Daunorubicin hydrochloride adverse event reports that FDA received

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

Name type: Generic name
Class: Anthracycline topoisomerase inhibitor
Also reported as: Daunorubicin Hcl, Daunorubicin Hydrochloride For Injection

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 3,431 adverse event reports that name Daunorubicin hydrochloride. In these reports the drug is a suspect or interacting product.

In the same period, 583 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 118 reports in the 12 months to June 2026 and 155 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, 118 (under 0.1%) name Daunorubicin hydrochloride. Reports from consumers or other non-health professionals were 6.9% of the reports that name Daunorubicin hydrochloride 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 Daunorubicin hydrochloride 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 52 reports that name Daunorubicin hydrochloride.
In January to March 2026, FDA received 23.
In April to June 2025, FDA received 28.

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 450 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 3,369 of the 3,431 reports (98.2%).

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 450 terms.

Reaction terms in the reports that name Daunorubicin hydrochloride, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 3,431 reports
Febrile neutropeniafever with low white blood cells	349	10.2%
Pyrexiafever	280	8.2%
Sepsisa severe body-wide response to infection	216	6.3%
Neutropenialow neutrophils, a type of white blood cell	209	6.1%
Hypotensionlow blood pressure	198	5.8%
Pneumonialung infection	181	5.3%
Bacterial infectiona bacterial infection	178	5.2%
Myelosuppression	159	4.6%
Pancytopenialow counts of all blood cells	143	4.2%
Infectionan infection, type not specified	139	4.1%
Secondary immunodeficiency	130	3.8%
Fungal infectiona fungal infection	120	3.5%
Platelet count decreasedlow platelet count	119	3.5%
Septic shockshock arising from infection	114	3.3%
Clostridium difficile colitisa bowel infection with C. difficile	110	3.2%
Respiratory failurethe lungs could not supply enough oxygen	109	3.2%
Thrombocytopenialow platelets	103	3%
Dyspnoeashortness of breath	99	2.9%
Diarrhoealoose or frequent stools	98	2.9%
Blood bilirubin increased	97	2.8%
White blood cell count decreasedlow white cell count	94	2.7%
Bone marrow failure	93	2.7%
Bronchopulmonary aspergillosis	92	2.7%
Haemoglobin decreasedlow haemoglobin	91	2.7%
Viral infectiona viral infection	88	2.6%
Hypoxialow oxygen	87	2.5%
Nauseafeeling sick	86	2.5%
Off label useused for a purpose or in a way not on the label	86	2.5%
Renal failure acute	85	2.5%
Vomitingbeing sick	84	2.4%
Alanine aminotransferase increasedraised liver enzyme (ALT)	79	2.3%
Pleural effusionfluid around the lung	79	2.3%
Respiratory distressdifficulty breathing	79	2.3%
Renal failurekidney failure	76	2.2%
Cellulitisa skin infection	74	2.2%
Multi-organ failure	74	2.2%
General physical health deteriorationgeneral decline in health	72	2.1%
Product use in unapproved indicationused for a purpose not on the label	72	2.1%
Mucosal inflammation	71	2.1%
Acute respiratory distress syndrome	70	2%
Aspartate aminotransferase increasedraised liver enzyme (AST)	70	2%
Blood culture positive	70	2%
Lymphopenia	68	2%
Acute myeloid leukaemia	65	1.9%
Cytomegalovirus viraemia	65	1.9%
Abdominal painstomach or belly pain	64	1.9%
Tachycardiafast heart rate	63	1.8%
Thymus hypoplasia	63	1.8%
Anaemialow red blood cells	62	1.8%
Deaththe patient died; cause not stated by this term	62	1.8%

Download all 450 terms of Daunorubicin hydrochloride (CSV)

The counts add to more than 3,431 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.

