Actemra Side Effects

Generic Name: tocilizumab

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

For the Consumer

Applies to tocilizumab: intravenous solution

In addition to its needed effects, some unwanted effects may be caused by tocilizumab (the active ingredient contained in Actemra). In the event that any of these side effects do occur, they may require medical attention.

If any of the following side effects occur while taking tocilizumab, check with your doctor or nurse immediately:

• Abdominal or stomach pain
• black, tarry stools
• bloody or cloudy urine
• blurred vision
• body aches or pain
• chest pain
• cough
• cough producing mucus
• diarrhea
• difficult, burning, or painful urination
• difficulty breathing
• difficulty swallowing
• dizziness
• ear congestion
• fast heartbeat
• feeling of warmth
• fever or chills
• frequent urge to urinate
• headache
• hives
• itching
• loss of appetite
• loss of consciousness
• loss of voice
• lower back or side pain
• nasal congestion
• 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
• shortness of breath or troubled breathing
• skin rash
• slow or fast heartbeat
• sneezing
• sore throat
• stuffy or runny nose
• sudden sweating
• tightness of the chest or wheezing
• ulcers, sores, or white spots in the mouth
• unusual bleeding or bruising
• unusual tiredness or weakness
• weakness

• Bladder pain
• blurred vision
• 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
• frequent urge to urinate
• 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 aches and pains
• muscle cramps or stiffness
• pain in the back, ribs, arms, or legs
• pain in the groin or genitals
• pale skin
• severe stomach pain
• sharp back pain just below the ribs
• shivering
• stomach upset
• sweating
• swelling
• swollen joints
• swollen, painful, or tender lymph glands in the face, neck, armpit, or groin
• tenderness in the stomach area
• trouble with sleeping
• troubled breathing with exertion
• unexplained runny nose or sneezing
• upper right abdominal or stomach pain
• vomiting
• yellow eyes and skin

• Acid or sour stomach
• belching
• changes in skin color
• confusion
• coughing or spitting up blood
• fainting
• gaseous abdominal or stomach pain
• lightheadedness
• neck pain
• night sweats
• noisy breathing
• pain
• pain, swelling, or redness in the joints
• rapid, shallow breathing
• recurrent fever
• red, tender, or oozing skin at incision
• stomach bloating, burning, cramping, or pain
• sudden high fever or low-grade fever for months
• swelling of the foot or leg
• swollen lymph nodes
• weight loss

• Dilated neck veins
• extreme fatigue
• severe abdominal or stomach pain, cramping, or burning
• swelling of the face, fingers, feet, or lower legs
• vomiting of material that looks like coffee grounds, severe and continuing
• weight gain

Minor Side Effects

Some of the side effects that can occur with tocilizumab may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

• 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
• warmth on the skin

• Abnormal or decreased touch sensation
• accumulation of pus
• back pain
• bleeding gums
• blemishes on the skin
• bloody eye
• chapped, red, or swollen lips
• earache
• feeling of constant movement of self or surroundings
• hives or welts
• irritation in the mouth
• loose teeth
• persistent breath odor or bad taste in your mouth
• pimples
• redness and swelling of the gums
• redness of the eye
• redness of the skin
• redness or swelling in the ear
• scaling, redness, burning, pain, or other signs of inflammation of the lips
• sensation of spinning
• sleeplessness
• sore mouth or tongue
• sores on the skin
• stomach soreness or discomfort
• swollen, red, or tender area of infection
• unable to sleep
• white patches in the mouth or on the tongue

• Bleeding after defecation
• 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
• earache
• flushed, dry skin
• fruit-like breath odor
• hearing loss
• increased hunger
• increased thirst
• increased urination
• itching ears
• loss of consciousness
• redness, swelling, or soreness of the tongue
• thirst
• 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

Of the 2876 patients tested for anti-tocilizumab (the active ingredient contained in Actemra) 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]

Common (1% to 10%): Hypersensitivity reaction
Postmarketing reports: Fatal anaphylaxis^[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]

Not all side effects for Actemra may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

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