Provenge (sipuleucel-T) is a prescription drug used to treat certain types of prostate cancer. Provenge can cause side effects that range from mild to serious. Examples include nausea and headache.

Specifically, Provenge is used in adults to treat metastatic and castration-resistant prostate cancer with few to no symptoms. (Metastatic means the cancer has spread from the prostate to other areas of your body. Castration-resistant means that treatment to lower levels of testosterone in your body hasn’t been effective in treating your cancer.)

The active ingredient in Provenge is sipuleucel-T. Provenge belongs to a group of drugs called autologous cellular immunotherapies and is made from your own immune cells. These cells are collected by a healthcare professional, altered in a lab, and then administered as an intravenous (IV) infusion (an injection into a vein given over time). This infusion is done in a doctor’s office or infusion center and typically takes about 60 minutes.

The drug’s mechanism of action (how it works) is by helping your immune system target and attack certain prostate cancer cells.

Keep reading to learn about common, mild, and serious side effects Provenge can cause. For a general overview of the drug, including details about its uses, see this article.

Some people may experience mild to serious side effects during Provenge treatment. Examples of the drug’s commonly reported side effects include:

Mild side effects have been reported with Provenge. These include:

In most cases, these side effects should be temporary. And some may be easily managed. But if you have symptoms that are ongoing or bothersome, talk with your doctor or pharmacist. And do not stop Provenge treatment unless your doctor recommends it.

Provenge may cause mild side effects other than those listed above. See the drug’s prescribing information for details.

Serious side effects have been reported with Provenge. These include:

If you develop serious side effects during Provenge treatment, call your doctor right away. If the side effects seem life threatening or you think you’re having a medical emergency, immediately call 911 or your local emergency number.

* To learn more about this side effect, see the “Side effects explained” section below.

Note: After the Food and Drug Administration (FDA) approves a drug, it tracks and reviews side effects of the medication. If you’d like to notify the FDA about a side effect you’ve had with Provenge, visit MedWatch.

Allergic reaction

For some people, Provenge can cause an allergic reaction, but it isn’t clear how often this side effect occurred in the drug’s studies.

What might help

If you have mild symptoms of an allergic reaction, such as a mild rash, call your doctor right away. They may suggest a treatment to manage your symptoms and can determine whether you should continue Provenge treatment.

If you have symptoms of a severe allergic reaction, such as swelling or difficulty breathing, call 911 or your local emergency number right away. These symptoms could be life threatening and require immediate medical care.

If your doctor confirms you’ve had a serious allergic reaction to Provenge, they may have you switch to a different treatment.

Learn more about some of the side effects Provenge may cause.

Infusion Reactions

Infusion reactions were a common side effect reported in studies of Provenge. Typically, these reactions were mild and started within a day of receiving treatment.

Mild symptoms of an infusion reaction include fever, fatigue, and chills. Some of these mild symptoms, such as fever and chills, resolved within 2 days of the infusion in the drug’s studies.

On rare occasions, infusion reactions were severe. Severe infusion reactions may cause symptoms such as:

Your risk of a severe infusion reaction is higher after receiving your second Provenge dose.

What might help

To lower your risk of an infusion reaction, your doctor will likely give you medications right before your Provenge treatment. They may give you an antihistamine, such as diphenhydramine (Benadryl), and a pain reliever, such as acetaminophen (Tylenol).

Your doctor will closely watch you for infusion reaction symptoms during your treatment. They can slow down or stop the infusion if you develop a reaction. Tell them right away if you experience any of the above symptoms after receiving Provenge.

Stroke

Stroke was a rare side effect reported in studies of Provenge. A stroke occurs when a blood vessel in your brain breaks or becomes blocked. The ruptured or blocked blood vessel prevents nutrients from reaching your brain. This leads to damage and death of brain cells and tissue.

People who experienced stroke in Provenge studies typically had underlying factors that increased their stroke risk. In general, medical conditions that can raise this risk include diabetes, high blood pressure, and high cholesterol. Stroke may cause symptoms such as:

What might help

A stroke is considered a medical emergency. Call 911 or your local emergency number right away. Be sure your doctor is aware that you’ve had a stroke before you start Provenge treatment. They may have you stop Provenge and can recommend a different treatment for your prostate cancer.

Keeping track of side effects

During your Provenge treatment, consider taking notes on any side effects you’re having. You can then share this information with your doctor. This is especially helpful when you first start a new drug or combination of treatments.

Your side effect notes can include things such as:

  • what dose of the drug you were taking when you had the side effect
  • how soon you had the side effect after starting that dose
  • what your symptoms were
  • how your symptoms affected your daily activities
  • what other medications you were taking
  • any other information you feel is important

Sharing notes with your doctor will help them learn more about how Provenge affects you. They can then use this information to adjust your treatment plan if needed.

Provenge can sometimes cause harmful effects in people with certain conditions. This is known as a drug-condition interaction. Other factors may also affect whether this drug is a good treatment option for you. Talk with your doctor about your health history before starting Provenge. Be sure to tell them if any of the following factors apply to you:

  • blood clot problems, such as deep vein thrombosis and pulmonary embolism
  • stroke
  • breathing or lung problems
  • heart problems, including heart attack
  • previous allergic reaction to Provenge
  • pregnancy
  • breastfeeding
  • alcohol consumption

Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.