Drug · FAERS side-effect profile with label screen
Deferoxamine side effects: what 2,124 FDA adverse event reports show
Drug class
Iron-chelating agent
FDA label, Indications wording of the closest related product
Label matched
Deferoxamine Mesylate (Deferoxamine)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
2,124 reports · 90% serious · 412 with death outcome · 53% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Deferoxamine Mesylate for Injection is an iron-chelating agent indicated: • As an adjunct to standard measures for the treatment of acute iron intoxication. ( 1.1 ) • For the treatment of transfusional iron overload in patients with chronic anemia. ( 1.
FDA label, Indications and Usage
What it is
Deferoxamine Mesylate for Injection, USP is an iron-chelating agent, available in vials for injection via intramuscular, subcutaneous, and intravenous administration. Deferoxamine Mesylate for.
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 (related wording) 8Likely indication confounding 1Lab value / disease marker 9Not in label — unassessed 22
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.
- 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. 74 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 |
|---|---|---|---|---|---|---|
| Sickle cell anaemia with crisis | 46 | 28.8 21.6–38.4ROR 29.4 · χ² 1,205 / p 3e-264 | 28.4 EB05 22.2 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 21.8 · ♀ 83% (drug 53%) | no trial data cached |
| Agranulocytosis (severe loss of white cells) | 49 | 26.2 19.9–34.6ROR 26.8 · χ² 1,162 / p 7e-255 | 25.9 EB05 20.4 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 16.8 | no trial data cached |
| Splenomegaly | 27 | 22.8 15.7–33.2ROR 23.1 · χ² 540 / p 8e-120 | 22.4 EB05 16.2 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 16.4 | no trial data cached |
| Myelodysplastic syndrome | 30 | 20.5 14.4–29.2ROR 20.8 · χ² 536 / p 6e-119 | 20.2 EB05 14.8 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 13.3 · ♀ 33% (drug 53%) · 90% clinician | no trial data cached |
| Hepatomegaly | 18 | 18.0 11.4–28.6ROR 18.2 · χ² 272 / p 2e-61 | 17.5 EB05 11.4 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 12.5 | no trial data cached |
| Visual acuity reduced | 48 | 14.2 10.7–18.7ROR 14.5 · χ² 574 / p 4e-127 | 14.0 EB05 10.8 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 12.0 | no trial data cached |
| Blood urea increased | 23 | 13.5 9.0–20.3ROR 13.6 · χ² 254 / p 2e-57 | 12.9 EB05 8.7 · IC025 +2.7 3/3 methods agree | Lab value / disease marker | serious PRR 8.8 · ♀ 23% (drug 53%) · 95% clinician | no trial data cached |
| Haematocrit decreased | 27 | 13.4 9.2–19.4ROR 13.5 · χ² 296 / p 1e-66 | 12.9 EB05 9.0 · IC025 +2.8 3/3 methods agree | Lab value / disease marker | serious PRR 8.2 | no trial data cached |
| Blood creatinine increased | 81 | 12.2 9.9–15.1ROR 12.7 · χ² 826 / p 7e-182 | 12.1 EB05 10.0 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.7 | no trial data cached |
| Blood lactate dehydrogenase increased | 19 | 11.8 7.5–18.4ROR 11.9 · χ² 177 / p 1e-40 | 10.8 EB05 6.9 · IC025 +2.4 3/3 methods agree | Lab value / disease marker | serious PRR 7.2 | no trial data cached |
| Haemoglobin decreased | 121 | 11.6 9.8–13.8ROR 12.3 · χ² 1,168 / p 3e-256 | 11.5 EB05 9.8 · IC025 +3.2 3/3 methods agree | Lab value / disease marker | serious PRR 7.6 | no trial data cached |
| Acute myeloid leukaemia | 18 | 11.4 7.2–18.1ROR 11.5 · χ² 161 / p 4e-37 | 10.4 EB05 6.5 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 7.4 | no trial data cached |
| Transfusion | 12 | 11.3 6.4–19.8ROR 11.3 · χ² 102 / p 2e-24 | 9.5 EB05 5.3 · IC025 +2.0 3/3 methods agree | Likely indication confounding term in indications | serious PRR 7.0 | no trial data cached |
| Multi-organ failure | 20 | 11.3 7.3–17.4ROR 11.4 · χ² 177 / p 1e-40 | 10.3 EB05 6.6 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 7.2 | no trial data cached |
| Caesarean section | 13 | 10.9 6.3–18.8ROR 11.0 · χ² 107 / p 2e-25 | 9.3 EB05 5.3 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 7.2 | no trial data cached |
