Doxorubicin

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. Intercalation inhibits nucleotide replication and action of DNA and RNA polymerases.

• 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 Adjuvant Breast Cancer Doxorubicin Hydrochloride Injection is indicated as a component of multi-agent adjuvant chemotherapy for treatment of women with axillary lymph node involvement following resection of primary breast cancer .ICD-10: C50.919, C85.90, C95.90

• Doxorubicin Hydrochloride Injection are contraindicated in patients with: • Severe myocardial insufficiency [see Warnings and Precautions (5.1) ] • Recent (occurring within the past 4–6 weeks) myocardial infarction [see Warnings and Precautions (5.1) ] • Severe persistent drug-induced myelosuppression [see Warnings and Precautions (5.4) ] • Severe hepatic impairment (defined as Child Pugh Class C or serum bilirubin level greater than 5 mg/dL) [see Warnings and Precautions (5.5) ] • Severe hypersensitivity reaction to doxorubicin hydrochloride, including anaphylaxis [see Adverse Reactions (6.2) ] • Severe myocardial insufficiency ( 4 ) • Recent myocardial infarction ( 4 ) • Severe persistent drug-induced myelosuppression ( 4 ) • Severe hepatic impairment ( 4 ) • Severe hypersensitivity to doxorubicin hydrochloride ( 4 )contraindicated

• Single agent : 60 to 75 mg/m 2 given intravenously every 21 days ( 2.2 ) • In combination : 40 to 75 mg/m 2 given intravenously every 21 to 28 days ( 2.2 ) • Discontinue Doxorubicin Hydrochloride Injection in patients who develop signs or symptoms of cardiomyopathy ( 2.3 ) • Reduce dose in patients with hepatic impairment ( 2.4 ) 2.1 Recommended Dosage for Adjuvant Breast Cancer The recommended dosage of Doxorubicin Hydrochloride Injection is 60 mg/m 2 administered as an intravenous bolus on day 1 of each 21-day treatment cycle, in combination with cyclophosphamide, for a total of four cycles . 2.2 Recommended Dosage for Other Cancers • The recommended dosage of Doxorubicin Hydrochloride Injection when used as a single agent is 60 mg/m 2 to 75 mg/m 2 intravenously every 21 days. • The recommended dosage of Doxorubicin Hydrochloride Injection, when administered in combination with other chemotherapy drugs, is 40 mg/m 2 to 75 mg/m 2 intravenously every 21 to 28 days. • Consider use of the lower Doxorubicin Hydrochloride Injection dose in the recommended dosage range or longer intervals between cycles for heavily pretreated patients, elderly patients, or obese patients. • Cumulative doses above 550 mg/m 2 are associated with an increased risk of cardiomyopathy [see Warnings and Precautions (5.1) ]. 2.3 Dosage Modifications for Adverse Reactions Cardiomyopathy Discontinue Doxorubicin Hydrochloride Injection in patients who develop signs or symptoms of cardiomyopathy [see Warnings and Precautions (5.1) ] .

• Radiation-Induced Toxicity : Can be increased by the administration of Doxorubicin Hydrochloride Injection. Radiation recall can occur in patients who receive Doxorubicin Hydrochloride Injection after prior radiation therapy. ( 5.7 ) • Embryo-Fetal Toxicity : Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and on the use of effective contraception. Advise males with female partners of reproductive potential to use effective contraception. Advise males with pregnant partners to use condoms. ( 5.8 , 8.1 , 8.3 ) 5.1 Cardiomyopathy and Arrhythmias Cardiomyopathy Doxorubicin hydrochloride can result in myocardial damage, including acute left ventricular failure. The risk of cardiomyopathy is generally proportional to the cumulative exposure. Include prior doses of other anthracyclines or anthracenediones in calculations of total cumulative dosage for doxorubicin hydrochloride. Cardiomyopathy may develop during treatment or up to several years after completion of treatment and can include decrease in LVEF and signs and symptoms of congestive heart failure (CHF). The probability of developing cardiomyopathy is estimated to be 1 to 2% at a total cumulative dose of 300 mg/m 2 of doxorubicin hydrochloride, 3 to 5% at a dose of 400 mg/m 2 , 5 to 8% at a dose of 450 mg/m 2 , and 6 to 20% at a dose of 500 mg/m 2 , when doxorubicin hydrochloride is administered every 3 weeks.

