Gemtuzumab Side Effects

Medically reviewed by Drugs.com. Last updated on Apr 6, 2025.

Applies to gemtuzumab: intravenous powder for solution.

Important warnings This medicine can cause some serious health issues

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 side effects

• black, tarry stools
• bloating or swelling of the face, arms, hands, lower legs, or feet
• blood in the stools or urine
• bluish color of the fingernails, lips, skin, palms, or nailbeds
• blurred vision
• burning or stinging of the skin
• chest pain
• chills
• confusion
• convulsions (seizures)
• cough or hoarseness
• cracked lips
• decrease or increase in urine
• diarrhea
• difficulty with swallowing
• dizziness
• dry mouth
• excessive sweating
• fainting
• fast or slow heartbeat
• fever
• flushed, dry skin
• fruit-like breath odor
• headache, sudden and severe
• heavy, nonmenstrual vaginal bleeding
• inability to speak
• increased thirst or hunger
• irregular heartbeat
• large, flat, blue, or purplish patches in the skin
• lightheadedness
• lower back, joint, or side pain
• loss of appetite
• mood changes
• muscle pain or cramps
• muscle trembling or twitching
• nausea or vomiting
• numbness or tingling in the hands, feet, or lips
• pain, difficulty, or burning while urinating
• painful cold sores or blisters on the lips, nose, eyes, or genitals
• pale skin
• palpitations
• persistent bleeding or oozing from puncture sites, mouth, or nose
• pinpoint red spots on the skin
• pounding in the ears
• rapid, shallow breathing
• rapid weight gain
• red or purplish patches or spots on the skin
• severe or continuing dull nervousness
• shortness of breath
• slurred speech
• small red or purple spots on the skin
• sneezing
• sore throat
• sores, ulcers, or white spots on the lips, tongue, or inside the mouth
• stomachache
• sweating
• swelling or inflammation of the mouth, face, fingers, feet, or lower legs
• swollen glands
• temporary blindness
• tightness in the chest
• tingling of the hands or feet
• troubled breathing, exertional
• unexplained nosebleeds
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusual weight gain or loss
• weakness in the arm or leg on one side of the body, sudden and severe
• wheezing
• yellow eyes or skin

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 side effects

• acid or sour stomach
• belching
• difficulty with moving
• dry, red, hot, or irritated skin
• full or bloated feeling or pressure in the stomach
• heartburn
• indigestion
• lack or loss of strength
• muscle pain or stiffness
• pain, swelling, or redness in the joints
• runny, stuffy nose
• stomach discomfort upset
• swelling of the abdominal or stomach area
• trouble with sleeping

For healthcare professionals

Applies to gemtuzumab: intravenous powder for injection.

Hematologic adverse events

• Very common (10% or more): Bleeding (25%), thrombocytopenia (24%), febrile neutropenia (18%)
• Common (1% to 10%): Hemorrhage
• Frequency not reported: Myelosuppression, anemia^[Ref]

Other

• Very common (10% or more): Fever (79%), fatigue (46%)
• Common (1% to 10%): Pain
• Frequency not reported: Chills^[Ref]

Gastrointestinal

• 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]

Respiratory

• 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]

Hepatic

• Very common (10% or more): Increased AST (40%), increased ALT (16%)
• Common (1% to 10%): Veno-occlusive liver disease (VOD) (sometimes fatal), hyperbilirubinemia^[Ref]

Genitourinary

• Postmarketing reports: Hemorrhagic cystitis (sometimes fatal)

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

Immunologic

• Very common (10% or more): Infection (44%), sepsis (32%)
• Postmarketing reports: Bacterial infections (including Stenotrophomonas infection), potential for immunogenicity^[Ref]

Renal

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

Cardiovascular

• Common (1% to 10%): Tachycardia
• Frequency not reported: QT interval prolongation, hypotension^[Ref]

Dermatologic

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

Nervous system

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

Metabolic

• 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]

Hypersensitivity

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

Further information

Gemtuzumab side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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