PROVENGE Side Effects

Fatigue, back pain, and nausea are some of the most commonly reported side effects of PROVENGE. Although most reactions to this medicine tend to be minor, there are serious problems that can occur during treatment. For example, notify your healthcare provider immediately if you develop fever, chest pain, a severe headache, or other potentially serious complications.

An Introduction to PROVENGE Side Effects

Just like any medicine, PROVENGE® (sipuleucel-T) can cause side effects. However, not everyone who receives the medication will have problems. In fact, most people tolerate it quite well. If side effects do occur, in most cases, they are minor and either require no treatment or are treated easily by you or your healthcare provider.
 
(This article covers many, but not all, of the possible side effects with PROVENGE. Your healthcare provider can discuss a more complete list with you.)
 

Common Side Effects of PROVENGE

PROVENGE has been studied extensively in clinical trials. In these studies, the side effects that occurred in a group of men who were given PROVENGE were documented and compared to the side effects that occurred in a group of men given a placebo (an injection that did not contain any active ingredients). As a result, it was possible to see what side effects occurred, how often they appeared, and how they compared to the placebo.
 
In these studies, common side effects of PROVENGE included but were not limited to:
 
  • Chills -- in up to 53.1 percent of people
  • Fatigue -- up to 41.1 percent
  • Fever -- up to 31.3 percent
  • Back pain -- up to 29.6 percent
  • Nausea -- up to 21.5 percent
  • Joint aches -- up to 19.6 percent
  • Headaches -- up to 18.1 percent
  • Tingling, pricking, or numbness of the skin -- up to 14.1 percent
  • Vomiting -- up to 13.3 percent
  • Constipation -- up to 12.3 percent
  • General pain -- up to 12.3 percent.
 
Other common side effects, occurring in 5 to 12.3 percent of people, included:
 
  • Tingling or numbness around the mouth
  • Pain in the arms, legs, neck, and bones
  • Muscle spasms
  • Dizziness
  • Weakness
  • Diarrhea
  • Flu-like symptoms
  • Shortness of breath
  • Swelling of the extremities
  • Hot flushes
  • Blood in the urine
  • Increased blood pressure (hypertension)
  • Decreased appetite and weight loss
  • Upper respiratory tract infections, such as the common cold
  • Insomnia
  • Coughing
  • Urinary tract infection (UTI)
  • A rash
  • Sweating
  • Tremors.
 
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