Doxorubicin adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Doxorubicin
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Generic name
Class: Anthracycline topoisomerase inhibitor
Also reported as: Doxorubicin Injection, Doxorubicin /00330902/, Doxorubicin Nos

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

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.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Reports on file

From January 2004 to June 2026, FDA received 54,401 adverse event reports that name Doxorubicin. In these reports the drug is a suspect or interacting product.

In the same period, 10,697 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 4,879 reports in the 12 months to June 2026 and 5,442 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Doxorubicin is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

openFDA FAERS release of 1 Oct 2026. Reports received through 30 Jun 2026.

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

No update is on record for this page. The record starts when FDA adds the reports of July to September 2026.

In April to June 2026, FDA received 1,229 reports that name Doxorubicin.
In January to March 2026, FDA received 1,136.
In April to June 2025, FDA received 1,146.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 2,122 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for 54,353 of the 54,401 reports (99.9%).

The reports of the other years are not in the counts.

So a count in the table can be lower than the count of FDA.

Find a reaction term

The table shows the first 50 of 2,122 terms.

Reaction terms in the reports that name Doxorubicin, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 54,401 reports
Febrile neutropeniafever with low white blood cells	5,645	10.4%
Disease progressionthe disease advanced	4,724	8.7%
Off label useused for a purpose or in a way not on the label	4,622	8.5%
Neutropenialow neutrophils, a type of white blood cell	4,001	7.4%
Drug ineffectivethe medicine did not work as expected	3,813	7%
Thrombocytopenialow platelets	2,490	4.6%
Anaemialow red blood cells	2,324	4.3%
Pyrexiafever	2,230	4.1%
Deaththe patient died; cause not stated by this term	1,861	3.4%
Sepsisa severe body-wide response to infection	1,859	3.4%
Pneumonialung infection	1,807	3.3%
Nauseafeeling sick	1,664	3.1%
Diarrhoealoose or frequent stools	1,563	2.9%
Pancytopenialow counts of all blood cells	1,425	2.6%
Malignant neoplasm progression	1,405	2.6%
Infectionan infection, type not specified	1,401	2.6%
Vomitingbeing sick	1,371	2.5%
Product use in unapproved indicationused for a purpose not on the label	1,359	2.5%
Mucosal inflammation	1,303	2.4%
Fatiguetiredness	1,275	2.3%
Neuropathy peripheralnerve damage in hands or feet	1,250	2.3%
Leukopenialow white blood cells	1,146	2.1%
Septic shockshock arising from infection	1,047	1.9%
Dyspnoeashortness of breath	1,034	1.9%
Haematotoxicity	954	1.8%
Acute myeloid leukaemia	911	1.7%
Toxicity to various agentspoisoning or toxic effect of one or more substances	869	1.6%
Cardiotoxicity	851	1.6%
Covid-19COVID-19 infection	851	1.6%
Acute kidney injurysudden loss of kidney function	838	1.5%
Myelodysplastic syndrome	798	1.5%
Respiratory failurethe lungs could not supply enough oxygen	789	1.5%
Disease recurrencethe disease came back	773	1.4%
Cardiac failureheart failure	767	1.4%
Astheniaweakness or lack of energy	730	1.3%
Diffuse large B-cell lymphoma	726	1.3%
Abdominal painstomach or belly pain	716	1.3%
Diffuse large B-cell lymphoma recurrent	704	1.3%
Therapy partial responder	700	1.3%
Cytokine release syndrome	697	1.3%
General physical health deteriorationgeneral decline in health	690	1.3%
Product use issuea problem in how the product was used	677	1.2%
Condition aggravatedthe condition being treated got worse	652	1.2%
Hypotensionlow blood pressure	608	1.1%
Bone marrow failure	604	1.1%
Stomatitissore mouth	593	1.1%
Constipation	592	1.1%
Tumour lysis syndrome	583	1.1%
Myelosuppression	577	1.1%
Pulmonary embolisma blood clot in the lung	562	1%

Download all 2,122 terms of Doxorubicin (CSV)

The counts add to more than 54,401 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Same ingredient, other names

Reporters write a brand name or a generic name. Each name has its own page and its own count.

Names of Doxorubicin with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Doxorubicin (this page)	Generic name	54,401
Doxorubicin hydrochloride	Generic name	35,913
Doxil	Brand name	4,921

