Prescription medicine

Doxorubicin Brand names: Doxil

Doxorubicin (Doxil) is a prescription medicine with an FDA approval on record since 1974. FDA's NDC Directory lists it from 16 generic labelers.

Generic listed
Boxed warning

Check it at the source: the doxorubicin FDA label on DailyMed (effective May 5, 2026, Pfizer Laboratories Div Pfizer Inc); the NDA 50467 record on Drugs@FDA; every doxorubicin label on DailyMed.

Highlights of the record

FDA label of May 5, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Boxed warning

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. The risk of cardiomyopathy is further increased with concomitant cardiotoxic therapy. Assess left ventricular ejection fraction (LVEF) before and regularly during and after treatment with doxorubicin hydrochloride [see Warnings and Precautions (5.1) ].

Secondary Malignancies: Secondary acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS) occur at a higher incidence in patients treated with anthracyclines, including doxorubicin hydrochloride [see Warnings and Precautions (5.2) ].

Extravasation and Tissue Necrosis: Extravasation of doxorubicin hydrochloride can result in severe local tissue injury and necrosis requiring wide excision of the affected area and skin grafting. Immediately terminate the drug and apply ice to the affected area [see Warnings and Precautions (5.3) ]. […]

Used for

From the label: indications and usage
Doxorubicin 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 Wi

Forms and strengths

2 mg/ml

Injection (solution); injection (suspension) (liposomal); injectable (liposomal); injection (powder) (lyophilized) for solution.

On the market

Earliest approval on file: August 7, 1974 Doxorubicin Hydrochloride, Pfizer; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: 27 first March 17, 1989; 18 with a marketed status in Drugs@FDA
Labelers listed (NDC): 19 of which 16 under generic applications, 3 under brand applications, repackagers included

Supply and safety

Pharmacy cost (NADAC): Not in the survey
Shortage (FDA): No current entry
Recalls by its makers (FDA): 5 since 2012 1 Class I among all firms' recalls; latest May 12, 2026; 2 more by firms not listed as its makers
FAERS reports: 95,404 through July 30, 2026

What is doxorubicin used for?

From the label: indications and usage
Doxorubicin 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 Wilms' tumor, metastatic neuroblastoma, metastatic soft tissue sarcoma, metastatic bone sarcomas, metastatic ovarian carcinoma, metastatic transitional cell bladder carcinoma, metastatic thyroid carcinoma, metastatic gastric carcinoma, metastatic bronchogenic carcinoma ( 1.2 ) 1.1 […]

Conditions named in the indications of doxorubicin's FDA labels, with every medicine labeled for each:

FDA pharmacologic class: Anthracycline Topoisomerase Inhibitor.

Source: FDA drug label (Doxorubicin Hydrochloride), Pfizer Laboratories Div Pfizer Inc, effective May 5, 2026 (SPL set 1fd148fb-0fbc-4b6f-b790-23546fb46a71), via openFDA; the full label on DailyMed

What does the patient leaflet for doxorubicin 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 Doxorubicin?
Doxorubicin may cause serious side effects including: • Heart muscle problems. Doxorubicin can cause heart muscle damage that may lead to heart failure. Heart failure means your heart does not pump blood well. Heart failure is irreversible in some cases and can lead to death. Heart failure can happen during your treatment with Doxorubicin or months to years after stopping treatment. Your risk of heart muscle damage increases with higher total amounts of Doxorubicin that you receive in your lifetime. Your risk of heart failure is higher if you: o have other heart problems o have had or are currently receiving radiation therapy to your chest o have had treatment with certain other anti-cancer medicines o take other medicines that can have severe side effects on your heart Tell your healthcare provider if you get any of these symptoms of heart failure during or after treatment with Doxorubicin: o extreme tiredness or weakness o shortness of breath o fast heartbeat o swelling of your feet and ankles Your healthcare provider will do tests to check the strength of your heart muscle before, during, and after your treatment with Doxorubicin. • Heart rhythm problems. Doxorubicin can cause serious heart rhythm problems that may lead to death. This can happen during your infusion, within a few hours after your infusion or anytime during treatment with Doxorubicin. Tell your healthcare provider if you get any symptoms of heart rhythm problems, such as feeling as if your heart is beating fast, irregular or slow, or you feel lightheaded, dizzy, short of breath, chest discomfort or you faint. • Risk of new cancers. […]

Is there a generic for doxorubicin (Doxil)?

The FDA approved the first generic doxorubicin on March 17, 1989. 27 generic applications are approved; 18 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 doxorubicin from 16 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.

1974 earliest approval on file
1989 first generic approved
red ticks recalls

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

Has doxorubicin been recalled?

