Doxil (doxorubicin hydrochloride) adverse event reports that FDA received

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

Name type: Brand name
Generic name: Doxorubicin hydrochloride
Class: Anthracycline topoisomerase inhibitor
Also reported as: Doxil /00330902/, Doxil /00330904/, Doxil /00055703/

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.

Drug reports received through 30 Jun 2026. Device reports have a separate cutoff, 30 Sep 2026. Why a report count is not a rate.

Reports on file

From January 2004 to June 2026, FDA received 4,921 adverse event reports that name Doxil. In these reports the drug is a suspect or interacting product.

In the same period, 1,955 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 28 reports in the 12 months to June 2026 and 54 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 28 (under 0.1%) name Doxil. Reports from consumers or other non-health professionals were 12.7% of the reports that name Doxil and 45.8% of all drug reports.

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 Doxil 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 29 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.

The latest update of the FDA data, recorded on 28 Oct 2026, changed no count of this page.

In April to June 2026, FDA received 6 reports that name Doxil.
In January to March 2026, FDA received 6.
In April to June 2025, FDA received 11.

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 401 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 4,915 of the 4,921 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 401 terms.

Reaction terms in the reports that name Doxil, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 4,921 reports
Febrile neutropeniafever with low white blood cells	376	7.6%
Nauseafeeling sick	320	6.5%
Off label useused for a purpose or in a way not on the label	275	5.6%
Vomitingbeing sick	262	5.3%
Interstitial lung diseasescarring or inflammation of lung tissue	245	5%
Neutropenialow neutrophils, a type of white blood cell	238	4.8%
Fatiguetiredness	227	4.6%
Pyrexiafever	220	4.5%
Anaemialow red blood cells	203	4.1%
Dyspnoeashortness of breath	189	3.8%
Palmar-plantar erythrodysaesthesia syndrome	186	3.8%
Product use in unapproved indicationused for a purpose not on the label	178	3.6%
Disease progressionthe disease advanced	166	3.4%
Pneumonialung infection	159	3.2%
Deaththe patient died; cause not stated by this term	155	3.1%
Diarrhoealoose or frequent stools	144	2.9%
Sepsisa severe body-wide response to infection	143	2.9%
Thrombocytopenialow platelets	142	2.9%
Astheniaweakness or lack of energy	141	2.9%
Malignant neoplasm progression	140	2.8%
Pancytopenialow counts of all blood cells	127	2.6%
Back pain	125	2.5%
Infusion related reactiona reaction during or soon after an infusion	117	2.4%
Rashskin rash	112	2.3%
Abdominal painstomach or belly pain	111	2.3%
Pleural effusionfluid around the lung	111	2.3%
Stomatitissore mouth	105	2.1%
Drug ineffectivethe medicine did not work as expected	98	2%
Mucosal inflammation	96	2%
Neuropathy peripheralnerve damage in hands or feet	96	2%
Painpain, site not specified	93	1.9%
Platelet count decreasedlow platelet count	87	1.8%
White blood cell count decreasedlow white cell count	86	1.7%
Hypotensionlow blood pressure	84	1.7%
Constipation	81	1.6%
Cardiac failureheart failure	77	1.6%
Dehydration	75	1.5%
Hypertensionhigh blood pressure	74	1.5%
Pulmonary embolisma blood clot in the lung	71	1.4%
Haemoglobin decreasedlow haemoglobin	70	1.4%
Myelodysplastic syndrome	69	1.4%
Leukopenialow white blood cells	68	1.4%
Malaisegeneral feeling of being unwell	68	1.4%
Respiratory failurethe lungs could not supply enough oxygen	66	1.3%
Dizzinesslight-headedness or unsteadiness	65	1.3%
Neutrophil count decreased	61	1.2%
General physical health deteriorationgeneral decline in health	59	1.2%
Alopeciahair loss	57	1.2%
Headachehead pain	57	1.2%
Small intestinal obstruction	56	1.1%

Download all 401 terms of Doxil (CSV)

