Deferasirox side effects: what 26,360 FDA adverse event reports show

Deferasirox · 1,129 reaction terms · 86,202 drug–reaction co-reports · data 2026-09-14

Drug class

Iron Chelator

FDA label (Established Pharmacologic Class)

Who reports

26,360 reports · 87% serious · 7,716 with death outcome · 49% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Deferasirox tablets for oral suspension are an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. (1.1) Deferasirox tablets for oral suspension is indicated for the treatme.

FDA label, Indications and Usage

What it is

Deferasirox is an iron chelating agent. Deferasirox tablets for oral suspension contain 125 mg, 250 mg, or 500 mg deferasirox. Deferasirox is designated chemically as 4-[3,5-Bis (2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl]-benzoic acid and its structural formula is: Deferasirox is a white to slightly yellow powder.

FDA label, Description section

Boxed warning

RENAL FAILURE, HEPATIC FAILURE, and GASTROINTESTINAL HEMORRHAGE Renal Failure • Deferasirox tablets for oral suspension can cause acute renal failure and death, particularly in patients with comorbidities and those who are in the advanced stages of their hematologic disorders.

FDA 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 3Labeled (related wording) 4Likely indication confounding 12Lab value / disease marker 3Not in label — unassessed 18

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.
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, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,089 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
Cardiac siderosis	19	1,861.9 815.2–4,252.9ROR 1,863.3 · calibrated p 7e-16 ✓	354.7 EB05 240.0 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	not fetched	no trial data cached
Cardiac iron overload	10	603.1 264.5–1,375.2ROR 603.3 · calibrated p 2e-11 ✓	207.0 EB05 120.2 · IC025 +3.2 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	not fetched	no trial data cached
Hepatic siderosis	27	399.4 251.3–634.7ROR 399.8 · calibrated p 7e-12 ✓	223.2 EB05 161.1 · IC025 +4.9 3/3 methods agree	Labeled (related wording) related wording	not fetched	no trial data cached
Serum ferritin abnormal	83	285.4 222.0–366.8ROR 286.3 · calibrated p 3e-11 ✓	199.9 EB05 166.3 · IC025 +6.2 3/3 methods agree	Likely indication confounding term in indications; also in warnings	not fetched	no trial data cached
Iron overload	273	269.9 235.3–309.5ROR 272.7 · calibrated p 3e-11 ✓	198.3 EB05 179.3 · IC025 +7.0 3/3 methods agree	Likely indication confounding term in indications; also in warnings	not fetched	no trial data cached
Liver iron concentration increased	20	257.0 155.1–425.9ROR 257.2 · calibrated p 5e-10 ✓	163.8 EB05 112.0 · IC025 +4.3 3/3 methods agree	Likely indication confounding term in indications	not fetched	no trial data cached
Urea cycle disorder	11	246.4 125.2–485.1ROR 246.5 · calibrated p 3e-9 ✓	142.0 EB05 84.6 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	not fetched	no trial data cached
Serum ferritin increased	1,179	230.9 216.6–246.1ROR 241.7 · calibrated p 7e-11 ✓	178.1 EB05 169.7 · IC025 +7.3 3/3 methods agree	Likely indication confounding term in indications; also in warnings	not fetched	no trial data cached
