What the label lists and what reports show
Ixabepilone side effects
Ixabepilone's FDA label: “The most common adverse reactions (≥20%) are peripheral sensory neuropathy, fatigue/asthenia, myalgia/arthralgia, alopecia, nausea, vomiting, stomatitis/mucositis, diarrhea, and musculoskeletal pain.” FAERS holds 1,049 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 vomiting (94 reports).
- No generic listed
- Boxed warning
Check it at the source: the ixabepilone FDA label on DailyMed (effective December 4, 2025, R-Pharm US Operating, 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 IXEMPRA?IXEMPRA may cause serious side effects including: Numbness, tingling, or burning in the hands or feet can occur during treatment with IXEMPRA peripheral neuropathy (PN). These symptoms may be new or get worse during treatment with IXEMPRA. If you have diabetes, you may have a higher risk for severe neuropathy. These symptoms often occur early during treatment with IXEMPRA. Tell your healthcare provider if you have any of these symptoms. Your dose of IXEMPRA may need to be decreased, stopped until your symptoms get better, or totally stopped. Low blood cell counts especially low white blood counts (neutropenia). Low white blood cell counts are common with IXEMPRA treatment, but can sometimes be severe and have led to death. White blood cells help protect the body from infections caused by bacteria. […]
Source: FDA drug label, R-Pharm US Operating, LLC, effective December 4, 2025 (SPL set 241f0b1e-8b95-470d-876f-bf1804daaf18), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (≥20%) are peripheral sensory neuropathy, fatigue/asthenia, myalgia/arthralgia, alopecia, nausea, vomiting, stomatitis/mucositis, diarrhea, and musculoskeletal pain.
Table 5: Hematologic Abnormalities in Patients with Metastatic or Locally Advanced Breast Cancer Treated with IXEMPRA
| Hematology Parameter | Grade 3 (%) | Grade 4 (%) | Grade 3 (%) | Grade 4 (%) | Grade 3 (%) | Grade 4 (%) |
|---|---|---|---|---|---|---|
| Neutropenia a | 32 | 36 | 9 | 2 | 31 | 23 |
| Leukopenia (WBC) | 41 | 16 | 5 | 1 | 36 | 13 |
| Anemia (Hgb) | 8 | 2 | 4 | 1 | 6 | 2 |
| Thrombocytopenia | 5 | 3 | 2 | 2 | 5 | 2 |
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 adverse reactions are discussed in greater detail in other sections. Peripheral neuropathy [see Warnings and Precautions ( 5.1 )] Myelosuppression [see Warnings and Precautions ( 5.2 )] Hypersensitivity reactions [see Warnings and Precautions ( 5.4 )] Cardiac Adverse reactions [see Warnings and Precautions ( 5.5) ] The most common adverse reactions (≥20%) are peripheral sensory neuropathy, fatigue/asthenia, myalgia/arthralgia, alopecia, nausea, vomiting, stomatitis/mucositis, diarrhea, and musculoskeletal pain. Additional reactions occurred in ≥20% in combination treatment: palmar-plantar erythrodysesthesia syndrome, anorexia, abdominal pain, nail disorder, and constipation ( 6 ). Hematologic laboratory abnormalities (>40%) include neutropenia, leukopenia, anemia, and thrombocytopenia ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact R-Pharm US at 1-844-586-8953 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 in the clinical trials of a drug cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in clinical practice. Unless otherwise specified, assessment of adverse reactions is based on one randomized study (Study 046) and one single-arm study (Study 081).
Source: FDA drug label, R-Pharm US Operating, LLC, effective December 4, 2025 (SPL set 241f0b1e-8b95-470d-876f-bf1804daaf18), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,049 reports list ixabepilone among the medicines taken, each a report of something that happened, not proof the medicine caused it; 240 are coded as a death and 419 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 23 reactions below, 15 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?
- Ixabepilone: 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