Doxorubicin (Adriamycin -- conventional; Doxil / Caelyx -- pegylated liposomal)
Pronunciation: dox-oh-ROO-bi-sin.
- Generic name
- doxorubicin hydrochloride
- Drug class
- Anthracycline antibiotic antineoplastic (topoisomerase II inhibitor)
- Form
- Injection: solution or lyophilized powder for reconstitution (conventional); pegylated liposomal injection (Doxil/Caelyx) -- a pharmacokinetically distinct formulation not interchangeable with the conventional one
- Route
- Intravenous infusion only (conventional formulation also has an intravesical/bladder-instillation route for superficial bladder tumours in some markets); must never be given intramuscularly or subcutaneously
- Legal status
- Prescription-only, hospital/specialist oncology-administered intravenous chemotherapy (not self-administered)
Availability and supply rules vary by country
Trade names by country: United States · United Kingdom · Canada · Australia · New Zealand
Australia: Doxorubicin Injection (conventional) (8), CAELYX (pegylated liposomal) (8) · Full directory
Boxed warning: Two different boxed warnings depending on formulation: conventional doxorubicin (cardiomyopathy, secondary malignancies, extravasation/tissue necrosis, severe myelosuppression) vs. liposomal doxorubicin/Doxil-Caelyx (cardiomyopathy, infusion-related reactions)
CONVENTIONAL doxorubicin (Adriamycin and generic doxorubicin hydrochloride injection) carries a real, current, 4-part US FDA boxed warning. First, cardiomyopathy: myocardial damage can occur, with incidence of 1% to 20% at cumulative doses of 300 to 500 mg/m2 when given every 3 weeks, increased further by concomitant cardiotoxic therapy; left ventricular ejection fraction (LVEF) is assessed before, during, and after treatment. Second, secondary malignancies: secondary acute myeloid leukaemia and myelodysplastic syndrome occur at a higher incidence in patients treated with anthracyclines, including doxorubicin. Third, extravasation and tissue necrosis: leakage of doxorubicin outside the vein can cause severe local tissue injury and necrosis requiring wide excision and skin grafting; the infusion is stopped immediately and ice applied to the area. Fourth, severe myelosuppression: can result in serious infection, septic shock, need for blood transfusions, hospitalisation, and death. LIPOSOMAL doxorubicin (Doxil in the US; Caelyx in the UK, EU, Canada, Australia, and New Zealand) is a pharmacokinetically distinct formulation with a DIFFERENT, 2-part boxed warning. First, cardiomyopathy: myocardial damage including acute left ventricular failure can occur, with an 11% risk at a cumulative anthracycline dose of 450 to 550 mg/m2 -- a materially different risk profile from the conventional product, and New Zealand's Medsafe data sheet for Caelyx specifically reports no increased cardiac-toxicity risk at cumulative anthracycline doses of 450 to 600 mg/m2 with the liposomal formulation. Second, infusion-related reactions: serious, life-threatening, and fatal reactions can occur during the infusion (occurring in 11% of solid-tumour patients in trials); the infusion is paused or slowed for reactions and stopped altogether for serious or life-threatening reactions. Regulators in the UK, Canada, and New Zealand explicitly state that the two formulations must never be used interchangeably because of these real pharmacokinetic and dosing differences. All decisions about cumulative dose, treatment continuation, or how to respond to extravasation or an infusion reaction are made by the treating oncology team, never by the patient. (1) (2) (10)
What doxorubicin hydrochloride is and how it works
Doxorubicin is an anthracycline chemotherapy medicine given by intravenous infusion in a hospital or specialist oncology setting. It exists in two genuinely different, non-interchangeable forms: conventional doxorubicin (Adriamycin), used across a wide range of cancers, and pegylated liposomal doxorubicin (Doxil/Caelyx), a distinct formulation used for a narrower set of cancers with a different safety profile. (1) (2)
Doxorubicin carries a genuine, current boxed warning -- the FDA's strongest safety warning -- and the exact warning depends on which formulation is used. Conventional doxorubicin's warning covers heart muscle damage that depends on the total lifetime dose received, a higher risk of a second blood cancer later in life, severe tissue damage if the medicine leaks outside the vein during infusion, and severe suppression of bone marrow function. Liposomal doxorubicin (Doxil/Caelyx) carries a different warning covering heart muscle damage (at a different cumulative dose range) and serious, sometimes life-threatening infusion reactions, plus a common skin reaction on the hands and feet. This is administered and monitored entirely by your oncology team -- there is no self-administered or self-directed dosing.
