Obinutuzumab Side Effects

Medically reviewed by Philip Thornton, DipPharm. Last updated on Aug 19, 2024.

Applies to obinutuzumab: intravenous solution.

Important warnings This medicine can cause some serious health issues

Intravenous route (solution)

Hepatitis B virus (HBV) reactivation can occur in patients receiving obinutuzumab or other CD20-directed cytolytic antibodies, which can progress to life-threatening or fatal fulminant hepatitis or hepatic failure.

Screen patients at baseline for HBV infection.

Monitor HBV-positive patients during and after treatment with obinutuzumab.

If HBV reactivation occurs, discontinue obinutuzumab and concomitant medications.

Life-threatening or fatal progressive multifocal leukoencephalopathy has also been reported.

Serious side effects of obinutuzumab

Along with its needed effects, obinutuzumab 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 obinutuzumab:

More common side effects

• back pain
• black, tarry stools
• bleeding gums
• blood in the urine or stools
• chest tightness
• chills
• cough
• fever
• flushing
• headache
• hoarseness
• lower back or side pain
• nausea
• painful or difficult urination
• pale skin
• pinpoint red spots on the skin
• sore throat
• trouble breathing
• ulcers, sores, or white spots in the mouth
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting

Less common side effects

• joint pain, stiffness, or swelling
• stomach pain
• swelling of the feet or lower legs

Rare side effects

• bruising
• confusion
• coughing or vomiting blood
• persistent bleeding or oozing from puncture sites, mouth, or nose
• rash

Incidence not known

• blurred vision
• dark urine
• dizziness
• drowsiness
• general tiredness and weakness
• light-colored stools
• seizures
• upper right abdominal or stomach pain
• yellow eyes and skin

Other side effects of obinutuzumab

Some side effects of obinutuzumab 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:

Incidence not known

• bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

For healthcare professionals

Applies to obinutuzumab: intravenous solution.

Cardiovascular adverse events

• Common (1% to 10%): Hypertension, cardiac failure
• Frequency not reported: Worsening of preexisting cardiac conditions with fatalities, atrial fibrillation^[Ref]

Hematologic

• Very common (10% or more): Neutropenia (41%), thrombocytopenia (15%), anemia (12%)
• Common (1% to 10%): Leukopenia, lymph node pain^[Ref]

Hepatic

• Very common (10% or more): AST (SGOT) increased (28%), ALT (SGPT) increased (25%)^[Ref]

Metabolic

• Very common (10% or more): Hypophosphatemia (36%), hypoalbuminemia (33%), hypoproteinemia (32%), hypocalcemia (32%), hypocalcemia (32%), hyperuricemia (28%), hyponatremia (26%), hyperkalemia (23%), hypernatremia (16%) alkaline phosphatase increased (16%), decreased appetite (14%)
• Common (1% to 10%): Tumor lysis syndrome, hyperuricemia^[Ref]

Musculoskeletal

• Common (1% to 10%): Arthralgia, back pain, musculoskeletal chest pain, pain in extremity, bone pain^[Ref]

Nervous system

• Very common (10% or more): Headache (18%), asthenia
• Frequency not reported: Progressive multifocal leukoencephalopathy (PML)^[Ref]

Other

• Very common (10% or more): Pyrexia (18%)^[Ref]

Renal

• Very common (10% or more): Creatinine increased (30%)^[Ref]

Respiratory

• Very common (10% or more): Cough (26%), pneumonia (14%), sinusitis (12%), upper respiratory tract infection
• Common (1% to 10%): Rhinitis, pharyngitis, nasopharyngitis, lung infection, nasal congestion, rhinorrhea, lung infection^[Ref]

Immunologic

• Very common (10% or more): Positive test for anti-obinutuzumab antibodies (13%)
• Common (1% to 10%): Infection (9%)
• Frequency not reported: Hepatitis B reactivation, immunogenicity^[Ref]

Dermatologic

• Very common (10% or more): Alopecia (13%)
• Common (1% to 10%): Pruritus, night sweats, eczema^[Ref]

Local

• Very common (10% or more): Infusion related reactions (69%)^[Ref]

Ocular

• Common (1% to 10%): Ocular hyperemia^[Ref]

Genitourinary

• Common (1% to 10%): Urinary tract infection, urinary incontinence, dysuria^[Ref]

Oncologic

• Common (1% to 10%): Squamous cell carcinoma of the skin^[Ref]

Gastrointestinal

• Very common (10% or more): Constipation (19%), diarrhea (10%)
• Common (1% to 10%): Oral herpes, dyspepsia, colitis, hemorrhoids^[Ref]

Hypersensitivity

• Frequency not reported: This drug can cause serious infusion reactions. See Warnings.^[Ref]

Frequently asked questions

• What is Gazyva used for and how does it work?

Further information

Obinutuzumab 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.

Medical Disclaimer