Drug · FAERS side-effect profile with label screen
Clofarabine side effects: what 2,271 FDA adverse event reports show
Drug class
Nucleoside Metabolic Inhibitor
FDA label (Established Pharmacologic Class) · compare the class
Who reports
2,271 reports · 95% serious · 900 with death outcome · 42% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Clofarabine injection is indicated for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens. Clofarabine injection is a nucleoside metabolic inhibitor indicated for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens.
FDA label, Indications and Usage
What it is
Clofarabine injection contains clofarabine, a purine nucleoside metabolic inhibitor.
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 12Labeled (related wording) 7Likely indication confounding 1Reporting / coding artifact 1Lab value / disease marker 1Not 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.
- 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. 57 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 |
|---|---|---|---|---|---|---|
| Haematotoxicity | 71 | 71.2 56.6–89.7ROR 73.5 · χ² 4,812 / p <1e-300 | 69.4 EB05 56.9 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious PRR 43.8 · 100% clinician | no trial data cached |
| Mucosal inflammation | 125 | 44.5 37.5–52.8ROR 47.0 · χ² 5,252 / p <1e-300 | 44.0 EB05 37.9 · IC025 +4.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 28.0 · 98% clinician | no trial data cached |
| Febrile neutropenia | 270 | 37.8 33.8–42.3ROR 42.8 · χ² 9,626 / p <1e-300 | 37.6 EB05 33.9 · IC025 +4.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 22.5 · 95% clinician | no trial data cached |
| Hyperbilirubinaemia | 42 | 37.8 28.0–51.0ROR 38.5 · χ² 1,462 / p <1e-300 | 37.1 EB05 28.6 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 22.6 · 93% clinician | no trial data cached |
| Bone marrow failure | 82 | 37.2 30.0–46.0ROR 38.5 · χ² 2,840 / p <1e-300 | 36.7 EB05 30.5 · IC025 +4.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 22.1 · ♀ 67% (drug 42%) | no trial data cached |
| Multi-organ failure | 68 | 35.9 28.4–45.4ROR 37.0 · χ² 2,267 / p <1e-300 | 35.5 EB05 28.9 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 21.6 | no trial data cached |
| Acute myeloid leukaemia | 60 | 35.7 27.8–45.9ROR 36.7 · χ² 1,984 / p <1e-300 | 35.2 EB05 28.4 · IC025 +4.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 21.2 | no trial data cached |
| Blood bilirubin increased | 97 | 33.2 27.3–40.3ROR 34.6 · χ² 2,988 / p <1e-300 | 32.9 EB05 27.7 · IC025 +4.5 3/3 methods agree | Lab value / disease marker | serious PRR 22.2 · 97% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 89 | 29.5 24.1–36.2ROR 30.7 · χ² 2,421 / p <1e-300 | 29.3 EB05 24.5 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 17.7 · 98% clinician | no trial data cached |
| Nephropathy toxic | 33 | 27.4 19.5–38.5ROR 27.8 · χ² 812 / p 6e-179 | 27.0 EB05 20.1 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 16.9 · ♀ 5% (drug 42%) · 100% clinician | no trial data cached |
| Palmar-plantar erythrodysaesthesia syndrome | 68 | 26.9 21.3–34.0ROR 27.7 · χ² 1,668 / p <1e-300 | 26.7 EB05 21.8 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 20.2 · 96% clinician | no trial data cached |
| Hepatotoxicity (liver damage) | 60 | 25.1 19.5–32.2ROR 25.7 · χ² 1,360 / p 6e-298 | 24.8 EB05 20.0 · IC025 +4.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 15.1 · 98% clinician | no trial data cached |
| Transaminases increased | 52 | 21.7 16.6–28.3ROR 22.1 · χ² 1,003 / p 2e-220 | 21.5 EB05 17.0 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 13.6 · 96% clinician | no trial data cached |
| Posterior reversible encephalopathy syndrome | 20 | 19.4 12.6–30.1ROR 19.6 · χ² 331 / p 3e-74 | 19.0 EB05 12.8 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 11.7 · 95% clinician | no trial data cached |
| Pancytopenia (all blood cells low) | 100 | 16.6 13.7–20.1ROR 17.3 · χ² 1,451 / p <1e-300 | 16.5 EB05 14.0 · IC025 +3.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.8 · 91% clinician | no trial data cached |
| Septic shock | 73 | 15.6 12.5–19.6ROR 16.1 · χ² 985 / p 2e-216 | 15.5 EB05 12.7 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.3 | no trial data cached |
