Cabazitaxel side effects: what 3,469 FDA adverse event reports show
Drug class
Microtubule inhibitor
Brand names
Jevtana
Who reports
3,469 reports · 86% serious · 693 with death outcome · 2% female
Used for
JEVTANA ® is indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing treatment regimen. JEVTANA is a microtubule inhibitor indicated in c.
What it is
JEVTANA (cabazitaxel) injection is an antineoplastic agent belonging to the taxane class that is for intravenous use. It is prepared by semi-synthesis with a precursor extracted from yew needles.
Boxed warning
NEUTROPENIA AND HYPERSENSITIVITY WARNING: NEUTROPENIA AND HYPERSENSITIVITY See full prescribing information for complete boxed warning. Neutropenic deaths have been reported. Obtain frequent blood counts to monitor for neutropenia. JEVTANA is contraindicated in patients with neutrophil counts of ≤1,500 cells/mm 3 .
Causality screen of the 40 strongest signals
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.
- 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.
- Outcome field, not a reaction Death is a report outcome, not a reaction term. It is dominated by the underlying illness; see the seriousness profile and the boxed warning instead.
- 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. 90 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Prostatic specific antigen increased | 198 | 87.6 76.5–100.4ROR 92.9 · χ² 16,639 / p <1e-300 | 85.7 EB05 76.1 · IC025 +5.9 3/3 methods agree | Lab value / disease marker | serious PRR 77.4 | no trial data cached |
| Metastases to bone | 129 | 48.0 40.5–56.9ROR 49.9 · χ² 5,852 / p <1e-300 | 47.3 EB05 40.9 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 32.1 | no trial data cached |
| Febrile neutropenia | 248 | 22.7 20.1–25.6ROR 24.4 · χ² 5,124 / p <1e-300 | 22.6 EB05 20.3 · IC025 +4.2 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 15.2 · 94% clinician | no trial data cached |
| Haematuria (blood in urine) | 124 | 21.9 18.4–26.1ROR 22.7 · χ² 2,451 / p <1e-300 | 21.8 EB05 18.8 · IC025 +4.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 15.6 · 91% clinician | no trial data cached |
| Osteonecrosis of jaw (jawbone death) | 88 | 21.4 17.4–26.3ROR 21.9 · χ² 1,688 / p <1e-300 | 21.3 EB05 17.8 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 14.3 | no trial data cached |
| Metastases to lung | 37 | 19.4 14.1–26.8ROR 19.6 · χ² 627 / p 1e-138 | 19.2 EB05 14.5 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 13.0 | no trial data cached |
| Metastases to liver | 41 | 14.2 10.4–19.2ROR 14.3 · χ² 488 / p 2e-108 | 13.9 EB05 10.5 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 9.5 | no trial data cached |
| Malignant neoplasm progression | 238 | 14.2 12.5–16.0ROR 15.1 · χ² 2,904 / p <1e-300 | 14.1 EB05 12.6 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious PRR 9.6 | no trial data cached |
| Bone marrow failure | 41 | 12.1 8.9–16.5ROR 12.3 · χ² 407 / p 7e-91 | 11.8 EB05 8.9 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.1 | no trial data cached |
| Disseminated intravascular coagulation | 27 | 11.6 7.9–16.9ROR 11.7 · χ² 250 / p 1e-56 | 10.9 EB05 7.6 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.7 · 93% clinician | no trial data cached |
| Neutrophil count decreased | 73 | 10.9 8.7–13.7ROR 11.1 · χ² 647 / p 4e-143 | 10.7 EB05 8.7 · IC025 +3.0 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 8.1 · 100% clinician | no trial data cached |
| Haematotoxicity | 16 | 10.4 6.4–17.0ROR 10.5 · χ² 127 / p 8e-30 | 9.1 EB05 5.6 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.1 | no trial data cached |
| Disease progression | 180 | 9.2 8.0–10.7ROR 9.7 · χ² 1,320 / p 3e-289 | 9.1 EB05 8.0 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 6.5 | no trial data cached |
| Urosepsis | 14 | 9.2 5.4–15.5ROR 9.2 · χ² 94 / p 2e-22 | 7.7 EB05 4.6 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.1 | no trial data cached |
| Polyneuropathy | 18 | 9.2 5.8–14.5ROR 9.2 · χ² 123 / p 8e-29 | 8.0 EB05 5.1 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.2 | no trial data cached |
