Gemtuzumab ozogamicin adverse event reports that FDA received

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

Name type: Generic name
Class: CD33-directed immunoconjugate
Also reported as: Gemtuzumab Ozogamicin 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 1,560 adverse event reports that name Gemtuzumab ozogamicin. In these reports the drug is a suspect or interacting product.

In the same period, 271 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 43 reports in the 12 months to June 2026 and 59 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, 43 (under 0.1%) name Gemtuzumab ozogamicin. Reports from consumers or other non-health professionals were 2.6% of the reports that name Gemtuzumab ozogamicin 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 Gemtuzumab ozogamicin 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 12 reports that name Gemtuzumab ozogamicin.
In January to March 2026, FDA received 3.
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 131 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 1,557 of the 1,560 reports (99.8%).

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 131 terms.

Reaction terms in the reports that name Gemtuzumab ozogamicin, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 1,560 reports
Febrile neutropeniafever with low white blood cells	323	20.7%
Sepsisa severe body-wide response to infection	129	8.3%
Venoocclusive liver disease	123	7.9%
Thrombocytopenialow platelets	96	6.2%
Pyrexiafever	95	6.1%
Neutropenialow neutrophils, a type of white blood cell	85	5.4%
Drug ineffectivethe medicine did not work as expected	83	5.3%
Pneumonialung infection	72	4.6%
Off label useused for a purpose or in a way not on the label	59	3.8%
Hypotensionlow blood pressure	51	3.3%
Septic shockshock arising from infection	49	3.1%
Platelet count decreasedlow platelet count	42	2.7%
Alanine aminotransferase increasedraised liver enzyme (ALT)	40	2.6%
Disease progressionthe disease advanced	39	2.5%
Acute myeloid leukaemia	37	2.4%
Multi-organ failure	34	2.2%
Renal failurekidney failure	34	2.2%
Cerebral haemorrhage	33	2.1%
Deaththe patient died; cause not stated by this term	33	2.1%
Respiratory failurethe lungs could not supply enough oxygen	32	2.1%
Bone marrow failure	31	2%
Drug resistance	30	1.9%
Diarrhoealoose or frequent stools	28	1.8%
Chillschills or shivering	27	1.7%
Mucosal inflammation	26	1.7%
Pancytopenialow counts of all blood cells	25	1.6%
Aspartate aminotransferase increasedraised liver enzyme (AST)	24	1.5%
Infectionan infection, type not specified	24	1.5%
White blood cell count decreasedlow white cell count	24	1.5%
Anaemialow red blood cells	23	1.5%
Venoocclusive disease	23	1.5%
Acute kidney injurysudden loss of kidney function	22	1.4%
Acute respiratory distress syndrome	21	1.3%
Bronchopulmonary aspergillosis	20	1.3%
Colitisinflamed bowel	19	1.2%
Haemorrhagebleeding	19	1.2%
Hypoxialow oxygen	19	1.2%
Neutropenic sepsis	19	1.2%
Fungal infectiona fungal infection	18	1.2%
Multiple organ dysfunction syndromeseveral organs failing	18	1.2%
Nauseafeeling sick	18	1.2%
Platelet count increased	18	1.2%
Vomitingbeing sick	18	1.2%
Dyspnoeashortness of breath	16	1%
Haemoglobin decreasedlow haemoglobin	16	1%
Renal failure acute	16	1%
Abdominal painstomach or belly pain	15	1%
Blood bilirubin increased	15	1%
Cardiac arrestthe heart stopped	15	1%
Hepatotoxicityliver injury	15	1%

Download all 131 terms of Gemtuzumab ozogamicin (CSV)