Mechanism of action: how doxorubicin hydrochloride works
Doxorubicin is an anthracycline that intercalates into DNA and inhibits topoisomerase II, blocking DNA replication and transcription in rapidly dividing cells, which underlies both its antitumour effect and its class-wide risks (myelosuppression, secondary malignancy, cardiotoxicity). Pegylation of the liposomal formulation prolongs circulation time and alters its distribution and cardiac-risk profile compared with the conventional formulation. (1) (2)
What doxorubicin hydrochloride is used for
Conventional doxorubicin -- broad oncology use
Used as a component of multi-agent adjuvant chemotherapy for breast cancer with axillary lymph node involvement, and for the treatment of acute lymphoblastic leukaemia, acute myeloblastic leukaemia, Hodgkin and non-Hodgkin lymphoma, metastatic breast cancer, Wilms' tumour, neuroblastoma, soft-tissue and bone sarcomas, ovarian carcinoma, transitional cell bladder carcinoma, thyroid carcinoma, gastric carcinoma, and bronchogenic carcinoma. Health Canada also describes its use, alone or in combination, for gynaecologic and testicular carcinomas and squamous cell carcinoma of the head and neck, and by direct instillation into the bladder for superficial bladder tumours. (1) (6)
Liposomal doxorubicin (Doxil/Caelyx) -- a narrower, different set of uses
Used for ovarian cancer after platinum-based chemotherapy has failed; AIDS-related Kaposi's sarcoma after failure of, or intolerance to, prior systemic chemotherapy; and multiple myeloma in combination with bortezomib in patients who have already received at least one prior therapy. Outside the United States (UK/EU/Canada/Australia/New Zealand, as Caelyx), it is also used for metastatic breast cancer specifically in patients considered to be at increased cardiac risk. This is a genuinely narrower indication list than conventional doxorubicin -- the two are not interchangeable. (2) (4)
Before taking doxorubicin hydrochloride
Do not take / not appropriate for
- Conventional doxorubicin must not be given if you have severe myocardial insufficiency, a recent heart attack, severe persistent bone marrow suppression from prior treatment, severe liver impairment, or a known hypersensitivity to doxorubicin. Health Canada also lists severe arrhythmias, a history of severe heart disease, and having already received the maximum lifetime cumulative dose of doxorubicin or a related anthracycline. (all countries, conventional formulation) (1) (6)
- Liposomal doxorubicin (Doxil/Caelyx) must not be given if you have a known hypersensitivity to doxorubicin or any component of the formulation. (all countries, liposomal formulation) (2)
- Conventional doxorubicin must not be combined with trastuzumab, because of an increased risk of cardiac dysfunction. (United States) (1)
- Conventional and liposomal doxorubicin must never be substituted for one another -- they have different pharmacokinetics and dosing schedules. (all countries) (4) (10)
Tell your clinician about
- Any history of heart disease, heart attack, or abnormal heart rhythm, since cardiomyopathy risk is central to both formulations' boxed warnings.
- Any previous chemotherapy with doxorubicin, daunorubicin, epirubicin, or other anthracyclines, since cumulative lifetime dose across all such medicines matters for cardiac risk.
- Any liver problems, since dose is adjusted for hepatic impairment.
- Whether you are pregnant, planning pregnancy, or breastfeeding, since doxorubicin can cause fetal harm.
