Prescription medicine
Docetaxel Brand names: Beizray, Docivyx; first approved as Taxotere
Docetaxel (Taxotere) is a prescription medicine with an FDA approval on record since 1996. FDA's NDC Directory lists it from 14 generic labelers.
- 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 NDA 20449 record on Drugs@FDA; every docetaxel label on DailyMed.
Highlights of the record
FDA label of July 15, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
TOXIC DEATHS, HEPATOTOXICITY, NEUTROPENIA, HYPERSENSITIVITY REACTIONS,.
and FLUID RETENTION Treatment-related mortality associated with DOCIVYX 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 DOCIVYX as a single agent at a dose of 100 mg/m 2 [see Warnings and Precautions (5.1) ]. Avoid the use of DOCIVYX 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 DOCIVYX [see Warnings and Precautions (5.2) ]. Do not administer DOCIVYX 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) ]. […]
Used for
From the label: indications and usageDOCIVYX is a microtubule inhibitor indicated for: Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure;
Forms and strengths
- 10 mg/ml
- 20 mg/ml
- 20 mg/2ml
- 80 mg/4ml
- 80 mg/8ml
- 160 mg/8ml
- 160 mg/16ml
Injection (solution); injection; injection (solution) (concentrate); kit.
On the market
- Earliest approval on file
- May 14, 1996 Taxotere, Sanofi Aventis Us; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 20 first November 5, 2014; 13 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 23 of which 14 under generic applications, 9 under brand applications, repackagers included
- Last listed patent
- May 16, 2036 Beizray injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- None current 2 past records
- Recalls by its makers (FDA)
- 7 since 2017 2 Class I among all firms' recalls; latest May 28, 2024
- FAERS reports
- 67,030 through July 30, 2026
What is docetaxel used for?
From the label: indications and usageDOCIVYX is a microtubule inhibitor indicated for: Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC ( 1.1 ) Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC ( 1.2 ) Castration- Resistant Prostate Cancer (CRPC): with prednisone in metastatic CRPC ( 1.3 ) Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction ( 1.4 ) Squamous […]
Conditions named in the indications of docetaxel's FDA labels, with every medicine labeled for each:
From other docetaxel labelsBreast cancer: Breast Cancer DOCIVYX is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy.
Lung cancer: Non-small Cell Lung Cancer DOCIVYX as a single agent is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior platinum-based chemotherapy.
Prostate cancer: Injection in combination with prednisone is indicated for the treatment of patients with metastatic castration-resistant prostate cancer.
FDA pharmacologic class: Microtubule Inhibitor.
Source: FDA drug label (DOCIVYX), Avyxa Pharma, LLC, effective July 15, 2025 (SPL set 4763744e-360e-4d37-be05-cce4114548cd), via openFDA; the full label on DailyMed
What does the patient leaflet for docetaxel say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about DOCIVYX ?DOCIVYX may cause serious side effects, including death. ● The chance of death in people who receive DOCIVYX is higher if you: o have liver problems o receive high doses of DOCIVYX o have non-small cell lung cancer and have been treated with chemotherapy medicines that contain platinum ● DOCIVYX can affect your blood cells. Your healthcare provider should do routine blood tests during treatment with DOCIVYX. This will include regular checks of your white blood cell counts. If your white blood cells are too low, your healthcare provider may not treat you with DOCIVYX until you have enough white blood cells. People with low white blood cell counts can develop life-threatening infections. The earliest sign of infection may be fever. Follow your healthcare provider's instructions for how often to take your temperature during treatment with DOCIVYX. Call your healthcare provider right away if you have a fever. ● Swelling (inflammation) of the small intestine and colon. This can happen at any time during treatment and could lead to death as early as the first day you get symptoms. Tell your healthcare provider right away if you develop new or worse symptoms of intestinal problems, including stomach (abdominal) pain or tenderness or diarrhea, with or without fever. ● Severe allergic reactions are medical emergencies that can happen in people who receive DOCIVYX and can lead to death. You may be at higher risk of developing a severe allergic reaction to DOCIVYX if you are allergic to paclitaxel. Your healthcare provider will monitor you closely for allergic reactions during your DOCIVYX infusion. […]
Source: FDA drug label (DOCIVYX), Avyxa Pharma, LLC, effective July 15, 2025 (SPL set 4763744e-360e-4d37-be05-cce4114548cd), via openFDA; the full label on DailyMed
Is there a generic for docetaxel (Taxotere)?
The FDA approved the first generic docetaxel on November 5, 2014. 20 generic applications are approved; 13 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists docetaxel from 14 labelers under a generic (ANDA) application and from 9 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Taxotere injection; a patent listed only for Beizray injection runs to May 16, 2036. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1996 earliest approval on file
- 2014 first generic approved
- 2036 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Is docetaxel in shortage?
No docetaxel presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 2 records are all marked to be discontinued, the latest updated February 20, 2026. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Docetaxel, Injection, 10 mg/1 mL (NDC 50742-431-08) | Ingenus Pharmaceuticals LLC | To Be Discontinued | February 20, 2026 |
| Docetaxel, Injection, 10 mg/1 mL (NDC 50742-463-16) | Ingenus Pharmaceuticals LLC | To Be Discontinued | February 20, 2026 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has docetaxel been recalled?
The FDA's Enforcement Report lists 7 recalls naming docetaxel since 2017: 2 Class I (the most serious), 5 Class II, 0 Class III; 2 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| May 28, 2024 | Class I | Sagent Pharmaceuticals | Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product. |
| December 8, 2020 | Class II | Shilpa Medicare Limited | CGMP Deviations |
| June 12, 2019 | Class II | Infusion Options, Inc. | Lack of Assurance of Sterility |
| March 6, 2019 | Class II | Dr. Reddy's Laboratories, Inc. | Defective Container: complaint for seal and cap vial issues that could lead to a lack of sterility assurance. |
| April 27, 2018 | Class II | Sanofi-Aventis U.S. LLC | Superpotent drug: over-concentrated vials of Docetaxel injection concentrate 20 mg/mL may have been distributed. |
| January 9, 2017 | Class II | Dr. Reddy's Laboratories, Inc. | Defective Container: Product complaints received of defect in the seal of the Docetaxel injection vials that the aluminum seal and/or stopper is removed when … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the docetaxel label say about other medicines?
The docetaxel label names 8 other medicines in its interaction, contraindication or warning sections. The labels of 11 other medicines name docetaxel. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Cisplatin | warnings and precautions | In gastric cancer patients treated with docetaxel in combination with cisplatin and fluorouracil (TCF), febrile neutropenia and/or neutropenic infection occurred in 12% of patients receiving G-CSF compared to 28% who did not. |
| Cyclophosphamide | warnings and precautions | Treatment-related AML or MDS has occurred in patients given anthracyclines and/or cyclophosphamide, including use in adjuvant therapy for breast cancer. |
| Dexamethasone | boxed warning | 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. |
| Doxorubicin | warnings and precautions | In the adjuvant breast cancer trial (TAX316) AML occurred in 3 of 744 patients who received DOCIVYX, doxorubicin and cyclophosphamide (TAC) and in 1 of 736 patients who received fluorouracil, doxorubicin, and cyclophosphamide [see Clinical Studies (14.2) ]. |
| Fluorouracil | warnings and precautions | In gastric cancer patients treated with docetaxel in combination with cisplatin and fluorouracil (TCF), febrile neutropenia and/or neutropenic infection occurred in 12% of patients receiving G-CSF compared to 28% who did not. |
| Ketoconazole | drug interactions | In vivo studies showed that the exposure of docetaxel increased 2.2-fold when it was coadministered with ketoconazole, a potent inhibitor of CYP3A4. |
| Paclitaxel | warnings and precautions | Patients who have previously experienced a hypersensitivity reaction to paclitaxel may develop a hypersensitivity reaction to docetaxel that may include severe or fatal reactions such as anaphylaxis. |
| Ritonavir | drug interactions | Protease inhibitors, particularly ritonavir, may increase the exposure of docetaxel. |
Other labels that name docetaxel
Source: FDA drug label (DOCIVYX), 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 for docetaxel?
The FDA Adverse Event Reporting System holds 67,030 reports that list docetaxel among the medicines taken, through July 30, 2026, 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.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as docetaxel?
14 other medicines are given the same way (intravenous) and in the same FDA class as docetaxel or labeled mainly for the same use (breast cancer), the same class first. Breast cancer lists all 44 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Paclitaxel | Breast cancer, Lung cancer | 20 labelers | n/a | No current entry |
| Eribulin | Breast cancer | 14 labelers | n/a | No current entry |
| Gemcitabine | Breast cancer, Lung cancer | 10 labelers | n/a | No current entry |
| Trastuzumab | Breast cancer | none listed | n/a | No current entry |
| Margetuximab | Breast cancer | none listed | n/a | No current entry |
| Trastuzumab emtansine | Breast cancer | none listed | n/a | No current entry |
| Trastuzumab-strf | Breast cancer | none listed | n/a | No current entry |
| Datopotamab deruxtecan | Breast cancer, Lung cancer | none listed | n/a | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does docetaxel compare with medicines for the same use?
1 side-by-side page set docetaxel beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to docetaxel
- 14 medicines for the same use
- Other microtubule inhibitors
- the pharmacologic class, with prices and generics
- Docetaxel side effects
- the label's list beside FAERS reports
- Docetaxel shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other