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

Applies to tocilizumab: solution.

Serious side effects of Actemra

Along with its needed effects, tocilizumab (the active ingredient contained in Actemra) 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

• Black, tarry stools
• bloody or cloudy urine
• blurred vision
• body aches or pain
• chest pain or tightness
• chills
• cough with or without mucus
• diarrhea
• difficult, burning, or painful urination
• difficulty breathing
• difficulty swallowing
• dizziness
• ear congestion
• fast heartbeat
• feeling of warmth
• fever
• frequent urge to urinate
• headache
• hives, itching, skin rash
• loss of appetite
• loss of consciousness
• loss of voice
• lower back or side pain
• nausea
• nervousness
• pain or tenderness around the eyes and cheekbones
• painful blisters on the trunk of the body
• pale skin
• pounding in the ears
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• redness of the face, neck, arms, and occasionally, upper chest
• slow or fast heartbeat
• sneezing
• sore throat
• stomach pain
• stuffy or runny nose
• sudden sweating
• ulcers, sores, or white spots in the mouth
• unusual bleeding or bruising
• unusual tiredness or weakness

Less common

• Accumulation of pus
• anxiety
• bladder pain
• burning feeling in the chest or stomach
• confusion
• dark urine
• decrease in height
• decreased urine
• difficulty moving
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• dry mouth
• fast, irregular, pounding, or racing heartbeat or pulse
• feeling hot
• general feeling of discomfort or illness
• heartburn
• increased thirst
• indigestion
• itching, pain, redness, swelling, tenderness, or warmth on the skin at the injection site
• joint pain
• light-colored stools
• loss of appetite
• mood changes
• muscle ache, pain, cramp, or stiffness
• numbness or tingling in the hands, feet, or lips
• pain in the back, ribs, arms, legs, groin, or genitals
• severe stomach pain
• sharp back pain just below the ribs
• shivering
• stomach upset
• sweating
• swollen joints
• swollen, painful, or tender lymph glands in the face, neck, armpit, or groin
• swollen, red, or tender area of infection
• tenderness in the stomach area
• trouble with sleeping
• unexplained runny nose or sneezing
• vomiting
• yellow eyes and skin

Rare

• Belching
• changes in skin color
• coughing or spitting up blood
• fainting
• gaseous stomach pain
• lightheadedness
• neck pain
• night sweats
• noisy breathing
• rapid, shallow breathing
• recurrent fever
• red, tender, or oozing skin at the wounded area
• sudden high fever or low-grade fever for months
• swelling of the foot or leg
• weight loss

Incidence not known

• Blistering, peeling, loosening of the skin
• bloating
• dilated neck veins
• pains in the stomach, side, or abdomen, possibly radiating to the back
• red skin lesions, often with a purple center
• red, irritated eyes
• severe stomach pain, cramping, or burning
• swelling of the face, fingers, feet, or lower legs
• vomiting of material that looks like coffee grounds, severe and continuous
• weight gain

Other side effects of Actemra

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

• Burning, dry, or itching eyes
• constipation
• discharge, excessive tearing
• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
• skin rash, encrusted, scaly and oozing
• swelling or inflammation of the mouth

Less common

• Abnormal or decreased touch sensation
• bleeding or redness and swelling of the gums
• blemishes on the skin
• bloody eye
• chapped, red, or swollen lips
• earache
• feeling of constant movement of self or surroundings
• irritation in the mouth
• loose teeth
• persistent breath odor or bad taste in your mouth
• pimples
• redness or swelling in the ear
• scaling, redness, burning, pain, or other signs of inflammation on the lips
• sensation of spinning
• sore mouth or tongue
• white patches in the mouth or on the tongue

Rare

• Bleeding after passing stool
• blindness
• bloody nose
• burning, numbness, tingling, or painful sensations
• change in hearing
• continuing ringing or buzzing or other unexplained noise in the ears
• coughing or spitting up blood
• decreased vision or other changes in vision
• dry mouth
• ear drainage
• flushed, dry skin
• fruit-like breath odor
• hearing loss
• increased hunger, thirst, urination
• itching ears
• uncomfortable swelling around the anus
• unexplained weight loss
• unsteadiness or awkwardness
• weakness in the arms, hands, legs, or feet

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]