- Any previous radiotherapy, since doxorubicin can increase radiation-related toxicity and can cause 'radiation recall' reactions at previously irradiated sites (conventional formulation).
How to take doxorubicin hydrochloride
- Doxorubicin, in both forms, is given only by intravenous infusion by an oncology team experienced in cytotoxic chemotherapy -- it is never self-administered.
- Conventional doxorubicin must never be given by intramuscular or subcutaneous injection, because of the severe tissue damage that would result.
- Liposomal doxorubicin (Doxil/Caelyx) is given as a slow infusion, starting at a slow rate to reduce the risk of an infusion reaction, and must never be given as a rapid bolus injection or undiluted.
- Report any stinging, burning, pain, or swelling at the infusion site immediately -- this is the one patient-directed action, since it may indicate the medicine is leaking outside the vein (extravasation), a genuine boxed-warning risk for the conventional formulation.
- Your total cumulative lifetime dose is tracked by your oncology team across all anthracycline medicines you have received, because cardiac risk rises with the cumulative total.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
Missed dose
Doxorubicin is given on a schedule set and tracked by your oncology team as part of a chemotherapy plan; contact your treatment team directly about any scheduling questions rather than adjusting anything yourself.
Overdose
Doxorubicin overdose is a medical emergency managed entirely by the treating oncology/hospital team -- exceeding recommended cumulative doses increases the risk of cardiotoxicity and severe myelosuppression. This is not a situation a patient manages at home. (9)
Side effects
Side effects and their urgency vary; report severe, persistent, or concerning symptoms.
Alopecia (hair loss), usually reversible, common with both formulations.
What to notice: Alopecia (hair loss), usually reversible, common with both formulations.
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1) (10)
Nausea and vomiting (conventional formulation).
What to notice: Nausea and vomiting (conventional formulation).
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)
Hand-foot syndrome (palmar-plantar erythrodysesthesia) -- painful redness, swelling, or peeling of the palms and soles -- a very common reaction specific to the liposomal formulation (reported in over 40% of patients in some clinical trials).
What to notice: Hand-foot syndrome (palmar-plantar erythrodysesthesia) -- painful redness, swelling, or peeling of the palms and soles -- a very common reaction specific to the liposomal formulation (reported in over 40% of patients in some clinical trials).
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (5) (10)
Asthenia, fatigue, fever, reduced appetite, mouth sores (stomatitis), diarrhoea, and constipation (liposomal formulation).
What to notice: Asthenia, fatigue, fever, reduced appetite, mouth sores (stomatitis), diarrhoea, and constipation (liposomal formulation).
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (2)
Serious warnings
Signs of heart problems (cardiomyopathy) -- both formulations, different cumulative-dose thresholds — boxed_warning
Symptoms: Shortness of breath, swelling of the legs or abdomen, unusual tiredness, or rapid weight gain, which can signal heart failure. This risk rises with your total lifetime (cumulative) dose and is monitored by your oncology team throughout and after treatment with heart function tests.
Action: Report these symptoms to your oncology team promptly; your care team tracks your cumulative dose and heart function (LVEF) specifically because of this real, boxed-warning-level risk, which can appear during treatment or years afterward. (1) (2)
Signs of infusion reaction -- liposomal formulation (Doxil/Caelyx) — boxed_warning
Symptoms: Flushing, shortness of breath, facial swelling, chest tightness, low blood pressure, or fever during or shortly after the infusion.
Action: This is monitored closely by your infusion team; the infusion may be slowed, paused, or stopped depending on severity, since serious, life-threatening, and fatal infusion-related reactions are a genuine boxed-warning risk for this formulation. (2)
Pain, burning, or swelling at the infusion site -- conventional formulation — boxed_warning
Symptoms: Stinging, burning, or swelling where the IV line is placed, which can indicate the medicine is leaking outside the vein (extravasation).
Action: Tell your nurse or infusion team immediately -- this is the one patient-directed action expected of you. Extravasation of conventional doxorubicin can cause severe tissue injury and necrosis that may require surgery, so the infusion team stops the infusion right away and treats the area if this occurs. (1)
Signs of severe infection or bleeding (myelosuppression) -- conventional formulation — boxed_warning
Symptoms: Fever, chills, unusual bruising or bleeding, or signs of infection.
Action: Seek urgent medical attention -- severe bone marrow suppression from conventional doxorubicin can lead to serious infection, septic shock, need for transfusion, hospitalisation, and death; your blood counts are monitored closely by your oncology team. (1)
Hand-foot syndrome (palmar-plantar erythrodysesthesia) -- liposomal formulation — serious
Symptoms: Painful redness, swelling, tingling, or peeling of the palms of the hands and soles of the feet.
Action: Report this to your oncology team -- dose delay or reduction may be needed; this is a very common (reported in over 40% of patients in clinical trials) reaction specific to the liposomal formulation. (5) (10)
Risk of a second blood cancer later in life -- conventional formulation — boxed_warning
Symptoms: Not immediately symptomatic -- a longer-term risk.
Action: Your oncology team discusses this real, boxed-warning-level risk (secondary acute myeloid leukaemia or myelodysplastic syndrome) as part of your overall treatment planning; it is not a risk you can monitor or manage yourself. (1)
Interactions
- Trastuzumab: must not be combined with conventional doxorubicin due to increased risk of cardiac dysfunction. (1)
- Other cardiotoxic medicines: combining with either formulation of doxorubicin increases cardiac risk; your oncology team weighs this carefully. (1)
- CYP3A4, CYP2D6, and P-glycoprotein inhibitors or inducers: avoid concurrent use with conventional doxorubicin where possible, as they can alter drug levels. (1)
- Prior or planned radiotherapy: doxorubicin can increase radiation-related toxicity and cause 'radiation recall' reactions at previously irradiated skin sites. (1)
Pregnancy, breastfeeding, kidney/liver function, age
Pregnancy
Doxorubicin can cause fetal harm and is not used in pregnancy except in carefully considered circumstances directed by a specialist oncology team; effective contraception is advised during and after treatment. (1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
Breastfeeding
Not used while breastfeeding; your oncology team will advise on timing. (1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
Children
Used in specific paediatric cancers (e.g. Wilms' tumour, neuroblastoma, certain leukaemias) under specialist paediatric oncology dosing, with lower cumulative-dose ceilings than adults. (1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
Elderly
Cardiac risk assessment is particularly important; dosing and monitoring are individualised by the oncology team. (1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
Hepatic_impairment
Dose is reduced for hepatic impairment for both formulations; severe hepatic impairment is a contraindication for conventional doxorubicin. (1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
Renal_impairment
Not specifically quantified with the same level of detail as hepatic impairment in the sources reviewed for this dossier; your oncology team will consider your overall clinical picture. (1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
Source_ids
US-DAILYMED-ADRIAMYCIN-2026,US-DAILYMED-DOXIL-2026 (1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
Monitoring
Before starting
- Baseline heart function (e.g. LVEF)
- Full blood count and liver function
- Total cumulative anthracycline dose already received from any prior treatment
- Confirmation of which formulation (conventional vs liposomal) is being given, since they are not interchangeable
During treatment
- Regular heart function monitoring, especially as cumulative dose rises.
- Regular blood counts to monitor for myelosuppression (conventional formulation).
- Close observation during liposomal infusions for infusion-related reactions, especially with the first dose.
- Monitoring for hand-foot syndrome with the liposomal formulation, and for signs of extravasation at the infusion site with the conventional formulation.
Storage
Doxorubicin, in both formulations, is stored, prepared, and administered exclusively by hospital pharmacy and oncology staff under controlled conditions -- it is not a medicine kept or handled by patients at home.
Professional information
Clinician-facing context only, sourced from the current US FDA Adriamycin and Doxil prescribing information, the Health Canada and New Zealand Medsafe primary sources directly parsed for this dossier, and the EMA Caelyx EPAR; verify against the current full label before prescribing.