The counts add to more than 1,560 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 (this page)	Generic name	1,560
Mylotarg	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 Gemtuzumab ozogamicin, 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	49	49	17	8	21	1	17	0
2005	65	64	33	8	25	0	20	1
2006	48	48	28	10	18	0	13	0
2007	46	46	33	16	19	0	14	0
2008	52	52	24	18	32	0	21	0
2009	68	68	33	17	36	1	25	0
2010	79	79	46	8	21	1	30	0
2011	117	117	51	29	39	4	42	0
2012	33	32	13	3	23	0	11	1
2013	46	46	16	13	27	1	14	0
2014	31	31	9	8	12	0	18	0
2015	36	36	12	1	15	0	19	0
2016	35	34	8	17	18	3	17	1
2017	50	50	12	12	25	0	24	0
2018	84	84	38	19	23	0	38	0
2019	51	51	10	6	31	1	24	0
2020	112	112	19	19	44	1	70	0
2021	146	146	27	28	74	0	53	0
2022	138	138	28	27	71	0	66	0
2023	119	118	21	31	66	1	57	1
2024	71	71	6	15	38	0	58	0
2025	67	67	17	13	39	0	61	0
2026	17	17	4	1	2	0	14	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 Gemtuzumab ozogamicin, 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 Gemtuzumab ozogamicin, by the year in which FDA received them
Year	Reports
2004	45
2005	65
2006	51
2007	47
2008	52
2009	67
2010	81
2011	126
2012	54
2013	32
2014	23
2015	38
2016	32
2017	58
2018	89
2019	64
2020	124
2021	144
2022	119
2023	110
2024	78
2025	46
2026	15

Reports that name Gemtuzumab ozogamicin, 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 Gemtuzumab ozogamicin
Age	Reports	Share
Under 2	21	1.3%
2 to 11	67	4.3%
12 to 17	64	4.1%
18 to 44	191	12.2%
45 to 64	363	23.3%
65 to 74	166	10.6%
75 and over	42	2.7%
Age not given	646	41.4%

Sex of the patient in the reports that name Gemtuzumab ozogamicin
Sex	Reports	Share
Female	543	34.8%
Male	558	35.8%
Unknown or not given	459	29.4%

Type of reporter in the reports that name Gemtuzumab ozogamicin
Reporter	Reports	Share
Physician	842	54%
Pharmacist	20	1.3%
Other health professional	504	32.3%
Lawyer	0	0%
Consumer or non-health professional	41	2.6%
Not given	153	9.8%

Age and sex are as the report gives them. The reporter is the primary source in the report. 20.6% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Gemtuzumab ozogamicin record
Indication as recorded (MedDRA)	Reports	Share
Acute myeloid leukaemia	1,018	65.3%
Acute myeloid leukaemia refractory	33	2.1%
Myelodysplastic syndrome	32	2.1%
Acute promyelocytic leukaemia	29	1.9%
Acute myeloid leukaemia recurrent	25	1.6%
Acute leukaemia	23	1.5%

The reporter fills in the indication, and the field is often empty. Each share is of all 1,560 reports.

Drugs in the same reports

Other drugs that the reports of Gemtuzumab ozogamicin name, in any role, in order of name
Drug	Reports that name the two
Cyclophosphamide	95
Cytarabine	858
Daunorubicin	205
Daunorubicin hydrochloride	153
Etoposide	237
Fludarabine	132
Mitoxantrone	151
Mitoxantrone hydrochloride	119
Ondansetron	139
Vancomycin	104

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

Mylotarg same ingredient
Gemtesa next in the A to Z list
Gemzar next in the A to Z list
Gemfibrozil next in the A to Z list
Gengraf next in the A to Z list
Gemcitabine/Gemcitabine Hydrochloride next in the A to Z list
Genosyl next in the A to Z list
Gemcitabine hydrochloride next in the A to Z list
Genotropin next in the A to Z list
Gemcitabine hcl next in the A to Z list
Genotropin Mq next in the A to Z list
Gemcitabine 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 Gemtuzumab ozogamicinThe 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. Gemtuzumab ozogamicin: adverse event reports that FDA received. https://reportedreactions.com/drug/gemtuzumab-ozogamicin/ 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 Gemtuzumab ozogamicin as a suspect or interacting product. The 271 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 Gemtuzumab ozogamicin 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 Gemtuzumab ozogamicin?

No. It is a count of what people reported to FDA: 1,560 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 (54%), other health professional (32.3%) and consumer or non-health professional (2.6%). 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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