| Cytomegalovirus infection | 27 | 15.0 10.3–21.8ROR 15.2 · χ² 339 / p 6e-76 | 14.6 EB05 10.3 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 9.2 · 96% clinician | no trial data cached |
| Staphylococcal infection | 51 | 14.2 10.9–18.7ROR 14.5 · χ² 615 / p 5e-136 | 14.1 EB05 11.0 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.5 · 96% clinician | no trial data cached |
| Aspartate aminotransferase increased | 81 | 14.1 11.4–17.5ROR 14.6 · χ² 974 / p 4e-214 | 14.0 EB05 11.6 · IC025 +3.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.2 · 95% clinician | no trial data cached |
| Bacterial infection | 28 | 13.9 9.6–20.1ROR 14.1 · χ² 323 / p 1e-72 | 13.5 EB05 9.5 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.4 · 93% clinician | no trial data cached |
| Encephalopathy | 36 | 13.6 9.8–18.8ROR 13.8 · χ² 407 / p 7e-91 | 13.3 EB05 9.8 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 · 94% clinician | no trial data cached |
| Oedema | 79 | 13.5 10.9–16.8ROR 13.9 · χ² 902 / p 2e-198 | 13.4 EB05 11.0 · IC025 +3.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.1 · ♀ 20% (drug 42%) · 100% clinician | no trial data cached |
| Bacteraemia | 17 | 13.4 8.3–21.4ROR 13.4 · χ² 182 / p 9e-42 | 12.4 EB05 7.6 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.1 | no trial data cached |
| Sepsis (blood infection) | 159 | 13.2 11.3–15.3ROR 14.1 · χ² 1,783 / p <1e-300 | 13.1 EB05 11.5 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.0 · 92% clinician | no trial data cached |
| Alanine aminotransferase increased | 86 | 12.9 10.5–15.9ROR 13.4 · χ² 937 / p 4e-206 | 12.8 EB05 10.6 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.8 · 95% clinician | no trial data cached |
| Cytokine release syndrome | 26 | 12.6 8.6–18.5ROR 12.7 · χ² 266 / p 3e-60 | 12.0 EB05 8.3 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.7 · 100% clinician | no trial data cached |
| Toxic epidermal necrolysis (severe skin peeling reaction) | 20 | 12.3 7.9–19.0ROR 12.4 · χ² 196 / p 1e-44 | 11.4 EB05 7.3 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.0 | no trial data cached |
| Renal failure acute | 54 | 11.6 8.9–15.1ROR 11.9 · χ² 513 / p 8e-114 | 11.3 EB05 8.9 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.1 · 93% clinician | no trial data cached |
| Neurotoxicity | 19 | 10.1 6.5–15.8ROR 10.2 · χ² 147 / p 4e-34 | 9.0 EB05 5.8 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 | no trial data cached |
| Coagulopathy | 18 | 10.0 6.3–15.9ROR 10.1 · χ² 137 / p 6e-32 | 8.8 EB05 5.6 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 | no trial data cached |
| Lung infection | 17 | 10.0 6.2–16.0ROR 10.0 · χ² 128 / p 5e-30 | 8.7 EB05 5.5 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.4 | no trial data cached |
| Respiratory failure | 76 | 9.6 7.7–12.0ROR 9.9 · χ² 580 / p 2e-128 | 9.4 EB05 7.7 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.7 | no trial data cached |
| Thrombotic microangiopathy | 10 | 9.5 5.1–17.7ROR 9.6 · χ² 68 / p 8e-17 | 7.5 EB05 4.1 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 | no trial data cached |
| Acute respiratory distress syndrome | 18 | 9.4 5.9–14.9ROR 9.5 · χ² 127 / p 1e-29 | 8.2 EB05 5.3 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.7 | no trial data cached |
| Fluid overload | 15 | 9.4 5.7–15.6ROR 9.4 · χ² 104 / p 9e-25 | 8.0 EB05 4.9 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 | no trial data cached |
| Disseminated intravascular coagulation | 14 | 9.2 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 5.1 | no trial data cached |
| Generalised oedema | 12 | 9.0 5.1–15.8ROR 9.0 · χ² 78 / p 6e-19 | 7.3 EB05 4.2 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 | no trial data cached |
| Myelodysplastic syndrome | 13 | 8.3 4.8–14.3ROR 8.3 · χ² 76 / p 1e-18 | 6.8 EB05 4.1 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 121 | 8.3 6.9–9.8ROR 8.7 · χ² 768 / p 2e-169 | 8.1 EB05 6.9 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.1 · 97% clinician | no trial data cached |
| Drug resistance | 22 | 7.9 5.2–12.0ROR 8.0 · χ² 126 / p 1e-29 | 7.0 EB05 4.8 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 5.4 · 91% clinician | 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 |
