Two medicines, side by side

Gemcitabine vs paclitaxel

Gemcitabine and paclitaxel are both labeled for breast cancer and lung cancer. Drugs@FDA records approvals of gemcitabine since 1996 and of paclitaxel since 1992. In FDA's classes, gemcitabine is a nucleoside metabolic inhibitor and paclitaxel a microtubule inhibitor.

Check it at the source: the gemcitabine FDA label on DailyMed (effective October 14, 2024); the paclitaxel FDA label on DailyMed (effective January 21, 2026).

Highlights of the gemcitabine record

Gemcitabine (Gemzar) · label of October 14, 2024

Used for

From the label: indications
Gemcitabine for Injection is a nucleoside metabolic inhibitor indicated: in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. […]

On the market

Earliest approval on file: May 15, 1996
Generic labelers: 10 labelers
Pharmacy cost: Not in the survey

Supply and safety

Shortage: No current entry
Recalls: 5

Highlights of the paclitaxel record

Paclitaxel (Taxol) · label of January 21, 2026

Boxed warning

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.

Used for

From the label: indications
Paclitaxel 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. […]

On the market

Earliest approval on file: December 29, 1992
Generic labelers: 19 labelers
Pharmacy cost: Not in the survey

Supply and safety

Shortage: No current entry
Recalls: 2

Source: FDA drug labels via openFDA (Gemcitabine label of October 14, 2024, Paclitaxel label of January 21, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)

How do gemcitabine and paclitaxel differ on the record?

In FDA's classes, gemcitabine is a nucleoside metabolic inhibitor and paclitaxel a microtubule inhibitor.

Only the paclitaxel label carries a boxed warning.

Generics: gemcitabine since 2010; paclitaxel since 2002 (Drugs@FDA).

	Gemcitabine	Paclitaxel
Labeled for	Breast cancer, Lung cancer	Breast cancer, Lung cancer
Pharmacologic class	Nucleoside Metabolic Inhibitor	Microtubule Inhibitor
How it works (label)	Gemcitabine kills cells undergoing DNA synthesis and blocks the progression of cells through the G1/S-phase boundary. Gemcitabine is metabolized by nucleoside kinases to diphosphate (dFdCDP) and triphosphate (dFdCTP) nucleosides.	n/a
Half-life (label)	The half-life of the terminal phase for gemcitabine triphosphate from mononuclear cells ranges from 1.7 to 19.4 hours.	n/a
Earliest approval on file (Drugs@FDA)	May 15, 1996	December 29, 1992
First generic approved	November 15, 2010	January 25, 2002
Generic labelers (NDC)	10 labelers	19 labelers
Pharmacy cost (NADAC, each one's most listed form; strengths differ)	n/a	n/a
12-month price change	n/a	n/a
Boxed warning	No	Yes
Shortage now	No current entry	No current entry
Recalls recorded	5	2
FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used)	53,011	98,464
DEA schedule	none	none

Source: Drugs@FDA, FDA NDC Directory, CMS NADAC of October 7, 2026, FDA shortages and recalls, FAERS via openFDA (FDA files October 8, 2026)

Do their labels mention each other?

Paclitaxel label, warnings and precautions
… 3 , then resume treatment at 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. ( 5.4 ) Severe hypersensitivity reactions with fatal outcome have been reported.

Paclitaxel label, warnings and precautions
WARNINGS AND PRECAUTIONS Sensory neuropathy occurs frequently and may require dose reduction or treatment interruption. ( 5.2 ) Sepsis occurred in patients with or without neutropenia who received protein bound paclitaxel in combination with gemcitabine; …

What both labels say about taking them together

Source: FDA drug labels via openFDA

What next?

Gemcitabine: the full record
Paclitaxel: the full record
Alternatives to gemcitabine: every medicine labeled for the same conditions