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Rituximab Side Effects

For the Consumer

Applies to rituximab: intravenous solution

As well as its needed effects, rituximab may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking rituximab, check with your doctor or nurse immediately:

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
  • confusion
  • convulsions
  • cough or hoarseness
  • difficulty with breathing
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • drowsiness
  • dry mouth
  • ear congestion
  • fever and chills
  • flushed, dry skin
  • fruit-like breath odor
  • headache
  • hives or welts
  • increased hunger
  • increased thirst
  • increased urination
  • itching
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • lower back or side pain
  • nausea
  • nervousness
  • 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
  • sneezing
  • sore throat
  • sores, ulcers, or white spots in the mouth or on the lips
  • stuffy or runny nose
  • sweating
  • 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
  • vomiting
Less common:
  • 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
  • diarrhea
  • difficulty with moving
  • discouragement
  • feeling sad or empty
  • irregular heartbeat
  • irritability
  • 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
Incidence not known:
  • 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
  • nosebleed
  • 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

Minor Side Effects

Some rituximab side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common:
  • Fear
  • increased cough
  • lack or loss of strength
  • night sweats
  • throat irritation
Less common:
  • Agitation or anxiety
  • change in taste
  • dry eyes
  • excessive muscle tone
  • feeling of constant movement of self or surroundings
  • heartburn
  • increase in body movements
  • lightheadedness
  • muscle tension
  • pain or redness at the injection site
  • sensation of spinning
  • sleepiness
  • swelling of the stomach

For Healthcare Professionals

Applies to rituximab: intravenous solution

Cardiovascular

Very common (10% or more): Hypotension (10%)
Common (1% to 10%): Hypertension, orthostatic hypotension, myocardial infarction, arrhythmia, atrial fibrillation, tachycardia
Uncommon (0.1% to 1%): Left ventricular failure, supraventricular tachycardia, ventricular tachycardia, angina, myocardial ischemia, bradycardia
Very rare (less than 0.01%): Heart failure, vasculitis (predominately cutaneous), leukocytoclastic vasculitis[Ref]

Dermatologic

Very common (10% or more): Night sweats (15%), rash (15%), pruritus (14%), angioedema (11%), alopecia
Common (1% to 10%): Flushing, urticaria, skin disorder
Very rare (less than 0.01%): Severe bullous skin reactions, Stevens-Johnson Syndrome, toxic epidermal necrolysis (Lyell's Syndrome)
Postmarketing reports: Severe mucocutaneous reactions[Ref]

Gastrointestinal

Very common (10% or more): Nausea (23%), abdominal pain (14%), diarrhea (10%), vomiting (10%)
Common (1% to 10%): Throat irritation, dysphagia, stomatitis, constipation, dyspepsia, anorexia
Uncommon (0.1% to 1%): Abdominal enlargement
Frequency not reported: GI perforation
Postmarketing reports: Bowel obstruction[Ref]

Hematologic

Very common (10% or more): Lymphopenia (48%), leukopenia (14%), neutropenia (14%), thrombocytopenia (12%)
Common (1% to 10%): Blood lactate dehydrogenase (LDH) increased, pancytopenia, granulocytopenia
Uncommon (0.1% to 1%): Anemia, coagulation disorders, aplastic anemia, hemolytic anemia, lymphadenopathy, transient aplastic anemia, hemolytic anemia
Postmarketing reports: Late neutropenia, marrow hypoplasia, Grade 3 to 4 prolonged or late-onset neutropenia, hyperviscosity syndrome in Waldenstrom's macroglobulinemia, prolonged hypogammaglobulinemia[Ref]

Hepatic

Very common (10% or more): Increased ALT (13%)
Frequency not reported: Hepatitis B reactivation with fulminant hepatitis, hepatic failure[Ref]

Hypersensitivity

Common (1% to 10%): Hypersensitivity
Rare (0.01% to 0.1%): Anaphylaxis
Very rare (less than 0.01%): Tumor lysis syndrome, cytokine release syndrome, serum sickness[Ref]

Immunologic

Very common (10% or more): Infection (bacterial, viral) (31%)
Common (1% to 10%): Sepsis, febrile infection, herpes zoster, fungal infections, infections of unknown etiology, acute bronchitis, sinusitis
Rare (less than 0.1%): Serious viral infections
Postmarketing reports: Lupus-like syndrome, serum sickness, increase in fatal infections in HIV-associated lymphoma, increased incidence of Grade 3 and 4 infections[Ref]

Local

Very common (10% or more): Acute infusion reactions (e.g., pain, fever, chills, rigors, pruritus, urticaria/rash, angioedema, sneezing, throat irritation, cough, and/or bronchospasm, with or without associated hypotension or hypertension) (27%)[Ref]

Metabolic

Very common (10% or more): Hypophosphatemia (12%)
Common (1% to 10%): Hyperglycemia, peripheral edema, hyperuricemia, weight decrease, peripheral edema, face edema, increased LDH, hypocalcemia[Ref]

Musculoskeletal

Very common (10% or more): Back pain (10%), myalgia (10%), arthralgia (10%)
Common (1% to 10%): Neck pain, hypertonia
Frequency not reported: Polyarticular arthritis[Ref]

Nervous system

Very common (10% or more): Headache (19%), dizziness (10%)
Common (1% to 10%): Pyrexia, paresthesia, hypoesthesia
Uncommon (0.1% to 1%): Dysgeusia
Postmarketing reports: Posterior reversible encephalopathy syndrome (PRES)/reversible posterior leukoencephalopathy syndrome (RPLS)[Ref]

Ocular

Common (1% to 10%): Lacrimation disorder, conjunctivitis
Very rare (less than 0.01%): Severe vision loss
Postmarketing reports: Uveitis, optic neuritis[Ref]

Oncologic

Postmarketing reports: Disease progression of Kaposi's sarcoma[Ref]

Other

Very common (10% or more): Fever (53%), chills (33%), asthenia (26%), fatigue (13%), pain (12%)
Common (1% to 10%): Migraine, asthenia, tinnitus, ear pain, tumor pain, flushing, malaise, cold syndrome, shivering, multi-organ failure
Very rare (less than 0.01%): Hearing loss[Ref]

Psychiatric

Common (1% to 10%): Anxiety, depression, nervousness, agitation, insomnia[Ref]

Renal

Very rare (less than 0.01%): Renal failure[Ref]

Respiratory

Very common (10% or more): Cough (13%), rhinitis (12%), epistaxis (11%), dyspnea (10%), bronchitis
Common (1% to 10%): Bronchospasm, sinusitis, pneumonia, chest pain
Uncommon (0.1% to 1%): Upper respiratory tract infection, asthma, bronchiolitis obliterans (fatal), lung disorder, hypoxia
Rare (0.01% to 0.1%): Interstitial lung disease
Very rare (less than 0.01%): Respiratory failure
Frequency not reported: Lung infiltration
Postmarketing reports: Pleuritis[Ref]

References

1. "Product Information. Rituxan (rituximab)." Genentech, South San Francisco, CA.

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL: http://www.appco.com.au/appguide/default.asp." ([2006]):

It is possible that some side effects of rituximab may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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