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Truxima Side Effects

Generic name: rituximab

Medically reviewed by Philip Thornton, DipPharm. Last updated on Nov 26, 2023.

Note: This document contains side effect information about rituximab. Some dosage forms listed on this page may not apply to the brand name Truxima.

Applies to rituximab: intravenous solution.

Warning

Intravenous route (Solution)

Fatal infusion-related reactions may occur within 24 hours of rituximab infusion; approximately 80% of fatal reactions occurred with the first infusion. Monitor patients and discontinue rituximab infusion after severe reactions. Severe and potentially fatal mucocutaneous reactions can occur. Reactivation of hepatitis B virus (HBV) may occur; in some cases, it results in fulminant hepatitis, hepatic failure, or death. Screen patients for HBV infection prior to treatment. Progressive multifocal leukoencephalopathy (PML) and death can also occur.

Intravenous route (Solution)

Warning: Fatal Infusion Reactions, Severe Mucocutaneous Reactions, Hepatitis B Virus Reactivation, and Progressive Multifocal LeukoencephalopathyFatal infusion-related reactions within 24 hours of rituximab infusion; approximately 80% of fatal infusion reactions occurred with first infusion. Monitor patients and discontinue rituximab-pvvr infusion for severe reactions.Severe mucocutaneous reactions, some with fatal outcomesHepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and deathProgressive multifocal leukoencephalopathy (PML) resulting in death

Intravenous route (Solution)

Fatal infusion reactions may occur within 24 hours of rituximab infusion; approximately 80% of fatal reactions occurred with the first infusion. Monitor patients and discontinue rituximab-abbs infusion for severe reactions. Severe and potentially fatal mucocutaneous reactions can occur. Reactivation of hepatitis B virus (HBV) may occur with some cases resulting in fulminant hepatitis, hepatic failure, or death. Screen patients for HBV infection prior to treatment. Progressive multifocal leukoencephalopathy (PML), including fatal PML, can also occur.

Intravenous route (Solution)

Warning: Fatal Infusion-Related Reactions, Severe Mucocutaneous Reactions, Hepatitis B Virus Reactivation, and Progressive Multifocal LeukoencephalopathyFatal infusion-related reactions within 24 hours of rituximab infusion; approximately 80% of fatal reactions occurred with first infusion. Monitor patients and discontinue rituximab-arrx infusion for severe reactions.Severe mucocutaneous reactions, some with fatal outcomes.Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death.Progressive multifocal leukoencephalopathy (PML) resulting in death.

Serious side effects of Truxima

Along with its needed effects, rituximab (the active ingredient contained in Truxima) 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

Less common

Incidence not known

Other side effects of Truxima

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

Less common

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]

Frequently asked questions

References

1. Product Information. Rituxan (rituximab). Genentech. 2001;PROD.

2. Cerner Multum, Inc. UK Summary of Product Characteristics.

3. Pharmaceutical Society of Australia. APPGuide online. Australian prescription products guide online. http://www.appco.com.au/appguide/default.asp 2006.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.