The FDA's Enforcement Report lists 7 recalls naming doxorubicin since 2012: 1 Class I (the most serious), 4 Class II, 2 Class III; 1 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of doxorubicin 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
May 12, 2026	Class I	SUN PHARMACEUTICAL INDUSTRIES INC	Presence of Particulate matter: Particulate matter identified as glass.
August 24, 2023	Class II	Baxter Healthcare Corporation	CGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions during transportation were released by mistake.
November 17, 2020	Class III	Fresenius Kabi USA, LLC	Cross Contamination with Other Products: trace amounts of octreotide found during testing
June 12, 2019	Class II	Infusion Options, Inc. not a listed maker	Lack of Assurance of Sterility
January 16, 2018	Class II	Sun Pharmaceutical Industries, Inc.	Lack Of Assurance Of Sterility
February 11, 2015	Class III	Mylan Institutional LLC	Correct Labeled Product Mispack: Ifosfamide Injection 50 mg/mL, 60 mL, correctly labeled vial may have been mis-packaged in a carton labeled Doxorubicin …
May 25, 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 because FDA …

Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026

What does the doxorubicin label say about other medicines?

The doxorubicin label names 7 other medicines in its interaction, contraindication or warning sections. The labels of 24 other medicines name doxorubicin. 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
Allopurinol	warnings and precautions	Hydration, urine alkalinization, and prophylaxis with allopurinol to prevent hyperuricemia may minimize potential complications of tumor lysis syndrome.
Cyclophosphamide	warnings and precautions	There is an additive or potentially synergistic increase in the risk of cardiomyopathy in patients who have received radiotherapy to the mediastinum or concomitant therapy with other known cardiotoxic agents, such as cyclophosphamide and trastuzumab.
Dexrazoxane	drug interactions	In a randomized trial in women with metastatic breast cancer, initiation of dexrazoxane with doxorubicin hydrochloride-based chemotherapy resulted in a significantly lower tumor response rate (48% vs. 63%; p = 0.007) and shorter time to progression compared to doxorubicin hydrochloride-based chemotherapy alone.
Paclitaxel	drug interactions	Paclitaxel Paclitaxel, when given prior to doxorubicin hydrochloride, increases the plasma-concentrations of doxorubicin and its metabolites.
Prednisone	drug interactions	In 11 patients with refractory leukemia treated with 6-mercaptopurine (500 mg/m 2 intravenously daily for 5 days per cycle every 2–3 weeks) and doxorubicin hydrochloride (50 mg/m 2 intravenous once per cycle every 2–3 weeks) alone or with vincristine and prednisone, all developed hepatic dysfunction manifested by …
Trastuzumab	drug interactions	Do not administer doxorubicin hydrochloride in combination with trastuzumab due to increased risk of cardiac dysfunction
Vincristine	drug interactions	In 11 patients with refractory leukemia treated with 6-mercaptopurine (500 mg/m 2 intravenously daily for 5 days per cycle every 2–3 weeks) and doxorubicin hydrochloride (50 mg/m 2 intravenous once per cycle every 2–3 weeks) alone or with vincristine and prednisone, all developed hepatic dysfunction manifested by …

Other labels that name doxorubicin

Check doxorubicin against other medicines

What do FAERS reports show for doxorubicin?

The FDA Adverse Event Reporting System holds 95,404 reports that list doxorubicin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 17,874 are coded as a death and 32,622 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

Febrile Neutropenia9,529
Off Label Use (a use or a product term, not a reaction)9,169
Disease Progression (a use or a product term, not a reaction)6,745
Neutropenia6,687
Drug Ineffective (a use or a product term, not a reaction)5,346
Pyrexia4,361
Anaemia4,095
Thrombocytopenia (named in the label)3,987

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What else is labeled for the same conditions as doxorubicin?

36 other medicines are given the same way (intravenous) and in the same FDA class as doxorubicin or labeled mainly for the same use (leukemia, lymphoma and myeloma), the same class first. Leukemia, lymphoma and myeloma lists all 98 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
Idarubicin	Leukemia, lymphoma and myeloma	2 labelers	n/a	No current entry
Daunorubicin	Leukemia, lymphoma and myeloma	2 labelers	n/a	No current entry
Cytarabine and daunorubicin	Leukemia, lymphoma and myeloma	none listed	n/a	No current entry
Cyclophosphamide	Leukemia, lymphoma and myeloma	15 labelers	n/a	No current entry
Bortezomib	Leukemia, lymphoma and myeloma	22 labelers	n/a	No current entry
Arsenic trioxide	Leukemia, lymphoma and myeloma	16 labelers	n/a	A presentation being discontinued
Bendamustine	Leukemia, lymphoma and myeloma	4 labelers	n/a	A presentation being discontinued
Nelarabine	Leukemia, lymphoma and myeloma	12 labelers	n/a	No current entry

Every medicine labeled for the same conditions as doxorubicin

Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)

How does doxorubicin compare with medicines for the same use?

2 side-by-side pages set doxorubicin beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.

What next?

Alternatives to doxorubicin: 36 medicines for the same use
Other anthracycline topoisomerase inhibitors: the pharmacologic class, with prices and generics
Doxorubicin side effects: the label's list beside FAERS reports
Check an interaction: what two or more labels say about each other