Prescription medicine
Collagenase clostridium histolyticum Brand names: Xiaflex
Collagenase clostridium histolyticum (Xiaflex) is a prescription medicine with an FDA approval on record since 2010. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the collagenase clostridium histolyticum FDA label on DailyMed (effective May 17, 2019); the BLA 125338 record on Drugs@FDA; every collagenase clostridium histolyticum label on DailyMed.
Highlights of the record
FDA label of May 17, 2019; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageCollagenase Santyl ◊ Ointment is indicated for debriding chronic dermal ulcers 2, 3, 4, 5, 6, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18 and severely burned areas.
Forms and strengths
Ointment; kit.
On the market
- Earliest approval on file
- February 2, 2010 Xiaflex, Auxilium Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 2 of which 0 under generic applications, 2 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2021 0 Class I among all firms' recalls; latest March 15, 2021
- FAERS reports
- 7,032 through July 30, 2026
What is collagenase clostridium histolyticum used for?
From the label: indications and usageCollagenase Santyl ◊ Ointment is indicated for debriding chronic dermal ulcers 2, 3, 4, 5, 6, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18 and severely burned areas. 3, 4, 5, 7, 16, 19, 20, 21
FDA pharmacologic class: Collagen-specific Enzyme.
Source: FDA drug label (COLLAGENASE SANTYL), SMITH & NEPHEW, INC, effective May 17, 2019 (SPL set 6b6fbfc6-98fa-46aa-88ef-ab00fbb08ffd), via openFDA; the full label on DailyMed
What does the patient leaflet for collagenase clostridium histolyticum say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about XIAFLEX for the treatment of Dupuytren’s contracture?XIAFLEX may cause serious side effects, including: Tendon rupture or ligament damage. Receiving an injection of XIAFLEX may cause damage to a tendon or ligament in your hand and cause it to break or weaken. This could require surgery to fix the damaged tendon or ligament. Call your healthcare provider right away if you have trouble bending your injected finger (towards the wrist) after the swelling goes down or you have problems using your treated hand after your follow-up visit. Nerve injury or other serious injury of the hand. After finger procedures, some people developed tears in the skin (lacerations), and local skin and soft-tissue necrosis (death of skin cells). Some lacerations and necrosis required skin grafting, or other surgery including amputation. Call your healthcare provider right away if you get numbness, tingling, increased pain, or tears in the skin (laceration) in your treated finger or hand after your injection or after your follow-up visit. Hypersensitivity reactions, including anaphylaxis. Severe allergic reactions can happen in people who receive XIAFLEX, because it contains foreign proteins. Call your healthcare provider right away if you have any of these symptoms of an allergic reaction after an injection of XIAFLEX: hives chest pain swollen face low blood pressure breathing trouble dizziness or fainting 4. Fainting: Fainting or near fainting can happen in people who receive XIAFLEX, especially following finger procedures. If you have dizziness or feel faint after receiving XIAFLEX, lie down until the symptoms go away.
From the patient leaflet: What should I avoid while receiving XIAFLEX?Avoid situations that may cause you to strain your stomach (abdominal) muscles, such as straining during bowel movements.
Source: FDA drug label (XIAFLEX), Endo USA, Inc., effective April 22, 2026 (SPL set 805cecd0-fd1f-11dd-87af-0800200c9a66), via openFDA; the full label on DailyMed
Is there a generic for collagenase clostridium histolyticum (Xiaflex)?
No generic collagenase clostridium histolyticum is approved (Drugs@FDA, October 8, 2026).
- 2010 earliest approval on file
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has collagenase clostridium histolyticum been recalled?
The FDA's Enforcement Report lists 1 recall naming collagenase clostridium histolyticum since 2021: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 15, 2021 | Class II | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the collagenase clostridium histolyticum label say about other medicines?
The collagenase clostridium histolyticum label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Aspirin | drug interactions | DRUG INTERACTIONS Anticoagulant drugs: XIAFLEX should be used with caution in patients receiving concomitant anticoagulants (except for low-dose aspirin) [see Warnings and Precautions (5.5)]. |
Check collagenase clostridium histolyticum against other medicines
Source: FDA drug label (COLLAGENASE SANTYL), SMITH & NEPHEW, INC, effective May 17, 2019 (SPL set 6b6fbfc6-98fa-46aa-88ef-ab00fbb08ffd), via openFDA; the full label on DailyMed
What do FAERS reports show for collagenase clostridium histolyticum?
The FDA Adverse Event Reporting System holds 7,032 reports that list collagenase clostridium histolyticum among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 494 are coded as a death and 634 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Collagenase clostridium histolyticum side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other