Iron Dextran side effects: what 1,434 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Infed
Who reports
1,434 reports · 65% serious · 123 with death outcome · 71% female
Used for
INFeD is indicated for treatment of adult and pediatric patients of age 4 months and older with documented iron deficiency who have intolerance to oral iron or have had an unsatisfactory response to oral iron. INFeD, an iron replacement product, is ind.
What it is
INFeD (iron dextran injection USP) is an iron replacement product provided as a dark brown, slightly viscous sterile liquid complex of ferric hydroxide and dextran for intravenous or intramuscular use.
Boxed warning
WARNING: RISK FOR ANAPHYLACTIC-TYPE REACTIONS Anaphylactic-type reactions, including fatalities, have been reported following the parenteral administration of iron dextran injection. Have resuscitation equipment and personnel trained in the detection and treatment of anaphylactic-type reactions readily available during INFeD administration.
Causality screen of the 28 strongest signals
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 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.
- 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. 23 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Full blood count abnormal | 36 | 50.0 36.2–69.1ROR 51.3 · χ² 1,676 / p <1e-300 | 48.6 EB05 36.7 · IC025 +4.3 3/3 methods agree | Lab value / disease marker | serious PRR 58.7 · ♀ 94% (drug 71%) | no trial data cached |
| Infusion related reaction (reaction during infusion) | 163 | 36.1 31.3–41.7ROR 40.6 · χ² 5,535 / p <1e-300 | 35.9 EB05 31.5 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 34.1 · 94% clinician | no trial data cached |
| Anaphylactic reaction (severe allergic reaction) | 109 | 29.0 24.2–34.8ROR 31.3 · χ² 2,924 / p <1e-300 | 28.8 EB05 24.6 · IC025 +4.4 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 24.3 | no trial data cached |
| Throat tightness | 42 | 22.7 16.9–30.6ROR 23.4 · χ² 851 / p 2e-187 | 22.5 EB05 17.3 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 23.3 · ♀ 92% (drug 71%) · 90% clinician | no trial data cached |
| Product preparation error | 23 | 16.2 10.8–24.4ROR 16.5 · χ² 314 / p 2e-70 | 15.8 EB05 10.8 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | 100% clinician | no trial data cached |
| Flushing | 110 | 15.7 13.2–18.8ROR 17.0 · χ² 1,510 / p <1e-300 | 15.7 EB05 13.3 · IC025 +3.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 26.6 | no trial data cached |
| Throat irritation | 48 | 15.7 11.9–20.7ROR 16.2 · χ² 646 / p 7e-143 | 15.5 EB05 12.1 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 19.4 · 96% clinician | no trial data cached |
| Type 2 diabetes mellitus | 35 | 15.1 10.9–21.0ROR 15.5 · χ² 449 / p 7e-100 | 14.9 EB05 11.0 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 14.1 · ♀ 97% (drug 71%) | no trial data cached |
| Hyperglycaemia (high blood sugar) | 35 | 14.1 10.2–19.5ROR 14.4 · χ² 413 / p 5e-92 | 13.8 EB05 10.2 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 14.1 · ♀ 100% (drug 71%) | no trial data cached |
| Oxygen saturation decreased | 46 | 12.0 9.1–16.0ROR 12.4 · χ² 456 / p 2e-101 | 11.7 EB05 9.0 · IC025 +2.9 3/3 methods agree | Lab value / disease marker | serious PRR 10.7 · ♀ 49% (drug 71%) | no trial data cached |
| Haematocrit decreased | 16 | 11.7 7.2–19.1ROR 11.8 · χ² 146 / p 6e-34 | 10.5 EB05 6.3 · IC025 +2.3 3/3 methods agree | Lab value / disease marker | serious PRR 10.9 | no trial data cached |
| Chest discomfort | 80 | 11.5 9.3–14.2ROR 12.1 · χ² 757 / p 7e-167 | 11.3 EB05 9.3 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 10.4 | no trial data cached |