United States (conventional)
Indication: Broad oncology use (breast cancer, leukaemias, lymphomas, sarcomas, and others)
Dose summary: 60-75 mg/m2 single agent IV; cumulative cardiomyopathy risk rises from 1% at 300 mg/m2 to 20% at 500 mg/m2.
Renal context: Not specifically quantified with equivalent detail to hepatic impairment in the source reviewed; severe hepatic impairment is contraindicated. (1)
United States (liposomal, Doxil)
Indication: Ovarian cancer (post-platinum failure); AIDS-related Kaposi's sarcoma; multiple myeloma with bortezomib
Dose summary: 50 mg/m2 IV every 4 weeks (ovarian); 20 mg/m2 IV every 3 weeks (Kaposi's sarcoma); 30 mg/m2 IV day 4 post-bortezomib (myeloma). 11% cardiomyopathy risk at cumulative anthracycline dose 450-550 mg/m2.
Renal context: Not specifically quantified with equivalent detail in the source reviewed. (2)
Canada / New Zealand (conventional)
Indication: Broad oncology use, plus intravesical use for superficial bladder tumours (Canada)
Dose summary: Recommended not to exceed a maximum cumulative dose of 550 mg/m2.
Renal context: Not specifically quantified in the sources reviewed. (6) (9)
Hepatic guidance
Dose reduction is required in hepatic impairment for both formulations; severe hepatic impairment is a contraindication for conventional doxorubicin.
Overdose note
Overdose increases the risk of acute myelosuppression and cardiotoxicity; management is supportive and specialist-directed in a hospital setting. (1) (2)
Frequently asked questions
Does doxorubicin have a boxed warning?
Yes, but the exact warning depends on which formulation is used. Conventional doxorubicin (Adriamycin/generic) carries a real, 4-part FDA boxed warning: cumulative-dose-dependent heart damage (cardiomyopathy), a higher risk of a second blood cancer later in life, severe tissue damage if the medicine leaks outside the vein, and severe suppression of bone marrow function. Liposomal doxorubicin (Doxil/Caelyx) carries a different, 2-part boxed warning: heart damage (at a different cumulative dose range) and serious, sometimes life-threatening infusion reactions. (1) (2)
Are conventional doxorubicin and liposomal doxorubicin (Doxil/Caelyx) the same medicine?
They contain the same active ingredient, but they are genuinely different formulations with different pharmacokinetics, different dosing schedules, different approved uses, and different safety profiles. Regulators explicitly state they must never be substituted for one another. (4) (10)
What is hand-foot syndrome and which form of doxorubicin causes it?
Hand-foot syndrome (palmar-plantar erythrodysesthesia) is painful redness, swelling, or peeling of the palms and soles. It is a very common reaction specific to liposomal doxorubicin (Doxil/Caelyx), reported in over 40% of patients in some clinical trials, and is not a typical feature of conventional doxorubicin. (5) (10)
Why does my cumulative dose matter so much with doxorubicin?
Heart damage (cardiomyopathy) from doxorubicin is dose-dependent and cumulative across your lifetime, including any prior anthracycline chemotherapy. Conventional doxorubicin's risk rises from about 1-2% at 300 mg/m2 to as much as 20% at 500 mg/m2, with a recommended lifetime ceiling of 550 mg/m2; the liposomal formulation appears to carry a lower cardiac risk at equivalent cumulative anthracycline doses, per New Zealand's Medsafe data. This is why your oncology team tracks your total lifetime dose carefully. (6) (10)
What is the mechanism of action of doxorubicin hydrochloride?