| Hypocalcaemia (low calcium) | 28 | 9.0 6.2–13.0ROR 9.0 · χ² 190 / p 1e-43 | 8.2 EB05 5.8 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 · 93% clinician | no trial data cached |
| Septic shock | 62 | 8.7 6.8–11.1ROR 8.8 · χ² 414 / p 2e-92 | 8.3 EB05 6.7 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.8 · 92% clinician | no trial data cached |
| Prostate cancer | 107 | 8.0 6.6–9.6ROR 8.2 · χ² 647 / p 4e-143 | 7.8 EB05 6.6 · IC025 +2.6 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 5.3 | no trial data cached |
| Retinal detachment | 12 | 7.9 4.5–13.9ROR 7.9 · χ² 65 / p 3e-16 | 6.4 EB05 3.8 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 170 | 7.6 6.6–8.8ROR 7.9 · χ² 972 / p 1e-213 | 7.5 EB05 6.6 · IC025 +2.6 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 5.2 · 91% clinician | no trial data cached |
| Hepatotoxicity (liver damage) | 27 | 7.4 5.1–10.7ROR 7.4 · χ² 142 / p 4e-33 | 6.7 EB05 4.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 | no trial data cached |
| Leukopenia (low white blood cells) | 57 | 6.9 5.3–8.9ROR 7.0 · χ² 283 / p 1e-63 | 6.6 EB05 5.3 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.8 | no trial data cached |
| Tooth fracture | 12 | 6.6 3.7–11.6ROR 6.6 · χ² 51 / p 4e-13 | 5.4 EB05 3.3 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 | no trial data cached |
| Interstitial lung disease | 51 | 6.4 4.9–8.4ROR 6.5 · χ² 227 / p 2e-51 | 6.1 EB05 4.8 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.3 · 98% clinician | no trial data cached |
| Melaena (black stool) | 22 | 6.0 4.0–9.2ROR 6.1 · χ² 87 / p 4e-21 | 5.4 EB05 3.8 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 | no trial data cached |
| Malnutrition | 11 | 6.0 3.3–10.8ROR 6.0 · χ² 41 / p 8e-11 | 4.9 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 | no trial data cached |
| Lymphadenopathy | 35 | 6.0 4.3–8.3ROR 6.0 · χ² 140 / p 1e-32 | 5.6 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | no trial data cached |
| Inappropriate antidiuretic hormone secretion | 10 | 5.9 3.2–11.0ROR 6.0 · χ² 36 / p 8e-10 | 4.8 EB05 2.8 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 | no trial data cached |
| Thrombocytopenia (low platelets) | 109 | 5.9 4.9–7.1ROR 6.1 · χ² 442 / p 2e-98 | 5.8 EB05 4.9 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.0 · 95% clinician | no trial data cached |
| Pulmonary embolism (lung blood clot) | 93 | 5.9 4.8–7.2ROR 6.0 · χ² 374 / p 1e-83 | 5.7 EB05 4.8 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.9 | no trial data cached |
| Urinary retention | 32 | 5.8 4.1–8.2ROR 5.9 · χ² 123 / p 7e-29 | 5.4 EB05 4.0 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.4 | no trial data cached |
| Sepsis (blood infection) | 105 | 5.7 4.7–6.9ROR 5.8 · χ² 403 / p 6e-90 | 5.6 EB05 4.7 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.8 | no trial data cached |
| Sudden death | 10 | 5.7 3.0–10.5ROR 5.7 · χ² 34 / p 3e-9 | 4.6 EB05 2.7 · IC025 +1.1 3/3 methods agree | Outcome field, not a reaction boxed warning mentions mortality | serious PRR 3.8 | no trial data cached |
| Pancytopenia (all blood cells low) | 52 | 5.6 4.3–7.4ROR 5.7 · χ² 194 / p 2e-44 | 5.4 EB05 4.3 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.7 · 92% clinician | no trial data cached |
| Anaemia (low red blood cells) | 177 | 5.6 4.9–6.5ROR 5.9 · χ² 671 / p 2e-148 | 5.5 EB05 4.9 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.1 · 95% clinician | no trial data cached |
| Dysuria (painful urination) | 32 | 5.3 3.7–7.4ROR 5.3 · χ² 106 / p 4e-25 | 4.9 EB05 3.6 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.7 | no trial data cached |
| Cholecystitis | 10 | 5.1 2.7–9.5ROR 5.1 · χ² 29 / p 4e-8 | 4.2 EB05 2.5 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 | no trial data cached |
| Musculoskeletal chest pain | 13 | 5.1 2.9–8.7ROR 5.1 · χ² 39 / p 3e-10 | 4.4 EB05 2.7 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.4 | no trial data cached |
| Cytopenia | 10 | 5.1 2.7–9.4ROR 5.1 · χ² 29 / p 4e-8 | 4.2 EB05 2.5 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.5 | no trial data cached |
