Drug · FAERS side-effect profile with label screen
Eribulin side effects: what 3,719 FDA adverse event reports show
Drug class
Microtubule inhibitor
FDA label, Indications wording of the closest related product
Label matched
Eribulin Mesylate (Eribulin Mesylate)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
3,719 reports · 93% serious · 659 with death outcome · 94% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Eribulin Mesylate Injection is a microtubule inhibitor indicated for the treatment of patients with: Metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting.
FDA label, Indications and Usage
What it is
Eribulin mesylate injection contains eribulin mesylate, a microtubule dynamics inhibitor. Eribulin mesylate is a synthetic analogue of halichondrin B, a product isolated from the marine sponge Halichondria okadai .
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 9Labeled (related wording) 9Likely indication confounding 1Reporting / coding artifact 1Lab value / disease marker 3Not in label — unassessed 17
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. 38 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 |
|---|---|---|---|---|---|---|
| Myelosuppression | 310 | 51.8 46.6–57.7ROR 56.5 · χ² 15,289 / p <1e-300 | 51.2 EB05 46.6 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious PRR 31.9 · 91% clinician | no trial data cached |
| Febrile neutropenia | 331 | 28.3 25.5–31.4ROR 31.0 · χ² 8,680 / p <1e-300 | 28.1 EB05 25.7 · IC025 +4.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 17.3 · 99% clinician | no trial data cached |
| Neutrophil count decreased | 170 | 23.8 20.5–27.5ROR 24.8 · χ² 3,674 / p <1e-300 | 23.6 EB05 20.8 · IC025 +4.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 16.8 · 96% clinician | no trial data cached |
| Leukopenia (low white blood cells) | 208 | 23.6 20.7–26.9ROR 24.9 · χ² 4,471 / p <1e-300 | 23.5 EB05 20.9 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 14.6 · 98% clinician | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 537 | 22.4 20.7–24.3ROR 26.1 · χ² 11,002 / p <1e-300 | 22.3 EB05 20.8 · IC025 +4.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 13.7 · 98% clinician | no trial data cached |
| Malignant neoplasm progression | 382 | 21.2 19.3–23.3ROR 23.5 · χ² 7,348 / p <1e-300 | 21.1 EB05 19.4 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious PRR 12.8 | no trial data cached |
| Interstitial lung disease | 181 | 21.2 18.4–24.4ROR 22.2 · χ² 3,458 / p <1e-300 | 21.1 EB05 18.6 · IC025 +4.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 13.2 · 99% clinician | no trial data cached |
| Breast cancer metastatic | 39 | 20.6 15.0–28.1ROR 20.8 · χ² 704 / p 2e-155 | 20.3 EB05 15.5 · IC025 +3.5 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 12.7 | no trial data cached |
| Metastases to central nervous system | 32 | 14.1 10.0–19.9ROR 14.2 · χ² 376 / p 4e-84 | 13.8 EB05 10.0 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.8 | no trial data cached |
| Lymphopenia | 34 | 13.7 9.8–19.1ROR 13.8 · χ² 386 / p 4e-86 | 13.3 EB05 9.7 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.9 · 100% clinician | no trial data cached |
| Metastases to liver | 41 | 13.2 9.7–17.9ROR 13.3 · χ² 450 / p 4e-100 | 12.9 EB05 9.8 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.2 | no trial data cached |
| Neuropathy peripheral (nerve damage in hands/feet) | 214 | 12.8 11.2–14.6ROR 13.5 · χ² 2,319 / p <1e-300 | 12.7 EB05 11.3 · IC025 +3.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.9 | no trial data cached |
| Mucosal inflammation | 58 | 12.6 9.7–16.2ROR 12.8 · χ² 606 / p 5e-134 | 12.3 EB05 9.8 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.3 · 93% clinician | no trial data cached |
| Osteonecrosis of jaw (jawbone death) | 55 | 12.5 9.6–16.2ROR 12.6 · χ² 568 / p 7e-126 | 12.2 EB05 9.6 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.8 · 95% clinician | no trial data cached |
| Pneumothorax | 34 | 12.1 8.7–16.9ROR 12.2 · χ² 335 / p 3e-75 | 11.7 EB05 8.5 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.6 · 100% clinician | no trial data cached |
| Metastases to bone | 32 | 11.0 7.8–15.6ROR 11.1 · χ² 282 / p 1e-63 | 10.5 EB05 7.5 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.9 | no trial data cached |
| Stomatitis (mouth sores) | 103 | 9.6 7.9–11.6ROR 9.8 · χ² 785 / p 6e-173 | 9.4 EB05 7.9 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.6 · 94% clinician | no trial data cached |
| White blood cell count decreased | 176 | 9.2 7.9–10.6ROR 9.6 · χ² 1,275 / p 1e-279 | 9.0 EB05 7.9 · IC025 +2.9 3/3 methods agree | Lab value / disease marker | serious PRR 7.7 · 94% clinician | no trial data cached |
| Palmar-plantar erythrodysaesthesia syndrome | 35 | 8.4 6.1–11.8ROR 8.5 · χ² 222 / p 1e-50 | 7.8 EB05 5.8 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 7.0 · 100% clinician | no trial data cached |
| Polyneuropathy | 17 | 8.1 5.0–13.0ROR 8.1 · χ² 98 / p 2e-23 | 6.9 EB05 4.5 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.2 | no trial data cached |
| Metastases to lung | 13 | 6.4 3.7–10.9ROR 6.4 · χ² 53 / p 1e-13 | 5.3 EB05 3.3 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.0 | no trial data cached |
| Neoplasm progression | 39 | 6.3 4.6–8.6ROR 6.3 · χ² 168 / p 1e-38 | 5.9 EB05 4.5 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 | no trial data cached |
| Disseminated intravascular coagulation | 15 | 6.0 3.6–9.9ROR 6.0 · χ² 57 / p 2e-14 | 5.1 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 | no trial data cached |
| Ascites | 31 | 5.9 4.2–8.4ROR 6.0 · χ² 123 / p 8e-29 | 5.5 EB05 4.0 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 | no trial data cached |
| Hepatic function abnormal | 39 | 5.9 4.3–8.1ROR 6.0 · χ² 155 / p 6e-36 | 5.6 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 · 97% clinician | no trial data cached |
| Pleural effusion | 61 | 5.7 4.4–7.2ROR 5.7 · χ² 229 / p 4e-52 | 5.4 EB05 4.4 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 | no trial data cached |
| Hepatic cirrhosis | 18 | 5.4 3.4–8.6ROR 5.5 · χ² 61 / p 3e-15 | 4.8 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 | no trial data cached |
| Blood bilirubin increased | 25 | 5.2 3.5–7.7ROR 5.2 · χ² 81 / p 1e-19 | 4.8 EB05 3.4 · IC025 +1.6 3/3 methods agree | Lab value / disease marker | serious PRR 3.6 · 96% clinician | no trial data cached |
| Thrombocytopenia (low platelets) | 100 | 5.1 4.2–6.1ROR 5.2 · χ² 323 / p 1e-72 | 4.9 EB05 4.2 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.1 · 98% clinician | no trial data cached |
| Pancytopenia (all blood cells low) | 49 | 5.0 3.8–6.6ROR 5.0 · χ² 151 / p 5e-35 | 4.7 EB05 3.7 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.1 · 94% clinician | no trial data cached |
| Mouth ulceration | 18 | 4.8 3.0–7.7ROR 4.8 · χ² 51 / p 5e-13 | 4.3 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 | no trial data cached |
| Ejection fraction decreased | 12 | 4.3 2.5–7.7ROR 4.4 · χ² 28 / p 7e-8 | 3.8 EB05 2.3 · IC025 +1.0 3/3 methods agree | Lab value / disease marker | serious PRR 3.0 | no trial data cached |
| Agranulocytosis (severe loss of white cells) | 14 | 4.3 2.5–7.2ROR 4.3 · χ² 32 / p 8e-9 | 3.8 EB05 2.4 · IC025 +1.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.7 | no trial data cached |
| Hypocalcaemia (low calcium) | 14 | 4.2 2.5–7.1ROR 4.2 · χ² 31 / p 1e-8 | 3.7 EB05 2.4 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 2.6 | no trial data cached |
| Pneumonitis | 20 | 4.2 2.7–6.5ROR 4.2 · χ² 45 / p 9e-12 | 3.8 EB05 2.6 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 2.7 · 90% clinician | no trial data cached |
| Hepatic failure | 22 | 4.1 2.7–6.2ROR 4.1 · χ² 49 / p 2e-12 | 3.8 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 2.6 · 100% clinician | no trial data cached |
| Sepsis (blood infection) | 79 | 4.0 3.2–5.0ROR 4.1 · χ² 175 / p 3e-40 | 3.9 EB05 3.2 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.5 · 93% clinician | no trial data cached |
| Sensory disturbance | 11 | 3.8 2.1–6.9ROR 3.9 · χ² 20 / p 3e-6 | 3.4 EB05 2.0 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 | no trial data cached |
| Platelet count decreased | 69 | 3.7 2.9–4.6ROR 3.7 · χ² 131 / p 1e-30 | 3.6 EB05 2.9 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.7 | no trial data cached |
| Bone marrow failure | 13 | 3.6 2.1–6.2ROR 3.6 · χ² 22 / p 2e-6 | 3.2 EB05 2.0 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 2.2 | 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 |
