What the label lists and what reports show
Paclitaxel side effects
Paclitaxel's FDA label: “Urinary tract infections and upper respiratory tract infections were the most frequently reported infectious complications.” FAERS holds 98,464 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 nausea (5,500 reports).
- Generic listed
- Boxed warning
Check it at the source: the paclitaxel FDA label on DailyMed (effective January 21, 2026, Natco Pharma USA 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 paclitaxel?Tel l your healthcare provider right away if you have: • severe stomach pain • severe diarrhea The most common side effects of paclitaxel include: • low red blood cell count (anemia) feeling weak or tired • hair loss • numbness, tingling, or burning in your hands or feet (neuropathy) • joint and muscle pain • nausea and vomiting • hypersensitivity reaction - trouble breathing; sudden swelling of your face, lips, tongue, throat, or trouble swallowing; hives (raised bumps) or rash • diarrhea • mouth or lip sores (mucositis) • infections - if you have a fever (temperature above 100.4°F) or other sign of infection, tell your healthcare provider right away • swelling of your hands, face, or feet • bleeding events • irritation at the injection site • low blood pressure (hypotension) Tell your healthcare provider if you have any side effect that bothers you or that does not go away. […]
Source: FDA drug label, Natco Pharma USA LLC, effective January 21, 2026 (SPL set a1eb16b4-285b-4e81-9c4e-1244d4a52af8), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsUrinary tract infections and upper respiratory tract infections were the most frequently reported infectious complications.
Table 10: Selected Adverse Reactions with a Higher Incidence (≥5% for All Grade Toxicity or ≥2% for Grade 3 or Higher Toxicity) in the Protein Bound Paclitaxel/Gemcitabine Arm
This table is printed in the Paclitaxel label published by Teva Pharmaceuticals, Inc. of November 1, 2023; the label quoted above does not print one.
| Reaction | System Organ Class All Grades | Adverse Reaction Grade 3 or Higher | Protein Bound Paclitaxel (125 mg/m 2 ) and gemcitabine (N=421) All Grades | Gemcitabine (N=402) Grade 3 or Higher |
|---|---|---|---|---|
| Fatigue | 248 (59%) | 77 (18%) | 183 (46%) | 37 (9%) |
| Nausea | 228 (54%) | 27 (6%) | 192 (48%) | 14 (3%) |
| Alopecia | 212 (50%) | 6 (1%) | 21 (5%) | 0 |
| Peripheral neuropathy a | 227 (54%) | 70 (17%) | 51 (13%) | 3 (1%) |
| Decreased appetite | 152 (36%) | 23 (5%) | 104 (26%) | 8 (2%) |
| Cough | 72 (17%) | 0 | 30 (7%) | 0 |
| Urinary tract infections b | 47 (11%) | 10 (2%) | 20 (5%) | 1 (<1%) |
| Pain in extremity | 48 (11%) | 3 (1%) | 24 (6%) | 3 (1%) |
| Arthralgia | 47 (11%) | 3 (1%) | 13 (3%) | 1 (<1%) |
| Depression | 51 (12%) | 1 (<1%) | 24 (6%) | 0 |
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, continuedPooled Analysis of Adverse Event Experiences from Single-Agent Studies: Data in the following table are based on the experience of 812 patients (493 with ovarian carcinoma and 319 with breast carcinoma) enrolled in 10 studies who received single- agent Paclitaxel Injection, USP. Two hundred and seventy-five patients were treated in eight Phase 2 studies with paclitaxel doses ranging from 135 to 300 mg/m 2 administered over 24 hours (in four of these studies, G-CSF was administered as hematopoietic support). Three hundred and one patients were treated in the randomized Phase 3 ovarian carcinoma study which compared two doses (135 or 175 mg/m 2 ) and two schedules (3 or 24 hours) of paclitaxel. Two hundred and thirty-six patients with breast carcinoma received paclitaxel (135 or 175 mg/m 2 ) administered over 3 hours in a controlled study. Table 10. Summarya of Adverse Events in Patients with Solid Tumors Receiving Single-Agent Paclitaxel None of the observed toxicities were clearly influenced by age. Table 10 Disease-Specific Adverse Event Experiences First-Line Ovary in Combination: For the 1084 patients who were evaluable for safety in the Phase 3 first-line ovary combination therapy studies, Table 11 shows the incidence of important adverse events. …
Source: FDA drug label, Natco Pharma USA LLC, effective January 21, 2026 (SPL set a1eb16b4-285b-4e81-9c4e-1244d4a52af8), via openFDA; the full label on DailyMed
What do FAERS reports show?
98,464 reports list paclitaxel among the medicines taken, each a report of something that happened, not proof the medicine caused it; 16,309 are coded as a death and 40,360 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 21 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?
- Paclitaxel: 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