Skip to main content

Tocilizumab Side Effects

Medically reviewed by Philip Thornton, DipPharm. Last updated on Feb 15, 2024.

Applies to tocilizumab: solution.

Warning

Intravenous route (Solution)

Risk Of Serious InfectionsPatients treated with tocilizumab products including tocilizumab-bavi are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.If a serious infection develops, interrupt tocilizumab-bavi until the infection is controlled.Reported infections include: 1. Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Patients should be tested for latent tuberculosis before tocilizumab-bavi use and during therapy. Treatment for latent infection should be initiated prior to tocilizumab-bavi use. 2. Invasive fungal infections, including candidiasis, aspergillosis, and pneumocystosis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease. 3. Bacterial, viral and other infections due to opportunistic pathogens.The risks and benefits of treatment with tocilizumab-bavi should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with tocilizumab-bavi, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.

Serious side effects of Tocilizumab

Along with its needed effects, tocilizumab 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 immediately if any of the following side effects occur while taking tocilizumab:

More common

Less common

Rare

Incidence not known

Other side effects of Tocilizumab

Some side effects of tocilizumab 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

Rare

For Healthcare Professionals

Applies to tocilizumab: intravenous solution, subcutaneous solution.

General

The most common adverse reactions were upper respiratory tract infections, nasopharyngitis, headache, hypertension, increased ALT, and injection site reactions. The most common serious adverse reactions were serious infections.[Ref]

Cardiovascular

Common (1% to 10%): Hypertension

Uncommon (0.1% to 1%): Myocardial infarction

Frequency not reported: Hypotension[Ref]

Dermatologic

Common (1% to 10%): Rash, pruritus, urticaria, cellulitis, skin reactions

Frequency not reported: Angioedema

Postmarketing reports: Stevens-Johnson syndrome[Ref]

Endocrine

Uncommon (0.1% to 1%): Hypothyroidism[Ref]

Gastrointestinal

GI perforations were primarily reported as complications of diverticulitis (including generalized purulent peritonitis, lower GI perforation, fistula, and abscess). Most patients who developed GI perforations were taking concomitant nonsteroidal anti-inflammatory medications (NSAIDs), corticosteroids, or methotrexate.[Ref]

Common (1% to 10%): Abdominal pain, mouth ulceration, gastritis, diarrhea, oral herpes simplex, upper abdominal pain, constipation, nausea

Uncommon (0.1% to 1%): Stomatitis, gastric ulcer, diverticulitis, gastrointestinal (GI) perforations

Frequency not reported: Gastroenteritis, diverticulitis complications (including generalized purulent peritonitis, lower GI perforation, fistula, abscess), epigastric discomfort

Postmarketing reports: Pancreatitis[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection

Hematologic

Very common (10% or more): Bleeding events

Common (1% to 10%): Leukopenia, neutropenia, thrombocytopenia, decreased neutrophil counts, decreased platelet counts, serious bleeding

Postmarketing reports: Hypofibrinogenemia, pancytopenia[Ref]

Hepatic

Increased ALT and AST greater than the upper limit of normal (ULN) to 3 times ULN (3 x ULN) were reported in up to 48% and up to 41% of patients, respectively. Increased ALT and AST greater than 3 to 5 x ULN were reported in up to 5% and up to 2% of patients, respectively. Increased ALT and AST greater than 5 x ULN were reported in up to 1.5% and up to 0.7% of patients, respectively.

ALT or AST at least 5 x ULN occurred in 11.7% of patients who received this drug for coronavirus disease 2019 (COVID-19).[Ref]

Very common (10% or more): Increased ALT (up to 48%), increased AST (up to 41%)

Common (1% to 10%): Increased hepatic transaminases, increased total bilirubin, hepatic events

Frequency not reported: Drug-induced hepatitis with hyperbilirubinemia

Postmarketing reports: Drug-induced liver injury, hepatitis, hepatic failure, jaundice[Ref]

Hypersensitivity

Common (1% to 10%): Hypersensitivity reactions (including anaphylaxis)

Uncommon (0.1% to 1%): Anaphylactic reactions

Frequency not reported: Anaphylactoid reactions

Postmarketing reports: Fatal anaphylaxis[Ref]

Immunologic

Common (1% to 10%): Anti-drug antibodies, neutralizing antibodies

Frequency not reported: Macrophage activation syndrome[Ref]

Local

Very common (10% or more): Injection site reactions (including erythema, pruritus, pain, hematoma)

Frequency not reported: Injection site swelling[Ref]

Metabolic

Very common (10% or more): Hypercholesterolemia

Common (1% to 10%): Hypokalemia

Uncommon (0.1% to 1%): Hypertriglyceridemia[Ref]

Musculoskeletal

Common (1% to 10%): Back pain

Frequency not reported: Bacterial arthritis, arthralgia[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness, stroke[Ref]

Ocular

Common (1% to 10%): Conjunctivitis[Ref]

Oncologic

Uncommon (0.1% to 1%): Malignancies[Ref]

Other

Very common (10% or more): Increased low-density lipoprotein (LDL) cholesterol (up to 47%), infection (up to 30.3%), increased total cholesterol (up to 25%), serious infection (up to 18.6%)

Common (1% to 10%): Peripheral edema, herpes zoster, increased weight, infusion-related reactions

Uncommon (0.1% to 1%): Opportunistic infections

Frequency not reported: Sepsis, increased lipid parameters (total cholesterol, LDL cholesterol, high-density lipoprotein cholesterol, triglycerides), active tuberculosis[Ref]

Psychiatric

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

Renal

Uncommon (0.1% to 1%): Nephrolithiasis[Ref]

Respiratory

Very common (10% or more): Upper respiratory tract infection

Common (1% to 10%): Cough, dyspnea, nasopharyngitis, bronchitis, pneumonia

Frequency not reported: Invasive pulmonary infections (including candidiasis, aspergillosis, coccidioidomycosis, pneumocystis jirovecii)

Postmarketing reports: Interstitial lung disease (including pneumonitis, pulmonary fibrosis; some fatal outcomes)[Ref]

Frequently asked questions

References

1. Product Information. Actemra (tocilizumab). Genentech. 2022;SUPPL-138/SUPPL-49.

2. Product Information. Actemra (tocilizumab). Roche Products Pty Ltd. 2022;Actemra 20220902.

3. Product Information. RoActemra (tocilizumab). Roche Products Ltd. 2022.

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.

Medical Disclaimer