Doxorubicin Hydrochloride
According to the FDA label: Doxorubicin hydrochloride liposome injection is an anthracycline topoisomerase inhibitor indicated for: Ovarian cancer: After failure of platinum-based chemotherapy ( 1.1 ) AIDS-related Kaposi's Sarcoma: After failure of prior systemic chemotherapy or intolerance to such therapy ( 1.2 ). Multiple Myeloma: In combination with bortezomib in patients who have not previously received bortezomib and have received at least one prior therapy ( 1.3 ).
86,430 adverse event reports submitted to the FDA (2004–2026)
Top Reported Adverse Events
The most frequently reported events in association with Doxorubicin Hydrochloride in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
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Febrile Neutropenia 8,913 reports
A fever occurring together with a low level of neutrophils, a type of infection-fighting white blood cell. It is taken seriously because infection is harder to fight when these cells are low.
Full definition in the glossary →Off Label Use 8,648 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →Disease Progression 6,354 reports
A report that the underlying condition being treated got worse over time. This describes the course of the illness, not necessarily an effect of the drug.
Full definition in the glossary →Neutropenia 6,298 reports
A low level of neutrophils, a type of white blood cell that fights infection.
Full definition in the glossary →Drug Ineffective 5,092 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Pyrexia 3,981 reports
The medical term for fever, meaning a raised body temperature.
Full definition in the glossary → See all drugs reporting this event →Thrombocytopenia 3,707 reports
A low level of platelets, the blood cells that help with clotting.
Full definition in the glossary →Anaemia 3,704 reports
A condition where there are too few healthy red blood cells to carry enough oxygen, often causing tiredness and paleness. Also spelled anemia in American English.
Full definition in the glossary → See all drugs reporting this event →Nausea 3,100 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Death 3,075 reports
A report that the person died. A death appearing in reports for a drug does not mean the drug caused it. Reports record that a death occurred while the medication was being used, which can happen for many unrelated reasons.
Full definition in the glossary →Product Use in Unapproved Indication 2,960 reports
Using a medication for a condition it is not officially approved to treat. Like off label use, this is a reporting category and does not by itself mean harm occurred.
Full definition in the glossary →Pneumonia 2,793 reports
An infection that inflames the air sacs in the lungs, which can cause cough, fever, and difficulty breathing.
Full definition in the glossary →Sepsis 2,760 reports
A serious, body-wide response to an infection that can become life threatening and needs urgent care.
Full definition in the glossary →Diarrhoea 2,660 reports
Loose or watery bowel movements, often frequent. Also spelled diarrhea in American English.
Full definition in the glossary → See all drugs reporting this event →Vomiting 2,543 reports
Throwing up the contents of the stomach.
Full definition in the glossary → See all drugs reporting this event →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 35,974 |
| Male | 30,684 |
| Unknown | 2,027 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 7,610 |
| 18-34 | 6,574 |
| 35-49 | 9,285 |
| 50-64 | 17,294 |
| 65-74 | 11,696 |
| 75+ | 5,348 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Doxorubicin Hydrochloride. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Other Serious | 59,162 |
| Hospitalization | 29,740 |
| Death | 16,498 |
| Life-Threatening | 6,814 |
| Non-Serious | 3,080 |
| Disability | 960 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Doxorubicin Hydrochloride. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2004 | 232 |
| 2005 | 408 |
| 2006 | 281 |
| 2007 | 441 |
| 2008 | 436 |
| 2009 | 243 |
| 2010 | 366 |
| 2011 | 959 |
| 2012 | 1,764 |
| 2013 | 3,400 |
| 2014 | 2,964 |
| 2015 | 4,015 |
| 2016 | 3,682 |
| 2017 | 4,634 |
| 2018 | 6,758 |
| 2019 | 5,762 |
| 2020 | 6,564 |
| 2021 | 5,774 |
| 2022 | 8,304 |
| 2023 | 10,053 |
| 2024 | 9,572 |
| 2025 | 8,063 |
| 2026 (partial) | 1,755 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Doxorubicin Hydrochloride
In FDA adverse event reports that mention Doxorubicin Hydrochloride, these medications appeared most often in the same report.
- Rituximab (33,559 reports)
- Prednisone (29,957 reports)
- Etoposide (18,920 reports)
- Dexamethasone (17,747 reports)
- Methotrexate (13,196 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026