Two medicines, side by side
Doxorubicin vs paclitaxel
Doxorubicin and paclitaxel are both labeled for breast cancer. Drugs@FDA records approvals of doxorubicin since 1974 and of paclitaxel since 1992. In FDA's classes, doxorubicin is an anthracycline topoisomerase inhibitor and paclitaxel a microtubule inhibitor.
Check it at the source: the doxorubicin FDA label on DailyMed (effective May 5, 2026); the paclitaxel FDA label on DailyMed (effective January 21, 2026).
Highlights of the doxorubicin record
Doxorubicin (Doxil) · label of May 5, 2026
CARDIOMYOPATHY, SECONDARY MALIGNANCIES, EXTRAVASATION AND TISSUE NECROSIS, and SEVERE MYELOSUPPRESSION
Cardiomyopathy: Myocardial damage, including acute left ventricular failure, can occur with doxorubicin hydrochloride. The risk of cardiomyopathy is proportional to the cumulative exposure with incidence rates from 1%–20% for cumulative doses ranging from 300 mg/m 2 to 500 mg/m 2 when doxorubicin hydrochloride is administered every 3 weeks.
Used for
From the label: indicationsDoxorubicin Hydrochloride Injection is an anthracycline topoisomerase inhibitor indicated: • as a component of multi‑agent adjuvant chemotherapy for treatment of women with axillary lymph node involvement following resection of primary breast cancer ( 1.1 ) • for the treatment of: acute lymphoblastic leukemia, acute myeloblastic leukemia, Hodgkin lymphoma, Non-Hodgkin lymphoma, metastatic breast cancer, metastatic […]
On the market
- Earliest approval on file
- August 7, 1974
- Generic labelers
- 16 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
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: indicationsPaclitaxel 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 (Doxorubicin label of May 5, 2026, Paclitaxel label of January 21, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do doxorubicin and paclitaxel differ on the record?
In FDA's classes, doxorubicin is an anthracycline topoisomerase inhibitor and paclitaxel a microtubule inhibitor.
Both labels carry a boxed warning; the records quote them.
Generics: doxorubicin since 1989; paclitaxel since 2002 (Drugs@FDA).
| Doxorubicin | Paclitaxel | |
|---|---|---|
| Labeled for | Leukemia, lymphoma and myeloma, Breast cancer | Breast cancer, Lung cancer |
| Pharmacologic class | Anthracycline Topoisomerase Inhibitor | Microtubule Inhibitor |
| How it works (label) | The cytotoxic effect of doxorubicin hydrochloride on malignant cells and its toxic effects on various organs are thought to be related to nucleotide base intercalation and cell membrane lipid binding activities of doxorubicin. | n/a |
| Half-life (label) | Distribution The distribution half-life is approximately 5 minutes. | n/a |
| Earliest approval on file (Drugs@FDA) | August 7, 1974 | December 29, 1992 |
| First generic approved | March 17, 1989 | January 25, 2002 |
| Generic labelers (NDC) | 16 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 | Yes | 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) | 95,404 | 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?
Doxorubicin label, drug interactionsPaclitaxel Paclitaxel, when given prior to doxorubicin hydrochloride, increases the plasma-concentrations of doxorubicin and its metabolites.
Paclitaxel label, drug interactionsReports 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.
Source: FDA drug labels via openFDA
What next?
- Alternatives to doxorubicin
- every medicine labeled for the same conditions