRR 44.1
- Skin induration — n=38, PRR 41.5
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 Iron Sucrose?
In FDA FAERS, the most frequently co-reported reaction terms for Iron Sucrose are drug hypersensitivity, nausea, dyspnoea, pruritus, vomiting, diarrhoea. 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 Iron Sucrose have an FDA boxed warning?
No. The FDA label retrieved for Iron Sucrose has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Iron Sucrose 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 6f19c80e-22e9-4bab-aa53-4d2d958119ed, effective 20260605; matched on
openfda.generic_name.exact:"IRON SUCROSE") - 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, fieldpatient.drug.openfda.generic_name.exact, 1,037 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.