What is PACLITAXEL used for?

PACLITAXEL is indicated for Advanced ovarian carcinoma, First-line ovarian carcinoma, Adjuvant breast cancer, Metastatic breast cancer, Non-small cell lung cancer.

What development phase is PACLITAXEL in?

PACLITAXEL is FDA-approved (marketed).

What are the side effects of PACLITAXEL?

Common side effects include Neutropenia <2,000/mm3, Neutropenia <500/mm3, Leukopenia <4,000/mm3, Thrombocytopenia <100,000/mm3, Thrombocytopenia <50,000/mm3, Anemia <11 g/dL.

Last reviewed 2026-04-20 · How we verify

PACLITAXEL

FDA-approved approved Small molecule Quality 37/100

Paciltaxel is a marketed chemotherapy agent primarily indicated for advanced ovarian carcinoma. Its key strength lies in its well-established efficacy and safety profile, supported by extensive clinical use. The primary risk is the expiration of the key composition patent in 2028, which could lead to increased competition from generics.

At a glance

Generic name	PACLITAXEL
Drug class	Microtubule Inhibitor [EPC]
Modality	Small molecule
Phase	FDA-approved
First approval	1992

Approved indications

Advanced ovarian carcinoma
First-line ovarian carcinoma
Adjuvant breast cancer
Metastatic breast cancer
Non-small cell lung cancer
AIDS-related Kaposi's sarcoma

Boxed warnings

WARNING Paclitaxel 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 to 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 ). 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.

Common side effects

Neutropenia <2,000/mm3
Neutropenia <500/mm3
Leukopenia <4,000/mm3
Thrombocytopenia <100,000/mm3
Thrombocytopenia <50,000/mm3
Anemia <11 g/dL
Anemia <8 g/dL
Infections
Bleeding
Red Cell Transfusions
Platelet Transfusions
Hypersensitivity Reaction

Drug interactions

cisplatin
substrates of CYP3A4 (e.g., midazolam, buspirone, felodipine, lovastatin, eletriptan, sildenafil, simvastatin, triazolam)
inhibitors of CYP3A4 (e.g., atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin)
inducers of CYP3A4 (e.g., rifampin, carbamazepine)
substrates of CYP2C8 (e.g., repaglinide, rosiglitazone)
inhibitors of CYP2C8 (e.g., gemfibrozil)
inducers of CYP2C8 (e.g., rifampin)
protease inhibitors (ritonavir, saquinavir, indinavir, nelfinavir)
doxorubicin

Key clinical trials

Primary sources

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

Source	Used for
FDA label	Mechanism, indications, dosing, boxed warnings, drug interactions
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

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

PACLITAXEL CI brief — competitive landscape report
PACLITAXEL updates RSS · CI watch RSS