OpenClaim

Inotuzumab Side Effects

The most commonly reported side effects of inotuzumab include death, febrile neutropenia, and venoocclusive liver disease, based on 2,959 FDA adverse event reports from 2008 to 2025. 4.9% of reports found the drug to be ineffective.

Inotuzumab side effects

Percentages show how often each reaction appears relative to total reports for inotuzumab.

1
Death10.8%320
2
Febrile Neutropenia8.8%259
3
Venoocclusive Liver Disease8.7%257
4
Off Label Use7.3%216
5
Pyrexia6.5%193
6
Acute Lymphocytic Leukaemia Recurrent5.7%168
7
Neoplasm Progression5.3%158
8
Thrombocytopenia5.0%147
9
Sepsis4.9%146
10
Drug Ineffective4.9%144
11
Cytokine Release Syndrome4.6%137
12
Venoocclusive Disease4.5%134
13
Neutropenia4.0%118
14
Platelet Count Decreased4.0%118
15
Pneumonia3.3%97

These are voluntary reports and do not establish that inotuzumab caused these reactions.

Report severity

95.2%Serious2,818 reports
41.4%Hospitalizations1,224 reports
33.4%Fatal988 reports

Seriousness is determined by the reporter, not by OpenClaim.

Inotuzumab drug interactions

Other drugs that appear in adverse event reports alongside inotuzumab. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Vincristine-sulfate31.2%924
2
Cyclophosphamide31.2%924
3
Methotrexate27.3%809
4
Dexamethasone26.7%789
5
Cytarabine23.0%682
6
Blinatumomab19.8%587
7
Rituximab19.3%570
8
Mesna8.7%256
9
Pegfilgrastim8.0%236
10
Doxorubicin-hydrochloride7.5%223
11
Fludarabine-phosphate6.9%204
12
Mercaptopurine6.7%197
13
Prednisone6.3%187
14
Prednisolone4.9%146
15
Pegaspargase4.9%145

Taken alongside

1
Cyclophosphamide7.1%210
2
Methotrexate7.0%207
3
Acyclovir6.8%201
4
Vincristine-sulfate6.7%199
5
Ondansetron6.3%186
6
Ursodiol6.2%184
7
Dexamethasone6.1%181
8
Allopurinol5.3%157
9
Acetaminophen5.3%156
10
Cytarabine5.2%153
11
Fluconazole4.6%136
12
Fludarabine-phosphate4.1%120
13
Furosemide3.9%114
14
Sulfamethoxazole3.8%111
15
Trimethoprim3.2%96

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports inotuzumab side effects

34.9% of inotuzumab adverse event reports involve female patients and 46.4% involve male patients. The largest age group is adult at 57%. These figures reflect who reports side effects, not underlying risk.

Sex

Female34.9%
Male46.4%
Unknown18.7%

Age group

< 21.5%
2–1110.3%
12–176.1%
18–6456.6%
65+25.5%

What is inotuzumab used for

Conditions and purposes for which patients were taking inotuzumab when the adverse event was reported.

Acute LeukaemiaAcute Lymphocytic LeukaemiaAcute Lymphocytic Leukaemia RecurrentAcute Lymphocytic Leukaemia RefractoryAcute Myeloid LeukaemiaAcute LeukaemiaAcute Lymphocytic LeukaemiaAcute Lymphocytic Leukaemia RecurrentAcute Lymphocytic Leukaemia RefractoryAspergillus InfectionB Precursor Type Acute LeukaemiaB Precursor Type Acute LeukaemiaB-cell LymphomaB-cell Lymphoma RefractoryB-cell Prolymphocytic Leukaemia

Showing 15 of 94 indications

Inotuzumab brand names and reporting trend

Inotuzumab is sold under the brand name Besponsa.

Brand names

Besponsa3,362

Quarterly reports (20082025)

2008201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking inotuzumab with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.