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Daclizumab Side Effects

In Summary

Commonly reported side effects of daclizumab include: antibody development and hyperglycemia. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to daclizumab: subcutaneous solution

In addition to its needed effects, some unwanted effects may be caused by daclizumab. In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking daclizumab:

More common:
  • Bladder pain
  • blistering, crusting, irritation, itching, or reddening of the skin
  • bloody or cloudy urine
  • body aches or pain
  • cough or hoarseness
  • cracked, dry, or scaly skin
  • difficult, burning, or painful urination
  • difficulty with breathing
  • discouragement
  • ear congestion
  • feeling sad or empty
  • fever or chills
  • frequent urge to urinate
  • headache
  • irritability
  • lack of appetite
  • loss of interest or pleasure
  • loss of voice
  • lower back or side pain
  • nasal congestion
  • painful or difficult urination
  • rash
  • runny nose
  • sneezing
  • sore throat
  • swelling
  • swollen, painful, or tender lymph glands in the neck, armpit, or groin
  • trouble concentrating
  • trouble sleeping
  • unusual tiredness or weakness
Less common:
  • Dark urine
  • general feeling of tiredness or weakness
  • itching skin
  • light-colored stools
  • persistent loss of appetite
  • red, scaling, or crusted skin
  • right upper quadrant tenderness
  • stomach pain, continuing
  • vomiting
  • yellow eyes or skin
Rare
  • Thoughts or attempts at killing oneself
  • watery or bloody diarrhea
Incidence not known:
  • Dizziness
  • fast heartbeat
  • hives or welts
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • tightness in the chest

Minor Side Effects

Some of the side effects that can occur with daclizumab 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:

Less common:
  • Blemishes on the skin
  • pimples
  • seizures

For Healthcare Professionals

Applies to daclizumab: intravenous solution, subcutaneous solution

Cardiovascular

Common (1% to 10%): Lymphadenopathy, lymphadenitis[Ref]

Dermatologic

Very common (10% or more): Rash (i.e., erythematous rash, exfoliative rash, macular rash, maculopapular rash, papular rash, pruritic rash, rash, vesicular rash) (11%)
Common (1% to 10%): Dermatitis (i.e., allergic dermatitis, atopic dermatitis, bullous dermatitis, dermatitis, exfoliative dermatitis, seborrheic dermatitis, eczema, allergic dermatitis), folliculitis, acne, psoriasis, erythema, pruritus, dry skin
Uncommon (0.1% to 1%): Toxic skin eruption, eczema nummular[Ref]

Gastrointestinal

Common (1% to 10%): Tonsillitis, diarrhea
Frequency not reported: Colitis[Ref]

Hematologic

Common (1% to 10%): Anemia, lymphocyte count decreased[Ref]

Hypersensitivity

Frequency not reported: Anaphylaxis[Ref]

Respiratory

Very common (10% or more): Nasopharyngitis (25%), upper respiratory tract infection (17%)
Common (1% to 10%): Bronchitis, pneumonia, laryngitis, rhinitis[Ref]

Psychiatric

Common (1% to 10%): Depression[Ref]

Other

Common (1% to 10%): Oropharyngeal pain, pyrexia[Ref]

Hepatic

Common (1% to 10%): ALT increased, AST increased, liver function test abnormal, hepatic enzymes increased[Ref]

Immunologic

Common (1% to 10%): Influenza, viral infection[Ref]

References

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

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

3. "Product Information. Zinbryta (daclizumab)." AbbVie US LLC, North Chicago, IL.

Not all side effects for daclizumab 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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