What are the side effects of Rituximab (rituximab)?

From the Guidelines

Rituximab can cause several severe side effects, including fatal infections, progressive multifocal leukoencephalopathy, and severe blood disorders, highlighting the need for careful patient monitoring and management. The side effects of rituximab can be categorized into common and serious adverse events. Common side effects include infusion reactions, such as fever and myalgias, as reported in studies by Oertel et al 1 and Choquet et al 1.

Common Side Effects

• Infusion reactions (fever, chills, nausea, headache, itching, and rash)
• Fatigue, weakness, and mild pain

Serious Side Effects

• Infections due to decreased immune function, including reactivation of hepatitis B and other viral infections, as warned in the package insert 1
• Cardiac problems, such as arrhythmias and heart failure, particularly in patients with pre-existing heart conditions
• Rare but serious side effects, including progressive multifocal leukoencephalopathy (PML), a potentially fatal brain infection, as reported in cases of systemic lupus erythematosus 1
• Blood disorders, such as neutropenia, thrombocytopenia, and anemia, which can be increased with long-term rituximab therapy, especially in patients who have received cytotoxic chemotherapy 1

Special Considerations

• Patients should receive premedication with acetaminophen and an antihistamine before infusions to reduce infusion reactions
• Close monitoring for signs of infection during and after treatment is essential
• The risk of side effects must be balanced against the benefits of rituximab therapy for conditions like lymphoma, rheumatoid arthritis, and other autoimmune disorders, as the treatment can have a significant impact on morbidity, mortality, and quality of life.

From the FDA Drug Label

RITUXAN can cause serious side effects that can lead to death including: Infusion-related reactions. Severe skin and mouth reactions. Hepatitis B virus (HBV) reactivation Progressive Multifocal Leukoencephalopathy (PML). Tumor Lysis Syndrome (TLS) Infections Cardiovascular Adverse Reactions Renal Toxicity Bowel Obstruction and Perforation Embryo-Fetal Toxicity

The side effects of Rituximab (rituximab) include:

• Infusion-related reactions: hives, rash, itching, swelling, sudden cough, shortness of breath, difficulty breathing, wheezing, weakness, dizziness, palpitations, chest pain
• Severe skin and mouth reactions: painful sores, ulcers, blisters, peeling skin, rash, pustules
• Hepatitis B virus reactivation: worsening fatigue, yellowing of skin or eyes
• Progressive Multifocal Leukoencephalopathy (PML): confusion, dizziness, loss of balance, difficulty walking or talking, decreased strength, vision problems
• Tumor Lysis Syndrome (TLS): nausea, vomiting, diarrhea, lethargy
• Infections: fever, cold symptoms, flu symptoms, earache, headache, dysuria, oral herpes simplex infection, painful wounds
• Cardiovascular Adverse Reactions: ventricular fibrillation, myocardial infarction, cardiogenic shock, chest pain, irregular heartbeats
• Renal Toxicity: renal toxicity, need for healthcare providers to monitor kidney function
• Bowel Obstruction and Perforation: severe abdominal pain, repeated vomiting
• Embryo-Fetal Toxicity: potential risk to a fetus, need for effective contraception during treatment and for 12 months after the last dose 2 Other side effects reported in clinical studies include:
• Neutropenia
• Anemia
• Peripheral sensory neuropathy
• Pulmonary toxicity
• Hepato-biliary toxicity
• Rash and/or pruritus
• Arthralgia
• Weight gain
• Febrile neutropenia
• Stomatitis
• Enteritis
• Sepsis
• Alanine aminotransferase increased
• Hypokalemia
• Infusion-related reactions
• Upper respiratory tract infection
• Nasopharyngitis
• Urinary tract infection
• Bronchitis
• Hypertension
• Nausea
• Pyrexia
• Pruritus 2

From the Research

Side Effects of Rituximab

The side effects of Rituximab can be categorized into several types, including:

• Infusion-related reactions, which can range from mild to severe and include symptoms such as rigors, chills, fever, and hypotension 3
• Hypersensitivity reactions, which can be classified as infusion-related, cytokine-release, type I (IgE/non-IgE), mixed, type III, and type IV reactions 4
• Cardiac, pulmonary, renal, and hematologic side effects, which can occur in some patients 5
• Cutaneous side effects, which can range from mild to severe and include symptoms such as rash, urticaria, and angioedema 5, 4
• Thrombocytopenia, which can occur as a long-term side effect of Rituximab 6
• Infections, which can occur in patients receiving Rituximab, particularly those with compromised immune systems 7

Common Side Effects

Some common side effects of Rituximab include:

• Infusion-related reactions, which occur in approximately 32% of patients during the first line treatment and 19% of patients during the second line treatment 3
• Anaphylaxis, which occurs in approximately 3.6% of patients 7
• Infections, which occur in approximately 47.9% of patients, with 17.9% experiencing severe infections 7

Severe Side Effects

Some severe side effects of Rituximab include:

• Fatal infusion reactions 5
• Tumor lysis syndrome 5
• Severe mucocutaneous reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis 5, 4
• Severe thrombocytopenia, which can occur in rare cases 6
• Lethal infections, which can occur in rare cases 7