TriangleLABELS · 68af240b-3f2d-450c-b2bf-6f12d5176562
Doxorubicin Hydrochloride
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Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.
- Label effective date
- 2026-05-05
- Captured
- 2026-09-09T23:37:51.659493+00:00
- Current indication reconciliation
- Not reconciled
Boxed warning in this label
- 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) ] . • Severe myelosuppression resulting in serious infection, septic shock, requirement for transfusions, hospitalization, and death may occur [see Warnings and Precautions (5.4) ] . WARNING: CARDIOMYOPATHY, SECONDARY MALIGNANCIES, EXTRAVASATION AND TISSUE NECROSIS, and SEVERE MYELOSUPPRESSION See full prescribing information for complete boxed warning. • Cardiomyopathy: Myocardial damage can occur with doxorubicin hydrochloride with incidences from 1%–20% for cumulative doses 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. ( 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. ( 5.2 ) • Extravasation and Tissue Necrosis: Extravasation of doxorubicin hydrochloride can result in severe local tissue injury and necrosis requiring wide excision and skin grafting. Immediately terminate the drug, and apply ice to the affected area. ( 5.3 ) • Severe myelosuppression resulting in serious infection, septic shock, requirement for transfusions, hospitalization, and death may occur. ( 5.4 )
Indications and usage: exact source text
- 1 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 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 . 1.2 Other Cancers Doxorubicin Hydrochloride Injection is indicated for the treatment of • acute lymphoblastic leukemia • acute myeloblastic leukemia • Hodgkin lymphoma • non-Hodgkin lymphoma (NHL) • metastatic breast cancer • metastatic Wilms' tumor • metastatic neuroblastoma • metastatic soft tissue sarcoma • metastatic bone sarcoma • metastatic ovarian carcinoma • metastatic transitional cell bladder carcinoma • metastatic thyroid carcinoma • metastatic gastric carcinoma • metastatic bronchogenic carcinoma
Full extracted label fields
- application numbers
- NDA050629
- boxed warning exact
- 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) ] . • Severe myelosuppression resulting in serious infection, septic shock, requirement for transfusions, hospitalization, and death may occur [see Warnings and Precautions (5.4) ] . WARNING: CARDIOMYOPATHY, SECONDARY MALIGNANCIES, EXTRAVASATION AND TISSUE NECROSIS, and SEVERE MYELOSUPPRESSION See full prescribing information for complete boxed warning. • Cardiomyopathy: Myocardial damage can occur with doxorubicin hydrochloride with incidences from 1%–20% for cumulative doses 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. ( 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. ( 5.2 ) • Extravasation and Tissue Necrosis: Extravasation of doxorubicin hydrochloride can result in severe local tissue injury and necrosis requiring wide excision and skin grafting. Immediately terminate the drug, and apply ice to the affected area. ( 5.3 ) • Severe myelosuppression resulting in serious infection, septic shock, requirement for transfusions, hospitalization, and death may occur. ( 5.4 )
- brand names
- Doxorubicin Hydrochloride
- current indication status
- not_reconciled
- dailymed set url
- https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1fd148fb-0fbc-4b6f-b790-23546fb46a71
- generic names
- DOXORUBICIN HYDROCHLORIDE
- id
- 68af240b-3f2d-450c-b2bf-6f12d5176562
- indications and usage exact
- 1 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 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 . 1.2 Other Cancers Doxorubicin Hydrochloride Injection is indicated for the treatment of • acute lymphoblastic leukemia • acute myeloblastic leukemia • Hodgkin lymphoma • non-Hodgkin lymphoma (NHL) • metastatic breast cancer • metastatic Wilms' tumor • metastatic neuroblastoma • metastatic soft tissue sarcoma • metastatic bone sarcoma • metastatic ovarian carcinoma • metastatic transitional cell bladder carcinoma • metastatic thyroid carcinoma • metastatic gastric carcinoma • metastatic bronchogenic carcinoma
- indications and usage tables exact
- is original packager
- true
- manufacturer names
- Pfizer Laboratories Div Pfizer Inc
- matched search terms
- cancer
- carcinoma
- lymphoma
- leukemia
- sarcoma
- sarcomas
- tumor
- neuroblastoma
- package ndcs
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- HUMAN PRESCRIPTION DRUG
- recent major changes exact
- record type
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- routes
- INTRAVENOUS
- rxcuis
- 1191138
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- source batch
- file
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- meta
- disclaimer
- Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.
- last updated
- 2026-09-09
- results
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- source url
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- spl effective date
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- 20260505
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- spl version
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- substance names
- DOXORUBICIN HYDROCHLORIDE
- uniis
- 82F2G7BL4E
- verification flags
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Drugs@FDA application source records
- application number
- NDA050629
- payload
- all indexed label documents
- Appl No
- 050629
- Application Docs Date
- 2002-09-25 00:00:00
- Application Docs ID
- 17949
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50467s64s67,50629s10s13lbl.pdf
- Submission No
- 10
- Submission Type
- SUPPL
- Appl No
- 050629
- Application Docs Date
- 2003-05-13 00:00:00
- Application Docs ID
- 17950
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- 0
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- Submission No
- 14
- Submission Type
- SUPPL
- Appl No
- 050629
- Application Docs Date
- 2003-05-29 00:00:00
- Application Docs ID
- 17951
- Application Docs Title
- 0
- Application Docs Type ID
- 2
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- http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50629se1-014slr016,50467se1-068,slr069_doxorubicin_lbl.pdf
- Submission No
- 16
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- SUPPL
- Appl No
- 050629
- Application Docs Date
- 2010-07-30 00:00:00
- Application Docs ID
- 17952
- Application Docs Title
- 0
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- 2
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- http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050629s017lbl.pdf
- Submission No
- 17
- Submission Type
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- Appl No
- 050629
- Application Docs Date
- 2011-09-26 00:00:00
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- 17953
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- 0
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- 2
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- Submission No
- 19
- Submission Type
- SUPPL
- Appl No
- 050629
- Application Docs Date
- 2013-11-01 00:00:00
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- 0
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- 2
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- http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050629s022lbl.pdf
- Submission No
- 22
- Submission Type
- SUPPL
- Appl No
- 050629
- Application Docs Date
- 2002-09-25 00:00:00
- Application Docs ID
- 39053
- Application Docs Title
- 0
- Application Docs Type ID
- 2
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- http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50467s64s67,50629s10s13lbl.pdf
- Submission No
- 13
- Submission Type
- SUPPL
- Appl No
- 050629
- Application Docs Date
- 2019-08-12 00:00:00
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- 59661
- Application Docs Title
- 0
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- 2
- Application Docs URL
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- 29
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- Appl No
- 050629
- Application Docs Date
- 2019-12-23 00:00:00
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- 61393
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- 0
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- 2
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- Submission No
- 28
- Submission Type
- SUPPL
- Appl No
- 050629
- Application Docs Date
- 2020-10-29 00:00:00
- Application Docs ID
- 65072
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050467s078,050629s030lbl.pdf
- Submission No
- 30
- Submission Type
- SUPPL
- Appl No
- 050629
- Application Docs Date
- 2024-05-15 00:00:00
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- 78469
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- 0
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- 2
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- approval interpretation
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- current indication status
- not_reconciled
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- 2024-05-15 00:00:00
- Application Docs ID
- 78469
- Application Docs Title
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- Active Ingredient
- DOXORUBICIN HYDROCHLORIDE
- Appl No
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- Drug Name
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- Form
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- Strength
- 150MG/75ML
- marketing status
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- 1 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 ly
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- 1 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,
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Preserved source evidence · Not medical advice