Doxorubicin: uses, dosing, side effects & brands
Doxorubicin is an anthracycline topoisomerase inhibitor sold in the U.S. under 3 brand and generic names, for urinary bladder neoplasms, breast neoplasms and gastrointestinal neoplasms. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Anthracycline Topoisomerase Inhibitor
- Treats (across its forms)
- Urinary Bladder Neoplasms, Breast Neoplasms and Gastrointestinal Neoplasms
- Available as
- Injectable · Liposomal · Powder · Solution · Suspension
- Sold as
- 3 products — Doxil (Liposomal), Doxorubicin Hydrochloride and Doxorubicin Hydrochloride (Liposomal)
- Prescription?
- Prescription only
- Generic available?
- Yes
- Boxed warning
- Boxed warning
How Doxil (Liposomal) is dosed
From the FDA label for Doxil (Liposomal) (application NDA050718). Other doxorubicin products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Administer DOXIL liposomal infusion at an initial rate of 1 mg/min to minimize the risk of infusion reactions. If no infusion-related reactions occur, increase rate of infusion to complete administration over 1 hour. Do not administer as bolus injection or undiluted solution ( 2 ). • Ovarian cancer: 50 mg/m 2 intravenously every 4 weeks ( 2.2 ) • AIDS-related Kaposi’s Sarcoma: 20 mg/m 2 intravenously every 3 weeks ( 2.3 ) • Multiple Myeloma: 30 mg/m 2 intravenously on day 4 following bortezomib ( 2.4 ) 2.1 Important Use Information Do not substitute DOXIL liposomal infusion for other doxorubicin hydrochloride products. Do not administer as an undiluted suspension or as an intravenous bolus [see Warnings and Precautions (5.2) ] . 2.2 Ovarian Cancer The recommended dose of DOXIL liposomal infusion is 50 mg/m 2 intravenously over 60 minutes every 28 days until disease progression or unacceptable toxicity. 2.3 AIDS-Related Kaposi’s Sarcoma The recommended dose of DOXIL liposomal infusion is 20 mg/m 2 intravenously over 60 minutes every 21 days until disease progression or unacceptable toxicity. 2.4 Multiple Myeloma The recommended dose of DOXIL liposomal infusion is 30 mg/m 2 intravenously over 60 minutes on day 4 of each 21-day cycle for eight cycles or until disease progression or unacceptable toxicity. Administer DOXIL liposomal infusion after bortezomib on day 4 of each cycle…
Everything below is the FDA label for Doxil (Liposomal) (injectable, liposomal). Doxorubicin is also sold as powder, solution and suspension, and those are different medicines to take — follow the label for the one you were prescribed.
Doxil (Liposomal) side effects
The following adverse reactions are discussed in more detail in other sections of the labeling. • Cardiomyopathy [see Warnings and Precautions (5.1) ] • Infusion-Related Reactions [see Warnings and Precautions (5.2) ] • Hand-Foot Syndrome [see Warnings and Precautions (5.3) ] • Secondary Oral Neoplasms [see Warnings and Precautions (5.4) ] Most common adverse reactions (>20%) are asthenia, fatigue, fever, anorexia, nausea, vomiting, stomatitis, diarrhea, constipation, hand-foot syndrome, rash, neutropenia, thrombocytopenia, and anemia ( 6 ). To report SUSPECTED ADVERSE REACTIONS contact Baxter Healthcare at 1-866-888-2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates on other clinical trials and may not reflect the rates observed in clinical practice. The safety data reflect exposure to DOXIL liposomal infusion in 1310 patients including: 239 patients with ovarian cancer, 753 patients with AIDS-related Kaposi’s sarcoma, and 318 patients with multiple myeloma. The most common adverse reactions (>20%) observed with DOXIL liposomal infusion are asthenia, fatigue, fever, nausea, stomatitis, vomiting, diarrhea, constipation, anorexia, hand-foot syndrome, rash and neutropenia, thrombocytopenia and anemia.…
Who shouldn’t take Doxil (Liposomal)
DOXIL liposomal infusion is contraindicated in patients who have a history of severe hypersensitivity reactions, including anaphylaxis, to doxorubicin hydrochloride [see Warnings and Precautions (5.2) ]. • Hypersensitivity reactions to doxorubicin hydrochloride or the components of DOXIL liposomal infusion ( 4 , 5.2 )
Doxil (Liposomal) drug interactions
No formal drug interaction studies have been conducted with DOXIL liposomal infusion.
Every doxorubicin product we track (3)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Pharmacy pays | |
|---|---|---|---|---|---|---|---|
| 1 | Not yet rated | Prescription | Injectable | No data | — | View → | |
| 2 | Not yet rated | Prescription | Injectable | No data | — | View → | |
| 3 | Not yet rated | Prescription | Injectable | No data | — | View → |
How long doxorubicin keeps
The date on a sealed pack is not the only one: some doxorubicin labels start a second clock once the product is opened or mixed, as short as 1 hour.
Does doxorubicin expire? The in-use limits and storage rules from its labelsDoxorubicin and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for doxorubicin: levels in milk, effects in breastfed infants, and the drugs it would consider insteadMost sources consider breastfeeding to be contraindicated during maternal antineoplastic drug therapy, especially anthracyclines such as doxorubicin. It might be possible to breastfeed safely during intermittent therapy with an appropriate period of breastfeeding abstinence; however, the high levels and persistence of the active metabolite doxorubicinol in milk make defining an appropriate abstinence interval difficult. Some have suggested a breastfeeding abstinence period of 5 to 10 days after a dose. More recent pharmacokinetic modeling using a worst-case scenario suggests that 13 days would be required to minimize both systemic and gut toxicity after the colostral phase.
National Institute of Child Health and Human Development, record revised March 15, 2025. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about doxorubicin
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 27,702 reports naming doxorubicin, and the FDA flagged 96% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- febrile neutropenia3,387 reports
- neutropenia2,077 reports
- pyrexia1,617 reports
- nausea1,340 reports
- anaemia1,321 reports
- thrombocytopenia1,166 reports
- vomiting1,103 reports
- diarrhoea1,026 reports
Read these as a signal, not a rate. A report does not mean doxorubicin caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved August 25, 2026.
Related calculators
Frequently asked questions
What is Doxil (Liposomal)?
The active ingredient in DOXIL liposomal infusion is doxorubicin hydrochloride, an anthracycline topoisomerase inhibitor, that is encapsulated in STEALTH liposomes for intravenous use.
What kind of drug is doxorubicin?
The FDA classifies doxorubicin as an anthracycline topoisomerase inhibitor. These chemotherapy drugs slip between the strands of a cancer cell's DNA and jam an enzyme called topoisomerase II that the cell needs to copy its DNA. This leaves the DNA broken and unrepairable, so the cancer cell stops dividing and dies. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take doxorubicin with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run doxorubicin against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is doxorubicin sold under?
We track 3 doxorubicin-containing products in the U.S.: Doxil (Liposomal), Doxorubicin Hydrochloride and Doxorubicin Hydrochloride (Liposomal). They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does doxorubicin come in?
Across the brands we track, doxorubicin is currently marketed as injectable, liposomal, powder, solution and suspension, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic doxorubicin?
Yes. Our catalog lists 2 generic doxorubicin products alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.
Cite this page
- APA
- pharmaranks. (2026, July 24). Doxorubicin: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/doxorubicin
- MLA
- “Doxorubicin: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/doxorubicin.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for doxorubicin on DailyMed (NIH) ↗ — including its boxed warning in full.