What the label lists and what reports show
Doxorubicin side effects
Doxorubicin's FDA label: “The most common (>10%) adverse reactions are alopecia, nausea and vomiting.” FAERS holds 95,404 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is febrile neutropenia (9,529 reports).
- Generic listed
- Boxed warning
Check it at the source: the doxorubicin FDA label on DailyMed (effective May 5, 2026, Pfizer Laboratories Div Pfizer Inc); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of Doxorubicin?Doxorubicin may cause serious side effects, including: • See “ What is the most important information I should know about Doxorubicin? ” The most common side effects of Doxorubicin include: • total hair loss (alopecia). Your hair may re-grow after your treatment. • nausea • vomiting Other side effects: • Red colored urine. You may have red colored urine for 1 to 2 days after your infusion of Doxorubicin. This is normal. Tell your healthcare provider if it does not stop in a few days, or if you see what looks like blood or blood clots in your urine. • Call your healthcare provider if you have severe symptoms that prevent you from eating or drinking, such as: o nausea o vomiting o diarrhea o mouth pain or sores Doxorubicin may cause fertility problems in males. This could affect your ability to father a child. Talk to your healthcare provider if this is a concern for you. […]
Source: FDA drug label, Pfizer Laboratories Div Pfizer Inc, effective May 5, 2026 (SPL set 1fd148fb-0fbc-4b6f-b790-23546fb46a71), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common (>10%) adverse reactions are alopecia, nausea and vomiting.
Table 2. Selected Adverse Reactions in Patients with Early Breast Cancer Involving Axillary Lymph Nodes
| Adverse Reactions | AC Includes pooled data from patients who received either AC for 4 cycles or AC for 4… % | Conventional CMF N = 739 % |
|---|---|---|
| Alopecia | 92 | 71 |
| Vomiting ≤12 hours | 34 | 25 |
| Vomiting >12 hours | 37 | 12 |
| Intractable | 5 | 2 |
| Grade 3 (1,000–1,999 /mm 3 ) | 3.4 | 9.4 |
| Grade 4 (<1000 /mm 3 ) | 0.3 | 0.3 |
| Shock, sepsis | 2 | 1 |
| Systemic infection | 2 | 1 |
| Asymptomatic | 0.2 | 0.1 |
| Transient | 0.1 | 0 |
| Symptomatic | 0.1 | 0 |
| Grade 3 (25,000–49,999 /mm 3 ) | 0 | 0.3 |
| Grade 4 (<25,000 /mm 3 ) | 0.1 | 0 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe 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. …
Source: FDA drug label, Pfizer Laboratories Div Pfizer Inc, effective May 5, 2026 (SPL set 1fd148fb-0fbc-4b6f-b790-23546fb46a71), via openFDA; the full label on DailyMed
What do FAERS reports show?
95,404 reports list doxorubicin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 17,874 are coded as a death and 32,622 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 20 reactions below, 9 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Doxorubicin: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions