Inotuzumab ozogamicin adverse event reports that FDA received

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

Name type: Generic name
Class: CD22-directed immunoconjugate

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 April 2007 to June 2026, FDA received 1,750 adverse event reports that name Inotuzumab ozogamicin. In these reports the drug is a suspect or interacting product.

In the same period, 495 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 137 reports in the 12 months to June 2026 and 158 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, 137 (under 0.1%) name Inotuzumab ozogamicin. Reports from consumers or other non-health professionals were 12.2% of the reports that name Inotuzumab 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 Inotuzumab 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 41 reports that name Inotuzumab ozogamicin.
In January to March 2026, FDA received 32.
In April to June 2025, FDA received 27.

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 207 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 1,741 of the 1,750 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 207 terms.

Reaction terms in the reports that name Inotuzumab ozogamicin, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 1,750 reports
Febrile neutropeniafever with low white blood cells	212	12.1%
Venoocclusive liver disease	161	9.2%
Deaththe patient died; cause not stated by this term	143	8.2%
Pyrexiafever	105	6%
Off label useused for a purpose or in a way not on the label	104	5.9%
Sepsisa severe body-wide response to infection	94	5.4%
Thrombocytopenialow platelets	91	5.2%
Drug ineffectivethe medicine did not work as expected	88	5%
Venoocclusive disease	81	4.6%
Neutropenialow neutrophils, a type of white blood cell	74	4.2%
Pneumonialung infection	69	3.9%
Cytokine release syndrome	63	3.6%
Platelet count decreasedlow platelet count	63	3.6%
Blood bilirubin increased	57	3.3%
Infectionan infection, type not specified	55	3.1%
Anaemialow red blood cells	51	2.9%
Multiple organ dysfunction syndromeseveral organs failing	49	2.8%
Hyponatraemialow blood sodium	47	2.7%
Nauseafeeling sick	43	2.5%
Diarrhoealoose or frequent stools	40	2.3%
Neoplasm progression	38	2.2%
Fatiguetiredness	34	1.9%
Hyperglycaemiahigh blood sugar	34	1.9%
Aspartate aminotransferase increasedraised liver enzyme (AST)	33	1.9%
White blood cell count decreasedlow white cell count	33	1.9%
Acute kidney injurysudden loss of kidney function	32	1.8%
Acute lymphocytic leukaemia recurrent	32	1.8%
Alanine aminotransferase increasedraised liver enzyme (ALT)	32	1.8%
Hypotensionlow blood pressure	32	1.8%
Ascitesfluid in the abdomen	31	1.8%
Hepatotoxicityliver injury	31	1.8%
Lower respiratory tract infectiona chest infection	30	1.7%
Cytopenia	26	1.5%
Neutrophil count decreased	25	1.4%
Pancytopenialow counts of all blood cells	25	1.4%
Disease progressionthe disease advanced	24	1.4%
Mucosal inflammation	24	1.4%
Vomitingbeing sick	24	1.4%
Covid-19COVID-19 infection	23	1.3%
Lymphocyte count decreased	23	1.3%
Subdural haematoma	23	1.3%
Weight increasedweight gain	23	1.3%
Encephalopathy	21	1.2%
Headachehead pain	21	1.2%
Myelosuppression	21	1.2%
Chillschills or shivering	20	1.1%
Septic shockshock arising from infection	20	1.1%
Hypokalaemialow blood potassium	19	1.1%
Mental status changes	19	1.1%
Acute lymphocytic leukaemia	18	1%

Download all 207 terms of Inotuzumab ozogamicin (CSV)

The counts add to more than 1,750 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 Inotuzumab ozogamicin with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Inotuzumab ozogamicin (this page)	Generic name	1,750
Besponsa	Brand name	669

Sum of the separately reported names: 2,419. 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 Inotuzumab 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
2008	5	5	2	1	2	0	3	0
2009	4	4	1	0	1	0	2	0
2010	15	15	1	1	13	1	3	0
2011	14	14	1	1	9	1	6	0
2012	22	21	2	1	20	0	1	1
2013	25	25	6	1	9	1	14	0
2014	47	47	9	2	36	0	15	0
2015	39	39	8	1	20	2	20	0
2016	76	75	22	3	48	2	35	1
2017	60	59	17	5	27	1	32	1
2018	132	130	38	8	86	0	48	2
2019	138	136	31	11	94	2	63	2
2020	129	129	38	22	73	0	64	0
2021	212	210	63	15	125	8	87	2
2022	226	225	52	13	138	0	88	1
2023	208	207	56	13	66	1	149	1
2024	161	158	73	21	64	2	107	3
2025	142	139	58	8	47	0	93	3
2026	95	95	37	2	11	0	69	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 Inotuzumab 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 Inotuzumab ozogamicin, by the year in which FDA received them
Year	Reports
2007	1
2008	5
2009	5
2010	13
2011	14
2012	29
2013	29
2014	54
2015	63
2016	69
2017	49
2018	131
2019	134
2020	135
2021	227
2022	213
2023	206
2024	159
2025	141
2026	73

Reports that name Inotuzumab 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 Inotuzumab ozogamicin
Age	Reports	Share
Under 2	17	1%
2 to 11	129	7.4%
12 to 17	84	4.8%
18 to 44	461	26.3%
45 to 64	347	19.8%
65 to 74	229	13.1%
75 and over	134	7.7%
Age not given	349	19.9%

Sex of the patient in the reports that name Inotuzumab ozogamicin
Sex	Reports	Share
Female	596	34.1%
Male	891	50.9%
Unknown or not given	263	15%

Type of reporter in the reports that name Inotuzumab ozogamicin
Reporter	Reports	Share
Physician	908	51.9%
Pharmacist	33	1.9%
Other health professional	582	33.3%
Lawyer	0	0%
Consumer or non-health professional	213	12.2%
Not given	14	0.8%

Age and sex are as the report gives them. The reporter is the primary source in the report. 49.9% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Inotuzumab ozogamicin record
Indication as recorded (MedDRA)	Reports	Share
Acute lymphocytic leukaemia	619	35.4%
B-cell type acute leukaemia	215	12.3%
Diffuse large b-cell lymphoma	91	5.2%
B precursor type acute leukaemia	89	5.1%
Acute lymphocytic leukaemia recurrent	65	3.7%
Non-hodgkin's lymphoma	65	3.7%

The reporter fills in the indication, and the field is often empty. Each share is of all 1,750 reports.

Drugs in the same reports

Other drugs that the reports of Inotuzumab ozogamicin name, in any role, in order of name
Drug	Reports that name the two
Blinatumomab	295
Cyclophosphamide	842
Cytarabine	612
Dexamethasone	661
Mesna	212
Methotrexate	421
Methotrexate sodium	340
Rituximab	533
Vincristine	347
Vincristine sulfate	498

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

Besponsa same ingredient
Inomax next in the A to Z list
Inovelon next in the A to Z list
Innovair next in the A to Z list
Inpefa next in the A to Z list
Innohep next in the A to Z list
Inqovi next in the A to Z list
Inlyta next in the A to Z list
Inrebic next in the A to Z list
Inlexzo next in the A to Z list
Inspra next in the A to Z list
Injectafer 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 Inotuzumab 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. Inotuzumab ozogamicin: adverse event reports that FDA received. https://reportedreactions.com/drug/inotuzumab-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 Inotuzumab ozogamicin as a suspect or interacting product. The 495 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 Inotuzumab 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 Inotuzumab ozogamicin?

No. It is a count of what people reported to FDA: 1,750 reports from April 2007 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 (51.9%), other health professional (33.3%) and consumer or non-health professional (12.2%). 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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