Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Collagenase clostridium histolyticum
Drug ID BADD_D00525
Description Collagenase clostridium histolyticum is an enzyme produced by the bacterium Clostridium histolyticum. It is beneficial in the breakdown of collagen plaques for the treatment of Dupuytren's contracture and Peyronie's disease.[L14882] The topical formulation is used for the debridement of necrotic tissue due to burns or chronic ulcers.[L14912] On July 6, 2020 a combination of injectable bacterial collagenases was approved by the FDA for the treatment of cellulite in adult women.[L14872] Also known as Qwo, this injection is the first approved injectable treatment for cellulite and was developed by Endo International.[L14892]
Indications and Usage Collagenase clostridium histolyticum is indicated for the treatment of adults with Dupuytren's contracture with a palpable cord. Additionally, it is used to treat men with Peyronie's disease diagnosed with a penile curvature deformity of at least a 30-degree angle at the beginning of therapy in addition to palpable plaques.[L14882] Collagenase ointment is used for the tissue debridement of chronic dermal ulcers and severely burned tissues.[L14952] The combination collagenase product, also known as Qwo, is used for the treatment of moderate to severe cellulite in the buttocks of adult women.[L14872]
Marketing Status approved; investigational
ATC Code M09AB02
DrugBank ID DB00048
KEGG ID D09596
MeSH ID D003012
PubChem ID Not Available
TTD Drug ID D0I4ZQ
NDC Product Code 66887-003; 65044-7466
UNII 9X7O8V25IT
Synonyms Microbial Collagenase | Clostridium histolyticum Collagenase | Collagenase, Clostridium histolyticum | Nucleolysin | Collagenase, Microbial | Collalysine | Clostridiopeptidase A | Collagenase Clostridium histolyticum | Clostridium histolyticum, Collagenase | histolyticum, Collagenase Clostridium | Collagenase-Like Peptidase | Collagenase Like Peptidase | Peptidase, Collagenase-Like
Chemical Information
Molecular Formula Not Available
CAS Registry Number 9001-12-1
SMILES Not Available
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Drug specific antibody present13.17.01.001--Not Available
Erythema23.03.06.001--Not Available
Injection site haemorrhage12.07.03.005; 08.02.03.005; 24.07.01.010--Not Available
Injection site reaction12.07.03.015; 08.02.03.014--
Lymph node pain01.09.01.007--
Lymphadenopathy01.09.01.002--Not Available
Oedema peripheral02.05.04.007; 14.05.06.011; 08.01.07.007--
Pain in extremity15.03.04.010--
Pruritus23.03.12.001--
Syncope24.06.02.012; 17.02.04.008; 02.11.04.015--
Tenderness08.01.08.005--Not Available
Axillary pain08.01.08.015--Not Available
Contusion15.03.05.007; 24.07.06.001; 23.03.11.002; 12.01.06.001--
Injection site swelling12.07.03.018; 08.02.03.017--Not Available
Skin laceration23.03.11.041; 12.01.06.016--Not Available
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