The counts add to more than 4,921 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	Generic name	54,401
Doxorubicin hydrochloride	Generic name	35,913
Doxil (this page)	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 Doxil, 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	131	125	44	7	47	0	0	56	6
2005	189	182	49	12	91	3	0	84	7
2006	146	143	33	13	101	3	0	45	3
2007	132	126	18	11	93	1	0	35	6
2008	147	142	17	1	77	4	0	69	5
2009	173	161	26	11	108	4	0	65	12
2010	179	171	23	6	57	6	0	113	8
2011	145	137	22	13	66	5	0	80	8
2012	46	45	20	8	26	1	0	22	1
2013	59	53	16	3	16	1	0	24	6
2014	63	59	15	6	33	1	0	36	4
2015	407	192	20	8	57	2	0	142	215
2016	182	132	28	5	68	2	0	60	50
2017	175	126	18	10	63	3	0	64	49
2018	125	82	14	7	43	9	0	47	43
2019	494	452	62	33	192	8	3	301	42
2020	1,271	1,256	199	85	371	15	1	934	15
2021	556	543	75	54	226	7	0	374	13
2022	91	84	13	8	35	2	0	56	7
2023	63	58	16	13	26	5	0	51	5
2024	71	64	10	5	37	3	0	57	7
2025	64	63	10	4	27	0	0	58	1
2026	12	10	0	0	4	0	0	9	2

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 Doxil, 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 Doxil, by the year in which FDA received them
Year	Reports
2004	54
2005	197
2006	214
2007	128
2008	151
2009	175
2010	184
2011	159
2012	57
2013	61
2014	55
2015	406
2016	176
2017	183
2018	118
2019	567
2020	1,262
2021	535
2022	77
2023	56
2024	57
2025	37
2026	12

Reports that name Doxil, 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 Doxil
Age	Reports	Share
Under 2	16	0.3%
2 to 11	64	1.3%
12 to 17	56	1.1%
18 to 44	464	9.4%
45 to 64	1,281	26%
65 to 74	788	16%
75 and over	408	8.3%
Age not given	1,844	37.5%

Sex of the patient in the reports that name Doxil
Sex	Reports	Share
Female	2,816	57.2%
Male	1,379	28%
Unknown or not given	726	14.8%

Type of reporter in the reports that name Doxil
Reporter	Reports	Share
Physician	2,084	42.3%
Pharmacist	421	8.6%
Other health professional	1,480	30.1%
Lawyer	28	0.6%
Consumer or non-health professional	623	12.7%
Not given	285	5.8%

Age and sex are as the report gives them. The reporter is the primary source in the report. 50.1% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Doxil record
Indication as recorded (MedDRA)	Reports	Share
Ovarian cancer	487	9.9%
Diffuse large b-cell lymphoma	441	9%
Multiple myeloma	308	6.3%
Plasma cell myeloma	194	3.9%
Breast cancer	192	3.9%
Ovarian cancer recurrent	115	2.3%

The reporter fills in the indication, and the field is often empty. Each share is of all 4,921 reports.

Drugs in the same reports

Other drugs that the reports of Doxil name, in any role, in order of name
Drug	Reports that name the two
Carboplatin	334
Cyclophosphamide	709
Dexamethasone	601
Etoposide	419
Prednisone	853
Procytox 2000mg/Vial	344
Rituximab	933
Velcade	406
Vincristine	894
Vincristine sulfate	613

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 same ingredient
Doxorubicin hydrochloride same ingredient
Daunorubicin hydrochloride same class
Ellence same class
Doxepin hydrochloride next in the A to Z list
Doxepin hcl next in the A to Z list
Doxepin next in the A to Z list
Doxorubicin Hydrochloride Liposome Injection 20 Mg/10 Ml and next in the A to Z list
Doxazosin mesylate next in the A to Z list
Doxorubicine next in the A to Z list
Doxazosin Mesilate next in the A to Z list
Doxorubicine Teva 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 DoxilThe 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. Doxil: adverse event reports that FDA received. https://reportedreactions.com/drug/doxil/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 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 29 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 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Doxil as a suspect or interacting product. The 1,955 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 Doxil 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 Doxil?

No. It is a count of what people reported to FDA: 4,921 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?

Physician (42.3%), other health professional (30.1%) and consumer or non-health professional (12.7%). 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