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Besponsa Side Effects

Generic name: inotuzumab ozogamicin

Medically reviewed by Philip Thornton, DipPharm. Last updated on Apr 4, 2023.

Note: This document contains side effect information about inotuzumab ozogamicin. Some dosage forms listed on this page may not apply to the brand name Besponsa.

Applies to inotuzumab ozogamicin: intravenous powder for solution.


Intravenous route (Powder for Solution)

Hepatotoxicity, including fatal and life-threatening VOD occurred in patients who received inotuzumab ozogamicin.A higher post-HSCT non-relapse mortality rate occurred in patients receiving inotuzumab ozogamicin.

Serious side effects of Besponsa

Along with its needed effects, inotuzumab ozogamicin (the active ingredient contained in Besponsa) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking inotuzumab ozogamicin:

More common

Other side effects of Besponsa

Some side effects of inotuzumab ozogamicin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

For Healthcare Professionals

Applies to inotuzumab ozogamicin: intravenous powder for injection.


Very common (10% or more): Thrombocytopenia (51%) (42% of which were Grade 3 or higher), neutropenia (49%) (48% of which were Grade 3 or higher), anemia (36%) (24% of which were Grade 3 or higher), leukopenia (35%) (33% of which were Grade 3 or higher), febrile neutropenia (26%) (all of which were Grade 3 or higher), lymphopenia (18%) (16% of which were Grade 3 of higher)

Common (1% to 10%): Pancytopenia (e.g., bone marrow failure, febrile bone marrow aplasia, pancytopenia)[Ref]


Common (1% to 10%): Hypersensitivity[Ref]


Very common (10% or more): Infection (48%) (28% of which were Grade 3 or higher)

Frequency not reported: Immunogenicity[Ref]


Common (1% to 10%): Infusion related reaction[Ref]


Frequency not reported: Muscle hemorrhage[Ref]


Frequency not reported: Conjunctival hemorrhage, eyelid bleeding[Ref]


Very common (10% or more): Decreased appetite (12%)

Common (1% to 10%): Lipase increased, amylase increased, hyperuricemia

Uncommon (0.1% to 1%): Tumor lysis syndrome[Ref]


Very common (10% or more): Vaginal hemorrhage (10%)

Frequency not reported: Menorrhagia, hematuria[Ref]


Very common (10% or more): Hyperbilirubinemia (21%), transaminases increased (26%), gamma-glutamyltransferase increased (21%), alkaline phosphatase increased (13%)[Ref]


Frequency not reported: Epistaxis[Ref]


Very common (10% or more): Fatigue (35%), pyrexia (32%), chills (11%)

Frequency not reported: Hemotympanum[Ref]

Nervous system

Very common (10% or more): Headache (28%)[Ref]


Very common (10% or more): Hemorrhage (33%) (5% of which were Grade 3 or higher)

Common (1% to 10%): QT prolonged

Frequency not reported: Intracranial hemorrhage, subdural hematoma[Ref]


Frequency not reported: Ecchymosis, hemorrhage subcutaneous, mesenteric hemorrhage, petechiae, post-procedural hematoma[Ref]


Very common (10% or more): Nausea (31%), abdominal pain (23%), diarrhea (17%), constipation (17%), vomiting (15%), stomatitis (13%)

Common (1% to 10%): Abdominal distention, ascites

Frequency not reported: GI hemorrhage, hemorrhagic gastritis, gingival bleeding, hematemesis, hematochezia, hemorrhoidal hemorrhage, intraabdominal hemorrhage, lip hemorrhage, upper/lower GI hemorrhage, mouth hemorrhage, oral mucosa hematoma, rectal hemorrhage[Ref]

Frequently asked questions


1. Product Information. Besponsa (inotuzumab ozogamicin). Wyeth Laboratories. 2017.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.