Blood iron increased	403	217.3 194.7–242.5ROR 220.6 · calibrated p 2e-10 ✓	169.0 EB05 155.6 · IC025 +7.0 3/3 methods agree	Likely indication confounding term in indications; also in warnings	not fetched	no trial data cached
Sickle cell anaemia	135	208.3 172.4–251.8ROR 209.4 · calibrated p 4e-10 ✓	161.1 EB05 139.5 · IC025 +6.4 3/3 methods agree	Labeled (related wording) related wording	not fetched	no trial data cached
Myelodysplastic syndrome transformation	89	162.3 129.2–203.8ROR 162.8 · calibrated p 4e-9 ✓	130.9 EB05 109.6 · IC025 +5.9 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	not fetched	no trial data cached
Haemosiderosis	45	159.6 115.9–219.9ROR 159.9 · calibrated p 6e-9 ✓	125.8 EB05 97.9 · IC025 +5.3 3/3 methods agree	Likely indication confounding term in indications; also in warnings	not fetched	no trial data cached
Thalassaemia beta	15	148.9 85.7–258.5ROR 148.9 · calibrated p 5e-8 ✓	108.4 EB05 69.7 · IC025 +3.8 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	not fetched	no trial data cached
Sickle cell anaemia with crisis	1,808	102.8 98.1–107.8ROR 110.3 · calibrated p 5e-8 ✓	90.9 EB05 87.5 · IC025 +6.4 3/3 methods agree	Not in label — unassessed	not fetched	no trial data cached
Sickle cell disease	47	90.5 67.0–122.4ROR 90.7 · calibrated p 4e-7 ✓	78.8 EB05 61.6 · IC025 +5.0 3/3 methods agree	Labeled adverse reaction exact term	not fetched	no trial data cached
Extramedullary haemopoiesis	16	87.1 52.0–146.0ROR 87.2 · calibrated p 1e-6 ✓	72.0 EB05 47.0 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	not fetched	no trial data cached
Haemochromatosis	89	85.6 68.8–106.5ROR 85.9 · calibrated p 5e-7 ✓	76.1 EB05 63.7 · IC025 +5.4 3/3 methods agree	Not in label — unassessed	not fetched	no trial data cached
Moyamoya disease	19	76.4 47.7–122.3ROR 76.4 · calibrated p 3e-6 ✓	65.3 EB05 44.2 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	not fetched	no trial data cached
Acute chest syndrome	56	54.3 41.5–71.2ROR 54.4 · calibrated p 1e-5 ✓	50.1 EB05 40.0 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	not fetched	no trial data cached
Blood product transfusion dependent	27	54.0 36.6–79.7ROR 54.1 · calibrated p 2e-5 ✓	48.9 EB05 35.3 · IC025 +4.1 3/3 methods agree	Labeled (related wording) related wording	not fetched	no trial data cached
Paroxysmal nocturnal haemoglobinuria	29	53.5 36.7–77.9ROR 53.6 · calibrated p 2e-5 ✓	48.6 EB05 35.5 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	not fetched	no trial data cached
Primary myelofibrosis	18	47.8 29.7–77.0ROR 47.9 · calibrated p 5e-5 ✓	43.2 EB05 28.9 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	not fetched	no trial data cached
Acute leukaemia	91	47.3 38.3–58.4ROR 47.4 · calibrated p 2e-5 ✓	44.3 EB05 37.1 · IC025 +4.8 3/3 methods agree	Not in label — unassessed	not fetched	no trial data cached
Bone marrow transplant	104	46.4 38.0–56.5ROR 46.5 · calibrated p 2e-5 ✓	43.5 EB05 36.9 · IC025 +4.9 3/3 methods agree	Not in label — unassessed	not fetched	no trial data cached
Serum ferritin decreased	94	46.1 37.4–56.7ROR 46.2 · calibrated p 3e-5 ✓	43.2 EB05 36.4 · IC025 +4.8 3/3 methods agree	Likely indication confounding term in indications; also in warnings	not fetched	no trial data cached
Complications of bone marrow transplant	19	43.6 27.4–69.1ROR 43.6 · calibrated p 7e-5 ✓	39.8 EB05 26.9 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	not fetched	no trial data cached
