Idarubicin adverse event reports that FDA received

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

Name type: Product name as reported

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 August 2004 to June 2026, FDA received 3,458 adverse event reports that name Idarubicin. The name is as reporters wrote it. In these reports the drug is a suspect or interacting product.

In the same period, 1,116 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 195 reports in the 12 months to June 2026 and 312 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, 195 (under 0.1%) name Idarubicin. Reports from consumers or other non-health professionals were 5.8% of the reports that name Idarubicin 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 Idarubicin 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 61 reports that name Idarubicin.
In January to March 2026, FDA received 27.
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 395 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 3,441 of the 3,458 reports (99.5%).

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 395 terms.

Reaction terms in the reports that name Idarubicin, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 3,458 reports
Febrile neutropeniafever with low white blood cells	529	15.3%
Off label useused for a purpose or in a way not on the label	356	10.3%
Neutropenialow neutrophils, a type of white blood cell	328	9.5%
Drug ineffectivethe medicine did not work as expected	288	8.3%
Thrombocytopenialow platelets	269	7.8%
Sepsisa severe body-wide response to infection	248	7.2%
Pancytopenialow counts of all blood cells	228	6.6%
Pyrexiafever	221	6.4%
Septic shockshock arising from infection	181	5.2%
Pneumonialung infection	176	5.1%
Acute myeloid leukaemia	165	4.8%
Product use in unapproved indicationused for a purpose not on the label	157	4.5%
Deaththe patient died; cause not stated by this term	153	4.4%
Mucosal inflammation	144	4.2%
Diarrhoealoose or frequent stools	135	3.9%
Respiratory failurethe lungs could not supply enough oxygen	114	3.3%
Anaemialow red blood cells	112	3.2%
Acute myeloid leukaemia recurrent	109	3.2%
Infectionan infection, type not specified	108	3.1%
Bone marrow failure	101	2.9%
Multiple organ dysfunction syndromeseveral organs failing	95	2.7%
Myelodysplastic syndrome	84	2.4%
Acute kidney injurysudden loss of kidney function	81	2.3%
Bronchopulmonary aspergillosis	76	2.2%
Disease progressionthe disease advanced	74	2.1%
Fungal infectiona fungal infection	72	2.1%
Headachehead pain	68	2%
Renal failurekidney failure	66	1.9%
Myelosuppression	64	1.9%
Hypotensionlow blood pressure	62	1.8%
Leukaemia recurrent	59	1.7%
Colitisinflamed bowel	55	1.6%
Drug resistance	55	1.6%
Neutropenic sepsis	55	1.6%
Condition aggravatedthe condition being treated got worse	52	1.5%
Graft versus host disease	52	1.5%
Haemorrhagebleeding	52	1.5%
Nauseafeeling sick	52	1.5%
Aspergillus infection	51	1.5%
Bacteraemia	50	1.4%
Mucormycosis	50	1.4%
Rash maculo-papulara rash of flat and raised spots	50	1.4%
Vomitingbeing sick	50	1.4%
Abdominal painstomach or belly pain	49	1.4%
Fusarium infection	49	1.4%
Dyspnoeashortness of breath	47	1.4%
Pneumonia fungal	46	1.3%
Cytomegalovirus infection reactivation	45	1.3%
Acute respiratory distress syndrome	44	1.3%
Pleural effusionfluid around the lung	44	1.3%

Download all 395 terms of Idarubicin (CSV)

The counts add to more than 3,458 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 Idarubicin, 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	2	2	0	0	0	0	0	2	0
2005	3	3	1	0	0	0	0	2	0
2009	2	2	1	0	0	0	0	2	0
2010	10	10	5	2	5	1	0	2	0
2011	24	24	15	2	7	0	0	14	0
2012	29	29	8	7	20	0	0	15	0
2013	143	140	49	45	80	3	0	72	3
2014	197	193	67	30	126	1	0	62	4
2015	222	217	57	45	87	2	0	104	5
2016	183	183	55	17	59	1	0	121	0
2017	286	283	87	28	72	4	0	197	3
2018	512	507	132	90	149	4	1	393	5
2019	238	237	71	39	115	3	1	177	1
2020	273	272	63	34	106	4	0	195	1
2021	204	200	42	23	81	7	0	142	4
2022	234	233	60	26	86	3	0	169	1
2023	222	222	60	33	86	1	0	163	0
2024	324	302	67	27	101	1	0	239	22
2025	232	231	49	51	100	4	0	195	1
2026	118	118	30	6	32	0	0	93	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 Idarubicin, 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 Idarubicin, by the year in which FDA received them
Year	Reports
2004	2
2005	3
2007	3
2008	5
2009	2
2010	9
2011	42
2012	44
2013	136
2014	203
2015	220
2016	188
2017	349
2018	503
2019	239
2020	301
2021	198
2022	220
2023	195
2024	326
2025	182
2026	88

Reports that name Idarubicin, 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 Idarubicin
Age	Reports	Share
Under 2	49	1.4%
2 to 11	266	7.7%
12 to 17	146	4.2%
18 to 44	724	20.9%
45 to 64	1,013	29.3%
65 to 74	415	12%
75 and over	75	2.2%
Age not given	770	22.3%

Sex of the patient in the reports that name Idarubicin
Sex	Reports	Share
Female	1,346	38.9%
Male	1,552	44.9%
Unknown or not given	560	16.2%

Type of reporter in the reports that name Idarubicin
Reporter	Reports	Share
Physician	1,185	34.3%
Pharmacist	71	2.1%
Other health professional	1,924	55.6%
Lawyer	0	0%
Consumer or non-health professional	199	5.8%
Not given	79	2.3%

Age and sex are as the report gives them. The reporter is the primary source in the report. 25% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Idarubicin record
Indication as recorded (MedDRA)	Reports	Share
Acute myeloid leukaemia	1,571	45.4%
Acute promyelocytic leukaemia	327	9.5%
Acute lymphocytic leukaemia	237	6.9%
Chemotherapy	67	1.9%
Myelodysplastic syndrome	44	1.3%
B-cell type acute leukaemia	40	1.2%

The reporter fills in the indication, and the field is often empty. Each share is of all 3,458 reports.

Drugs in the same reports

Other drugs that the reports of Idarubicin name, in any role, in order of name
Drug	Reports that name the two
Cyclophosphamide	588
Cytarabine	2,638
Daunorubicin	322
Dexamethasone	509
Etoposide	634
Fludarabine	904
Methotrexate	671
Mitoxantrone	360
Venetoclax	293
Vincristine	443

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

Icy Hot Medicated No Mess Applicator next in the A to Z list
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Icosapent ethyl next in the A to Z list
Idelalisib next in the A to Z list
Icodextrin next in the A to Z list
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Iclusig next in the A to Z list
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Idursulfase next in the A to Z list

These links are for navigation. No count selected them.

Official pages

DailyMed labels for IdarubicinThe 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. Idarubicin: adverse event reports that FDA received. https://reportedreactions.com/drug/idarubicin/ 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 Idarubicin as a suspect or interacting product. The 1,116 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 Idarubicin 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 Idarubicin?

No. It is a count of what people reported to FDA: 3,458 reports from August 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 (55.6%), physician (34.3%) and consumer or non-health professional (5.8%). 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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