Pharmacologic class (EPC) · 2 drug pages

CD22-directed immunoconjugate: adverse event reports filed with FDA

2,419 reports list a drug in this class as a suspect or interacting product, 2007–2026.

Read first · FDA's statement on these data

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. openFDA, FDA

FDA adds: "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 "cannot be used to estimate the incidence of these events."

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.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

2,419
reports across the class: 0% of all reports; 179
reports, 12 months to June 2026: 215 in the 12 months before; 96%
marked serious by the reporter: 57.4% across all reports; 2
drugs with a page: brand and generic names counted separately

CD22-directed immunoconjugate is a pharmacologic class (an FDA Established Pharmacologic Class) with 2 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 2,419 adverse event reports received by FDA, 0% of the database, from April 2007 to June 2026.

179 reports arrived in the 12 months to June 2026, down 17% from 215 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 96% of the class's reports are marked serious, 34% record death among the outcomes and 43.3% record hospitalisation, as reported.

Across the class the reactions recorded most often are death (11.5%), febrile neutropenia (10%) and venoocclusive liver disease (9.9%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
Inotuzumab ozogamicin	generic	1,750	137	99%	Febrile neutropenia
BesponsaInotuzumab ozogamicin	brand	669	42	88%	Death

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Deaththe patient died; cause not stated by this term11.5%279
Febrile neutropeniafever with low white blood cells10%242
Venoocclusive liver disease9.9%240
Neoplasm progression6.3%152
Off label useused for a purpose or in a way not on the label6.3%152
Pyrexiafever6.1%148
Thrombocytopenialow platelets4.9%119
Sepsisa severe body-wide response to infection4.6%111
Venoocclusive disease4.4%107
Platelet count decreasedlow platelet count4.4%106
Neutropenialow neutrophils, a type of white blood cell3.7%90
Drug ineffectivethe medicine did not work as expected3.6%88
Pneumonialung infection3.2%77
Blood bilirubin increased3.1%76
Cytokine release syndrome3.1%76
Infectionan infection, type not specified2.9%70
Multiple organ dysfunction syndromeseveral organs failing2.6%64
White blood cell count decreasedlow white cell count2.6%63
Anaemialow red blood cells2.4%59
Nauseafeeling sick2.4%57
Ascitesfluid in the abdomen2.3%55
Diarrhoealoose or frequent stools1.9%47
Hyponatraemialow blood sodium1.9%47
Fatiguetiredness1.8%44
Neutrophil count decreased1.8%43

Solid bar: share of all class reports. Hollow bar: the median share across the 2 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death34%822

Life-threatening7.7%187

Hospitalisation (initial or prolonged)43.3%1,048

Disability1.1%27

Congenital anomaly0%0

Other serious51.6%1,247

Not serious4%97

Patient age

Under 20.8%19

2 to 116.9%166

12 to 174.2%102

18 to 4424.9%603

45 to 6419.6%474

65 to 7413.2%320

75 and over8%194

Age not given22.4%541

Who reported

Physician56%1,354

Pharmacist4.2%102

Other health professional26.9%650

Lawyer0%0

Consumer or non-health professional12.3%297

Not given0.7%16

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about CD22-directed immunoconjugate reports

Which drugs are in the CD22-directed immunoconjugate class on this site?

Inotuzumab ozogamicin and Besponsa. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

2,419 reports through June 2026, 179 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

death (11.5%), febrile neutropenia (10%), venoocclusive liver disease (9.9%), neoplasm progression (6.3%) and off label use (6.3%).

Can the members table be used to rank the drugs?

No. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.