The following clinically significant adverse reactions are described elsewhere in the labeling. • Cardiomyopathy and Arrhythmias [see Warnings and Precautions (5.1) ] • Secondary Malignancies [see Warnings and Precautions (5.2) ] • Extravasation and Tissue Necrosis [see Warnings and Precautions (5.3) ] • Severe Myelosuppression [see Warnings and Precautions (5.4) ] • Tumor Lysis Syndrome [see Warnings and Precautions (5.6) ] • Radiation Sensitization and Radiation Recall [see Warnings and Precautions (5.7) ] The most common (>10%) adverse reactions are alopecia, nausea and vomiting. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc. at 1-800-438-1985 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, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Breast Cancer The safety data below were collected from 1492 women who received doxorubicin hydrochloride at a dose of 60 mg/m 2 and cyclophosphamide at a dose of 600 mg/m 2 (AC) every 3 weeks for 4 cycles for the adjuvant treatment of axillary lymph node positive breast cancer. The median number of cycles received was 4. Selected adverse reactions reported in this study are provided in Table 2. No treatment-related deaths were reported in patients on either arm of the study. Table 2.

• Lactation : Advise not to breastfeed ( 8.2 ) • Females and Males of Reproductive Potential : May impair fertility ( 8.3 ) 8.1 Pregnancy Risk Summary Based on findings in animals and its mechanism of action, Doxorubicin Hydrochloride Injection can cause fetal harm when administered to a pregnant woman; avoid the use of Doxorubicin Hydrochloride Injection during the 1 st trimester. Available human data do not establish the presence or absence of major birth defects and miscarriage related to the use of doxorubicin hydrochloride during the 2 nd and 3 rd trimesters. Doxorubicin hydrochloride was teratogenic and embryotoxic in rats and embryotoxic in rabbits when administered during organogenesis at doses approximately 0.07 times (based on body surface area) the recommended human dose of 60 mg/m 2 (see Data ) . Advise pregnant women of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data Doxorubicin hydrochloride was teratogenic and embryotoxic at doses of 0.8 mg/kg/day (about 0.07 times the recommended human dose based on body surface area) when administered during the period of organogenesis in rats. Teratogenicity and embryotoxicity were also seen using discrete periods of treatment.

Metabolism

Pharmacokinetic studies conducted in patients with various types of tumors have shown that doxorubicin follows multiphasic disposition after intravenous injection. In four patients, doxorubicin demonstrated dose-independent pharmacokinetics across a dose range of 30 mg/m 2 to 70 mg/m 2 .

Few cases of overdose have been described. A 58-year-old man with acute lymphoblastic leukemia received 10-fold overdose of doxorubicin hydrochloride (300 mg/m 2 ) in one day. He was treated with charcoal filtration, hemopoietic growth factor (G-CSF), proton pump inhibitor and antimicrobial prophylaxis. The patient suffered sinus tachycardia, grade 4 neutropenia and thrombocytopenia for 11 days, severe mucositis and sepsis. The patient recovered completely 26 days after the overdose. A 17-year-old girl with osteogenic sarcoma received 150 mg of doxorubicin hydrochloride daily for 2 days (intended dose was 50 mg per day for 3 days). The patient developed severe mucositis on days 4–7 after the overdose and chills and pyrexia on day 7. The patient was treated with antibiotics and platelets and recovered 18 days after overdose.

