Rituxan Side Effects & Safety

The safety of Rituxan in RA has been evaluated in controlled clinical trials including 2,578 patients with RA who were treated with Rituxan for a total exposure of 5,014 patient-years. Among these patients, side effects or adverse reactions that occurred in more than 10% of patients included infusion-related reactions and infections including upper respiratory tract infection, nasophyaryngitis, urinary tract infection, and bronchitis.1

Among the 2,578 patients who received Rituxan in controlled trials, serious infections occurred at a rate of 4.31 per 100 patient years, with the most common serious infections including pneumonia or lower respiratory tract infections, cellulitis, and urinary tract infections. The rate of serous cardiac side effects was 1.93 per 100 patient years, with the rate of myocardial infarction (MI or heart attack) of 0.56 per 100 patient years, which is comparable with the rate of MI in the general population.1


Most common side effects occurring in Rituxan RA clinical trials1*

Side effect Rituxan + TX (N=540) Placebo + MTX (N=398)
Hypertension 8% 5%
Nausea 8% 5%
Upper respiratory tract infection 7% 6%
Arthralgia 6% 4%
Pyrexia 5% 2%
Pruritis 5% 1%
Chills 3% 2%
Dyspepsia 3% <1%
Rhinitis 3% 2%
Paresthesia 2% <1%
Urticaria 2% <1%
Abdominal pain (upper) 2% 1%
Throat irritation 2% 0%
Anxiety 2% 1%
Migraine 2% <1%
Asthenia 2% <1%
*Occurring in at least 2% of patients and at least 1% greater than placebo in clinical studies up to week 24.


Warnings and precautions

There are several warnings and precautions you should know about before you start treatment with Rituxan.

Infusion reactions. Infusion reactions are the most common side effect with Rituxan. In some patients these reactions can be serious and even fatal. The signs and symptoms of infusion reaction include hives, rash, itching, swelling of the lips, tongue, throat, or face, sudden cough, shortness of breath or difficulty breathing, wheezing, weakness, dizziness, feeling faint, palpitations (rapid beating, racing, or fluttering of heart), and chest pain. Serious infusion reactions with Rituxan can occur during administration or within 24 hours of an infusion. Before your IV infusion of Rituxan, your doctor will give you medications that will decrease the chance that you will experience a severe infusion reaction.1  As soon as you begin to feel symptoms during an infusion, notify your infusion nurse so that appropriate interventions can be started.  The nurse will stop the infusion until your symptoms subside, perhaps giving you an extra dose of steroids or benadryl, and then restart the infusion at a slower rate.

Progressive multifocal leukoencephalopathy. Rituxan can cause progressive multifocal leukoencephalopathy (PML), which is a serious viral infection of the brain that affects people with weakened immune function. The signs of PML include confusion or difficulty thinking, loss of balance, changes in the way you walk or talk, weakness affecting one side of the body, and vision problems (loss of or blurred vision). PML can cause severe disability and even death. There is no known treatment, cure, or prevention for PML.1

Skin and mouth reactions. Rituxan can cause severe reactions affecting the skin and mouth. These include painful sores and ulcers on the skin, lips, or mouth, blisters, skin peeling, rash, and pustules. If you experience any of these symptoms, contact your doctor immediately.1


Pregnancy and nursing

Rituxan is a pregnancy category C drug. While there have been no well-controlled studies in humans, post-marketing data showed that infants exposed to Rituxan in utero developed B-cell lymphocytopenia (a decrease in levels of white blood cells) lasting less than 6 months. Rituxan should only be used in pregnant women if the potential benefits justify the risk to the fetus.1

It is unknown whether Rituxan is excreted into human milk. Because of the potential for adverse effects to the nursing infant, the unknown risks of exposure to Rituxan should be weighed against the benefits of breastfeeding.1


Drug interactions

Studies investigating potential drug interactions with Rituxan have not been conducted. In clinical trials in RA, Rituxan was administered together with the disease-modifying anti-rheumatic drug methotrexate and cyclophosphamide without significant interactions that affected exposure to Rituxan.1

Rituxan is sometimes used off-label to treat other autoimmune diseases such as multiple sclerosis, neuromyelitis optica, and lupus.

Written by: Jonathan Simmons | Last reviewed: September 2013.
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