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Daclizumab Side 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

Cardiovascular side effects including tachycardia have been reported in at least 5% of patients.[Ref]

Dermatologic

Dermatologic side effects including impaired wound healing without infection and acne have been reported in at least 5% of patients. Pruritus, hirsutism, rash, night sweats, and increased sweating have been reported in between 2% and 5% of patients.[Ref]

Gastrointestinal

Gastrointestinal side effects including constipation, nausea, diarrhea, vomiting, abdominal pain, pyrosis, dyspepsia, abdominal distention, and epigastric pain (not food related) have been reported in at least 5% of patients. Flatulence, gastritis, and hemorrhoids have been reported in between 2% and 5% of patients.[Ref]

Genitourinary

Genitourinary side effects including oliguria, dysuria, and renal tubular necrosis have been reported in at least 5% of patients. Renal damage, urinary retention, hydronephrosis, urinary tract bleeding, urinary tract disorder, and renal insufficiency have been reported in between 2% and 5% of patients.[Ref]

Hematologic

Hematologic side effects including thrombosis have been reported in at least 5% of patients.[Ref]

Hypersensitivity

It is recommended that medications used in the treatment of severe hypersensitivity reactions be available for immediate use. If a severe hypersensitivity reaction occurs, therapy with daclizumab should be permanently discontinued.[Ref]

Hypersensitivity side effects including anaphylaxis have been reported both on initial exposure and following reexposure to daclizumab.[Ref]

Respiratory

Respiratory side effects including dyspnea, pulmonary edema, and coughing have been reported in at least 5% of patients. Atelectasis, congestion, pharyngitis, rhinitis, hypoxia, rales, abnormal breath sounds, and pleural effusion have been reported in between 2% and 5% of patients.[Ref]

Psychiatric

Psychiatric side effects including depression and anxiety have been reported in between 2% and 5% of patients.[Ref]

Other

Other side effects including lymphocele have been reported in at least 5% of patients.[Ref]

References

1. "Product Information. Zenapax (daclizumab)." Roche Laboratories, Nutley, NJ.

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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