Rituxan Side Effects
Generic Name: rituximab
Note: This document contains side effect information about rituximab. Some of the dosage forms listed on this page may not apply to the brand name Rituxan.
Some side effects of Rituxan may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
For the Consumer
Applies to rituximab: intravenous solution
Along with its needed effects, rituximab (the active ingredient contained in Rituxan) 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 rituximab:More common
- Abdominal or stomach pain
- black, tarry stools
- bleeding gums
- bloating or swelling of the face, arms, hands, lower legs, or feet
- blood in the urine or stools
- blurred vision
- body aches or pain
- chest pain
- cough or hoarseness
- difficulty with breathing
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- dry mouth
- ear congestion
- fever and chills
- flushed, dry skin
- fruit-like breath odor
- hives or welts
- increased hunger
- increased thirst
- increased urination
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- lower back or side pain
- noisy breathing
- pain or tenderness around the eyes and cheekbones
- painful or difficult urination
- pale skin
- pinpoint red spots on the skin
- pounding in the ears
- shortness of breath
- skin rash
- slow or fast heartbeat
- sore throat
- sores, ulcers, or white spots in the mouth or on the lips
- stuffy or runny nose
- swelling of the tongue or throat
- swollen glands
- tightness of the chest
- tingling of the hands or feet
- troubled breathing with exertion
- unusual bleeding or bruising
- unusual tiredness or weakness
- unusual weight gain or loss
- Blistering, peeling, or loosening of the skin
- blisters in the mouth
- blisters on the trunk, scalp, or other areas
- burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feeling
- burning, tingling, numbness or pain in the hands, arms, feet, or legs
- decreased frequency and amount of urination
- difficulty with moving
- feeling sad or empty
- irregular heartbeat
- joint or muscle pain
- loss of appetite
- loss of interest or pleasure
- muscle cramps
- muscle pain or stiffness
- numbness or tingling in the hands, feet, or lips
- pain at the injection site
- pain, swelling, or redness in the joints
- red skin lesions, often with a purple center
- red, itchy lining of the eye
- redness of the face, neck, arms, and occasionally, upper chest
- stabbing pain
- trouble concentrating
- trouble sleeping
- Abdominal or stomach cramps
- blue-yellow color blindness
- blurred vision or other change in vision
- burning or stinging of the skin
- decreased vision
- dilated neck veins
- dry cough
- extreme fatigue
- eye pain, tearing
- feeling of discomfort, illness, or weakness
- irregular breathing
- painful cold sores or blisters on the lips, nose, eyes, or genitals
- sensitivity of the eye to light
- severe abdominal or stomach pain
- severe vomiting, sometimes with blood
- sores, welting, or blisters
- swelling, stiffness, redness, or warmth around many joints
- swollen and inflamed joints
- swollen lymph glands
- vision loss
Some side effects of rituximab 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
- increased cough
- lack or loss of strength
- night sweats
- throat irritation
- Agitation or anxiety
- change in taste
- dry eyes
- excessive muscle tone
- feeling of constant movement of self or surroundings
- increase in body movements
- muscle tension
- pain or redness at the injection site
- sensation of spinning
- swelling of the stomach
For Healthcare Professionals
Applies to rituximab: intravenous solution
General side effects have included fever (49%), chills (32%), asthenia (16%), headache (14%), and abdominal pain (6%).
In general, severe side effects from rituximab (the active ingredient contained in Rituxan) may be more likely in patients with higher circulating white counts or a greater tumor burden. Severe and life-threatening (Grade 3 and 4) events have been reported in 10% of patients. The Grade 3 and 4 adverse events included neutropenia (1.9%), chills (1.6%), leukopenia (1.3%), thrombocytopenia (1.3%), hypotension (1%), anemia (1%), bronchospasm (1%), urticaria (1%), headache (0.6%), abdominal pain (0.6%), and arrhythmia (0.6%). A fatal case of septicemia has also been reported.
A cytokine-release syndrome consisting mainly of fever, chills, and stiffness during the first infusion has also been reported when the drug has been administered systemically.
In almost all cases, the infusion related event was reported in relation to the first infusion.
Fatal outcomes were most frequently associated with female patients, patients with pulmonary infiltrates, and patients CLL or mantle cell lymphoma.
Other side effects have included death within 24 hours of infusion (0.04% to 0.07%). Death has occurred as part of an infusion related complex which included hypoxia, pulmonary infiltrates, adult respiratory distress syndrome, myocardial infarction, ventricular fibrillation, or cardiogenic shock.
A case of serum sickness has also been reported.