| Subdural haematoma | 12 | 5.1 2.9–8.9ROR 5.1 · χ² 35 / p 2e-9 | 4.3 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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 | 248 | 22.7 20.1–25.6ROR 24.4 · χ² 5,124 / p <1e-300 | 22.6 EB05 20.3 · IC025 +4.2 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 15.2 · 94% clinician | no trial data cached |
| Malignant neoplasm progression | 238 | 14.2 12.5–16.0ROR 15.1 · χ² 2,904 / p <1e-300 | 14.1 EB05 12.6 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious PRR 9.6 | no trial data cached |
| Prostatic specific antigen increased | 198 | 87.6 76.5–100.4ROR 92.9 · χ² 16,639 / p <1e-300 | 85.7 EB05 76.1 · IC025 +5.9 3/3 methods agree | Lab value / disease marker | serious PRR 77.4 | no trial data cached |
| Disease progression | 180 | 9.2 8.0–10.7ROR 9.7 · χ² 1,320 / p 3e-289 | 9.1 EB05 8.0 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 6.5 | no trial data cached |
| Anaemia (low red blood cells) | 177 | 5.6 4.9–6.5ROR 5.9 · χ² 671 / p 2e-148 | 5.5 EB05 4.9 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.1 · 95% clinician | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 170 | 7.6 6.6–8.8ROR 7.9 · χ² 972 / p 1e-213 | 7.5 EB05 6.6 · IC025 +2.6 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 5.2 · 91% clinician | no trial data cached |
| Metastases to bone | 129 | 48.0 40.5–56.9ROR 49.9 · χ² 5,852 / p <1e-300 | 47.3 EB05 40.9 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 32.1 | no trial data cached |
| Haematuria (blood in urine) | 124 | 21.9 18.4–26.1ROR 22.7 · χ² 2,451 / p <1e-300 | 21.8 EB05 18.8 · IC025 +4.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 15.6 · 91% clinician | no trial data cached |
| Thrombocytopenia (low platelets) | 109 | 5.9 4.9–7.1ROR 6.1 · χ² 442 / p 2e-98 | 5.8 EB05 4.9 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.0 · 95% clinician | no trial data cached |
| Prostate cancer | 107 | 8.0 6.6–9.6ROR 8.2 · χ² 647 / p 4e-143 | 7.8 EB05 6.6 · IC025 +2.6 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 5.3 | no trial data cached |
| Sepsis (blood infection) | 105 | 5.7 4.7–6.9ROR 5.8 · χ² 403 / p 6e-90 | 5.6 EB05 4.7 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.8 | no trial data cached |
| Pulmonary embolism (lung blood clot) | 93 | 5.9 4.8–7.2ROR 6.0 · χ² 374 / p 1e-83 | 5.7 EB05 4.8 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.9 | no trial data cached |
| Osteonecrosis of jaw (jawbone death) | 88 | 21.4 17.4–26.3ROR 21.9 · χ² 1,688 / p <1e-300 | 21.3 EB05 17.8 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 14.3 | no trial data cached |
| General physical health deterioration | 87 | 4.6 3.7–5.6ROR 4.7 · χ² 241 / p 1e-54 | 4.5 EB05 3.7 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 3.5 | no trial data cached |
| Neutrophil count decreased | 73 | 10.9 8.7–13.7ROR 11.1 · χ² 647 / p 4e-143 | 10.7 EB05 8.7 · IC025 +3.0 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 8.1 · 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.
- Metastases to bone — n=129, PRR 48.0
- Osteonecrosis of jaw — n=88, PRR 21.4
- Metastases to lung — n=37, PRR 19.4
- Metastases to liver — n=41, PRR 14.2
- Hypocalcaemia — n=28, PRR 9.0
- Hepatotoxicity — n=27, PRR 7.4
- Melaena — n=22, PRR 6.0
- Lymphadenopathy — n=35, PRR 6.0
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 Cabazitaxel?
In FDA FAERS, the most frequently co-reported reaction terms for Cabazitaxel are febrile neutropenia, prostatic specific antigen increased, anaemia, neutropenia, metastases to bone, haematuria. 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 Cabazitaxel have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: NEUTROPENIA AND HYPERSENSITIVITY WARNING: NEUTROPENIA AND HYPERSENSITIVITY See full prescribing information for complete boxed warning. Neutropenic deaths have been reported. Obtain frequent blood counts to monitor for neutropenia. JEVTANA is contraindicated in patients with neutrophil counts of ≤1,500 cells/mm 3 .
Do FAERS signals prove that Cabazitaxel 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 de3d9c26-572b-4ea4-9b2d-dd58a2b3e8fa, effective 20251007; matched on
openfda.generic_name.exact:"CABAZITAXEL") - 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, 130 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.