| Transaminases increased | 23 | 10.2 6.8–15.4ROR 10.3 · χ² 182 / p 8e-42 | 9.3 EB05 6.3 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.7 | no trial data cached |
| Polyneuropathy | 12 | 10.0 5.7–17.5ROR 10.0 · χ² 88 / p 3e-21 | 8.2 EB05 4.7 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 | no trial data cached |
| Ejection fraction decreased | 15 | 9.5 5.7–15.8ROR 9.6 · χ² 106 / p 4e-25 | 8.1 EB05 5.0 · IC025 +2.0 3/3 methods agree | Lab value / disease marker | serious PRR 6.7 | no trial data cached |
| Pulmonary hypertension | 20 | 9.4 6.1–14.6ROR 9.5 · χ² 143 / p 3e-33 | 8.4 EB05 5.5 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 | no trial data cached |
| Infusion site pain | 12 | 9.3 5.3–16.3ROR 9.3 · χ² 81 / p 1e-19 | 7.6 EB05 4.4 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious n=7 | no trial data cached |
| Bone marrow failure | 19 | 9.2 5.9–14.4ROR 9.2 · χ² 130 / p 2e-30 | 8.1 EB05 5.3 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 | no trial data cached |
| Blood bilirubin increased | 25 | 9.1 6.2–13.5ROR 9.2 · χ² 173 / p 1e-39 | 8.3 EB05 5.7 · IC025 +2.3 3/3 methods agree | Lab value / disease marker | serious PRR 6.4 | no trial data cached |
| Obstructive airways disorder | 10 | 8.8 4.8–16.4ROR 8.9 · χ² 62 / p 2e-15 | 6.9 EB05 3.8 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 | no trial data cached |
| Neutrophil count decreased | 36 | 8.8 6.3–12.1ROR 8.9 · χ² 241 / p 1e-54 | 8.2 EB05 6.1 · IC025 +2.4 3/3 methods agree | Lab value / disease marker | serious PRR 5.5 | no trial data cached |
| Macular degeneration | 10 | 8.3 4.5–15.4ROR 8.3 · χ² 57 / p 2e-14 | 6.5 EB05 3.6 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Hepatic failure | 25 | 8.2 5.5–12.1ROR 8.3 · χ² 150 / p 8e-35 | 7.4 EB05 5.1 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.3 · 92% clinician | no trial data cached |
| Cardiomyopathy | 12 | 8.0 4.6–14.1ROR 8.0 · χ² 67 / p 2e-16 | 6.5 EB05 3.8 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | no trial data cached |
| Chromaturia | 18 | 7.9 5.0–12.5ROR 7.9 · χ² 101 / p 4e-24 | 6.8 EB05 4.5 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 | no trial data cached |
| Hepatic function abnormal | 29 | 7.7 5.4–11.1ROR 7.8 · χ² 163 / p 1e-37 | 7.0 EB05 5.1 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.3 · 100% clinician | no trial data cached |
| Coagulopathy | 13 | 7.7 4.5–13.3ROR 7.8 · χ² 70 / p 4e-17 | 6.4 EB05 3.9 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | no trial data cached |
| Prescribed overdose | 15 | 7.7 4.6–12.7ROR 7.7 · χ² 80 / p 2e-19 | 6.4 EB05 4.1 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 | no trial data cached |
| Liver disorder | 34 | 7.6 5.4–10.6ROR 7.7 · χ² 188 / p 5e-43 | 7.0 EB05 5.2 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 | no trial data cached |
| Alanine aminotransferase increased | 47 | 7.6 5.7–10.0ROR 7.7 · χ² 261 / p 4e-59 | 7.1 EB05 5.5 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.1 | no trial data cached |
| Metabolic acidosis | 24 | 7.5 5.0–11.1ROR 7.6 · χ² 129 / p 4e-30 | 6.7 EB05 4.7 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 · 96% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 21 | 7.4 4.9–11.4ROR 7.5 · χ² 111 / p 4e-26 | 6.6 EB05 4.5 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 · 90% clinician | no trial data cached |
| Nephrolithiasis (kidney stones) | 34 | 7.3 5.3–10.2ROR 7.4 · χ² 180 / p 2e-41 | 6.8 EB05 5.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 · ♀ 26% (drug 53%) | no trial data cached |
| Acute hepatic failure | 10 | 7.3 3.9–13.5ROR 7.3 · χ² 48 / p 2e-12 | 5.7 EB05 3.3 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.7 | no trial data cached |
| Red blood cell count decreased | 21 | 7.2 4.7–11.1ROR 7.3 · χ² 107 / p 2e-25 | 6.4 EB05 4.4 · IC025 +1.9 3/3 methods agree | Lab value / disease marker | serious PRR 4.7 | no trial data cached |
| Deafness | 19 | 7.2 4.6–11.2ROR 7.2 · χ² 95 / p 1e-22 | 6.2 EB05 4.2 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.8 | no trial data cached |
| Gamma-glutamyltransferase increased | 16 | 7.1 4.4–11.6ROR 7.2 · χ² 78 / p 5e-19 | 6.1 EB05 3.9 · IC025 +1.7 3/3 methods agree | Lab value / disease marker | 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 |
|---|---|---|---|---|---|---|
| Haemoglobin decreased | 121 | 11.6 9.8–13.8ROR 12.3 · χ² 1,168 / p 3e-256 | 11.5 EB05 9.8 · IC025 +3.2 3/3 methods agree | Lab value / disease marker | serious PRR 7.6 | no trial data cached |
| Blood creatinine increased | 81 | 12.2 9.9–15.1ROR 12.7 · χ² 826 / p 7e-182 | 12.1 EB05 10.0 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.7 | no trial data cached |
| White blood cell count decreased | 60 | 5.5 4.3–7.0ROR 5.6 · χ² 215 / p 5e-49 | 5.2 EB05 4.2 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.3 | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 55 | 4.0 3.1–5.2ROR 4.1 · χ² 122 / p 1e-28 | 3.9 EB05 3.1 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 2.7 · 92% clinician | no trial data cached |
| Cardiac failure (heart failure) | 52 | 6.4 4.9–8.4ROR 6.5 · χ² 232 / p 1e-52 | 6.1 EB05 4.8 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.1 · 92% clinician | no trial data cached |
| Platelet count decreased | 50 | 4.6 3.5–6.1ROR 4.7 · χ² 140 / p 2e-32 | 4.5 EB05 3.5 · IC025 +1.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.5 | no trial data cached |
| Renal impairment | 50 | 5.9 4.5–7.8ROR 6.0 · χ² 199 / p 2e-45 | 5.6 EB05 4.4 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 · ♀ 33% (drug 53%) | no trial data cached |
| Agranulocytosis (severe loss of white cells) | 49 | 26.2 19.9–34.6ROR 26.8 · χ² 1,162 / p 7e-255 | 25.9 EB05 20.4 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 16.8 | no trial data cached |
| Visual acuity reduced | 48 | 14.2 10.7–18.7ROR 14.5 · χ² 574 / p 4e-127 | 14.0 EB05 10.8 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 12.0 | no trial data cached |
| Alanine aminotransferase increased | 47 | 7.6 5.7–10.0ROR 7.7 · χ² 261 / p 4e-59 | 7.1 EB05 5.5 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.1 | no trial data cached |
| Sickle cell anaemia with crisis | 46 | 28.8 21.6–38.4ROR 29.4 · χ² 1,205 / p 3e-264 | 28.4 EB05 22.2 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 21.8 · ♀ 83% (drug 53%) | no trial data cached |
| Neutrophil count decreased | 36 | 8.8 6.3–12.1ROR 8.9 · χ² 241 / p 1e-54 | 8.2 EB05 6.1 · IC025 +2.4 3/3 methods agree | Lab value / disease marker | serious PRR 5.5 | no trial data cached |
| Febrile neutropenia | 34 | 5.1 3.6–7.1ROR 5.1 · χ² 107 / p 2e-25 | 4.8 EB05 3.6 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 | no trial data cached |
| Pancytopenia (all blood cells low) | 34 | 6.0 4.3–8.4ROR 6.1 · χ² 138 / p 4e-32 | 5.6 EB05 4.2 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.9 · ♀ 33% (drug 53%) · 90% clinician | no trial data cached |
| Nephrolithiasis (kidney stones) | 34 | 7.3 5.3–10.2ROR 7.4 · χ² 180 / p 2e-41 | 6.8 EB05 5.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 · ♀ 26% (drug 53%) | 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.
- Sickle cell anaemia with crisis — n=46, PRR 28.8
- Agranulocytosis — n=49, PRR 26.2
- Splenomegaly — n=27, PRR 22.8
- Myelodysplastic syndrome — n=30, PRR 20.5
- Visual acuity reduced — n=48, PRR 14.2
- Multi-organ failure — n=20, PRR 11.3
- Pulmonary hypertension — n=20, PRR 9.4
- Liver disorder — n=34, PRR 7.6
- Metabolic acidosis — n=24, PRR 7.5
- Multiple organ dysfunction syndrome — n=21, PRR 7.4
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 Deferoxamine?
In FDA FAERS, the most frequently co-reported reaction terms for Deferoxamine are haemoglobin decreased, blood creatinine increased, white blood cell count decreased, neutropenia, cardiac failure, platelet count decreased. 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 Deferoxamine have an FDA boxed warning?
No. The FDA label retrieved for Deferoxamine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Deferoxamine 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 d91e16df-8daa-4cd2-86a2-273eaa2446e0, effective 20260615; matched on
openfda.generic_name.exact:"DEFEROXAMINE MESYLATE") - 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, 114 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.