Outcomes by year

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

Outcomes in the reports that name Daunorubicin hydrochloride, 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	66	66	31	4	40	1	0	40	0
2005	199	162	66	17	110	1	0	79	37
2006	130	126	34	5	85	2	0	36	4
2007	235	215	59	6	118	0	0	68	20
2008	166	157	53	16	90	3	0	53	9
2009	277	265	97	16	143	2	0	95	12
2010	268	240	59	15	164	4	0	74	28
2011	230	221	66	31	101	3	0	97	9
2012	334	331	78	35	162	5	2	156	3
2013	57	57	15	7	36	1	0	33	0
2014	25	25	6	4	15	0	0	13	0
2015	34	34	11	5	15	1	0	17	0
2016	29	26	5	8	14	2	1	19	3
2017	52	50	13	3	13	1	0	38	2
2018	109	108	33	9	26	0	0	84	1
2019	126	125	65	11	44	2	2	89	1
2020	135	135	62	18	49	1	1	90	0
2021	166	166	49	39	51	5	0	108	0
2022	183	183	36	36	92	3	1	120	0
2023	198	198	30	39	91	6	2	152	0
2024	200	198	41	27	92	2	0	153	2
2025	122	121	17	19	61	2	0	83	1
2026	90	90	25	16	51	1	0	71	0

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 Daunorubicin hydrochloride, 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 Daunorubicin hydrochloride, by the year in which FDA received them
Year	Reports
2004	60
2005	204
2006	127
2007	241
2008	161
2009	262
2010	286
2011	232
2012	354
2013	54
2014	21
2015	38
2016	35
2017	54
2018	137
2019	129
2020	131
2021	173
2022	175
2023	202
2024	184
2025	96
2026	75

Reports that name Daunorubicin hydrochloride, 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 Daunorubicin hydrochloride
Age	Reports	Share
Under 2	153	4.5%
2 to 11	495	14.4%
12 to 17	230	6.7%
18 to 44	493	14.4%
45 to 64	468	13.6%
65 to 74	212	6.2%
75 and over	31	0.9%
Age not given	1,349	39.3%

Sex of the patient in the reports that name Daunorubicin hydrochloride
Sex	Reports	Share
Female	1,352	39.4%
Male	1,557	45.4%
Unknown or not given	522	15.2%

Type of reporter in the reports that name Daunorubicin hydrochloride
Reporter	Reports	Share
Physician	1,138	33.2%
Pharmacist	97	2.8%
Other health professional	1,103	32.1%
Lawyer	0	0%
Consumer or non-health professional	238	6.9%
Not given	855	24.9%

Age and sex are as the report gives them. The reporter is the primary source in the report. 33.2% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Daunorubicin hydrochloride record
Indication as recorded (MedDRA)	Reports	Share
Acute myeloid leukaemia	887	25.9%
Acute lymphocytic leukaemia	860	25.1%
Chemotherapy	51	1.5%
B precursor type acute leukaemia	48	1.4%
Acute leukaemia	41	1.2%
B-cell type acute leukaemia	37	1.1%

The reporter fills in the indication, and the field is often empty. Each share is of all 3,431 reports.

Drugs in the same reports

Other drugs that the reports of Daunorubicin hydrochloride name, in any role, in order of name
Drug	Reports that name the two
Asparaginase	347
Cyclophosphamide	904
Cytarabine	2,462
Dexamethasone	545
Etoposide	792
Mercaptopurine	515
Methotrexate	1,047
Prednisone	570
Vincristine	571
Vincristine sulfate	967

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

Doxil same class
Doxorubicin same class
Doxorubicin hydrochloride same class
Daunorubicin next in the A to Z list
Daunorubicine next in the A to Z list
Daunomycin next in the A to Z list
Dawnzera next in the A to Z list
DaTscan next in the A to Z list
Daxas next in the A to Z list
Datroway next in the A to Z list
Daxibotulinumtoxin A-Lanm next in the A to Z list
Dasatinib 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 Daunorubicin hydrochlorideThe 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. Daunorubicin hydrochloride: adverse event reports that FDA received. https://reportedreactions.com/drug/daunorubicin-hydrochloride/ 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 Daunorubicin hydrochloride as a suspect or interacting product. The 583 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 Daunorubicin hydrochloride 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 Daunorubicin hydrochloride?

No. It is a count of what people reported to FDA: 3,431 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 (33.2%), other health professional (32.1%) and consumer or non-health professional (6.9%). 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.

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