Arsenic trioxide adverse event reports that FDA received

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

Name type: Generic name
Also reported as: Arsenic Trioxide 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.

Reports on file

From April 2004 to June 2026, FDA received 1,022 adverse event reports that name Arsenic trioxide. In these reports the drug is a suspect or interacting product.

In the same period, 151 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 98 reports in the 12 months to June 2026 and 110 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 Arsenic trioxide 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 15 reports that name Arsenic trioxide.
In January to March 2026, FDA received 20.
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 110 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 1,000 of the 1,022 reports (97.8%).

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 110 terms.

Reaction terms in the reports that name Arsenic trioxide, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 1,022 reports
Differentiation syndrome	168	16.4%
Off label useused for a purpose or in a way not on the label	126	12.3%
Electrocardiogram QT prolongeda QT prolongation on the ECG	107	10.5%
Drug ineffectivethe medicine did not work as expected	44	4.3%
Idiopathic intracranial hypertension	33	3.2%
Acute kidney injurysudden loss of kidney function	32	3.1%
Neutropenialow neutrophils, a type of white blood cell	31	3%
Acute promyelocytic leukaemia differentiation syndrome	29	2.8%
Pyrexiafever	29	2.8%
Diarrhoealoose or frequent stools	27	2.6%
Leukaemia recurrent	27	2.6%
Anaemialow red blood cells	26	2.5%
Febrile neutropeniafever with low white blood cells	26	2.5%
Thrombocytopenialow platelets	25	2.4%
Pneumonialung infection	24	2.3%
Respiratory failurethe lungs could not supply enough oxygen	24	2.3%
Deaththe patient died; cause not stated by this term	23	2.3%
Fatiguetiredness	23	2.3%
Hypotensionlow blood pressure	23	2.3%
White blood cell count increased	23	2.3%
Dyspnoeashortness of breath	22	2.2%
Intentional product use issuedeliberate use not as intended	22	2.2%
Myelodysplastic syndrome transformation	22	2.2%
Pericarditisinflammation of the sac around the heart	22	2.2%
Hyperleukocytosis	21	2.1%
Product use in unapproved indicationused for a purpose not on the label	21	2.1%
Hypokalaemialow blood potassium	20	2%
Neuropathy peripheralnerve damage in hands or feet	19	1.9%
Nauseafeeling sick	18	1.8%
Acute myeloid leukaemia	17	1.7%
Headachehead pain	17	1.7%
Neurotoxicity	17	1.7%
Vomitingbeing sick	17	1.7%
Lymphopenia	16	1.6%
Activated partial thromboplastin time prolonged	15	1.5%
Drug interactionan interaction between medicines	15	1.5%
Disease progressionthe disease advanced	14	1.4%
Pericardial effusionfluid around the heart	14	1.4%
Toxicity to various agentspoisoning or toxic effect of one or more substances	14	1.4%
Cardiac arrestthe heart stopped	13	1.3%
Disseminated intravascular coagulation	13	1.3%
Haematopoietic neoplasm	13	1.3%
Hepatotoxicityliver injury	13	1.3%
Bone marrow necrosis	12	1.2%
Drug resistance	12	1.2%
Pleural effusionfluid around the lung	12	1.2%
Second primary malignancy	12	1.2%
Acute promyelocytic leukaemia	11	1.1%
Disturbance in attentiondifficulty concentrating	11	1.1%
Intracranial pressure increased	11	1.1%

Download all 110 terms of Arsenic trioxide (CSV)

The counts add to more than 1,022 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 Arsenic trioxide with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Arsenic trioxide (this page)	Generic name	1,022
Trisenox	Brand name	1,096

Sum of the separately reported names: 2,118. 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 Arsenic trioxide, 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	Other Serious (Important Medical Events)	Not serious
2004	6	5	1	0	4	0	0	1
2005	23	22	6	3	13	0	10	1
2006	28	28	6	5	17	0	12	0
2007	13	13	6	3	5	1	5	0
2008	26	26	4	1	21	0	4	0
2009	32	30	6	0	21	0	5	2
2010	2	2	0	0	0	0	2	0
2011	29	28	6	0	16	1	10	1
2012	18	18	0	1	6	0	12	0
2013	8	8	3	1	3	0	4	0
2014	13	13	4	1	3	0	8	0
2015	13	13	4	0	0	0	11	0
2016	19	19	1	1	6	1	15	0
2017	39	39	3	2	4	0	38	0
2018	123	121	22	16	6	0	105	2
2019	52	52	10	0	21	0	39	0
2020	83	78	5	2	14	0	67	5
2021	69	69	12	4	20	0	55	0
2022	93	93	7	5	35	0	57	0
2023	63	62	4	15	20	1	48	1
2024	107	106	7	11	46	3	85	1
2025	120	119	27	3	42	2	94	1
2026	43	43	5	2	27	0	30	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 Arsenic trioxide, 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 Arsenic trioxide, by the year in which FDA received them
Year	Reports
2004	6
2005	21
2006	29
2007	13
2008	27
2009	32
2010	2
2011	27
2012	22
2013	9
2014	15
2015	13
2016	14
2017	41
2018	134
2019	65
2020	72
2021	65
2022	95
2023	62
2024	107
2025	116
2026	35

Reports that name Arsenic trioxide, 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 Arsenic trioxide
Age	Reports	Share
Under 2	0	0%
2 to 11	28	2.7%
12 to 17	49	4.8%
18 to 44	239	23.4%
45 to 64	206	20.2%
65 to 74	121	11.8%
75 and over	75	7.3%
Age not given	304	29.7%

Sex of the patient in the reports that name Arsenic trioxide
Sex	Reports	Share
Female	376	36.8%
Male	397	38.8%
Unknown or not given	249	24.4%

Type of reporter in the reports that name Arsenic trioxide
Reporter	Reports	Share
Physician	294	28.8%
Pharmacist	21	2.1%
Other health professional	628	61.4%
Lawyer	0	0%
Consumer or non-health professional	41	4%
Not given	38	3.7%

Age and sex are as the report gives them. The reporter is the primary source in the report. 41.7% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Arsenic trioxide record
Indication as recorded (MedDRA)	Reports	Share
Acute promyelocytic leukaemia	633	61.9%
Acute myeloid leukaemia	44	4.3%
Myelodysplastic syndrome	30	2.9%
Colorectal cancer metastatic	15	1.5%
Ewing's sarcoma	10	1%
Leukaemia recurrent	10	1%

The reporter fills in the indication, and the field is often empty. Each share is of all 1,022 reports.

Pages near this one

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These links are for navigation. No count selected them.

Official pages

DailyMed labels for Arsenic trioxideThe 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. Arsenic trioxide: adverse event reports that FDA received. https://reportedreactions.com/drug/arsenic-trioxide/ 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 Arsenic trioxide as a suspect or interacting product. The 151 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 Arsenic trioxide 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 Arsenic trioxide?

No. It is a count of what people reported to FDA: 1,022 reports from April 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 (61.4%), physician (28.8%) 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.

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