Drug · FAERS side-effect profile with label screen
Vinorelbine side effects: what 6,868 FDA adverse event reports show
Drug class
Vinca alkaloid
FDA label, Indications wording
Who reports
6,868 reports · 98% serious · 1,452 with death outcome · 68% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Vinorelbine Injection is indicated: In combination with cisplatin for first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) As a single agent for the treatment of patients with metastatic NSCLC Vinorelb.
FDA label, Indications and Usage
What it is
Vinorelbine Injection, USP contains vinorelbine, a semi-synthetic vinca alkaloid.
FDA label, Description section
Boxed warning
MYELOSUPPRESSION Severe myelosuppression resulting in serious infection, septic shock, hospitalization and death can occur [see Warnings and Precautions ( 5.1 )]. Decrease the dose or withhold vinorelbine in accord with recommended dose modifications [see Dosage and Administration ( 2.2 )].
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 — boxed warning 9Labeled adverse reaction 4Labeled (related wording) 1Reporting / coding artifact 4Lab value / disease marker 2Not in label — unassessed 20
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. 262 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 |
|---|---|---|---|---|---|---|
| Breast cancer metastatic | 249 | 72.5 64.1–82.1ROR 75.2 · χ² 17,093 / p <1e-300 | 70.5 EB05 63.4 · IC025 +5.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 42.4 · ♀ 99% (drug 68%) · 93% clinician | no trial data cached |
| Metastases to lung | 183 | 49.2 42.6–56.8ROR 50.5 · χ² 8,455 / p <1e-300 | 48.2 EB05 42.6 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious PRR 28.4 · ♀ 88% (drug 68%) · 94% clinician | no trial data cached |
| Metastases to bone | 252 | 47.8 42.3–54.0ROR 49.5 · χ² 11,319 / p <1e-300 | 46.9 EB05 42.2 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious PRR 27.9 · ♀ 93% (drug 68%) · 91% clinician | no trial data cached |
| Metastases to liver | 254 | 44.9 39.7–50.7ROR 46.6 · χ² 10,700 / p <1e-300 | 44.1 EB05 39.7 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 26.1 · ♀ 97% (drug 68%) | no trial data cached |
| Haematotoxicity | 133 | 44.4 37.5–52.6ROR 45.3 · χ² 5,523 / p <1e-300 | 43.5 EB05 37.7 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 26.5 · 95% clinician | no trial data cached |
| Metastases to central nervous system | 173 | 41.8 36.0–48.5ROR 42.8 · χ² 6,757 / p <1e-300 | 41.1 EB05 36.2 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 24.5 · ♀ 88% (drug 68%) · 91% clinician | no trial data cached |
| Palmar-plantar erythrodysaesthesia syndrome | 239 | 31.5 27.8–35.7ROR 32.6 · χ² 6,965 / p <1e-300 | 31.1 EB05 28.0 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 24.1 · ♀ 96% (drug 68%) · 93% clinician | no trial data cached |
| Mucosal inflammation | 203 | 24.0 20.9–27.5ROR 24.7 · χ² 4,414 / p <1e-300 | 23.7 EB05 21.1 · IC025 +4.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 14.8 · ♀ 89% (drug 68%) · 92% clinician | no trial data cached |
| Malignant neoplasm progression | 699 | 21.1 19.7–22.6ROR 23.4 · χ² 13,329 / p <1e-300 | 20.9 EB05 19.7 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious PRR 12.6 | no trial data cached |
| Disease progression | 776 | 20.2 18.9–21.6ROR 22.7 · χ² 14,142 / p <1e-300 | 20.1 EB05 18.9 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious PRR 13.3 · 94% clinician | no trial data cached |
