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When used to treat a certain penis condition (Peyronie's disease), this drug has rarely caused very serious injury to the penis (such as penile fracture/hematoma). The injury could be permanent and/or require surgery to fix. Tell your doctor right away if you develop symptoms of serious injury to your penis, such as severe pain/bruising/swelling of the penis, loss of ability to maintain an erection, difficulty urinating, blood in the urine, or a popping sound/feeling in an erect penis. To receive collagenase clostridium histolyticum for treatment of Peyronie's disease in the United States, you must understand, agree to, and carefully follow the requirements of the REMS Program for this medication. If you live in Canada or any other country, consult your doctor and pharmacist for your country's regulations.

See also How to Use and Warning sections. Pain, swelling, bruising, bleeding, redness, itching at or around the injection site may occur. Swollen, painful areas in the elbow and underarm (swollen lymph nodes) may also occur when this medication is injected in the hand. If any of these effects last or get worse, tell your doctor promptly. Tell your doctor right away if you have dizziness or feel faint. Sitting or lying down may help. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. If treating Dupuytren's contracture, tell your doctor right away if you have any serious side effects, including: signs of infection (such as fever, chills, increasing redness/swelling), signs of nerve injury (such as numbness/tingling/pain/strange feeling in the treated hand), tears in the skin around the injection site (lacerations). Serious (possibly permanent) injury to the tendons/ligaments of the hand is a rare side effect of this drug/procedure. The injury may require surgery to repair. Tell your doctor right away if you have difficulty moving your fingers or hand after your doctor has told you it is okay to move them. Some people using this medication for Peyronie's disease have developed lower back pain soon after receiving an injection. Tell your doctor right away if you have sudden lower back pain or back pain that spreads to your legs, feet, arms, or chest. The back pain may also include spasms and make it hard to walk. These symptoms usually go away after 15 minutes but may last longer. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Some products that may interact with this drug include: drugs that can cause bleeding/bruising (including aspirin, antiplatelet drugs such as clopidogrel, NSAIDs such as ibuprofen, "blood thinners" such as warfarin). Your doctor may tell you to stop taking these medications 7 days before your injection. If so, ask your doctor when it is safe to start taking them again. If your doctor has told you to take low-dose aspirin to prevent heart attack or stroke (usually 81-162 milligrams a day), you should keep taking the aspirin unless your doctor tells you not to. Ask your doctor or pharmacist for more details.