|---|---|---|---|---|---|---|
| Neutropenia (low neutrophils (infection-fighting cells)) | 537 | 22.4 20.7–24.3ROR 26.1 · χ² 11,002 / p <1e-300 | 22.3 EB05 20.8 · IC025 +4.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 13.7 · 98% clinician | no trial data cached |
| Malignant neoplasm progression | 382 | 21.2 19.3–23.3ROR 23.5 · χ² 7,348 / p <1e-300 | 21.1 EB05 19.4 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious PRR 12.8 | no trial data cached |
| Febrile neutropenia | 331 | 28.3 25.5–31.4ROR 31.0 · χ² 8,680 / p <1e-300 | 28.1 EB05 25.7 · IC025 +4.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 17.3 · 99% clinician | no trial data cached |
| Myelosuppression | 310 | 51.8 46.6–57.7ROR 56.5 · χ² 15,289 / p <1e-300 | 51.2 EB05 46.6 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious PRR 31.9 · 91% clinician | no trial data cached |
| Pyrexia (fever) | 215 | 3.5 3.1–4.0ROR 3.7 · χ² 388 / p 1e-86 | 3.5 EB05 3.1 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.6 · 92% clinician | no trial data cached |
| Neuropathy peripheral (nerve damage in hands/feet) | 214 | 12.8 11.2–14.6ROR 13.5 · χ² 2,319 / p <1e-300 | 12.7 EB05 11.3 · IC025 +3.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.9 | no trial data cached |
| Leukopenia (low white blood cells) | 208 | 23.6 20.7–26.9ROR 24.9 · χ² 4,471 / p <1e-300 | 23.5 EB05 20.9 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 14.6 · 98% clinician | no trial data cached |
| Interstitial lung disease | 181 | 21.2 18.4–24.4ROR 22.2 · χ² 3,458 / p <1e-300 | 21.1 EB05 18.6 · IC025 +4.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 13.2 · 99% clinician | no trial data cached |
| White blood cell count decreased | 176 | 9.2 7.9–10.6ROR 9.6 · χ² 1,275 / p 1e-279 | 9.0 EB05 7.9 · IC025 +2.9 3/3 methods agree | Lab value / disease marker | serious PRR 7.7 · 94% clinician | no trial data cached |
| Neutrophil count decreased | 170 | 23.8 20.5–27.5ROR 24.8 · χ² 3,674 / p <1e-300 | 23.6 EB05 20.8 · IC025 +4.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 16.8 · 96% clinician | no trial data cached |
| Anaemia (low red blood cells) | 107 | 3.2 2.6–3.8ROR 3.2 · χ² 157 / p 2e-36 | 3.1 EB05 2.7 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.1 · 96% clinician | no trial data cached |
| Stomatitis (mouth sores) | 103 | 9.6 7.9–11.6ROR 9.8 · χ² 785 / p 6e-173 | 9.4 EB05 7.9 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.6 · 94% clinician | no trial data cached |
| Alopecia (hair loss) | 102 | 2.9 2.4–3.5ROR 3.0 · χ² 128 / p 5e-30 | 2.9 EB05 2.5 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.8 | no trial data cached |
| Thrombocytopenia (low platelets) | 100 | 5.1 4.2–6.1ROR 5.2 · χ² 323 / p 1e-72 | 4.9 EB05 4.2 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.1 · 98% clinician | no trial data cached |
| Sepsis (blood infection) | 79 | 4.0 3.2–5.0ROR 4.1 · χ² 175 / p 3e-40 | 3.9 EB05 3.2 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.5 · 93% 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.
- Myelosuppression — n=310, PRR 51.8
- Leukopenia — n=208, PRR 23.6
- Osteonecrosis of jaw — n=55, PRR 12.5
- Pneumothorax — n=34, PRR 12.1
- Palmar-plantar erythrodysaesthesia syndrome — n=35, PRR 8.4
- Neoplasm progression — n=39, PRR 6.3
- Ascites — n=31, PRR 5.9
- Hepatic function abnormal — n=39, PRR 5.9
- Pleural effusion — n=61, PRR 5.7
- Pneumonitis — n=20, PRR 4.2
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 Eribulin?
In FDA FAERS, the most frequently co-reported reaction terms for Eribulin are neutropenia, febrile neutropenia, myelosuppression, pyrexia, neuropathy peripheral, leukopenia. 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 Eribulin have an FDA boxed warning?
No. The FDA label retrieved for Eribulin has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Eribulin 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 1a1a9cff-d5da-4232-b98f-26f55208dfc4, effective 20260325; matched on
openfda.generic_name.exact:"ERIBULIN 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, 78 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.