• Dec 23, 1987NDANDA050629Pfizer
• Mar 17, 1989ANDAANDA062921Hikma
• Mar 17, 1989ANDAANDA062975Hikma
• Sep 13, 1994ANDAANDA064097Hikma
• Oct 26, 1995ANDAANDA063277Fresenius Kabi Usa
• Nov 17, 1995NDANDA050718Baxter Hlthcare Corp
• Oct 28, 2011ANDAANDA200170Mylan Labs Ltd
• Feb 15, 2012ANDAANDA091418Sun Pharm Inds

1. 1Febrile Neutropenia9,2769.9%
2. 2Off Label Use8,9519.6%
3. 3Disease Progression6,5957.1%
4. 4Neutropenia6,5377.0%
5. 5Drug Ineffective5,2085.6%
6. 6Pyrexia4,2464.6%
7. 7Anaemia3,9814.3%
8. 8Thrombocytopenia3,8824.2%
9. 9Nausea3,4883.7%
10. 10Death3,3523.6%
11. 11Product Use In Unapproved Indication3,1113.3%
12. 12Pneumonia2,9983.2%
13. 13Sepsis2,8973.1%
14. 14Diarrhoea2,8383.0%
15. 15Alopecia2,8223.0%

Recent PubMed references pinned to Doxorubicin as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Doxorubicin-induced early-onset chronic progressive cardiotoxicity, pharmacogenetics and survival among breast cancer patients in Zimbabwe.
  South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde · 2026 · Mazhindu T, Nyangwara VA, Borok MZ, et al.
  PMID 42246857DOI 10.7196/SAMJ.2026.v116i5.3655
• Assessment of Doxorubicin Internalization and Cytotoxicity in Primary Tumor Spheroids After Collagen Digestion.
  Current protocols · 2026 · Lo Cicero A, Lo Buglio G, Campora S, et al.
  PMID 42222873DOI 10.1002/cpz1.70394
• Synergistic Effect of Doxorubicin-Thermo-Iodized Oil Pickering Emulsions on the Interventional Embolization-Chemotherapy- Immunity of VX2 Rabbit Liver Cancer.
  International journal of nanomedicine · 2026 · Li L, Xie W, Sun H, et al.
  PMID 42220971DOI 10.2147/IJN.S569851
• DNA Damage Repair Pathways and Targeted Therapy for Doxorubicin-Resistant Breast Cancer.
  Frontiers in bioscience (Landmark edition) · 2026 · Wu Y, Li X, Wang W, et al.
  PMID 42216534DOI 10.31083/FBL47143
• Bioinspired polydopamine interfacial engineering of plant-derived exosomes enhances doxorubicin bioactivity in 2D and 3D breast cancer models.
  Biomaterials advances · 2026 · Khosravani G, Irani S, Mirfakhraie R, et al.
  PMID 42202649DOI 10.1016/j.bioadv.2026.214972
• Multimodal Nanobubbles Carrying Indocyanine Green and VCAM-1 Targeting Peptide for Molecular Imaging of DOX-Induced Cardiotoxicity.
  International journal of nanomedicine · 2026 · Sun Y, Zhang J, Liu D, et al.
  PMID 42199653DOI 10.2147/IJN.S594765
• Neuregulin-1β Mitigates Doxorubicin-Induced Cardiotoxicity via Serping1 in Cardiac Fibroblasts.
  International journal of molecular sciences · 2026 · Aghagolzadeh P, Xu L, Klinger P, et al.
  PMID 42196592DOI 10.3390/ijms27104616
• Protective Effect of Edaravone on Doxorubicin-Induced Thyroid Dysfunction in Rats Revealed by (99m)Tc Pertechnetate Thyroid Gland Scintigraphy and Biochemical Methods.
  Medicina (Kaunas, Lithuania) · 2026 · Kalın M, Aygun H, Karakullukcu HK, et al.
  PMID 42195147DOI 10.3390/medicina62050894

