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Inotuzumab ozogamicin Side Effects

For the Consumer

Applies to inotuzumab ozogamicin: intravenous powder for solution

Along with its needed effects, inotuzumab ozogamicin 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
  • Black, tarry stools
  • bleeding gums
  • blood in the urine or stools
  • chest pain
  • chills
  • cough or hoarseness
  • coughing up blood
  • difficulty in breathing or swallowing
  • dizziness
  • fever
  • headache
  • increased menstrual flow or vaginal bleeding
  • lower back or side pain
  • nosebleeds
  • painful or difficult urination
  • pale skin
  • paralysis
  • pinpoint red spots on the skin
  • prolonged bleeding from cuts
  • red or dark brown urine
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • swollen glands
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • yellow eyes or skin

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]


1. "Product Information. Besponsa (inotuzumab ozogamicin)." Wyeth Laboratories, Philadelphia, PA.

Some side effects of inotuzumab ozogamicin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.