Holoxan adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Holoxan
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 January 2004 to September 2021, FDA received 1,180 adverse event reports that name Holoxan. The name is as reporters wrote it. In these reports the drug is a suspect or interacting product.

In the same period, 63 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 0 reports in the 12 months to June 2026 and 0 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Reports from consumers or other non-health professionals were 8.7% of the reports that name Holoxan 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 Holoxan 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.

FDA received no report that names Holoxan in April to June 2026, in January to March 2026 or in April to June 2025.

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 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 1,172 of the 1,180 reports (99.3%).

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 122 terms.

Reaction terms in the reports that name Holoxan, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 1,180 reports
Encephalopathy	110	9.3%
Bone marrow failure	82	6.9%
Disease progressionthe disease advanced	82	6.9%
Neutropenialow neutrophils, a type of white blood cell	77	6.5%
Off label useused for a purpose or in a way not on the label	75	6.4%
Febrile neutropeniafever with low white blood cells	59	5%
Myelosuppression	57	4.8%
Deaththe patient died; cause not stated by this term	56	4.7%
Pyrexiafever	52	4.4%
Confusional stateconfusion	50	4.2%
Anaemialow red blood cells	43	3.6%
Disease recurrencethe disease came back	41	3.5%
Thrombocytopenialow platelets	32	2.7%
Febrile bone marrow aplasia	28	2.4%
Acute kidney injurysudden loss of kidney function	27	2.3%
Product use in unapproved indicationused for a purpose not on the label	27	2.3%
Astheniaweakness or lack of energy	26	2.2%
Renal impairmentreduced kidney function	25	2.1%
Sepsisa severe body-wide response to infection	25	2.1%
Somnolencedrowsiness	25	2.1%
Acute myeloid leukaemia	24	2%
Leukopenialow white blood cells	24	2%
Malignant neoplasm progression	24	2%
Septic shockshock arising from infection	24	2%
Renal failurekidney failure	23	1.9%
Nauseafeeling sick	21	1.8%
Cystitis haemorrhagic	20	1.7%
Drug ineffectivethe medicine did not work as expected	19	1.6%
Vomitingbeing sick	19	1.6%
Pancytopenialow counts of all blood cells	16	1.4%
Renal failure acute	16	1.4%
Fatiguetiredness	15	1.3%
Decreased appetitereduced appetite	14	1.2%
Mucosal inflammation	14	1.2%
Pneumonialung infection	14	1.2%
White blood cell count decreasedlow white cell count	14	1.2%
Coma	13	1.1%
Cytopenia	13	1.1%
Toxic encephalopathy	13	1.1%
Cardiac failureheart failure	12	1%
Dehydration	12	1%
Diarrhoealoose or frequent stools	11	0.9%
Erythemaskin redness	11	0.9%
Myoclonus	11	0.9%
Nervous system disorder	11	0.9%
Neurotoxicity	11	0.9%
Aplasia	10	0.8%
Disorientation	10	0.8%
Dyspnoeashortness of breath	10	0.8%
Tremorshaking	10	0.8%

Download all 122 terms of Holoxan (CSV)

The counts add to more than 1,180 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 Holoxan, 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	23	23	3	7	16	1	0	4	0
2005	18	18	4	2	15	0	0	4	0
2006	21	21	2	1	16	1	0	8	0
2007	25	25	4	5	22	0	0	5	0
2008	14	14	2	3	9	0	0	5	0
2009	13	13	4	0	7	0	0	6	0
2010	26	26	6	5	20	2	0	5	0
2011	8	8	0	1	8	1	0	0	0
2012	37	37	10	6	32	0	0	9	0
2013	100	100	19	8	40	2	0	66	0
2014	192	192	140	9	20	2	0	42	0
2015	31	31	5	4	11	1	0	15	0
2016	49	49	8	0	20	3	0	30	0
2017	53	53	2	7	40	3	0	16	0
2018	135	135	36	9	65	2	0	81	0
2019	173	173	20	12	88	5	0	88	0
2020	174	173	11	12	101	3	1	99	1
2021	88	88	8	7	57	1	0	41	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 Holoxan, by the year in which FDA received them

Show the figures of the chart as a table

Reports that name Holoxan, by the year in which FDA received them
Year	Reports
2004	19
2005	15
2006	28
2007	21
2008	18
2009	13
2010	26
2011	10
2012	47
2013	96
2014	187
2015	31
2016	57
2017	56
2018	140
2019	169
2020	166
2021	81

Reports that name Holoxan, 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 Holoxan
Age	Reports	Share
Under 2	21	1.8%
2 to 11	120	10.2%
12 to 17	103	8.7%
18 to 44	302	25.6%
45 to 64	250	21.2%
65 to 74	107	9.1%
75 and over	18	1.5%
Age not given	259	21.9%

Sex of the patient in the reports that name Holoxan
Sex	Reports	Share
Female	430	36.4%
Male	545	46.2%
Unknown or not given	205	17.4%

Type of reporter in the reports that name Holoxan
Reporter	Reports	Share
Physician	517	43.8%
Pharmacist	106	9%
Other health professional	429	36.4%
Lawyer	4	0.3%
Consumer or non-health professional	103	8.7%
Not given	21	1.8%

Age and sex are as the report gives them. The reporter is the primary source in the report. 4.6% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Holoxan record
Indication as recorded (MedDRA)	Reports	Share
Osteosarcoma	96	8.1%
Ewing's sarcoma	93	7.9%
Sarcoma	87	7.4%
Diffuse large b-cell lymphoma	52	4.4%
B-cell lymphoma	37	3.1%
Central nervous system lymphoma	24	2%

The reporter fills in the indication, and the field is often empty. Each share is of all 1,180 reports.

Drugs in the same reports

Other drugs that the reports of Holoxan name, in any role, in order of name
Drug	Reports that name the two
0 9% Sodium Chloride Injection	131
Carboplatin	133
Cisplatin	140
Dexamethasone	112
Doxorubicin	173
Etoposide	398
Mesna	109
Methotrexate	154
Rituximab	94
Vincristine	191

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.

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These links are for navigation. No count selected them.

Official pages

DailyMed labels for HoloxanThe 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. Holoxan: adverse event reports that FDA received. https://reportedreactions.com/drug/holoxan/ 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 Holoxan as a suspect or interacting product. The 63 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 Holoxan 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 Holoxan?

No. It is a count of what people reported to FDA: 1,180 reports from January 2004 to September 2021. 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 (43.8%), other health professional (36.4%) and pharmacist (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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