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Provenge Side Effects

Generic Name: sipuleucel-T

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

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

For the Consumer

Applies to sipuleucel-T: intravenous suspension

As well as its needed effects, sipuleucel-T (the active ingredient contained in Provenge) 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

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


General side effects have included chills, fever, fatigue, citrate toxicity, influenza-like illness, decreased weight, and sweating.[Ref]


Gastrointestinal side effects have included nausea, vomiting, constipation, diarrhea, and anorexia.[Ref]


Musculoskeletal side effects have included back pain, joint ache, muscle ache, musculoskeletal pain, muscle spasms, bone pain, musculoskeletal chest pain, and neck pain.[Ref]

Nervous system

Nervous system side effects have included headache, dizziness, paresthesia, pain, oral paresthesia, pain in extremity, asthenia, insomnia, and tremor.[Ref]


Cardiovascular side effects have included peripheral edema and hot flashes.[Ref]


Hematologic side effects have included anemia.[Ref]


Respiratory side effects have included dyspnea, cough, and upper respiratory infection.[Ref]


Genitourinary side effects have included hematuria and urinary tract infection.[Ref]


Dermatologic side effects have included rash.[Ref]


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

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