Applies to rituximab: intravenous solution.

Serious side effects of Rituximab

Along with its needed effects, rituximab 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

• Black, tarry stools
• bleeding gums
• bloating or swelling of the face, arms, hands, lower legs, or feet
• bloody urine
• blurred vision
• body aches or pain
• chest pain or tightness
• chills
• clay-colored stools
• confusion
• dark urine
• diarrhea
• difficulty breathing
• difficulty in moving
• dizziness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• dry mouth
• ear congestion
• fever
• flushed, dry skin
• fruit-like breath odor
• headache
• hoarseness
• increased cough
• increased hunger
• increased thirst
• increased urination
• itching, skin rash
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• loss of appetite
• loss of voice
• lower back or side pain
• muscle pain or stiffness
• nausea
• nervousness
• noisy breathing
• nosebleed
• pain in the joints
• pain or tenderness around the eyes and cheekbones
• painful or difficult urination
• pale skin
• pinpoint red spots on the skin
• pounding in the ears
• rapid weight gain
• slow or fast heartbeat
• sneezing
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• stomach pain
• stuffy or runny nose
• swollen glands
• tingling of the hands or feet
• trouble breathing
• unexplained weight loss
• unpleasant breath odor
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusual weight gain or loss
• vomiting
• vomiting of blood
• yellow eyes or skin

Less common

• Fear
• headache, severe and throbbing
• lack or loss of strength

Incidence not known

• Back pain
• blindness
• blistering, peeling, or loosening of the skin
• blue-yellow color blindness
• chest discomfort
• cough producing mucus
• decreased vision
• dilated neck veins
• drowsiness
• dry cough
• eye pain
• feeling of discomfort
• general feeling of discomfort, illness, or weakness
• high fever
• irregular breathing
• irregular heartbeat
• joint swelling
• red skin lesions, often with a purple center
• red, irritated eyes
• redness, soreness, or itching skin
• seizures
• sores, welts, or blisters
• stomach pain or cramps
• swelling of the face, fingers, feet, or lower legs

Other side effects of Rituximab

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

• Night sweats
• throat irritation

Less common

• Acid or sour stomach
• belching
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• feeling of warmth
• heartburn
• indigestion
• muscle cramps
• redness of the face, neck, arms, and occasionally, upper chest
• stomach discomfort or upset

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]