The following clinically significant adverse reactions are described elsewhere in the labeling.
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/m2 and cyclophosphamide at a dose of 600 mg/m2 (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.
| Adverse Reactions | AC* N = 1492 | Conventional CMF N = 739 |
|---|---|---|
| % | % | |
| AC = doxorubicin hydrochloride, cyclophosphamide; CMF = cyclophosphamide, methotrexate, fluorouracil | ||
| ||
Alopecia | 92 | 71 |
Vomiting | ||
Vomiting ≤12 hours | 34 | 25 |
Vomiting >12 hours | 37 | 12 |
Intractable | 5 | 2 |
Leukopenia | ||
Grade 3 (1,000–1,999 /mm3) | 3.4 | 9.4 |
Grade 4 (<1000 /mm3) | 0.3 | 0.3 |
Shock, sepsis | 2 | 1 |
Systemic infection | 2 | 1 |
Cardiac dysfunction | ||
Asymptomatic | 0.2 | 0.1 |
Transient | 0.1 | 0 |
Symptomatic | 0.1 | 0 |
Thrombocytopenia | ||
Grade 3 (25,000–49,999 /mm3) | 0 | 0.3 |
Grade 4 (<25,000 /mm3) | 0.1 | 0 |
The following adverse reactions have been identified during postapproval use of Doxorubicin Hydrochloride Injection. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Cardiac – Cardiogenic shock
Cutaneous – Skin and nail hyperpigmentation, oncolysis, rash, itching, photosensitivity, urticaria, acral erythema, palmar plantar erythrodysesthesia
Gastrointestinal – Nausea, mucositis, stomatitis, necrotizing colitis, typhlitis, gastric erosions, gastrointestinal tract bleeding, hematochezia, esophagitis, anorexia, abdominal pain, dehydration, diarrhea, hyperpigmentation of the oral mucosa
Hypersensitivity – Anaphylaxis
Laboratory Abnormalities – Increased ALT, increased AST
Neurological – Peripheral sensory and motor neuropathy, seizures, coma
Ocular – Conjunctivitis, keratitis, lacrimation
Vascular – Phlebosclerosis, phlebitis/thrombophlebitis, hot flashes, thromboembolism
Other – Malaise/asthenia, fever, chills, weight gain
The following clinically significant adverse reactions are described elsewhere in the labeling.
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/m2 and cyclophosphamide at a dose of 600 mg/m2 (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.
| Adverse Reactions | AC* N = 1492 | Conventional CMF N = 739 |
|---|---|---|
| % | % | |
| AC = doxorubicin hydrochloride, cyclophosphamide; CMF = cyclophosphamide, methotrexate, fluorouracil | ||
| ||
Alopecia | 92 | 71 |
Vomiting | ||
Vomiting ≤12 hours | 34 | 25 |
Vomiting >12 hours | 37 | 12 |
Intractable | 5 | 2 |
Leukopenia | ||
Grade 3 (1,000–1,999 /mm3) | 3.4 | 9.4 |
Grade 4 (<1000 /mm3) | 0.3 | 0.3 |
Shock, sepsis | 2 | 1 |
Systemic infection | 2 | 1 |
Cardiac dysfunction | ||
Asymptomatic | 0.2 | 0.1 |
Transient | 0.1 | 0 |
Symptomatic | 0.1 | 0 |
Thrombocytopenia | ||
Grade 3 (25,000–49,999 /mm3) | 0 | 0.3 |
Grade 4 (<25,000 /mm3) | 0.1 | 0 |
The following adverse reactions have been identified during postapproval use of Doxorubicin Hydrochloride Injection. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Cardiac – Cardiogenic shock
Cutaneous – Skin and nail hyperpigmentation, oncolysis, rash, itching, photosensitivity, urticaria, acral erythema, palmar plantar erythrodysesthesia
Gastrointestinal – Nausea, mucositis, stomatitis, necrotizing colitis, typhlitis, gastric erosions, gastrointestinal tract bleeding, hematochezia, esophagitis, anorexia, abdominal pain, dehydration, diarrhea, hyperpigmentation of the oral mucosa
Hypersensitivity – Anaphylaxis
Laboratory Abnormalities – Increased ALT, increased AST
Neurological – Peripheral sensory and motor neuropathy, seizures, coma
Ocular – Conjunctivitis, keratitis, lacrimation
Vascular – Phlebosclerosis, phlebitis/thrombophlebitis, hot flashes, thromboembolism
Other – Malaise/asthenia, fever, chills, weight gain
{{section_body_html_patient}}
Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine.
*Speak with a Pfizer Medical Information Professional regarding your medical inquiry. Available 9AM-5PM ET Monday to Friday; excluding holidays.
Submit a medical question for Pfizer prescription products.
Pfizer Safety
To report an adverse event related to the Pfizer-BioNTech COVID-19 Vaccine, and you are not part of a clinical trial* for this product, click the link below to submit your information:
Pfizer Safety Reporting Site*If you are involved in a clinical trial for this product, adverse events should be reported to your coordinating study site.
If you cannot use the above website, or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at (800) 438-1985.
FDA Medwatch
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatch or call (800) 822-7967.