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Tocilizumab Side Effects

For the Consumer

Applies to tocilizumab: intravenous solution

As well as its needed effects, tocilizumab may cause unwanted side effects that require medical attention.

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

More common:
  • 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
Less common:
  • 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
Rare:
  • 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
Incidence not known:
  • 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

Severity: Minor

Some tocilizumab side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned 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
  • warmth on the skin
Less common:
  • 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
Rare:
  • 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 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]

References

1. Cerner Multum, Inc. "Australian Product Information." O 0

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. "Product Information. Actemra (tocilizumab)." Genentech, South San Francisco, CA.

It is possible that some side effects of tocilizumab may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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