Drug
Collagenase Clostridium Histolyticum
Important: Reactions below are the flagged terms from this drug’s
FAERS report history (min. 3 co-reports per term) — PRR/ROR indicate
disproportionality in spontaneous reporting, not causation.
Data from FDA FAERS via openFDA. Last recalculated: 2026-09-14.
| Reaction | Co-reports (a) | PRR | ROR | Signal | |
|---|---|---|---|---|---|
| 1 | Laceration | 85 | 34.8 | 35.3 | signal |
| 2 | Contusion | 670 | 27.2 | 30.9 | signal |
| 3 | Tendon Rupture | 82 | 25.8 | 26.2 | signal |
| 4 | Swelling | 576 | 24.0 | 26.8 | signal |
| 5 | Nodule | 75 | 22.4 | 22.7 | signal |
| 6 | Skin Laceration | 61 | 22.0 | 22.2 | signal |
| 7 | Haematoma | 141 | 21.1 | 21.6 | signal |
| 8 | Tenderness | 43 | 16.0 | 16.1 | signal |
| 9 | Procedural Pain | 101 | 14.2 | 14.4 | signal |
| 10 | Injection Site Haematoma | 46 | 12.2 | 12.3 | signal |
| 11 | Injection Site Nodule | 33 | 11.7 | 11.7 | signal |
| 12 | Injection Site Swelling | 213 | 10.9 | 11.3 | signal |
| 13 | Erectile Dysfunction | 67 | 10.1 | 10.2 | signal |
| 14 | Skin Discolouration | 117 | 9.9 | 10.1 | signal |
| 15 | Injection Site Bruising | 191 | 9.4 | 9.7 | signal |
| 16 | Drug Effect Less Than Expected | 31 | 8.5 | 8.6 | signal |
| 17 | Injection Site Discolouration | 26 | 8.1 | 8.2 | signal |
| 18 | Mass | 27 | 7.5 | 7.5 | signal |
| 19 | Lymphadenopathy | 64 | 7.0 | 7.1 | signal |
| 20 | Injection Site Discomfort | 18 | 6.8 | 6.8 | signal |
| 21 | Disease Recurrence | 72 | 5.8 | 5.9 | signal |
| 22 | Dysuria | 47 | 4.9 | 5.0 | signal |
| 23 | Discomfort | 74 | 4.7 | 4.8 | signal |
| 24 | Inappropriate Schedule Of Product Administration | 212 | 4.6 | 4.8 | signal |
| 25 | Inappropriate Schedule Of Drug Administration | 82 | 4.4 | 4.5 | signal |
| 26 | Blister | 62 | 4.3 | 4.3 | signal |
| 27 | Peripheral Swelling | 164 | 4.1 | 4.2 | signal |
| 28 | Therapeutic Product Effect Decreased | 47 | 4.1 | 4.1 | signal |
| 29 | Injection Site Pain | 321 | 4.1 | 4.3 | signal |
| 30 | Product Administration Error | 21 | 4.1 | 4.1 | signal |
| 31 | Drug Ineffective | 1,358 | 4.0 | 5.0 | signal |
| 32 | Scar | 17 | 3.8 | 3.8 | signal |
| 33 | Joint Range Of Motion Decreased | 13 | 3.8 | 3.8 | signal |
| 34 | Incorrect Product Administration Duration | 18 | 3.4 | 3.4 | signal |
| 35 | Drug Effect Decreased | 48 | 3.4 | 3.4 | signal |
| 36 | Pain | 506 | 3.2 | 3.4 | signal |
| 37 | Pelvic Pain | 14 | 3.0 | 3.0 | signal |
| 38 | Wrong Technique In Product Usage Process | 151 | 2.9 | 3.0 | signal |
| 39 | Treatment Noncompliance | 40 | 2.9 | 2.9 | signal |
| 40 | Condition Aggravated | 208 | 2.7 | 2.7 | signal |
| 41 | Wound | 19 | 2.6 | 2.7 | signal |
