Actemra Side Effects
Generic name: tocilizumab
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.
Warning
Intravenous route (Solution)
Patients treated with tocilizumab are at increased risk for infections, some progressing to serious infections leading to hospitalization or death. These infections have included bacterial infection, tuberculosis, invasive fungal, or other opportunistic infections. Evaluate for latent tuberculosis and treat if necessary prior to initiation of therapy. Monitor patients receiving tocilizumab for signs and symptoms of infection, including tuberculosis, even if initial latent tuberculosis test is negative.
Subcutaneous route (Solution)
Patients treated with tocilizumab are at increased risk for infections, some progressing to serious infections leading to hospitalization or death. These infections have included bacterial infection, tuberculosis, invasive fungal, or other opportunistic infections. Evaluate for latent tuberculosis and treat if necessary prior to initiation of therapy. Monitor patients receiving tocilizumab for signs and symptoms of infection, including tuberculosis, even if initial latent tuberculosis test is negative.
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
- bladder pain
- burning feeling in the chest or stomach
- confusion
- dark urine
- decrease in height
- difficulty moving
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- fast, irregular, pounding, or racing heartbeat or pulse
- feeling hot
- general feeling of discomfort or illness
- heartburn
- indigestion
- itching, pain, redness, swelling, tenderness, or warmth on the skin at the injection site
- joint pain
- light-colored stools
- muscle ache, pain, cramp, or stiffness
- 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.
Respiratory
Very common (10% or more): Upper respiratory tract infection
Common (1% to 10%): Cough, dyspnea, nasopharyngitis, bronchitis[Ref]
Nervous system
Common (1% to 10%): Headache, dizziness[Ref]
Cardiovascular
Common (1% to 10%): Hypertension[Ref]
Dermatologic
Common (1% to 10%): Rash, pruritus, urticaria
Frequency not reported: Angioedema
Postmarketing reports: Stevens-Johnson Syndrome[Ref]
General
The most common serious adverse reactions were serious infections.[Ref]
Hypersensitivity
Common (1% to 10%): Hypersensitivity reaction
Postmarketing reports: Fatal anaphylaxis[Ref]
Of the 2876 patients tested for anti-tocilizumab antibodies in controlled clinical trials, 1.6% (46 patients) were positive; 5 patients experienced a hypersensitivity reaction that lead to treatment withdrawal. However, in 1.1% (30 patients) of those who developed antibodies there was no apparent correlation to clinical response.[Ref]
Oncologic
Frequency not reported: Malignancies[Ref]
Gastrointestinal
Common (1% to 10%): Abdominal pain, mouth ulceration, gastritis, diarrhea
Uncommon (0.1% to 1%): Stomatitis, gastric ulcer, diverticulitis
Rare (0.01% to 0.1%): Gastrointestinal perforation (most patients who developed GI perforations were taking concomitant nonsteroidal anti-inflammatory medications (NSAIDs), corticosteroids, or methotrexate)[Ref]
Hematologic
Very common (10% or more): Leukopenia, neutropenia, thrombocytopenia[Ref]
Hepatic
Common (1% to 10%): Transaminases increased, total bilirubin increased[Ref]
Immunologic
Common (1% to 10%): Cellulitis, pneumonia, oral herpes simplex, herpes zoster[Ref]
Local
Common (1% to 10%): Injection site reaction[Ref]
Metabolic
Very common (10% or more): Hypercholesterolemia
Common (1% to 10%): Weight increased, peripheral edema
Uncommon (0.1% to 1%): Hypertriglyceridemia[Ref]
Musculoskeletal
Common (1% to 10%): Back pain
Frequency not reported: Bacterial arthritis[Ref]
Ocular
Common (1% to 10%): Conjunctivitis[Ref]
Other
Common (1% to 10%): Peripheral edema[Ref]
Renal
Uncommon (0.1% to 1%): Nephrolithiasis[Ref]
Endocrine
Uncommon (0.1% to 1%): Hypothyroidism[Ref]
Frequently asked questions
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More about Actemra (tocilizumab)
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Related treatment guides
References
1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
2. Cerner Multum, Inc. "Australian Product Information." O 0
3. "Product Information. Actemra (tocilizumab)." Genentech (2010):
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.