| Unresponsive to stimuli | 20 | 11.4 7.4–17.6ROR 11.5 · χ² 179 / p 4e-41 | 10.4 EB05 6.7 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.7 · ♀ 45% (drug 71%) · 95% clinician | no trial data cached |
| Anaphylactic shock | 19 | 10.8 6.9–16.9ROR 11.0 · χ² 160 / p 6e-37 | 9.8 EB05 6.2 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.6 | no trial data cached |
| Pelvic pain | 12 | 9.6 5.5–16.9ROR 9.7 · χ² 84 / p 2e-20 | 7.9 EB05 4.5 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 13.2 | no trial data cached |
| Respiratory distress | 18 | 9.5 6.0–15.1ROR 9.6 · χ² 129 / p 3e-30 | 8.4 EB05 5.3 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.1 | no trial data cached |
| Cardio-respiratory arrest | 27 | 9.4 6.4–13.6ROR 9.5 · χ² 194 / p 2e-44 | 8.6 EB05 6.0 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 · ♀ 50% (drug 71%) · 96% clinician | no trial data cached |
| Sneezing | 14 | 9.1 5.4–15.4ROR 9.2 · χ² 94 / p 2e-22 | 7.7 EB05 4.6 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 11.6 | no trial data cached |
| Feeling hot | 36 | 8.6 6.2–11.8ROR 8.8 · χ² 234 / p 5e-53 | 8.0 EB05 5.9 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 11.6 · 91% clinician | no trial data cached |
| Chest pain | 102 | 8.0 6.7–9.7ROR 8.6 · χ² 626 / p 2e-138 | 7.8 EB05 6.6 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.2 | no trial data cached |
| Pulmonary hypertension | 10 | 7.0 3.8–13.0ROR 7.0 · χ² 46 / p 8e-12 | 5.5 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 | no trial data cached |
| Lip swelling | 15 | 6.6 4.0–10.9ROR 6.7 · χ² 66 / p 3e-16 | 5.6 EB05 3.6 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.8 | no trial data cached |
| Skin discolouration | 19 | 6.0 3.9–9.4ROR 6.1 · χ² 75 / p 2e-18 | 5.3 EB05 3.6 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 7.4 | no trial data cached |
| Asthma | 42 | 5.5 4.1–7.4ROR 5.6 · χ² 150 / p 9e-35 | 5.2 EB05 4.0 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.5 · ♀ 100% (drug 71%) | no trial data cached |
| Maternal exposure during pregnancy | 33 | 5.5 3.9–7.7ROR 5.6 · χ² 116 / p 2e-27 | 5.1 EB05 3.8 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 4.5 · ♀ 100% (drug 71%) | no trial data cached |
| Respiratory arrest | 10 | 5.3 2.8–9.7ROR 5.3 · χ² 30 / p 2e-8 | 4.3 EB05 2.5 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.7 | no trial data cached |
| Exposure during pregnancy | 20 | 4.7 3.0–7.3ROR 4.7 · χ² 55 / p 7e-14 | 4.3 EB05 2.9 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 5.3 · 95% clinician | no trial data cached |
| Product storage error | 12 | 2.0 1.2–3.6ROR 2.0 · χ² 5 / p 0.011 | 2.0 EB05 1.2 · IC025 -0.0 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | – | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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 |
|---|---|---|---|---|---|---|
| Infusion related reaction (reaction during infusion) | 163 | 36.1 31.3–41.7ROR 40.6 · χ² 5,535 / p <1e-300 | 35.9 EB05 31.5 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 34.1 · 94% clinician | no trial data cached |
| Flushing | 110 | 15.7 13.2–18.8ROR 17.0 · χ² 1,510 / p <1e-300 | 15.7 EB05 13.3 · IC025 +3.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 26.6 | no trial data cached |
| Anaphylactic reaction (severe allergic reaction) | 109 | 29.0 24.2–34.8ROR 31.3 · χ² 2,924 / p <1e-300 | 28.8 EB05 24.6 · IC025 +4.4 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 24.3 | no trial data cached |
| Chest pain | 102 | 8.0 6.7–9.7ROR 8.6 · χ² 626 / p 2e-138 | 7.8 EB05 6.6 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.2 | no trial data cached |
