What the label lists and what reports show
Cabazitaxel side effects
Cabazitaxel's FDA label: “Most common all grades adverse reactions and laboratory abnormalities (≥10%) with JEVTANA 20 mg/m 2 or 25 mg/m 2 are neutropenia, anemia, diarrhea, nausea, fatigue, asthenia, vomiting, hematuria, constipation, decreased appetite, back pain, and abdominal pain.” FAERS holds 3,469 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is febrile neutropenia (248 reports).
- No generic listed
- Boxed warning
Check it at the source: the cabazitaxel FDA label on DailyMed (effective October 7, 2025, Sanofi-Aventis U.S. LLC); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of JEVTANA?JEVTANA may cause serious side effects including: The most common side effects of JEVTANA include: Low red blood cell count (anemia). Low red blood cell count is common with JEVTANA, but can sometimes also be serious. Your healthcare provider will regularly check your red blood cell count. Symptoms of anemia include shortness of breath and tiredness. Low blood platelet count. Low platelet count is common with JEVTANA, but can sometimes also be serious. Tell your healthcare provider if you have any unusual bruising or bleeding. diarrhea nausea tiredness weakness vomiting constipation decreased appetite back pain stomach (abdominal) pain JEVTANA may cause fertility problems in males. This may affect your ability to father a child. Talk to your healthcare provider if you have concerns about fertility. […]
Source: FDA drug label, Sanofi-Aventis U.S. LLC, effective October 7, 2025 (SPL set de3d9c26-572b-4ea4-9b2d-dd58a2b3e8fa), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common all grades adverse reactions and laboratory abnormalities (≥10%) with JEVTANA 20 mg/m 2 or 25 mg/m 2 are neutropenia, anemia, diarrhea, nausea, fatigue, asthenia, vomiting, hematuria, constipation, decreased appetite, back pain, and abdominal pain.
Table 2: Adverse Reactions Graded using NCI CTCAE version 3. and Hematologic Abnormalities in ≥5% of Patients in TROPIC
| Reaction | Grade 1–4 % | Grade 3–4 % | Grade 1–4 % | Grade 3–4 % |
|---|---|---|---|---|
| Anemia Based on laboratory values, JEVTANA: n=369, mitoxantrone: n=370. | 98 | 11 | 82 | 5 |
| Leukopenia | 96 | 69 | 93 | 42 |
| Neutropenia | 94 | 82 | 87 | 58 |
| Thrombocytopenia | 48 | 4 | 43 | 2 |
| Febrile Neutropenia | 7 | 7 | 1 | 1 |
| Diarrhea | 47 | 6 | 11 | <1 |
| Nausea | 34 | 2 | 23 | <1 |
| Vomiting | 22 | 2 | 10 | 0 |
| Constipation | 20 | 1 | 15 | <1 |
| Abdominal Pain Includes abdominal discomfort, abdominal pain lower, abdominal pain upper,… | 17 | 2 | 6 | 0 |
| Dyspepsia Includes gastroesophageal reflux disease and reflux gastritis. | 10 | 0 | 2 | 0 |
| Fatigue | 37 | 5 | 27 | 3 |
| Asthenia | 20 | 5 | 12 | 2 |
| Pyrexia | 12 | 1 | 6 | <1 |
| Peripheral Edema | 9 | <1 | 9 | <1 |
| Mucosal Inflammation | 6 | <1 | 3 | <1 |
| Pain | 5 | 1 | 5 | 2 |
| Hematuria | 17 | 2 | 4 | <1 |
| Dysuria | 7 | 0 | 1 | 0 |
| Back Pain | 16 | 4 | 12 | 3 |
| Arthralgia | 11 | 1 | 8 | 1 |
| Muscle Spasms | 7 | 0 | 3 | 0 |
| Anorexia | 16 | <1 | 11 | <1 |
| Dehydration | 5 | 2 | 3 | <1 |
| Peripheral Neuropathy Includes peripheral motor neuropathy and peripheral sensory… | 13 | <1 | 3 | <1 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following serious adverse reactions are discussed in greater detail in another section of the label: Bone Marrow Suppression [see Warnings and Precautions (5.1) ] Increased Toxicities in Elderly Patients [see Warnings and Precautions (5.2) ] Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.4) ] Renal Failure [see Warnings and Precautions (5.5) ] Urinary Disorders Including Cystitis [see Warnings and Precautions (5.6) ] Respiratory Disorders [see Warnings and Precautions (5.7) ] Use in Patients with Hepatic Impairment [see Warnings and Precautions (5.8) ] Most common all grades adverse reactions and laboratory abnormalities (≥10%) with JEVTANA 20 mg/m 2 or 25 mg/m 2 are neutropenia, anemia, diarrhea, nausea, fatigue, asthenia, vomiting, hematuria, constipation, decreased appetite, back pain, and abdominal pain. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact sanofi-aventis U.S. LLC at 1-800-633-1610 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other trials and may not reflect the rates observed in clinical practice. …
Source: FDA drug label, Sanofi-Aventis U.S. LLC, effective October 7, 2025 (SPL set de3d9c26-572b-4ea4-9b2d-dd58a2b3e8fa), via openFDA; the full label on DailyMed
What do FAERS reports show?
3,469 reports list cabazitaxel among the medicines taken, each a report of something that happened, not proof the medicine caused it; 693 are coded as a death and 1,329 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 20 reactions below, 16 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Cabazitaxel: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions