Xiaflex (collagenase clostridium histolyticum) is a brand-name injection that’s prescribed for Peyronie’s disease and Dupuytren’s contracture in adults. As with other drugs, Xiaflex can cause side effects. These include injection site pain and swelling.
Xiaflex can cause certain side effects, some of which are more common than others. These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.
These are just a few of the more common side effects reported by people who received Xiaflex for Dupuytren’s contracture in clinical trials:
- injection site reactions, such as bruising, pain, bleeding, swelling, itching, or broken skin
- swollen or painful lymph nodes, such as in the armpit
These are just a few of the more common side effects reported by people who received Xiaflex for Peyronie’s disease in clinical trials:
- injection site reactions, such as pain, swelling, blisters, bruising, or discoloration
- painful erection
- itchiness of the penis or scrotum
Mild side effects can occur with Xiaflex use. This list doesn’t include all possible mild side effects of the drug. For more information, you can refer to Xiaflex’s prescribing information.
Mild side effects that have been seen when Xiaflex is prescribed for Dupuytren’s contracture include:
- injection site reactions, such as bruising, pain, bleeding, swelling, itching, or broken skin
- swollen or painful lymph nodes, such as in the armpit
- mild allergic reaction*
Mild side effects that have been seen when Xiaflex is prescribed for Peyronie’s disease include:
- injection site reactions, such as pain, swelling, blisters, bruising, or discoloration
- itchiness of the penis or scrotum
- sexual side effects, such as painful erection, painful sex, or erectile dysfunction
- mild allergic reaction*
These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.
Note: After the Food and Drug Administration (FDA) approves a drug, it tracks and reviews side effects of the medication. If you develop a side effect while taking Xiaflex and want to tell the FDA about it, visit MedWatch.
* An allergic reaction is possible after receiving Xiaflex. For more information, see the “Side effect specifics” section below.
Xiaflex may cause serious side effects. The list below may not include all possible serious side effects of the drug. For more information, you can refer to Xiaflex’s prescribing information.
If you develop serious side effects after receiving Xiaflex, 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.
Serious side effects and symptoms that have been reported with Xiaflex when prescribed for Dupuytren’s contracture include:
- Severe damage to the nerves or skin of your hand, which may be permanent. Symptoms can include:
- pain, numbness or tingling in the hands or fingers
- tears or splits in the skin
- Fainting. Symptoms can include:
- feeling light-headed, warm, clammy, or nauseous
- dizziness when standing up after sitting or laying down
- Ligament damage or ruptured tendon.*
- Severe allergic reaction.†
Serious side effects and symptoms that have been reported with Xiaflex when prescribed for Peyronie’s disease include:
- Fainting. Symptoms can include:
- feeling light-headed, warm, clammy, or nauseous
- dizziness when standing up from sitting or laying down
- Sudden and severe back pain after injection, which may spread to the chest, arms, and legs. Symptoms are brief and may include:
- low back pain that extends to your legs, arms, or chest
- headache
- shortness of breath
- difficulty walking
- Risk of penile fracture or other serious penis injury when used for Peyronie’s disease.*
- Severe allergic reaction†
* Xiaflex has a
† An allergic reaction is possible after receiving Xiaflex. For more information, see the “Side effect specifics” section below.
Xiaflex may cause several side effects. Here are some frequently asked questions about the drug’s side effects and their answers.
How long do side effects of Xiaflex usually last?
Side effects from Xiaflex may last for a few days to weeks. Injection site reactions, such as swelling, bruising, and pain, typically go away after a few days.
If you’re receiving Xiaflex injections into your hand for Dupuytren’s contracture, this drug may cause certain reactions around the injection site. Examples include bruising, pain, and swelling. These side effects may reduce how well your hand functions.
It may take 2–4 weeks to regain typical function, or longer if the injection causes severe damage to the nerves or skin of your hand. Your doctor may recommend that you avoid lifting objects with your affected hand until it heals.
If you receive Xiaflex for Peyronie’s disease, it may take 4 weeks or more for the swelling and bruising on your penis to go away. If you’re sexually active, let your doctor know. They’ll advise when it’s safe for you to resume sexual activity.
If you have concerns about what to expect with Xiaflex treatment, talk with your doctor.
Can Xiaflex cause long-term side effects?
It’s possible. Most of Xiaflex’s reported side effects go away a few days to weeks after an injection. However, certain long-term side effects are possible with this drug.
When given for Dupuytren’s contracture, Xiaflex can cause a tendon rupture or ligament damage at the injection site. Additionally, when used for Peyronie’s disease, it can cause serious injury to the penis, including fracture.
For more details about these side effects, see “Side effect specifics,” just below.
Learn more about some of the side effects that Xiaflex may cause. To find out how often side effects occurred in clinical trials, see the prescribing information for Xiaflex.
