Last reviewed 2026-04-20 · How we verify

DOCETAXEL

DOCETAXEL is a Microtubule Inhibitor [EPC] drug. It is currently FDA-approved (first approved 1995).

At a glance

Approved indications

No approved indications tracked.

Boxed warnings

• WARNING: TOXIC DEATHS, HEPATOTOXICITY, NEUTROPENIA, HYPERSENSITIVITY REACTIONS, and FLUID RETENTION Treatment-related mortality associated with docetaxel is increased in patients with abnormal liver function, in patients receiving higher doses, and in patients with non-small cell lung carcinoma and a history of prior treatment with platinum-based chemotherapy who receive docetaxel as a single agent at a dose of 100 mg/m 2 [ see Warnings and Precautions (5.1) ] . Avoid the use of Docetaxel Injection in patients with bilirubin > upper limit of normal (ULN), or to patients with AST and/or ALT >1.5 × ULN concomitant with alkaline phosphatase >2.5 × ULN. Patients with elevations of bilirubin or abnormalities of transaminase concurrent with alkaline phosphatase are at increased risk for the development of severe neutropenia, febrile neutropenia, infections, severe thrombocytopenia, severe stomatitis, severe skin toxicity, and toxic death. Patients with isolated elevations of transaminase >1.5 × ULN also had a higher rate of febrile neutropenia. Measure bilirubin, AST or ALT, and alkaline phosphatase prior to each cycle of Docetaxel Injection [ see Warnings and Precautions (5.2) ]. Do not administer Docetaxel Injection to patients with neutrophil counts of <1500 cells/mm 3 . Monitor blood counts frequently as neutropenia may be severe and result in infection [ see Warnings and Precautions (5.3) ]. Do not administer Docetaxel Injection to patients who have a history of severe hypersensitivity reactions to docetaxel or to other drugs formulated with polysorbate 80 [ see Contraindications (4) ]. Severe hypersensitivity reactions have been reported in patients despite dexamethasone premedication. Hypersensitivity reactions require immediate discontinuation of the Docetaxel Injection infusion and administration of appropriate therapy [ see Warnings and Precautions (5.5) ]. Severe fluid retention occurred in 6.5% (6/92) of patients despite use of dexamethasone premedication. It was characterized by one or more of the following events: poorly tolerated peripheral edema, generalized edema, pleural effusion requiring urgent drainage, dyspnea at rest, cardiac tamponade, or pronounced abdominal distention (due to ascites) [ see Warnings and Precautions (5.6) ]. WARNING: TOXIC DEATHS, HEPATOTOXICITY, NEUTROPENIA, HYPERSENSITIVITY REACTIONS, and FLUID RETENTION See full prescribing information for complete boxed warning. • Treatment-related mortality increases with abnormal liver function, at higher doses, and in patients with NSCLC and prior platinum-based therapy receiving docetaxel at 100 mg/m 2 ( 5.1 ) • Avoid use of Docetaxel Injection if bilirubin > ULN, or if AST and/or ALT >1.5 × ULN concomitant with alkaline phosphatase >2.5 × ULN. LFT elevations increase risk of severe or life-threatening complications. Obtain LFTs before each treatment cycle ( 5.2 ) • Do not administer Docetaxel Injection to patients with neutrophil counts <1500 cells/mm 3 . Obtain frequent blood counts to monitor for neutropenia ( 4 , 5.3 ) • Severe hypersensitivity, including fatal anaphylaxis, has been reported in patients who received dexamethasone premedication. Severe reactions require immediate discontinuation of Docetaxel Injection and administration of appropriate therapy ( 5.5 ) • Contraindicated if history of severe hypersensitivity reactions to docetaxel or to drugs formulated with polysorbate 80 ( 4 ) • Severe fluid retention may occur despite dexamethasone ( 5.6 )

Common side effects

• Neutropenia
• Febrile neutropenia
• Infections
• Anemia
• Thrombocytopenia
• Neuropathy
• Dysgeusia
• Dyspnea
• Constipation
• Anorexia
• Nail disorders
• Fluid retention

Serious adverse events

• Severe neutropenia
• Febrile neutropenia
• Severe infectious episodes
• Hypersensitivity reactions
• Thrombocytopenia with gastrointestinal hemorrhage

Key clinical trials

• A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001) (PHASE3)
• Becotatug Vedotin for LA-NPC With a Suboptimal Response to Induction Chemotherapy Combined With Immunotherapy (PHASE2)
• Docetaxel to Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration Sensitive Prostate Cancer and Suboptimal PSA Response (PHASE3)
• Phase II Trial of Neoadjuvant Chemotherapy (NAC) Alone or in Combination With Immunotherapy Vaccine PRGN-2009 in Subjects With Newly Diagnosed HPV-Associated Oropharyngeal (Head and Neck) Cancer (PHASE2)
• Testing the Addition of an Anti-cancer Drug, Abemaciclib, to the Usual Chemotherapy Treatment (Gemcitabine) for Soft Tissue Sarcoma (PHASE1, PHASE2)
• 177 LuPSMA-617 vs Docetaxel in Metastatic Castration Resistant and PSMA-Positive Prostate Cancer (PHASE2)
• Comparing the New Anti-cancer Drug Eribulin With Chemotherapy Against the Usual Chemotherapy Alone in Metastatic Urothelial Cancer (PHASE3)
• HER2 Directed Dendritic Cell Vaccine During Neoadjuvant Therapy of HER2+Breast Cancer (EARLY_PHASE1)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• DOCETAXEL CI brief — competitive landscape report
• DOCETAXEL updates RSS · CI watch RSS

Frequently asked questions about DOCETAXEL

Related

• Drug class: All Microtubule Inhibitor [EPC] drugs

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing