Prescription medicine
Paclitaxel Brand names: Abraxane; first approved as Taxol
Paclitaxel (Taxol) is a prescription medicine with an FDA approval on record since 1992. FDA's NDC Directory lists it from 19 generic labelers.
- Generic listed
- Boxed warning
Check it at the source: the paclitaxel FDA label on DailyMed (effective January 21, 2026, Natco Pharma USA LLC); the NDA 20262 record on Drugs@FDA; every paclitaxel label on DailyMed.
Highlights of the record
FDA label of January 21, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Paclitaxel Injection, USP should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available. Anaphylaxis and severe hypersensitivity reactions characterized by dyspnea and hypotension requiring treatment, angioedema, and generalized urticaria have occurred in 2%-4% of patients receiving paclitaxel in clinical trials. Fatal reactions have occurred in patients despite premedication. All patients should be pretreated with corticosteroids, diphenhydramine, and H 2 antagonists. ( See DOSAGE AND ADMINISTRATION section. ) Patients who experience severe hypersensitivity reactions to paclitaxel should not be rechallenged with the drug. Paclitaxel therapy should not be given to patients with solid tumors who have baseline neutrophil counts of less than 1,500 cells/mm 3 and should not be given to patients with AIDS-related Kaposi’s sarcoma if the baseline neutrophil count is less than 1,000 cells/mm 3 . In order to monitor the occurrence of bone marrow suppression, primarily neutropenia, which may be severe and result in infection, it is recommended that frequent peripheral blood cell counts be performed on all patients receiving paclitaxel.
Used for
From the label: indications and usagePaclitaxel Injection, USP is indicated as subsequent therapy for the treatment of advanced carcinoma of the ovary.
Forms and strengths
- 100 mg
- 6 mg/ml
- 100 mg/20ml
Injection (solution); injection (powder) (lyophilized) for suspension; injection; injection (solution) (concentrate).
On the market
- Earliest approval on file
- December 29, 1992 Taxol, Hq Spclt Pharma; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 20 first January 25, 2002; 13 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 22 of which 19 under generic applications, 3 under brand applications, repackagers included
- Last listed patent
- July 12, 2034 Abraxane injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2012 0 Class I among all firms' recalls; latest November 8, 2013; 2 more by firms not listed as its makers
- FAERS reports
- 98,464 through July 30, 2026
What is paclitaxel used for?
From the label: indications and usagePaclitaxel 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. […]
Conditions named in the indications of paclitaxel's FDA labels, with every medicine labeled for each:
From other paclitaxel labelsLung cancer: Paclitaxel, in combination with cisplatin, is indicated for the first-line treatment of nonsmall cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy.
FDA pharmacologic class: Microtubule Inhibitor.
Source: FDA drug label (Paclitaxel), 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 patient leaflet for paclitaxel 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 paclitaxel?Paclitaxel can cause serious side effects including death. Serious allergic reactions (anaphylaxis) can happen in people who receive paclitaxel. Anaphylaxis is a serious medical emergency that can lead to death and must be treated right away. Tel l your healthcare provider right away if you have any of these signs of an allergic reaction: • trouble breathing • sudden swelling of your face, lips, tongue, throat, or trouble swallowing • hives (raised bumps) or rash Your healthcare provider will give you medicines to lessen your chance of having an allergic reaction.
Source: FDA drug label (Paclitaxel), Natco Pharma USA LLC, effective January 21, 2026 (SPL set a1eb16b4-285b-4e81-9c4e-1244d4a52af8), via openFDA; the full label on DailyMed
Is there a generic for paclitaxel (Taxol)?
The FDA approved the first generic paclitaxel on January 25, 2002. 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 paclitaxel from 19 labelers under a generic (ANDA) application and from 3 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 Taxol injection; a patent listed only for Abraxane injection runs to July 12, 2034. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1992 earliest approval on file
- 2002 first generic approved
- 2034 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has paclitaxel been recalled?
The FDA's Enforcement Report lists 4 recalls naming paclitaxel since 2012: 0 Class I (the most serious), 3 Class II, 1 Class III; 0 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of paclitaxel and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| June 12, 2019 | Class II | Infusion Options, Inc. not a listed maker | Lack of Assurance of Sterility |
| November 8, 2013 | Class III | Fresenius Kabi USA, LLC | Labeling: Incorrect or Missing Package Insert- Missing text on the product insert in the "Clinical Studies" and "Specific Adverse Events" sections. |
| June 27, 2012 | Class II | Hospira Inc. | The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are being recalled due to visible … |
| May 21, 2012 | Class II | Franck's Lab Inc., d.b.a. Franck's Compounding Lab not a listed maker | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the paclitaxel label say about other medicines?
The paclitaxel label names 25 other medicines in its interaction, contraindication or warning sections. The labels of 31 other medicines name paclitaxel. 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 |
|---|---|---|
| Atazanavir | drug interactions | Caution should be exercised when paclitaxel is concomitantly administered with known substrates (eg, midazolam, buspirone, felodipine, lovastatin, eletriptan, sildenafil, simvastatin, and triazolam), inhibitors (eg, atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir … |
| Buspirone | drug interactions | Caution should be exercised when paclitaxel is concomitantly administered with known substrates (eg, midazolam, buspirone, felodipine, lovastatin, eletriptan, sildenafil, simvastatin, and triazolam), inhibitors (eg, atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir … |
| Carbamazepine | drug interactions | … ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin), and inducers (eg, rifampin and carbamazepine) of CYP3A4. ( See CLINICAL PHARMACOLOGY section. ) Caution should also be exercised when paclitaxel is concomitantly administered with known substrates (eg, repaglinide and rosiglitazone) … |
| Carboplatin | warnings and precautions | In patients with NSCLC, resume treatment if recommended at permanently reduced doses for both weekly protein-bound paclitaxel for Injectable Suspension (albumin-bound) and every-3-week carboplatin after ANC recovers to at least 1,500 cells/mm 3 and platelet count of at least 100,000 cells/mm 3 on Day 1 or to an ANC of … |
| Castor oil | contraindications | CONTRAINDICATIONS Paclitaxel Injection, USP is contraindicated in patients who have a history of hypersensitivity reactions to paclitaxel or other drugs formulated in Polyoxyl 35 Castor Oil, NF. |
| Cisplatin | drug interactions | Pharmacokinetic data from these patients demonstrated a decrease in paclitaxel clearance of approximately 33% when paclitaxel was administered following cisplatin. |
| Clarithromycin | drug interactions | Caution should be exercised when paclitaxel is concomitantly administered with known substrates (eg, midazolam, buspirone, felodipine, lovastatin, eletriptan, sildenafil, simvastatin, and triazolam), inhibitors (eg, atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir … |
| Diphenhydramine | boxed warning | All patients should be pretreated with corticosteroids, diphenhydramine, and H 2 antagonists. ( See DOSAGE AND ADMINISTRATION section. ) Patients who experience severe hypersensitivity reactions to paclitaxel should not be rechallenged with the drug. |
| Doxorubicin | drug interactions | Reports in the literature suggest that plasma levels of doxorubicin (and its active metabolite doxorubicinol) may be increased when paclitaxel and doxorubicin are used in combination. |
| Eletriptan | drug interactions | Caution should be exercised when paclitaxel is concomitantly administered with known substrates (eg, midazolam, buspirone, felodipine, lovastatin, eletriptan, sildenafil, simvastatin, and triazolam), inhibitors (eg, atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir … |
| Felodipine | drug interactions | Caution should be exercised when paclitaxel is concomitantly administered with known substrates (eg, midazolam, buspirone, felodipine, lovastatin, eletriptan, sildenafil, simvastatin, and triazolam), inhibitors (eg, atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir … |
| Gemcitabine | warnings and precautions | … reduced dose levels. ( 5.3 ) Pneumonitis occurred with the use of protein bound paclitaxel in combination with gemcitabine; permanently discontinue treatment with Paclitaxel Protein-Bound Particles for Injectable Suspension (albumin-bound) and gemcitabine. … |
| Gemfibrozil | drug interactions | … paclitaxel is concomitantly administered with known substrates (eg, repaglinide and rosiglitazone), inhibitors (eg, gemfibrozil), and inducers (eg, rifampin) of CYP2C8. ( See CLINICAL PHARMACOLOGY. … |
| Itraconazole | drug interactions | Caution should be exercised when paclitaxel is concomitantly administered with known substrates (eg, midazolam, buspirone, felodipine, lovastatin, eletriptan, sildenafil, simvastatin, and triazolam), inhibitors (eg, atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir … |
Every other medicine the paclitaxel label names
| Medicine named | Section | What the label says |
|---|---|---|
| Ketoconazole | drug interactions | … inhibitors (eg, atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin), and inducers (eg, rifampin and carbamazepine) of … |
| Lovastatin | drug interactions | Caution should be exercised when paclitaxel is concomitantly administered with known substrates (eg, midazolam, buspirone, felodipine, lovastatin, eletriptan, sildenafil, simvastatin, and triazolam) … |
| Midazolam | drug interactions | Caution should be exercised when paclitaxel is concomitantly administered with known substrates (eg, midazolam, buspirone, felodipine, lovastatin, eletriptan, sildenafil, simvastatin, and triazolam) … |
| Nefazodone | drug interactions | … atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin), and inducers (eg, rifampin and carbamazepine) of CYP3A4. … |
| Nelfinavir | drug interactions | … clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin), and inducers (eg, rifampin and carbamazepine) of CYP3A4. … |
| Repaglinide | drug interactions | … paclitaxel is concomitantly administered with known substrates (eg, repaglinide and rosiglitazone), inhibitors (eg, gemfibrozil), and inducers (eg, rifampin) of CYP2C8. ( See CLINICAL PHARMACOLOGY. … |
| Rifampin | drug interactions | … nelfinavir, ritonavir, saquinavir, and telithromycin), and inducers (eg, rifampin and carbamazepine) of CYP3A4. ( See CLINICAL PHARMACOLOGY section. … |
| Ritonavir | drug interactions | … clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin), and inducers (eg, rifampin and carbamazepine) of CYP3A4. … |
| Sildenafil | drug interactions | … substrates (eg, midazolam, buspirone, felodipine, lovastatin, eletriptan, sildenafil, simvastatin, and triazolam), inhibitors (eg, atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole … |
| Simvastatin | drug interactions | … midazolam, buspirone, felodipine, lovastatin, eletriptan, sildenafil, simvastatin, and triazolam), inhibitors (eg, atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone … |
| Triazolam | drug interactions | … buspirone, felodipine, lovastatin, eletriptan, sildenafil, simvastatin, and triazolam), inhibitors (eg, atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir … |
Other labels that name paclitaxel
Source: FDA drug label (Paclitaxel), 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 for paclitaxel?
The FDA Adverse Event Reporting System holds 98,464 reports that list paclitaxel among the medicines taken, through July 30, 2026, 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.
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 paclitaxel?
14 other medicines are given the same way (intravenous) and in the same FDA class as paclitaxel 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 |
|---|---|---|---|---|
| Docetaxel | Breast cancer, Lung cancer | 14 labelers | n/a | A presentation being discontinued |
| 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 |
Every medicine labeled for the same conditions as paclitaxel
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does paclitaxel compare with medicines for the same use?
4 side-by-side pages set paclitaxel beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to paclitaxel
- 14 medicines for the same use
- Other microtubule inhibitors
- the pharmacologic class, with prices and generics
- Paclitaxel side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other