Reticulocyte count increased	42	43.4 31.8–59.2ROR 43.4 · calibrated p 5e-5 ✓	40.5 EB05 31.2 · IC025 +4.3 3/3 methods agree	Lab value / disease marker	not fetched	no trial data cached
Myeloproliferative disorder	11	37.3 20.4–68.3ROR 37.3 · calibrated p 3e-4 ✓	33.8 EB05 20.1 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	not fetched	no trial data cached
Blast cell count increased	47	37.2 27.8–49.9ROR 37.3 · calibrated p 1e-4 ✓	35.1 EB05 27.5 · IC025 +4.2 3/3 methods agree	Lab value / disease marker	not fetched	no trial data cached
Hypersplenism	21	35.3 22.8–54.7ROR 35.4 · calibrated p 2e-4 ✓	32.9 EB05 22.7 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	not fetched	no trial data cached
Myelofibrosis	120	32.8 27.3–39.3ROR 32.9 · calibrated p 2e-4 ✓	31.4 EB05 26.9 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	not fetched	no trial data cached
Transfusion reaction	34	32.1 22.8–45.2ROR 32.2 · calibrated p 3e-4 ✓	30.4 EB05 22.8 · IC025 +3.9 3/3 methods agree	Likely indication confounding term in indications; also in warnings	not fetched	no trial data cached
Extravascular haemolysis	16	31.5 19.1–51.9ROR 31.5 · calibrated p 4e-4 ✓	29.4 EB05 19.2 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	not fetched	no trial data cached
Fungal endocarditis	11	30.9 16.9–56.5ROR 30.9 · calibrated p 7e-4 ✓	28.4 EB05 16.8 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	not fetched	no trial data cached
Reticulocyte count decreased	16	30.2 18.3–49.8ROR 30.2 · calibrated p 5e-4 ✓	28.3 EB05 18.4 · IC025 +3.1 3/3 methods agree	Lab value / disease marker	not fetched	no trial data cached
Glycosuria	47	28.6 21.4–38.3ROR 28.7 · calibrated p 4e-4 ✓	27.4 EB05 21.4 · IC025 +3.9 3/3 methods agree	Labeled adverse reaction exact term	not fetched	no trial data cached
Myelodysplastic syndrome	474	26.9 24.6–29.5ROR 27.4 · calibrated p 4e-4 ✓	26.0 EB05 24.1 · IC025 +4.5 3/3 methods agree	Labeled adverse reaction exact term	not fetched	no trial data cached
Blood iron abnormal	32	26.8 18.8–38.1ROR 26.8 · calibrated p 7e-4 ✓	25.6 EB05 19.0 · IC025 +3.6 3/3 methods agree	Likely indication confounding term in indications; also in warnings	not fetched	no trial data cached
Biopsy bone marrow	15	26.4 15.8–44.1ROR 26.4 · calibrated p 0.001 ✓	24.8 EB05 15.9 · IC025 +3.0 3/3 methods agree	Labeled (related wording) related wording	not fetched	no trial data cached
Renal tubular acidosis	66	24.7 19.4–31.6ROR 24.8 · calibrated p 8e-4 ✓	23.9 EB05 19.4 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	not fetched	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
Death	4,703	4.4 4.3–4.5ROR 5.1 · calibrated p 0.225	4.3 EB05 4.2 · IC025 +2.1 3/3 methods agree	Outcome field, not a reaction boxed warning mentions mortality	not fetched	no trial data cached
Diarrhoea (diarrhea)	2,343	2.9 2.8–3.0ROR 3.1 · calibrated p 0.598	2.9 EB05 2.8 · IC025 +1.5 3/3 methods agree	Labeled adverse reaction exact term	not fetched	no trial data cached
Sickle cell anaemia with crisis	1,808	102.8 98.1–107.8ROR 110.3 · calibrated p 5e-8 ✓	90.9 EB05 87.5 · IC025 +6.4 3/3 methods agree	Not in label — unassessed	not fetched	no trial data cached
Pyrexia (fever)	1,475	3.4 3.2–3.6ROR 3.5 · calibrated p 0.475	3.4 EB05 3.2 · IC025 +1.7 3/3 methods agree	Labeled adverse reaction exact term	not fetched	no trial data cached
