Paclitaxel: Side Effects, Uses & Monitoring
Paclitaxel Injection, USP is indicated as subsequent therapy for the treatment of advanced carcinoma of the ovary.
- Data source
- FDA labeling via NIH DailyMed (label b4c5d08a…)
- Label version
- current
- Last reviewed
- 2026
Reported adverse reactions
Reactions listed in current FDA labeling, with the highest frequency reported across summarized placebo-controlled trials.
| Adverse reaction (as reported in labeling) | Reported frequency* |
|---|---|
| Febrile neutropenia | 90% |
| • alopecia | 87% |
| • nausea/vomiting | 18% |
| • injection site reaction | 13% |
| • mucositis | 13% |
| • hypersensitivity reactionf | 4% |
| • neurosensory toxicity | 3% |
| • cardio vascular events | 2% |
| • myalga/arthralgia | 2% |
| • neuromotor toxicity | 1% |
*Highest percentage reported for the active moiety across placebo-controlled trial tables in current FDA labeling. Values reflect trial reporting, not your individual risk.
Labeled uses (from FDA prescribing information)
Paclitaxel Injection, USP is indicated as subsequent therapy for the treatment of advanced carcinoma of the ovary. As first-line therapy, paclitaxel is indicated in combination with cisplatin. Paclitaxel is indicated for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy. In the clinical trial, there was an overall favorable effect on disease-free and overall survival in the total population of patients with receptor-positive and receptor-negative tumors, but the benefit has been specifically demonstrated by available data (median follow-up 30 months) only in the patients with estrogen and progesterone receptornegative tumors. (See CLINICAL STUDIES: Breast Carcinoma. ) Paclitaxel Injection, USP is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. Paclitaxel, in combination with cisplatin, is indicated for the first-line treatment of nonsmall cell lung cancer in patients who are not candidates for p…
Conditions associated with Paclitaxel in labeling
Frequently Asked Questions
What is Paclitaxel used for?
FDA labeling lists the approved uses shown above under "Labeled uses." This summary is informational; only a qualified prescriber can determine whether a medication is appropriate for you.
What are the most commonly reported side effects of Paclitaxel?
The table above shows adverse reactions and the highest frequencies reported in placebo-controlled trials summarized in current FDA labeling for Paclitaxel. Individual risk varies.
Does Paclitaxel require lab monitoring?
Monitoring needs vary. Ask your healthcare provider whether any lab tests apply while taking Paclitaxel.
Where does this information come from?
All clinical facts on this page were extracted from the current FDA-registered product labeling for this ingredient, published by manufacturers through NIH DailyMed. See the source link below.
Medical disclaimer: Educational content extracted from public FDA labeling. Not medical advice. Always consult a qualified healthcare professional before starting, stopping, or changing any medication.