Provenge Side Effects

Generic name: sipuleucel-T

Medically reviewed by Drugs.com. Last updated on Jul 13, 2024.

Note: This document provides detailed information about Provenge Side Effects associated with sipuleucel-T. Some dosage forms listed on this page may not apply specifically to the brand name Provenge.

Applies to sipuleucel-T: intravenous suspension.

Serious side effects of Provenge

Along with its needed effects, sipuleucel-T (the active ingredient contained in Provenge) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking sipuleucel-T:

More common side effects

• 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

Other side effects of Provenge

Some side effects of sipuleucel-T may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common side effects

• 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 side effects

• 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.

Other adverse events

• 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

Cardiovascular

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

Musculoskeletal

• 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]

Gastrointestinal

• 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]

Metabolic

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

Hematologic

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

Respiratory

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

Genitourinary

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

Dermatologic

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

Further information

Provenge side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer