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Sipuleucel-T Side Effects

For the Consumer

Applies to sipuleucel-T: intravenous suspension

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

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

More common:
  • Bladder pain
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • bloody or cloudy urine
  • body aches or pain
  • chest pain
  • chills
  • confusion
  • cough
  • diarrhea
  • difficult, burning, or painful urination
  • difficulty with breathing
  • difficulty with speaking
  • double vision
  • ear congestion
  • fever
  • frequent urge to urinate
  • general feeling of discomfort or illness
  • headache
  • inability to move the arms, legs, or facial muscles
  • inability to speak
  • joint pain
  • loss of appetite
  • loss of voice
  • lower back or side pain
  • muscle aches and pains
  • nasal congestion
  • nausea
  • pale skin
  • rapid weight gain
  • runny nose
  • shivering
  • shortness of breath
  • slow speech
  • sneezing
  • sore throat
  • sweating
  • tightness in the chest
  • tingling of the hands or feet
  • trouble sleeping
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • unusual weight gain or loss
  • vomiting
  • wheezing

Minor Side Effects

Some sipuleucel-T 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:
  • Back pain
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • decreased weight
  • dizziness
  • feeling of warmth
  • lack or loss of strength
  • loss of appetite
  • muscle ache
  • muscle or bone pain
  • muscle spasms
  • neck pain
  • rash
  • redness of the face, neck, arms, and occasionally, upper chest
  • sleeplessness
  • sudden sweating
  • unable to sleep
  • weight loss
Less common:
  • Shakiness in the legs, arms, hands, or feet
  • trembling or shaking of the hands or feet

For Healthcare Professionals

Applies to sipuleucel-T: intravenous suspension


Very common (10% or more): Acute infusion reactions (71.2%), chills (53.1%), fatigue (41.1%), fever (31.3%)
Common (1% to 10%): Influenza-like illness, peripheral edema, hot flush


Common (1% to 10%): Hypertension
Uncommon (0.1% to 1%): Myocardial infarction
Postmarketing reports: Hypotension, thromboembolic events (deep vein thrombosis and pulmonary embolism)[Ref]


Very common (10% or more): Back pain (29.6%), joint ache (19.6%), extremity pain (12.1%)
Common (1% to 10%): Musculoskeletal pain, muscle spasms, bone pain, musculoskeletal chest pain, neck pain[Ref]


Very common (10% or more): Nausea (21.5%), vomiting (13.3%), constipation (12.3%), oral paresthesia (12.3%), diarrhea (10%)[Ref]

Nervous system

Very common (10% or more): Headache (18.1%), paresthesia (14.1%), dizziness (11.8%), muscle ache (11.8%), asthenia (10.8%)
Common (1% to 10%): Insomnia, tremor, cerebrovascular events (hemorrhagic and ischemic strokes)
Postmarketing reports: Transient ischemic attack, syncope[Ref]


Very common (10% or more): Citrate toxicity (14.8%)
Common (1% to 10%): Anorexia, decreased weight


Very common (10% or more): Anemia (12.5%)
Common (1% to 10%): Hematuria[Ref]


Common (1% to 10%): Dyspnea, upper respiratory tract infection, cough[Ref]


Common (1% to 10%): Urinary tract infection[Ref]


Common (1% to 10%): Rash, sweating[Ref]


1. "Product Information. Provenge (sipuleucel-T)." Dendreon Corporation, Seattle, WA.

It is possible that some side effects of sipuleucel-T 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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