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Gemtuzumab Side Effects

Medically reviewed by Last updated on Sep 29, 2023.

Applies to gemtuzumab: intravenous powder for solution.


Intravenous route (Powder for Solution)

Should only be used as single agent chemotherapy and not in combination chemotherapy regimens outside clinical trials. Severe myelosuppression occurs when gemtuzumab is used at recommended doses. Severe hypersensitivity reactions (including anaphylaxis), and other infusion-related reactions which may include severe pulmonary events have occurred with therapy. Some of these hypersensitivity reactions have been fatal. Patients with high peripheral blast counts may be at greater risk for pulmonary events and tumor lysis syndrome; physicians should consider leukoreduction with hydroxyurea or leukapheresis to reduce the peripheral white count to below 30,000/ microliters prior to administration of gemtuzumab. Hepatotoxicity, including severe hepatic veno-occlusive disease (VOD), has been reported with therapy. Physicians should monitor their patients carefully for symptoms of hepatotoxicity, particularly VOD.

Serious side effects of Gemtuzumab

Along with its needed effects, gemtuzumab 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 gemtuzumab:

More common

Other side effects of Gemtuzumab

Some side effects of gemtuzumab 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 gemtuzumab: intravenous powder for injection.


Very common (10% or more): Bleeding (25%), thrombocytopenia (24%), febrile neutropenia (18%)

Common (1% to 10%): Hemorrhage

Frequency not reported: Myelosuppression, anemia[Ref]


Very common (10% or more): Fever (79%), fatigue (46%)

Common (1% to 10%): Pain

Frequency not reported: Chills[Ref]


Very common (10% or more): Nausea (21%), vomiting (21%), constipation (21%), mucositis (21%)

Common (1% to 10%): Diarrhea

Postmarketing reports: Neutropenic colitis (sometimes fatal)[Ref]


Common (1% to 10%): Pneumonia, lung edema

Frequency not reported: Hypoxia, respiratory failure, dyspnea

Postmarketing reports: Fungal lung infections (including Pulmonary mycosis and Pneumocystis jirovecii pneumonia) (sometimes fatal), interstitial pneumonia (sometimes fatal)[Ref]


Very common (10% or more): Increased AST (40%), increased ALT (16%)

Common (1% to 10%): Veno-occlusive liver disease (VOD) (sometimes fatal), hyperbilirubinemia[Ref]


Postmarketing reports: Hemorrhagic cystitis (sometimes fatal)

Genitourinary side effects have included vaginal hemorrhage (12%) and hematuria (10%)[Ref]


Very common (10% or more): Infection (44%), sepsis (32%)

Postmarketing reports: Bacterial infections (including Stenotrophomonas infection), potential for immunogenicity[Ref]


Frequency not reported: Renal failure secondary to tumor lysis syndrome[Ref]


Common (1% to 10%): Tachycardia

Frequency not reported: QT interval prolongation, hypotension[Ref]


Very common (10% or more): Rash (16%)[Ref]

Nervous system

Very common (10% or more): Headache (19%)[Ref]


Very common (10% or more): Hypophosphatemia (64%), hypokalemia (57%), hyponatremia (44%), alkaline phosphatase increased (13%), aspartate aminotransferase increased (14%), alanine aminotransferase increased (10%)

Common (1% to 10%): Blood bilirubin increased[Ref]


Frequency not reported: Hypersensitivity (including anaphylaxis)[Ref]


1. Product Information. Mylotarg (gemtuzumab ozogamicin). Wyeth-Ayerst Laboratories. PROD.

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.