Sum of the separately reported names: 95,235. A report that names two of these names is in the sum two times. The sum is not the number of reports for the ingredient.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Doxorubicin, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Congenital Anomaly/Birth Defect	Other Serious (Important Medical Events)	Not serious
2004	55	53	15	8	30	0	0	14	2
2005	176	162	50	5	89	2	0	80	14
2006	95	86	32	6	47	0	0	25	9
2007	38	38	5	3	20	0	0	17	0
2008	23	23	4	0	6	0	0	16	0
2009	54	53	9	4	35	0	0	16	1
2010	131	131	38	5	51	4	0	61	0
2011	385	385	67	11	85	3	2	285	0
2012	811	809	182	36	361	13	6	412	2
2013	2,574	2,562	846	123	748	34	9	1,353	12
2014	2,335	2,315	835	70	589	21	3	1,284	20
2015	2,741	2,625	582	126	772	35	11	1,770	116
2016	2,399	2,372	540	151	751	25	1	1,628	27
2017	3,016	2,937	586	288	927	21	13	2,211	79
2018	4,054	4,017	792	349	1,436	43	15	2,888	37
2019	3,298	3,232	611	243	1,087	24	14	2,364	66
2020	3,800	3,758	799	282	1,193	34	12	2,757	42
2021	3,387	3,323	634	341	1,272	34	19	2,364	64
2022	4,768	4,697	895	401	1,560	29	15	3,492	71
2023	6,186	6,120	999	485	1,878	59	11	4,898	66
2024	5,804	5,471	986	567	1,986	59	10	4,430	333
2025	5,346	5,247	918	583	1,864	41	17	4,266	99
2026	2,925	2,860	607	286	1,020	30	5	2,313	65

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Doxorubicin, by the year in which FDA received them

The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.

Show the figures of the chart as a table

Reports that name Doxorubicin, by the year in which FDA received them
Year	Reports
2004	48
2005	176
2006	101
2007	45
2008	31
2009	55
2010	141
2011	476
2012	1,035
2013	2,655
2014	2,432
2015	2,856
2016	2,507
2017	3,088
2018	4,223
2019	3,549
2020	3,870
2021	3,388
2022	4,784
2023	6,186
2024	5,618
2025	4,772
2026	2,365

Reports that name Doxorubicin, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Doxorubicin
Age	Reports	Share
Under 2	491	0.9%
2 to 11	2,203	4%
12 to 17	1,737	3.2%
18 to 44	7,720	14.2%
45 to 64	12,886	23.7%
65 to 74	7,313	13.4%
75 and over	3,367	6.2%
Age not given	18,684	34.3%

Sex of the patient in the reports that name Doxorubicin
Sex	Reports	Share
Female	20,902	38.4%
Male	19,578	36%
Unknown or not given	13,921	25.6%

Type of reporter in the reports that name Doxorubicin
Reporter	Reports	Share
Physician	24,568	45.2%
Pharmacist	1,663	3.1%
Other health professional	25,136	46.2%
Lawyer	125	0.2%
Consumer or non-health professional	2,154	4%
Not given	755	1.4%

Age and sex are as the report gives them. The reporter is the primary source in the report. 25.1% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Doxorubicin record
Indication as recorded (MedDRA)	Reports	Share
Diffuse large b-cell lymphoma	11,022	20.3%
Hodgkin's disease	2,586	4.8%
B-cell lymphoma	2,455	4.5%
Breast cancer	2,222	4.1%
Non-hodgkin's lymphoma	1,569	2.9%
Acute lymphocytic leukaemia	1,484	2.7%

The reporter fills in the indication, and the field is often empty. Each share is of all 54,401 reports.

Drugs in the same reports

Other drugs that the reports of Doxorubicin name, in any role, in order of name
Drug	Reports that name the two
Cisplatin	7,400
Cyclophosphamide	37,494
Cytarabine	8,050
Dexamethasone	11,350
Etoposide	13,583
Methotrexate	8,486
Prednisolone	8,839
Prednisone	20,480
Rituximab	22,824
Vincristine	30,388

The table has the 10 drug names that these reports name most. Two names in one report says only that the report recorded the two. It says nothing about the part of a product in the event.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Pages near this one

Doxorubicin hydrochloride same ingredient
Doxil same ingredient
Daunorubicin hydrochloride same class
Ellence same class
Epirubicin hydrochloride same class
Doxepin hydrochloride next in the A to Z list
Doxorubicin Hydrochloride Liposome Injection 20 Mg/10 Ml and next in the A to Z list
Doxepin hcl next in the A to Z list
Doxorubicine next in the A to Z list
Doxepin next in the A to Z list
Doxorubicine Teva next in the A to Z list
Doxazosin mesylate next in the A to Z list

These links are for navigation. No count selected them. The class page lists each drug of the class.

Official pages

DailyMed labels for DoxorubicinThe labels (prescribing information) that have this name, at the National Library of Medicine.
MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Doxorubicin: adverse event reports that FDA received. https://reportedreactions.com/drug/doxorubicin/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 1 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 1 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Oct 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Doxorubicin as a suspect or interacting product. The 10,697 reports that name it only as a concomitant medicine are not in the count. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Do these reports show that Doxorubicin was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Doxorubicin?

No. It is a count of what people reported to FDA: 54,401 reports from January 2004 to June 2026. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Other health professional (46.2%), physician (45.2%) and consumer or non-health professional (4%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.

To the top of the page