Mylotarg (gemtuzumab ozogamicin) adverse event reports that FDA received

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

Name type: Brand name
Generic name: Gemtuzumab ozogamicin
Class: CD33-directed immunoconjugate
Also reported as: Mylotarg /01278901/

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 1,818 adverse event reports that name Mylotarg. In these reports the drug is a suspect or interacting product.

In the same period, 104 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 33 reports in the 12 months to June 2026 and 62 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, 33 (under 0.1%) name Mylotarg. Reports from consumers or other non-health professionals were 4.9% of the reports that name Mylotarg 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 Mylotarg 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 7 reports that name Mylotarg.
In January to March 2026, FDA received 11.
In April to June 2025, FDA received 12.

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 216 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 1,816 of the 1,818 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 216 terms.

Reaction terms in the reports that name Mylotarg, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 1,818 reports
Febrile neutropeniafever with low white blood cells	334	18.4%
Pyrexiafever	211	11.6%
Platelet count decreasedlow platelet count	181	10%
Sepsisa severe body-wide response to infection	157	8.6%
White blood cell count decreasedlow white cell count	152	8.4%
Aspartate aminotransferase increasedraised liver enzyme (AST)	138	7.6%
Venoocclusive liver disease	127	7%
Chillschills or shivering	120	6.6%
Thrombocytopenialow platelets	115	6.3%
Infusion related reactiona reaction during or soon after an infusion	112	6.2%
Alanine aminotransferase increasedraised liver enzyme (ALT)	107	5.9%
Blood bilirubin increased	99	5.4%
Neutropenialow neutrophils, a type of white blood cell	95	5.2%
Pneumonialung infection	94	5.2%
Weight increasedweight gain	92	5.1%
Disease progressionthe disease advanced	90	5%
Acute myeloid leukaemia	89	4.9%
Haemoglobin decreasedlow haemoglobin	88	4.8%
Blood alkaline phosphatase increased	86	4.7%
Anaemialow red blood cells	84	4.6%
Neutrophil count decreased	84	4.6%
Hypotensionlow blood pressure	83	4.6%
Pancytopenialow counts of all blood cells	77	4.2%
Nauseafeeling sick	72	4%
Pleural effusionfluid around the lung	67	3.7%
Condition aggravatedthe condition being treated got worse	64	3.5%
Bone marrow failure	62	3.4%
Ascitesfluid in the abdomen	60	3.3%
Disseminated intravascular coagulation	60	3.3%
Diarrhoealoose or frequent stools	58	3.2%
Deaththe patient died; cause not stated by this term	57	3.1%
Dyspnoeashortness of breath	57	3.1%
Blood lactate dehydrogenase increased	55	3%
Renal failurekidney failure	54	3%
Vomitingbeing sick	54	3%
Infectionan infection, type not specified	51	2.8%
Septic shockshock arising from infection	48	2.6%
Multi-organ failure	47	2.6%
Malignant neoplasm progression	43	2.4%
Haematocrit decreased	41	2.3%
Neoplasm progression	41	2.3%
Hypokalaemialow blood potassium	39	2.1%
Respiratory failurethe lungs could not supply enough oxygen	39	2.1%
Hypoxialow oxygen	38	2.1%
Gastrointestinal haemorrhagebleeding in the stomach or bowel	36	2%
Hepatic failureliver failure	35	1.9%
Acute respiratory distress syndrome	34	1.9%
Venoocclusive disease	34	1.9%
Blood creatinine increasedraised creatinine, a kidney test	33	1.8%
Painpain, site not specified	32	1.8%

Download all 216 terms of Mylotarg (CSV)

The counts add to more than 1,818 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 Gemtuzumab ozogamicin with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Gemtuzumab ozogamicin	Generic name	1,560
Mylotarg (this page)	Brand name	1,818