The 10 most recently updated of 2,994 ClinicalTrials.gov registrations naming Doxorubicin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Eflornithine (DFMO) for Ewing Sarcoma and Osteosarcoma
  Recruiting · Phase 2 · Interventional · 406 enrolled · Milton S. Hershey Medical Center
  NCT07321912updated 2026-06-12
• A Study to Test the Addition of the Drug Cabozantinib to Chemotherapy in Patients With Newly Diagnosed Osteosarcoma
  Recruiting · Phase 2 · Phase 3 · Interventional · 1,122 enrolled · National Cancer Institute (NCI)
  NCT05691478updated 2026-06-12
• Olvi-Vec Oncolytic Immunotherapy in Patients With Recurrent or Refractory Ovarian Cancer
  Completed · Phase 1 · Phase 2 · Interventional · 46 enrolled · Genelux Corporation
  NCT02759588updated 2026-06-12
• Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma
  Recruiting · Phase 3 · Interventional · 478 enrolled · National Cancer Institute (NCI)
  NCT06172296updated 2026-06-12
• Albumin-bound Paclitaxel Combined With Liposomal Doxorubicin in the Treatment of Advanced or Unresectable Angiosarcoma
  Recruiting · Phase 2 · Interventional · 69 enrolled · Sun Yat-sen University
  NCT04859465updated 2026-06-12
• Adding an Immunotherapy Drug, MEDI4736 (Durvalumab), to the Usual Chemotherapy Treatment (Paclitaxel, Cyclophosphamide, and Doxorubicin) for Stage II-III Breast Cancer
  Recruiting · Phase 3 · Interventional · 3,680 enrolled · National Cancer Institute (NCI)
  NCT06058377updated 2026-06-12
• A Clinical Study of Raludotatug Deruxtecan in People With Ovarian Cancer (MK-5909-003)
  Recruiting · Phase 1 · Phase 2 · Interventional · 460 enrolled · Merck Sharp & Dohme LLC
  NCT06843447updated 2026-06-12
• Toripalimab Combined With CAV/IE Regimen
  Recruiting · Phase 2 · Interventional · 134 enrolled · Sun Yat-sen University
  NCT04589741updated 2026-06-12
• A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032)
  Recruiting · Phase 3 · Interventional · 2,400 enrolled · Merck Sharp & Dohme LLC
  NCT06966700updated 2026-06-12
• A Study of Brentuximab Vedotin in Combination With Cyclophosphamide, Doxorubicin (Hydroxydaunorubicin), Prednisone (CHP) in Chinese Participants With CD30-Positive (CD30+) Peripheral T-Cell Lymphomas (PTCL)
  Active not recruiting · Phase 2 · Interventional · 52 enrolled · Takeda
  NCT05673785updated 2026-06-12

CPIC-curated drug–gene pairs for Doxorubicin. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

• CBR3CPIC D (provisional)ClinPGx 3
• G6PDCPIC C
  G6PD
• HAS3CPIC D (provisional)
• NQO1CPIC D (provisional)
• SLC28A3CPIC B/C (provisional)ClinPGx 2B

Frequently asked questions

How does Doxorubicin work?

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. Intercalation inhibits nucleotide replication and action of DNA and RNA polymerases.

What is Doxorubicin used for?

According to FDA labeling, Doxorubicin carries indications including: 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 Adjuvant Breast Cancer Doxorubicin Hydrochloride Injection is indicated as a component of multi-agent adjuvant chemotherapy for treatment of women with axillary lymph node involvement following resection of primary breast cancer .. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Doxorubicin?

Doxorubicin is classified as Anthracyclines and related substances, Anthracycline Topoisomerase Inhibitor, Topoisomerase 2 Inhibitors, Topoisomerase Inhibitors, Decreased DNA Integrity, Decreased RNA Integrity.

What are the brand names for Doxorubicin?

Doxorubicin is marketed under brand names including Adriamycin, Caelyx, Doxil.

What are the contraindications for Doxorubicin?

Doxorubicin labeling lists contraindications including: Doxorubicin Hydrochloride Injection are contraindicated in patients with: • Severe myocardial insufficiency [see Warnings and Precautions (5.1) ] • Recent (occurring within the past 4–6 weeks) myocardial infarction [see Warnings and Precautions (5.1) ] • Severe persistent drug-induced myelosuppression [see Warnings and Precautions (5.4) ] • Severe hepatic impairment (defined as Child Pugh Class C or serum bilirubin level greater than 5 mg/dL) [see Warnings and Precautions (5.5) ] • Severe hypersensitivity reaction to doxorubicin hydrochloride, including anaphylaxis [see Adverse Reactions (6.2) ] • Severe myocardial insufficiency ( 4 ) • Recent myocardial infarction ( 4 ) • Severe persistent drug-induced myelosuppression ( 4 ) • Severe hepatic impairment ( 4 ) • Severe hypersensitivity to doxorubicin hydrochloride ( 4 ). Always consult the full prescribing information and a clinician.