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Zenapax Side Effects

Generic Name: daclizumab

Note: This page contains side effects data for the generic drug daclizumab. It is possible that some of the dosage forms included below may not apply to the brand name Zenapax.

For the Consumer

Applies to daclizumab: subcutaneous solution

As well as its needed effects, daclizumab (the active ingredient contained in Zenapax) may cause unwanted side effects that require medical attention.

Major Side Effects

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

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 daclizumab 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:

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

For Healthcare Professionals

Applies to daclizumab: intravenous solution, subcutaneous solution

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]

Metabolic

The manufacturer has reported that 32% of 88 daclizumab (the active ingredient contained in Zenapax) treated patients had high fasting glucose values compared to 16% of 64 placebo treated patients. Most of these high values occurred either on the first day post-transplant when patients received high doses of corticosteroids or in patients with diabetes.[Ref]

Metabolic side effects including edema and edema of the extremities have been reported in at least 5% of patients. Fluid overload, diabetes mellitus, and dehydration have been reported in between 2% and 5% of patients.[Ref]

Nervous system

Nervous system side effects including tremor, headache, dizziness, hypertension, hypotension, and aggravated hypertension have been reported in at least 5% of patients. Leg cramps and prickly sensation 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]

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 (the active ingredient contained in Zenapax) should be permanently discontinued.[Ref]

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

General

General side effects including posttraumatic pain, insomnia, chest pain, fever, pain, and fatigue have been reported in at least 5% of patients. Shivering and generalized weakness have been reported in between 2% and 5% of patients.[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]

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]

Musculoskeletal

Musculoskeletal side effects including musculoskeletal pain and back pain have been reported in at least 5% of patients. Arthralgia and myalgia have been reported in between 2% and 5% of patients.[Ref]

Cardiovascular

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

Hematologic

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

Other

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

Psychiatric

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

Ocular

Ocular side effects including blurred vision have been reported in between 2% and 5% of patients.[Ref]

Local

Local side effects including application site reaction have been reported in between 2% and 5% of patients.[Ref]

References

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

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

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