| 42 | Local Swelling | 12 | 2.6 | 2.6 | signal |
| 43 | Product Administered At Inappropriate Site | 12 | 2.6 | 2.6 | signal |
| 44 | Deformity | 6 | 2.5 | 2.5 | no signal |
| 45 | Pain In Extremity | 187 | 2.5 | 2.5 | signal |
| 46 | Nerve Injury | 7 | 2.4 | 2.4 | signal |
| 47 | Therapeutic Product Effect Incomplete | 41 | 2.2 | 2.3 | signal |
| 48 | Breast Pain | 6 | 2.2 | 2.2 | no signal |
| 49 | Ill-defined Disorder | 32 | 2.0 | 2.0 | signal |
| 50 | Impaired Work Ability | 11 | 2.0 | 2.0 | no signal |
| 51 | Musculoskeletal Stiffness | 44 | 1.9 | 2.0 | no signal |
| 52 | Carpal Tunnel Syndrome | 7 | 1.9 | 1.9 | no signal |
| 53 | Injection Site Haemorrhage | 39 | 1.9 | 1.9 | no signal |
| 54 | Temperature Intolerance | 5 | 1.9 | 1.9 | no signal |
| 55 | Burning Sensation | 34 | 1.9 | 1.9 | no signal |
| 56 | Product Preparation Error | 10 | 1.9 | 1.9 | no signal |
| 57 | Incorrect Route Of Product Administration | 8 | 1.8 | 1.8 | no signal |
| 58 | Renal Pain | 5 | 1.8 | 1.8 | no signal |
| 59 | Intentional Product Use Issue | 41 | 1.8 | 1.8 | no signal |
| 60 | Genital Haemorrhage | 6 | 1.8 | 1.8 | no signal |
| 61 | Haemorrhage | 48 | 1.8 | 1.8 | no signal |
| 62 | Presyncope | 11 | 1.8 | 1.8 | no signal |
| 63 | Unevaluable Event | 34 | 1.7 | 1.7 | no signal |
| 64 | Immune System Disorder | 5 | 1.5 | 1.5 | no signal |
| 65 | Internal Haemorrhage | 4 | 1.4 | 1.4 | no signal |
| 66 | Sexual Dysfunction | 4 | 1.3 | 1.3 | no signal |
| 67 | Injection Site Mass | 12 | 1.3 | 1.3 | no signal |
| 68 | Skin Exfoliation | 27 | 1.3 | 1.3 | no signal |
| 69 | Injection Site Irritation | 4 | 1.2 | 1.2 | no signal |
| 70 | Hernia | 6 | 1.2 | 1.2 | no signal |
| 71 | Influenza Like Illness | 24 | 1.1 | 1.1 | no signal |
| 72 | Product Quality Issue | 39 | 1.1 | 1.1 | no signal |
| 73 | Hereditary Angioedema | 3 | 1.1 | 1.1 | no signal |
| 74 | Injection Site Erythema | 28 | 0.9 | 0.9 | no signal |
| 75 | Prostatic Specific Antigen Increased | 3 | 0.8 | 0.8 | no signal |
| 76 | Product Dose Omission | 14 | 0.8 | 0.8 | no signal |
| 77 | Injection Site Pruritus | 13 | 0.8 | 0.8 | no signal |
| 78 | Skin Irritation | 8 | 0.7 | 0.7 | no signal |
| 79 | Product Storage Error | 15 | 0.7 | 0.7 | no signal |
| 80 | Wrong Technique In Drug Usage Process | 6 | 0.6 | 0.6 | no signal |
| 81 | Injection Site Warmth | 3 | 0.6 | 0.6 | no signal |
| 82 | Incorrect Drug Administration Duration | 4 | 0.5 | 0.5 | no signal |
| 83 | Injection Site Rash | 4 | 0.5 | 0.5 | no signal |
| 84 | Prostate Cancer | 10 | 0.5 | 0.5 | no signal |
| 85 | Accidental Exposure To Product | 9 | 0.3 | 0.3 | no signal |
| 86 | Incorrect Route Of Drug Administration | 3 | 0.3 | 0.3 | no signal |