| Chest discomfort | 80 | 11.5 9.3–14.2ROR 12.1 · χ² 757 / p 7e-167 | 11.3 EB05 9.3 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 10.4 | no trial data cached |
| Throat irritation | 48 | 15.7 11.9–20.7ROR 16.2 · χ² 646 / p 7e-143 | 15.5 EB05 12.1 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 19.4 · 96% clinician | no trial data cached |
| Oxygen saturation decreased | 46 | 12.0 9.1–16.0ROR 12.4 · χ² 456 / p 2e-101 | 11.7 EB05 9.0 · IC025 +2.9 3/3 methods agree | Lab value / disease marker | serious PRR 10.7 · ♀ 49% (drug 71%) | no trial data cached |
| Asthma | 42 | 5.5 4.1–7.4ROR 5.6 · χ² 150 / p 9e-35 | 5.2 EB05 4.0 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.5 · ♀ 100% (drug 71%) | no trial data cached |
| Throat tightness | 42 | 22.7 16.9–30.6ROR 23.4 · χ² 851 / p 2e-187 | 22.5 EB05 17.3 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 23.3 · ♀ 92% (drug 71%) · 90% clinician | no trial data cached |
| Feeling hot | 36 | 8.6 6.2–11.8ROR 8.8 · χ² 234 / p 5e-53 | 8.0 EB05 5.9 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 11.6 · 91% clinician | no trial data cached |
| Full blood count abnormal | 36 | 50.0 36.2–69.1ROR 51.3 · χ² 1,676 / p <1e-300 | 48.6 EB05 36.7 · IC025 +4.3 3/3 methods agree | Lab value / disease marker | serious PRR 58.7 · ♀ 94% (drug 71%) | no trial data cached |
| Hyperglycaemia (high blood sugar) | 35 | 14.1 10.2–19.5ROR 14.4 · χ² 413 / p 5e-92 | 13.8 EB05 10.2 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 14.1 · ♀ 100% (drug 71%) | no trial data cached |
| Type 2 diabetes mellitus | 35 | 15.1 10.9–21.0ROR 15.5 · χ² 449 / p 7e-100 | 14.9 EB05 11.0 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 14.1 · ♀ 97% (drug 71%) | no trial data cached |
| Maternal exposure during pregnancy | 33 | 5.5 3.9–7.7ROR 5.6 · χ² 116 / p 2e-27 | 5.1 EB05 3.8 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 4.5 · ♀ 100% (drug 71%) | no trial data cached |
| Cardio-respiratory arrest | 27 | 9.4 6.4–13.6ROR 9.5 · χ² 194 / p 2e-44 | 8.6 EB05 6.0 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 · ♀ 50% (drug 71%) · 96% clinician | 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.
- Infusion related reaction — n=163, PRR 36.1
- Throat tightness — n=42, PRR 22.7
- Throat irritation — n=48, PRR 15.7
- Type 2 diabetes mellitus — n=35, PRR 15.1
- Hyperglycaemia — n=35, PRR 14.1
- Chest discomfort — n=80, PRR 11.5
- Unresponsive to stimuli — n=20, PRR 11.4
- Cardio-respiratory arrest — n=27, PRR 9.4
- Feeling hot — n=36, PRR 8.6
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 Dextran?
In FDA FAERS, the most frequently co-reported reaction terms for Iron Dextran are infusion related reaction, flushing, anaphylactic reaction, chest pain, chest discomfort, throat irritation. 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 Dextran have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: WARNING: RISK FOR ANAPHYLACTIC-TYPE REACTIONS Anaphylactic-type reactions, including fatalities, have been reported following the parenteral administration of iron dextran injection. Have resuscitation equipment and personnel trained in the detection and treatment of anaphylactic-type reactions readily available during INFeD administration.
Do FAERS signals prove that Iron Dextran 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 99bf34be-cb8a-46d1-9637-5544dc2da287, effective 20260415; matched on
openfda.generic_name.exact:"IRON DEXTRAN") - 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, 51 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.