|---|---|---|---|---|---|---|
| Febrile neutropenia | 270 | 37.8 33.8–42.3ROR 42.8 · χ² 9,626 / p <1e-300 | 37.6 EB05 33.9 · IC025 +4.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 22.5 · 95% clinician | no trial data cached |
| Sepsis (blood infection) | 159 | 13.2 11.3–15.3ROR 14.1 · χ² 1,783 / p <1e-300 | 13.1 EB05 11.5 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.0 · 92% clinician | no trial data cached |
| Mucosal inflammation | 125 | 44.5 37.5–52.8ROR 47.0 · χ² 5,252 / p <1e-300 | 44.0 EB05 37.9 · IC025 +4.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 28.0 · 98% clinician | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 121 | 8.3 6.9–9.8ROR 8.7 · χ² 768 / p 2e-169 | 8.1 EB05 6.9 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.1 · 97% clinician | no trial data cached |
| Pancytopenia (all blood cells low) | 100 | 16.6 13.7–20.1ROR 17.3 · χ² 1,451 / p <1e-300 | 16.5 EB05 14.0 · IC025 +3.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.8 · 91% clinician | no trial data cached |
| Blood bilirubin increased | 97 | 33.2 27.3–40.3ROR 34.6 · χ² 2,988 / p <1e-300 | 32.9 EB05 27.7 · IC025 +4.5 3/3 methods agree | Lab value / disease marker | serious PRR 22.2 · 97% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 89 | 29.5 24.1–36.2ROR 30.7 · χ² 2,421 / p <1e-300 | 29.3 EB05 24.5 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 17.7 · 98% clinician | no trial data cached |
| Alanine aminotransferase increased | 86 | 12.9 10.5–15.9ROR 13.4 · χ² 937 / p 4e-206 | 12.8 EB05 10.6 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.8 · 95% clinician | no trial data cached |
| Bone marrow failure | 82 | 37.2 30.0–46.0ROR 38.5 · χ² 2,840 / p <1e-300 | 36.7 EB05 30.5 · IC025 +4.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 22.1 · ♀ 67% (drug 42%) | no trial data cached |
| Thrombocytopenia (low platelets) | 81 | 6.7 5.4–8.3ROR 6.9 · χ² 390 / p 5e-87 | 6.5 EB05 5.4 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.1 · 99% clinician | no trial data cached |
| Aspartate aminotransferase increased | 81 | 14.1 11.4–17.5ROR 14.6 · χ² 974 / p 4e-214 | 14.0 EB05 11.6 · IC025 +3.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.2 · 95% clinician | no trial data cached |
| Oedema | 79 | 13.5 10.9–16.8ROR 13.9 · χ² 902 / p 2e-198 | 13.4 EB05 11.0 · IC025 +3.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.1 · ♀ 20% (drug 42%) · 100% clinician | no trial data cached |
| Respiratory failure | 76 | 9.6 7.7–12.0ROR 9.9 · χ² 580 / p 2e-128 | 9.4 EB05 7.7 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.7 | no trial data cached |
| Septic shock | 73 | 15.6 12.5–19.6ROR 16.1 · χ² 985 / p 2e-216 | 15.5 EB05 12.7 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.3 | no trial data cached |
| Haematotoxicity | 71 | 71.2 56.6–89.7ROR 73.5 · χ² 4,812 / p <1e-300 | 69.4 EB05 56.9 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious PRR 43.8 · 100% 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.
- Haematotoxicity — n=71, PRR 71.2
- Hyperbilirubinaemia — n=42, PRR 37.8
- Multi-organ failure — n=68, PRR 35.9
- Multiple organ dysfunction syndrome — n=89, PRR 29.5
- Nephropathy toxic — n=33, PRR 27.4
- Palmar-plantar erythrodysaesthesia syndrome — n=68, PRR 26.9
- Transaminases increased — n=52, PRR 21.7
- Posterior reversible encephalopathy syndrome — n=20, PRR 19.4
- Cytomegalovirus infection — n=27, PRR 15.0
- Encephalopathy — n=36, PRR 13.6
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 Clofarabine?
In FDA FAERS, the most frequently co-reported reaction terms for Clofarabine are febrile neutropenia, sepsis, mucosal inflammation, neutropenia, pancytopenia, blood bilirubin increased. 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 Clofarabine have an FDA boxed warning?
No. The FDA label retrieved for Clofarabine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Clofarabine 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 26b2de66-6518-49ab-820e-492454cbc873, effective 20260824; matched on
openfda.generic_name.exact:"CLOFARABINE") - 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, 97 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.