Risk of penile fracture or other serious penis injury when used for Peyronie’s disease
Xiaflex carries a boxed warning about the risk of penile fracture or other serious penis injury when used for Peyronie’s disease. In clinical trials of Xiaflex, this side effect was rare. Symptoms of penile fracture or other serious injury to the penis include:
- severe bleeding under the skin, which may require surgery to drain
- severe bruising and swelling of the skin
- sudden loss of erection
- popping sound or sensation during an erection
- pain in the penis
- difficulty urinating or blood in the urine
Due to these risks, Xiaflex is only available through a drug safety program known as the Risk Evaluation and Mitigation Strategy (REMS) program when prescribed for Peyronie’s disease.
What you can do
If you notice any of the symptoms above, contact your doctor right away. However, if you think you’re having a medical emergency, immediately call 911 or your local emergency number. This is a serious medical condition that may require surgery to treat.
Tendon rupture and ligament damage
It’s possible to develop tendon rupture or ligament damage from treatment with Xiaflex for Dupuytren’s contracture. However, in the drug’s clinical trials, these side effects were rare.
Symptoms of tendon rupture or ligament damage include:
- weakness in the injected hand or finger
- difficulty using your hand after your follow-up appointment
- challenges bending your treated finger toward your wrist
What you can do
If you experience any of the symptoms above, contact your doctor right away. They’ll determine the cause of your symptoms. If you do have a ruptured tendon or damaged ligament, it may require surgery to treat. Your doctor will recommend the best treatment option for you, as well as ways to manage your symptoms.
Allergic reaction
As with most drugs, Xiaflex can cause an allergic reaction in some people. In clinical trials, this side effect was more common when Xiaflex was used for Dupuytren’s contracture than when it was used for Peyronie’s disease.
Symptoms can be mild or serious and can include:
- skin rash
- itching
- flushing (temporary warmth, redness, or deepening of skin color)
- swelling under your skin, typically in your eyelids, lips, hands, or feet
- swelling of your mouth, tongue, or throat, which can make it hard to breathe
What you can do
For mild symptoms of an allergic reaction, call your doctor right away. They may recommend ways to ease your symptoms and determine whether you should keep taking Xiaflex. However, if your symptoms are serious and you think you’re having a medical emergency, immediately call 911 or your local emergency number.
This drug comes with a boxed warning about serious penile injury, including fracture.
Boxed warning: Risk of penile fracture or other serious penis injury when used for Peyronie’s disease
This drug has a
Other precautions
Be sure to talk with your doctor about your health history before you receive Xiaflex. This drug may not be the right treatment for you if you have certain medical conditions or other factors that affect your health. These are considered drug-condition or drug-factor interactions. The conditions and factors to consider include:
Peyronie’s plaques in the urethra. Peyronie’s disease, which Xiaflex is prescribed to treat, causes scar tissue to form under the skin of the penis. This type of scar tissue is also known as a plaque. If plaques have formed in your urethra, your doctor will likely not prescribe Xiaflex. Receiving a Xiaflex injection into the urethra could cause permanent damage. For this reason, your doctor may recommend a different treatment option for you.
Risk of bleeding. Tell your doctor if you have a blood clotting disorder or take an anticoagulant drug. Xiaflex is an injection, which can cause bleeding. It’s not known how Xiaflex may affect you if you have higher risk of excessive bleeding. For this reason, your doctor will determine whether Xiaflex is safe for you to receive. If they decide it’s not safe, they may recommend a different treatment option for your condition.
Allergic reaction. If you’ve had an allergic reaction to Xiaflex or any of its ingredients, your doctor will likely not prescribe Xiaflex. Ask your doctor what other medications may be better options for you.
Pregnancy or breastfeeding. It’s important to tell your doctor if you’re pregnant, breastfeeding, or planning for either before you receive Xiaflex. If you are, this drug may not be safe for you. Your doctor will determine the safest treatment option for your condition.
Alcohol consumption. If you drink alcohol, Xiaflex may be safe for you to receive. There are no known interactions between alcohol and Xiaflex. If you have questions about drinking alcohol during treatment, talk with your doctor.
If you’d like to learn more about Xiaflex, talk with your doctor or pharmacist. They can help answer any questions you have about side effects from taking the drug.
Besides talking with your doctor, you can do some research on your own. These articles might help:
- More information about Xiaflex. For details about other aspects of Xiaflex, refer to this article.
- Cost. If you’d like to learn about Xiaflex and cost, see this article.
- Dosage. For information about the dosage of Xiaflex, view this article.
- A look at your condition. For details about Peyronie’s disease, see our men’s health hub. To learn more about Dupuytren’s contracture, see this article.
Disclaimer: Medical News Today 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.