What the label lists and what reports show
Docetaxel side effects
Docetaxel's FDA label: “The most common adverse reactions across all DOCIVYX indications are infections, neutropenia, anemia, febrile neutropenia, hypersensitivity, thrombocytopenia, neuropathy, dysgeusia, dyspnea, constipation, anorexia, nail disorders, fluid retention, asthenia …” FAERS holds 67,030 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 alopecia (16,970 reports).
- Generic listed
- A presentation discontinued
- Boxed warning
Check it at the source: the docetaxel FDA label on DailyMed (effective July 15, 2025, Avyxa Pharma, 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 DOCIVYX ?DOCIVYX may cause serious side effects including death. ● See "What is the most important information I should know about DOCIVYX ?" ● Neurologic problems. Neurologic symptoms are common in people who receive DOCIVYX but can be severe. Tell your healthcare provider right away if you have numbness, tingling, or burning in your hands or feet (peripheral neuropathy) or weakness of your legs, feet, arms, or hands (motor weakness). ● Vision problems including blurred vision or loss of vision. Tell your healthcare provider right away if you have any vision changes. ● DOCIVYX contains alcohol. The alcohol content in DOCIVYX may impair your ability to drive or use machinery right after receiving DOCIVYX. Consider whether you should drive, operate machinery or do other dangerous activities right after you receive DOCIVYX treatment. ● Tumor lysis syndrome (TLS). […]
Source: FDA drug label, Avyxa Pharma, LLC, effective July 15, 2025 (SPL set 4763744e-360e-4d37-be05-cce4114548cd), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions across all DOCIVYX indications are infections, neutropenia, anemia, febrile neutropenia, hypersensitivity, thrombocytopenia, neuropathy, dysgeusia, dyspnea, constipation, anorexia, nail disorders, fluid retention, asthenia, pain, nausea, diarrhea, vomiting, mucositis, alopecia, skin reactions, and myalgia.
Table 8: Adverse Reactions Regardless of Relationship to Treatment in Chemotherapy-Naive Advanced Non-small Cell Lung Cancer Patients Receiving DOCIVYX in Combination with Cisplatin
| Reaction | DOCIVYX 75 mg/m 2 + Cisplatin 75 mg/m 2 n=406 % 91 74 | Vinorelbine 25 mg/m 2 + Cisplatin 100 mg/m 2 n=396 % 90 78 |
|---|---|---|
| Febrile Neutropenia | 5 | 5 |
| Any | 89 | 94 |
| Grade 3/4 | 7 | 25 |
| Any | 35 | 37 |
| Grade 3/4 | 8 | 8 |
| Any | 33 | 29 |
| Grade 3/4 | <1 | 1 |
| Any | 12 | 4 |
| Grade 3/4 | 3 | <1 |
| Fluid Retention † Any | 54 | 42 |
| Any | 47 | 42 |
| Grade 3/4 | 4 | 4 |
| Any | 19 | 17 |
| Grade 3/4 | 3 | 6 |
| Any | 16 | 14 |
| Grade 3/4 | <1 | 1 |
| Any | 72 | 76 |
| Grade 3/4 | 10 | 17 |
| Any | 55 | 61 |
| Grade 3/4 | 8 | 16 |
| Any | 47 | 25 |
| Grade 3/4 | 7 | 3 |
| Any | 42 | 40 |
| All severe or life- threatening events | 5 | 5 |
| Any | 24 | 21 |
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 most serious adverse reactions from DOCIVYX are: Toxic Deaths [see Boxed Warning, Warnings and Precautions (5.1) ] Hepatic Impairment [see Boxed Warning, Warnings and Precautions (5.2) ] Hematologic Effects [see Boxed Warning, Warnings and Precautions (5.3) ] Enterocolitis and Neutropenic Colitis [see Warnings and Precautions (5.4) ] Hypersensitivity Reactions [see Boxed Warning, Warnings and Precautions (5.5) ] Fluid Retention [see Boxed Warning, Warnings and Precautions (5.6) ] Second Primary Malignancies [see Warnings and Precautions (5.7) ] Cutaneous Reactions [see Warnings and Precautions (5.8) ] Neurologic Reactions [see Warnings and Precautions (5.9) ] Eye Disorders [see Warnings and Precautions (5.10)] Asthenia [see Warnings and Precautions (5.11) ] Alcohol Content [see Warnings and Precautions (5.13) ] The most common adverse reactions across all DOCIVYX indications are infections, neutropenia, anemia, febrile neutropenia, hypersensitivity, thrombocytopenia, neuropathy, dysgeusia, dyspnea, constipation, anorexia, nail disorders, fluid retention, asthenia, pain, nausea, diarrhea, vomiting, mucositis, alopecia, skin reactions, and myalgia. Incidence varies depending on the indication. Adverse reactions are described according to indication. …
Source: FDA drug label, Avyxa Pharma, LLC, effective July 15, 2025 (SPL set 4763744e-360e-4d37-be05-cce4114548cd), via openFDA; the full label on DailyMed
What do FAERS reports show?
67,030 reports list docetaxel among the medicines taken, each a report of something that happened, not proof the medicine caused it; 8,847 are coded as a death and 20,424 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, 11 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?
- Docetaxel: 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