If you have Peyronie’s disease or Dupuytren’s contracture, your doctor might suggest Xiaflex as a treatment option for you. Xiaflex is a prescription drug used as a short-term treatment for these conditions in adults.

The active ingredient in Xiaflex is collagenase clostridium histolyticum. (An active ingredient is what makes a drug work.)

For more information about Xiaflex, including details about its uses, see this in-depth article.

Like other drugs, Xiaflex can cause mild to serious side effects. Keep reading to learn more.

Some people may experience mild to serious side effects during their Xiaflex treatment. These side effects can vary depending on which condition the drug is being used to treat.

Below are a few of the more common side effects reported by people who took Xiaflex in studies.

More common side effects in people receiving Xiaflex injections for Peyronie’s disease include:

  • hematoma (pooling of blood under the skin) at the injection site
  • injection site reactions, such as swelling, pain, or bruising
  • blood blisters on the penis

More common side effects in people receiving Xiaflex injections for Dupuytren’s contracture

include:

  • swelling or bruising, usually in the affected hand
  • other injection site reactions, such as skin discoloration, pain, and warmth

For more information about these common side effects (including the percentage of people who experienced them in studies), see the drug’s prescribing information.

Some people may experience mild side effects during their Xiaflex treatment. These side effects can vary depending on which condition the drug is being used to treat.

Mild side effects that have been reported by people receiving Xiaflex differ based on the disease being treated. See the table below for details.

Mild side effects of Xiaflex for Dupuytren’s contractureMild side effects of Xiaflex for Peyronie’s disease
• swelling or bruising, usually in the affected hand
• bleeding at the injection site*
• other injection site reactions, such as skin
discoloration, pain, and warmth pain in the hand
• tenderness
• itchiness
• breaks in the skin of the affected hand
• swelling or pain in the lymph nodes
• underarm pain
• mild allergic reaction*
• bleeding at the injection site*
• swelling or pain in the penis or at the injection site
• bruising of the penis
blood blisters on the penis
• genital itching
• painful erections
erectile dysfunction
• discoloration of skin on the penis
• pain during sex
• skin growths, including vesicles and nodules
• mild allergic reaction*

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

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

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

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

In rare cases, Xiaflex can cause serious side effects. These side effects can vary depending on which condition the drug is being used to treat.

Serious side effects that have been reported with Xiaflex include:

  • tendon rupture or serious injury to the hand or fingers* (when used for Dupuytren’s contracture)
  • feeling faint or temporary loss of consciousness
  • severe back pain after injection into the penis*
  • penile fracture and other penis injuries† (when used for Peyronie’s disease)
  • severe allergic reaction*

If you develop serious side effects during your Xiaflex treatment, call your doctor right away. But if your 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.
Xiaflex has a boxed warning for this side effect. This is the most serious warning from the Food and Drug Administration (FDA). To learn more, see the “Side effects explained” section below.

Get answers to some frequently asked questions about Xiaflex’s side effects.

How long does Xiaflex stay in your system?

Xiaflex is injected directly into your hand or penis, depending on the condition it’s treating.

Very small amounts of Xiaflex pass into your blood. And after 30 minutes, the drug can no longer be detected in your blood.

This explains why the side effects of Xiaflex mainly occur in the area where you receive the injection. In some cases, people may feel faint or temporarily lose consciousness. But this usually happens because of the pain or bleeding from the injection.

If you have other questions about how long Xiaflex stays in your system or how it may affect you, talk with your doctor or pharmacist.

Can Xiaflex cause infection?

Yes, depending on the condition it’s being used to treat. People receiving Xiaflex injections into the hand for Dupuytren’s contracture have a risk of infection. But in studies, there were no reports of infections in people receiving Xiaflex injections into the penis for Peyronie’s disease.

Symptoms of an infection can include:

  • fever
  • chills
  • skin discoloration at the injection site
  • swelling at the injection site

If you have symptoms of infection after receiving a Xiaflex injection into your hand, talk with your doctor. You’ll also have a follow-up appointment after your injection, where your doctor will check for symptoms of an infection.