Nausea	1,440	1.5 1.4–1.5ROR 1.5 · calibrated p 0.628	1.5 EB05 1.4 · IC025 +0.5	Labeled adverse reaction exact term	not fetched	no trial data cached
Haemoglobin decreased	1,411	11.0 10.5–11.6ROR 11.6 · calibrated p 0.019 ✓	10.9 EB05 10.4 · IC025 +3.4 3/3 methods agree	Labeled (related wording) related wording	not fetched	no trial data cached
Pneumonia (lung infection)	1,253	3.1 2.9–3.3ROR 3.2 · calibrated p 0.566	3.1 EB05 2.9 · IC025 +1.5 3/3 methods agree	Labeled (related wording) related wording	not fetched	no trial data cached
Serum ferritin increased	1,179	230.9 216.6–246.1ROR 241.7 · calibrated p 7e-11 ✓	178.1 EB05 169.7 · IC025 +7.3 3/3 methods agree	Likely indication confounding term in indications; also in warnings	not fetched	no trial data cached
Malaise (feeling unwell)	1,133	2.1 1.9–2.2ROR 2.1 · calibrated p 0.998	2.0 EB05 2.0 · IC025 +0.9	Not in label — unassessed	not fetched	no trial data cached
Fatigue (tiredness)	1,125	1.2 1.1–1.2ROR 1.2 · calibrated p 0.413	1.2 EB05 1.1 · IC025 +0.1	Labeled adverse reaction exact term	not fetched	no trial data cached
Vomiting	1,104	1.9 1.8–2.0ROR 1.9 · calibrated p 0.896	1.9 EB05 1.8 · IC025 +0.8	Labeled adverse reaction exact term	not fetched	no trial data cached
Abdominal pain	906	3.1 2.9–3.3ROR 3.2 · calibrated p 0.570	3.1 EB05 2.9 · IC025 +1.5 3/3 methods agree	Labeled adverse reaction exact term	not fetched	no trial data cached
Pain	898	1.2 1.1–1.2ROR 1.2 · calibrated p 0.418	1.2 EB05 1.1 · IC025 +0.1	Labeled adverse reaction exact term	not fetched	no trial data cached
Blood creatinine increased	836	10.3 9.6–11.0ROR 10.6 · calibrated p 0.027 ✓	10.1 EB05 9.6 · IC025 +3.2 3/3 methods agree	Labeled — boxed warning synonym match	not fetched	no trial data cached
Platelet count decreased	820	6.2 5.8–6.6ROR 6.3 · calibrated p 0.131	6.1 EB05 5.8 · IC025 +2.5 3/3 methods agree	Labeled — boxed warning synonym match	not fetched	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=1,808, PRR 102.8
Haemochromatosis — n=89, PRR 85.6
Acute chest syndrome — n=56, PRR 54.3
Paroxysmal nocturnal haemoglobinuria — n=29, PRR 53.5
Acute leukaemia — n=91, PRR 47.3
Bone marrow transplant — n=104, PRR 46.4
Hypersplenism — n=21, PRR 35.3
Myelofibrosis — n=120, PRR 32.8
Renal tubular acidosis — n=66, PRR 24.7

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 Deferasirox?

In FDA FAERS, the most frequently co-reported reaction terms for Deferasirox are diarrhoea, sickle cell anaemia with crisis, pyrexia, nausea, haemoglobin decreased, pneumonia. 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 Deferasirox have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: RENAL FAILURE, HEPATIC FAILURE, and GASTROINTESTINAL HEMORRHAGE Renal Failure • Deferasirox tablets for oral suspension can cause acute renal failure and death, particularly in patients with comorbidities and those who are in the advanced stages of their hematologic disorders.

Do FAERS signals prove that Deferasirox 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 1f9f1a69-bf71-4e6a-88b0-90f08c4da79f, effective 20230316; matched on openfda.generic_name.exact:"DEFERASIROX")
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, 1,129 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath

Page generated 2026-10-14. 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.