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Actemra Side Effects

Generic Name: tocilizumab

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

For the Consumer

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.

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
  • 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
  • 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
  • slow or fast heartbeat
  • sneezing
  • sore throat
  • stomach pain
  • stuffy or runny nose
  • sudden sweating
  • tightness of the chest
  • 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, or 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
  • troubled breathing with exertion
  • 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

  • Dilated neck veins
  • extreme tiredness or weakness
  • 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

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

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]

References

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

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

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

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.

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