Sum of the separately reported names: 3,378. 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 Mylotarg, 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	126	126	49	18	83	2	53	0
2005	101	98	35	18	63	1	51	3
2006	281	278	93	85	181	2	127	3
2007	151	140	52	48	95	3	80	11
2008	66	65	18	22	38	1	40	1
2009	70	69	24	13	37	1	29	1
2010	41	37	18	4	18	0	21	4
2011	48	44	17	10	22	1	22	4
2012	34	34	6	4	15	0	19	0
2013	30	29	14	8	14	1	11	1
2014	27	26	5	3	7	0	19	1
2015	35	35	12	8	18	3	17	0
2016	33	32	7	6	18	1	19	1
2017	60	54	13	11	28	2	29	6
2018	119	86	48	2	25	0	34	33
2019	107	102	33	7	36	0	59	5
2020	55	54	21	5	21	0	29	1
2021	125	123	33	24	59	0	61	2
2022	111	106	23	14	39	2	57	5
2023	71	71	17	20	32	2	33	0
2024	43	39	11	9	23	0	14	4
2025	64	62	16	9	36	1	35	2
2026	20	20	6	1	6	3	13	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 Mylotarg, 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 Mylotarg, by the year in which FDA received them
Year	Reports
2004	102
2005	111
2006	291
2007	152
2008	66
2009	66
2010	48
2011	67
2012	44
2013	22
2014	23
2015	37
2016	30
2017	55
2018	126
2019	96
2020	56
2021	144
2022	91
2023	73
2024	40
2025	57
2026	18

Reports that name Mylotarg, 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 Mylotarg
Age	Reports	Share
Under 2	16	0.9%
2 to 11	61	3.4%
12 to 17	56	3.1%
18 to 44	248	13.6%
45 to 64	490	27%
65 to 74	309	17%
75 and over	153	8.4%
Age not given	485	26.7%

Sex of the patient in the reports that name Mylotarg
Sex	Reports	Share
Female	749	41.2%
Male	912	50.2%
Unknown or not given	157	8.6%

Type of reporter in the reports that name Mylotarg
Reporter	Reports	Share
Physician	766	42.1%
Pharmacist	114	6.3%
Other health professional	359	19.7%
Lawyer	0	0%
Consumer or non-health professional	89	4.9%
Not given	490	27%

Age and sex are as the report gives them. The reporter is the primary source in the report. 41.1% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Mylotarg record
Indication as recorded (MedDRA)	Reports	Share
Acute myeloid leukaemia	1,100	60.5%
Acute myeloid leukaemia recurrent	161	8.9%
Acute leukaemia	40	2.2%
Myelodysplastic syndrome	20	1.1%
Acute promyelocytic leukaemia	16	0.9%
Acute myeloid leukaemia refractory	8	0.4%

The reporter fills in the indication, and the field is often empty. Each share is of all 1,818 reports.

Drugs in the same reports

Other drugs that the reports of Mylotarg name, in any role, in order of name
Drug	Reports that name the two
Acetaminophen	90
Acyclovir	115
Allopurinol	129
Cytarabine	636
Daunorubicin	222
Daunorubicin hydrochloride	154
Diflucan	91
Etoposide	90
Fluconazole	59
Vancomycin	100

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

Gemtuzumab ozogamicin same ingredient
Myleran next in the A to Z list
Myobloc next in the A to Z list
Myfortic next in the A to Z list
Myocet next in the A to Z list
Myfenax next in the A to Z list
Myochrysine next in the A to Z list
Myfembree next in the A to Z list
Myorisan next in the A to Z list
Mydayis next in the A to Z list
Myoview next in the A to Z list
Mycophenolic acid 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 MylotargThe 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. Mylotarg: adverse event reports that FDA received. https://reportedreactions.com/drug/mylotarg/ 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 Mylotarg as a suspect or interacting product. The 104 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 Mylotarg 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 Mylotarg?

No. It is a count of what people reported to FDA: 1,818 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 (42.1%), other health professional (19.7%) and pharmacist (6.3%). 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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