Immunologic side effects have included B-cell depletion in 70% to 80% of patients. This was associated with decreased serum immunoglobulins in a minority of patients. An increase in fatal infection in HIV-related lymphoma patients has been reported when rituximab (the active ingredient contained in Rituxan) was used in combination with CHOP chemotherapy compared to CHOP alone. One fatal case of a reactivation of a cytomegalovirus has been reported.
Serious viral infections, either new, reactivated or exacerbated, have been identified. The majority of patients received rituximab in combination with chemotherapy or as part of a hematopoietic stem cell transplant. These viral infections included JC virus [progressive multifocal leukoencephalopathy (PML)], cytomegalovirus, herpes simplex virus, parvovirus B19, varicella zoster virus, West Nile virus, hepatitis B, and hepatitis C. In some cases, the viral infections occurred up to one year following discontinuation of rituximab and have resulted in death.
An increased incidence of grade 3 and 4 infections has been reported in patients with previously treated lymphoma without known HIV infection.
In general, the incidence of infection was not increased.
The signs of PML include confusion, dizziness or loss of balance, difficulty talking or walking, and vision problems. Recognition of these warning signs of PML may be obscured by the fact that these warning signs are also associated with the underlying diseases for which rituximab may be prescribed. Reactivation or exacerbation of viral infections including JC virus leading to PML may occur when patients receive rituximab for any reason. Physicians should maintain a high degree of suspicion for the development of PML in patients under treatment with rituximab. Patients who have been treated with rituximab and present or develop new neurological signs or symptoms should be evaluated for PML.
The majority of the patients received rituximab (the active ingredient contained in Rituxan) in combination with chemotherapy. Median time to the diagnosis of hepatitis was approximately four months after the initiation of rituximab and approximately one month after the last dose.
Patients at high risk of hepatitis B virus infection should be screened before initiation of rituximab. Carriers of hepatitis B should be closely monitored for clinical and laboratory signs of active hepatitis B virus infection and for signs of hepatitis during and for up to several months following rituximab therapy.
In patients who develop viral hepatitis, rituximab and any concomitant chemotherapy should be discontinued and appropriate treatment including antiviral therapy should be initiated. There are insufficient data regarding the safety of resuming rituximab therapy in patients who develop hepatitis subsequent to hepatitis B virus reactivation.
Hepatic side effects including hepatitis B virus reactivation with fulminant hepatitis, hepatic failure, and death have been reported in some patients with hematologic malignancies treated with rituximab.
Cardiovascular side effects have included myocardial infarction, ventricular fibrillation, and cardiogenic shock (as parts of an infusion related reaction). Hypotension (10%) has also been reported.
Respiratory side effects have included rhinitis (8%), bronchospasm (8%), throat irritation (6%), hypoxia, pulmonary infiltrates, fatal bronchiolitis obliterans, pneumonitis (including interstitial pneumonitis), adult respiratory distress syndrome (as parts of an infusion related reaction), and pneumocystis pneumonia.
Gastrointestinal side effects have included nausea (18%) and vomiting (7%).
Hematological side effects have included leukopenia (11%), thrombocytopenia (8%), and neutropenia (7%). Severe cytopenias include neutropenia (1.9%), thrombocytopenia (1.3%), anemia (1%), and hypogammaglobulinemia. Postmarketing reports of grade 3 to 4 prolonged or late onset neutropenia have been received.
Metabolic side effects have included angioedema (13%).
Musculoskeletal side effects have included myalgia (7%).
Nervous system side effects have included dizziness (7%).
The major clinical features of the cutaneous cytokine-release syndrome are pain in the nodules and/or urticarial reaction at the tumor sites.
Dermatologic side effects have included pruritus (10%), rash (10%), and urticaria (8%). Several cases of psoriasis have been reported. A cutaneous cytokine-release syndrome has been reported when the drug was administered locally for cutaneous B-cell lymphoma.
The risk of TLS has been higher in patients with high numbers of circulating malignant cells.
Renal side effects have included tumor lysis syndrome (TLS) (0.04% to 0.05%) within the first 12 to 24 hours following the first rituximab infusion. TLS is characterized by a rapid reduction in tumor volume and includes renal insufficiency, hyperkalemia, hypocalcemia, hyperuricemia, or hyperphosphatemia.
Oncologic side effects have included disease progression of Kaposi's sarcoma. A case of eccrine squamous syringometaplasia has also been reported.
Ocular side effects including a case of bilateral conjunctivitis have been reported.
Genitourinary side effects including a case of pyelonephritis have been reported.
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