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

Boxed warning: Risk of penile fracture and other serious penis injuries when used to treat Peyronie’s disease

Xiaflex has a boxed warning for the risk of penile fracture and other serious penis injuries when used to treat Peyronie’s disease. A boxed warning is the most serious warning from the Food and Drug Administration (FDA).

With penile fracture, certain tissues in the penis are ruptured. When this occurs, you may hear a popping or snapping sound. Penile fracture is a medical emergency.

Other penis injuries that can happen with Xiaflex include hematoma (pooling of blood under the skin) at the injection site. With a penile hematoma, the tissues in your penis can become severely damaged and may even die.

Symptoms of penile fracture or other serious penis injuries may include:

  • bruising or pain in your penis
  • trouble urinating
  • blood in your urine
  • sudden erectile dysfunction

What might help

If you experience any of the symptoms above during your Xiaflex treatment, talk with your doctor right away or go to the closest emergency room.

To lower the risk of injury to your penis, you should not have sexual activity during much of your Xiaflex treatment cycle. Your doctor will explain this when you start treatment.

Using the correct injection technique with Xiaflex may help prevent injury to the penis. For Peyronie’s disease, only certain doctors may prescribe Xiaflex through a Risk Evaluation and Mitigation Strategy (REMS) program.

The Xiaflex REMS program provides doctors with specific training on how to inject Xiaflex. Also, the healthcare center where doctors administer Xiaflex must become certified to inject Xiaflex. This ensures that only doctors with appropriate training can inject Xiaflex.

If you have questions about the risk involved with getting Xiaflex injections, talk with your doctor before starting treatment.

Tendon rupture or serious injury to the hand or fingers*

Tendon rupture or injury to the hand or finger can occur in people receiving Xiaflex injections for Dupuytren’s contracture. This severe but rare side effect can occur if the doctor injects Xiaflex directly into a tendon or ligament.

Other injuries that can occur with Xiaflex injections into the hand include:

What might help

If you have symptoms of severe injury to the hand or fingers during your Xiaflex treatment, tell your doctor. Sometimes people need surgery to repair tendon rupture or other injuries to the hand or skin.

To help prevent tendon rupture and other hand injuries with Xiaflex injections, your doctor will carefully inject Xiaflex. Avoiding an injection into tendons, nerves, and blood vessels helps prevents injury.

Severe back pain after Xiaflex injection into the penis

Some people may have temporary severe back pain after receiving Xiaflex injections into the penis. The pain usually starts within a few minutes after the injection.

In severe situations, people may have pain in the back that spreads into their legs, arms, or chest. Other related symptoms after Xiaflex injections include:

  • chest pain
  • headache
  • trouble breathing

What might help

Back pain from Xiaflex injections usually goes away without treatment. Sometimes the pain can last for 15 minutes or longer, although this is rare.

If you have back pain after your injection, talk with your doctor. They may recommend pain medications that can help relieve your pain.

Bleeding at the injection site

Bleeding is common with Xiaflex injections for Peyronie’s disease and Dupuytren’s contracture. When your doctor injects Xiaflex, they might damage a small blood vessel. This can cause bruising or light bleeding.

In rare situations, you may have a hematoma (pooling of blood under the skin) after an injection. Hematoma is a rare side effect, but it’s more likely when receiving Xiaflex injections into the penis.

What might help

If you have a hematoma in your penis, you might need surgery to drain the blood. Hematoma in the penis can sometimes cause people to feel faint or lose consciousness. If you’re feeling faint after an injection, your doctor will have you continue lying down for a while to help prevent a fall.

After receiving Xiaflex injections, you can help prevent bleeding by following your doctor’s instructions. For Dupuytren’s contracture, you’ll wear a splint on your hand to help prevent injury. After a Xiaflex injection into your penis for Peyronie’s disease, your doctor will wrap the area with a bandage.

If you’re concerned about any bleeding or bruising at the Xiaflex injection site, talk with your doctor.

