Paclitaxel: Side Effects, Uses & Monitoring

Facts extracted from current FDA product labeling for Paclitaxel. Educational only — not medical advice.

Reported adverse reactions

ReactionHighest frequency reported*
Febrile neutropenia90%
•  alopecia87%
•  nausea/vomiting18%
•  injection site reaction13%
•  mucositis13%
•  hypersensitivity reactionf4%
•  neurosensory toxicity3%
•  cardio vascular events2%
•  myalga/arthralgia2%
•  neuromotor toxicity1%

*Highest percentage across placebo-controlled trial tables summarized in current labeling.

Labeled uses

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…

Source: FDA labeling via NIH DailyMed (set b4c5d08a…). Not affiliated with FDA or NIH.

Medical disclaimer: Always consult a qualified healthcare professional about any medication.