| Ejection fraction decreased | 91 | 17.9 14.6–22.0ROR 18.2 · χ² 1,432 / p <1e-300 | 17.8 EB05 14.9 · IC025 +3.7 3/3 methods agree | Lab value / disease marker | serious PRR 11.3 · 95% clinician | no trial data cached |
| Polyneuropathy | 68 | 17.5 13.8–22.2ROR 17.7 · χ² 1,039 / p 3e-228 | 17.4 EB05 14.1 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 10.4 | no trial data cached |
| Febrile neutropenia | 371 | 17.2 15.6–19.0ROR 18.1 · χ² 5,629 / p <1e-300 | 17.1 EB05 15.7 · IC025 +3.9 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 10.0 · 93% clinician | no trial data cached |
| Therapy partial responder | 80 | 16.3 13.1–20.3ROR 16.5 · χ² 1,128 / p 1e-247 | 16.1 EB05 13.4 · IC025 +3.5 3/3 methods agree | Reporting / coding artifact | serious PRR 11.6 · 96% clinician | no trial data cached |
| Osteonecrosis of jaw (jawbone death) | 129 | 15.9 13.4–18.8ROR 16.2 · χ² 1,777 / p <1e-300 | 15.8 EB05 13.6 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 9.3 · ♀ 90% (drug 68%) · 95% clinician | no trial data cached |
| Pneumonitis | 139 | 15.8 13.4–18.6ROR 16.1 · χ² 1,901 / p <1e-300 | 15.7 EB05 13.6 · IC025 +3.6 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 9.6 · 96% clinician | no trial data cached |
| Bone marrow failure | 105 | 15.7 13.0–19.0ROR 16.0 · χ² 1,429 / p <1e-300 | 15.6 EB05 13.2 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 9.3 · 95% clinician | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 668 | 15.1 14.1–16.3ROR 16.6 · χ² 8,810 / p <1e-300 | 15.0 EB05 14.1 · IC025 +3.8 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 9.2 · 94% clinician | no trial data cached |
| Pneumocystis jirovecii pneumonia | 49 | 15.0 11.4–19.9ROR 15.1 · χ² 625 / p 3e-138 | 14.8 EB05 11.6 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.6 · 96% clinician | no trial data cached |
| Neoplasm progression | 144 | 12.6 10.7–14.8ROR 12.8 · χ² 1,518 / p <1e-300 | 12.4 EB05 10.8 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 9.9 | no trial data cached |
| Leukopenia (low white blood cells) | 200 | 12.3 10.7–14.1ROR 12.6 · χ² 2,058 / p <1e-300 | 12.2 EB05 10.8 · IC025 +3.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.4 · 96% clinician | no trial data cached |
| Ascites | 110 | 11.5 9.5–13.8ROR 11.6 · χ² 1,037 / p 9e-228 | 11.3 EB05 9.6 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 · ♀ 96% (drug 68%) | no trial data cached |
| Neurotoxicity | 63 | 11.1 8.7–14.2ROR 11.2 · χ² 568 / p 9e-126 | 10.8 EB05 8.7 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.5 · ♀ 92% (drug 68%) · 95% clinician | no trial data cached |
| Nephropathy toxic | 40 | 11.0 8.1–15.0ROR 11.1 · χ² 353 / p 6e-79 | 10.5 EB05 7.9 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 · ♀ 24% (drug 68%) · 100% clinician | no trial data cached |
| Oesophagitis | 39 | 10.9 8.0–14.9ROR 11.0 · χ² 341 / p 2e-76 | 10.4 EB05 7.8 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.1 | no trial data cached |
| Pleural effusion | 210 | 10.6 9.2–12.1ROR 10.9 · χ² 1,807 / p <1e-300 | 10.4 EB05 9.3 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.4 | no trial data cached |
| Thrombocytopenia (low platelets) | 375 | 10.3 9.3–11.4ROR 10.8 · χ² 3,145 / p <1e-300 | 10.2 EB05 9.4 · IC025 +3.2 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 6.2 · 92% clinician | no trial data cached |
| Clostridium difficile colitis | 32 | 9.2 6.5–13.0ROR 9.3 · χ² 226 / p 2e-51 | 8.5 EB05 6.2 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 · ♀ 10% (drug 68%) · 94% clinician | no trial data cached |
| Hepatotoxicity (liver damage) | 65 | 9.0 7.0–11.4ROR 9.1 · χ² 452 / p 1e-100 | 8.6 EB05 6.9 · IC025 +2.7 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 5.4 · 97% clinician | no trial data cached |
| Pneumothorax | 46 | 8.9 6.7–11.9ROR 8.9 · χ² 313 / p 2e-70 | 8.4 EB05 6.5 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 · 91% clinician | no trial data cached |
| Blood lactate dehydrogenase increased | 46 | 8.8 6.6–11.8ROR 8.9 · χ² 311 / p 7e-70 | 8.3 EB05 6.4 · IC025 +2.5 3/3 methods agree | Lab value / disease marker | serious PRR 5.5 · ♀ 42% (drug 68%) · 91% clinician | no trial data cached |
| Acute myeloid leukaemia | 41 | 8.1 5.9–10.9ROR 8.1 · χ² 246 / p 1e-55 | 7.5 EB05 5.7 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 · 100% clinician | no trial data cached |
| Thrombotic microangiopathy | 25 | 7.9 5.3–11.7ROR 7.9 · χ² 143 / p 2e-33 | 7.1 EB05 5.0 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 · 92% clinician | no trial data cached |
| Drug resistance | 64 | 7.6 6.0–9.7ROR 7.7 · χ² 361 / p 7e-81 | 7.3 EB05 5.9 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 4.9 · 90% clinician | no trial data cached |
| Myelodysplastic syndrome | 36 | 7.6 5.5–10.5ROR 7.6 · χ² 200 / p 1e-45 | 7.1 EB05 5.3 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 · 97% clinician | no trial data cached |
| Myelosuppression | 81 | 7.3 5.9–9.0ROR 7.4 · χ² 433 / p 2e-96 | 7.0 EB05 5.8 · IC025 +2.4 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 4.3 · 99% clinician | no trial data cached |
| Anaemia (low red blood cells) | 452 | 7.2 6.6–7.9ROR 7.7 · χ² 2,444 / p <1e-300 | 7.2 EB05 6.6 · IC025 +2.7 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 4.7 | no trial data cached |
| Interstitial lung disease | 114 | 7.2 6.0–8.7ROR 7.3 · χ² 604 / p 9e-134 | 7.0 EB05 6.0 · IC025 +2.5 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 4.3 · ♀ 32% (drug 68%) · 97% clinician | no trial data cached |
| Neuropathy peripheral (nerve damage in hands/feet) | 221 | 7.2 6.3–8.1ROR 7.4 · χ² 1,166 / p 8e-256 | 7.0 EB05 6.3 · IC025 +2.6 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 4.9 | no trial data cached |
| Pericardial effusion | 52 | 6.9 5.3–9.1ROR 7.0 · χ² 257 / p 4e-58 | 6.6 EB05 5.2 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 | 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 |
|---|---|---|---|---|---|---|
| Disease progression | 776 | 20.2 18.9–21.6ROR 22.7 · χ² 14,142 / p <1e-300 | 20.1 EB05 18.9 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious PRR 13.3 · 94% clinician | no trial data cached |
| Malignant neoplasm progression | 699 | 21.1 19.7–22.6ROR 23.4 · χ² 13,329 / p <1e-300 | 20.9 EB05 19.7 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious PRR 12.6 | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 668 | 15.1 14.1–16.3ROR 16.6 · χ² 8,810 / p <1e-300 | 15.0 EB05 14.1 · IC025 +3.8 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 9.2 · 94% clinician | no trial data cached |
| Off label use (used outside approved label) | 656 | 2.3 2.1–2.5ROR 2.4 · χ² 506 / p 2e-112 | 2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 2.5 | no trial data cached |