Allergic reaction

Like most drugs, Xiaflex can cause an allergic reaction in some people. If you’re prescribed Xiaflex for Dupuytren’s contracture, your risk of itchiness increases with additional injections. But for Peyronie’s disease, the risk of itchiness is the same even after several injections.

Symptoms can be mild to serious and can include:

  • skin rash
  • itchiness
  • flushing (temporary warmth, redness, or deepening of skin color)
  • swelling under your skin, usually in your eyelids, lips, hands, or feet
  • swelling of your mouth, tongue, or throat, which can make it hard to breathe

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 option to manage your symptoms. Examples include:

  • an antihistamine you take by mouth, such as Benadryl (diphenhydramine)
  • a product you apply to your skin, such as hydrocortisone cream

If your doctor confirms you’ve had a mild allergic reaction to Xiaflex, they’ll decide whether you should continue receiving it.

If you have symptoms of a severe allergic reaction, such as swelling or trouble 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 Xiaflex, they may have you switch to a different treatment.

Keeping track of side effects

During your Xiaflex 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 taking new drugs or using a combination of treatments.

Your side effect notes can include things such as:

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

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

Xiaflex comes with several warnings. See below for details.

Boxed warning: Risk of penile fracture and other serious penile injuries when used to treat Peyronie’s disease

Xiaflex has a boxed warning for the risk of penile fracture and other serious penis injuries when used to treat Peyronie’s disease. A boxed warning is the most serious warning from the Food and Drug Administration (FDA).

If you hear a pop or snap sound in your penis, call your doctor right away. You may have a penile fracture.

Other penis injuries that can happen with Xiaflex include hematoma (pooling of blood under the skin) at the injection site. With a penile hematoma, the tissues in your penis can become severely damaged and may even die.

To learn more, see the “Side effects explained” section above.

Other warnings

Xiaflex may not be right for you if you have certain medical conditions. These are known as drug-condition interactions. Other factors may also affect whether Xiaflex is a good treatment option for you.

Talk with your doctor about your health history before starting Xiaflex. Factors to consider include those discussed below.

Blood clotting problem. Xiaflex injections can cause bleeding at the injection site. If you have a blood clotting problem or you take a blood thinner, you may have a higher risk of this side effect.

Due to this risk, your doctor will likely not prescribe Xiaflex if you have a blood clotting problem or take a blood thinner. Talk with your doctor about treatment options that may be safer for you.

Allergic reaction. If you’ve had an allergic reaction to Xiaflex or any of its ingredients, your doctor will likely not prescribe Xiaflex. Ask them what other medications are better options for you.

Peyronie’s plaques in the urethra. If you have a Peyronie’s plaque in your urethra (the tube urine passes through), your doctor will not prescribe Xiaflex. This is because Xiaflex could damage your urethra. Your doctor can tell you about other treatment options to treat your condition.

Alcohol and Xiaflex

It should be safe to drink alcohol during your Xiaflex treatment.

If you have questions about consuming alcohol during your Xiaflex treatment, talk with your doctor or pharmacist.

Pregnancy and breastfeeding while using Xiaflex

It isn’t known whether it’s safe to receive Xiaflex injections while pregnant or breastfeeding.

If you’re pregnant or breastfeeding, or planning to become pregnant or to breastfeed, talk with your doctor before starting treatment with Xiaflex.

Side effects of Xiaflex can differ depending on the condition it’s used to treat. But most side effects caused by the drug are mild.

If you have any questions about side effects that can occur with Xiaflex, talk with your doctor. They can also tell you more about what to expect after a Xiaflex injection.

Examples of questions you may want to ask your doctor include:

  • Does my risk of penis fracture increase with the number of Xiaflex injections I receive?
  • Do I have a higher risk of penis fracture with Xiaflex because I’m over 65 years old?
  • Can Xiaflex injections cause rheumatoid arthritis in my hand?
  • Can I still receive Xiaflex if I’m taking a blood thinner?

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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.