Doxorubicin is an anthracycline that intercalates into DNA and inhibits topoisomerase II, blocking DNA replication and transcription in rapidly dividing cells, which underlies both its antitumour effect and its class-wide risks (myelosuppression, secondary malignancy, cardiotoxicity). Pegylation of the liposomal formulation prolongs circulation time and alters its distribution and cardiac-risk profile compared with the conventional formulation. (1) (2)
What is the generic name of Doxorubicin (Adriamycin -- conventional; Doxil / Caelyx -- pegylated liposomal)?
References
- ADRIAMYCIN (doxorubicin HCl) for Injection -- full prescribing information (conventional, non-liposomal)U.S. Food and Drug Administration / DailyMed (NIH), full prescribing information, Hikma Pharmaceuticals (Adriamycin brand + generic doxorubicin HCl) · United States · accessed 2026-07-31 · source 1
- DOXIL (doxorubicin hydrochloride liposome injection) -- full prescribing information (pegylated liposomal)U.S. Food and Drug Administration / DailyMed (NIH), full prescribing information · United States · accessed 2026-07-31 · source 2
- Doxorubicin 2 mg/ml Concentrate for Solution for Infusion -- Summary of Product Characteristics (conventional, non-liposomal)electronic medicines compendium (emc), United Kingdom -- Accord Healthcare · United Kingdom · accessed 2026-07-31 · source 3
- Doxorubicin Baxter pegylated liposomal 2 mg/ml concentrate for solution for infusion -- Summary of Product Characteristicselectronic medicines compendium (emc), United Kingdom -- Baxter (pegylated liposomal doxorubicin, marketed as Doxorubicin Baxter pegylated liposomal / Caelyx) · United Kingdom · accessed 2026-07-31 · source 4
- Caelyx pegylated liposomal (doxorubicin hydrochloride) -- EPAR product informationEuropean Medicines Agency (EMA) -- centrally authorised European Public Assessment Report (EPAR) product information · European Union · accessed 2026-07-31 · source 5
- DOXORUBICIN HYDROCHLORIDE INJECTION -- Health Canada Product MonographHealth Canada product monograph (conventional, non-liposomal doxorubicin hydrochloride injection) · Canada · accessed 2026-07-31 · source 6
- CAELYX (pegylated liposomal doxorubicin hydrochloride for injection) -- Health Canada Product Monograph (Baxter Corporation, revised 2024-04-02)Health Canada product monograph (pegylated liposomal doxorubicin) · Canada · accessed 2026-07-31 · source 7
- Doxorubicin Injection (Pfizer, conventional) and CAELYX doxorubicin hydrochloride 20 mg/10 mL concentrated injection vial (liposomal) -- ARTG entriesTherapeutic Goods Administration (TGA), Australia · Australia · accessed 2026-07-31 · source 8
- Adriamycin (doxorubicin hydrochloride) injection -- New Zealand Data Sheet (conventional, non-liposomal)Medsafe (New Zealand Medicines and Medical Devices Safety Authority) · New Zealand · accessed 2026-07-31 · source 9
- CAELYX (pegylated liposomal doxorubicin hydrochloride) -- New Zealand Data Sheet (25 February 2026)Medsafe (New Zealand Medicines and Medical Devices Safety Authority) · New Zealand · accessed 2026-07-31 · source 10
Brand names by country
Single-ingredient doxorubicin hydrochloride names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.
Priority countries
United States
- DOXIL2 mg/mL · baxter healthcare corporation
- Doxorubicin Hydrochloride Liposome2 mg/mL · sagent pharmaceuticals
- doxorubicin hydrochloride, Liposomal2 mg/mL · baxter healthcare corporation
United Kingdom
- Doxorubicin (generic; Accord and other manufacturers, conventional) (3)MHRA licensed emc smpc confirmed · 2 mg/mL concentrate for solution for infusion · Accord Healthcare Ltd and other UK generic manufacturers
- Doxorubicin Baxter pegylated liposomal (Caelyx-equivalent formulation) (4)MHRA licensed emc smpc confirmed · 2 mg/mL concentrate for solution for infusion · Baxter
Canada
- ADRIAMYCIN PFS
- CAELYX
- MYOCET