| Diarrhoea (diarrhea) | 508 | 2.4 2.2–2.6ROR 2.5 · χ² 432 / p 4e-96 | 2.4 EB05 2.2 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.5 · 91% clinician | no trial data cached |
| Nausea | 503 | 1.9 1.8–2.1ROR 2.0 · χ² 240 / p 2e-54 | 1.9 EB05 1.8 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 2.2 · 91% clinician | no trial data cached |
| Fatigue (tiredness) | 452 | 1.8 1.6–1.9ROR 1.8 · χ² 159 / p 1e-36 | 1.8 EB05 1.6 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 2.0 · 90% clinician | no trial data cached |
| Anaemia (low red blood cells) | 452 | 7.2 6.6–7.9ROR 7.7 · χ² 2,444 / p <1e-300 | 7.2 EB05 6.6 · IC025 +2.7 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 4.7 | no trial data cached |
| Vomiting | 395 | 2.6 2.3–2.8ROR 2.7 · χ² 387 / p 2e-86 | 2.6 EB05 2.4 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.3 · 91% clinician | no trial data cached |
| Thrombocytopenia (low platelets) | 375 | 10.3 9.3–11.4ROR 10.8 · χ² 3,145 / p <1e-300 | 10.2 EB05 9.4 · IC025 +3.2 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 6.2 · 92% clinician | no trial data cached |
| Febrile neutropenia | 371 | 17.2 15.6–19.0ROR 18.1 · χ² 5,629 / p <1e-300 | 17.1 EB05 15.7 · IC025 +3.9 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 10.0 · 93% clinician | no trial data cached |
| Pyrexia (fever) | 352 | 3.1 2.8–3.4ROR 3.2 · χ² 509 / p 7e-113 | 3.1 EB05 2.8 · IC025 +1.5 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 2.3 | no trial data cached |
| Death | 332 | 1.2 1.1–1.3ROR 1.2 · χ² 9 / p 0.001 | 1.2 EB05 1.1 · IC025 +0.1 | Outcome field, not a reaction boxed warning mentions mortality | serious PRR 0.7 | no trial data cached |
| Dyspnoea (shortness of breath) | 332 | 1.8 1.6–2.0ROR 1.8 · χ² 119 / p 6e-28 | 1.8 EB05 1.6 · IC025 +0.7 | Labeled — boxed warning exact term | serious PRR 1.5 | no trial data cached |
| Asthenia (weakness) | 288 | 2.3 2.1–2.6ROR 2.4 · χ² 223 / p 8e-51 | 2.3 EB05 2.1 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.0 | 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.
- Metastases to lung — n=183, PRR 49.2
- Metastases to bone — n=252, PRR 47.8
- Metastases to liver — n=254, PRR 44.9
- Haematotoxicity — n=133, PRR 44.4
- Metastases to central nervous system — n=173, PRR 41.8
- Palmar-plantar erythrodysaesthesia syndrome — n=239, PRR 31.5
- Polyneuropathy — n=68, PRR 17.5
- Osteonecrosis of jaw — n=129, PRR 15.9
- Bone marrow failure — n=105, PRR 15.7
- Pneumocystis jirovecii pneumonia — n=49, PRR 15.0
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 Vinorelbine?
In FDA FAERS, the most frequently co-reported reaction terms for Vinorelbine are neutropenia, diarrhoea, nausea, fatigue, anaemia, vomiting. 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 Vinorelbine have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: MYELOSUPPRESSION Severe myelosuppression resulting in serious infection, septic shock, hospitalization and death can occur [see Warnings and Precautions ( 5.1 )]. Decrease the dose or withhold vinorelbine in accord with recommended dose modifications [see Dosage and Administration ( 2.2 )].
Do FAERS signals prove that Vinorelbine 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 10a70995-e04d-4044-b1dc-c9aa27460397, effective 20240816; matched on
openfda.generic_name.exact:"VINORELBINE") - 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, 302 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.