Mild to moderate transient adverse events1,2
Most adverse events that occured in the clinical studies were local to the treated area, mild or moderate in severity and resolved without intervention before the next scheduled injection. 79% of the adverse events resolved within two weeks.1,2
|All adverse events||464 (84,2)||102 (36,3)|
|Penile ecchymosis*||441 (80,0)||73 (26,0)|
|Penile swelling**||303 (55,0)||9 (3,2)|
|Penile pain***||250 (45,4)||26 (9,3)|
|Blood blister||25 (4,5)||0 (0,0)|
|Penile blister||18 (3,3)||0 (0,0)|
|Pruritus general||17 (3,1)||0 (0,0)|
* Includes injection site hematoma, penile hematoma, contusion, ecchymosis, penile hemorrhage and injection ites, hemorrhage.
** Includes injection site swelling, penile edema, penile swelling, local swelling, scrotal swelling and injection site edema.
*** Includes injection site pain, penile pain and injection site discomfort.
Serious adverse events
Corporal rupture was reported as a serious adverse event after Xiapex injection in 5 out of 1044 patients (0.5%) in the controlled and uncontrolled clinical trials in Peyronie’s disease. In other Xiapex-treated patients (9 of 1044; 0.9%), a combination of penile ecchymoses or haematoma, sudden penile detumescence, and/or a penile “popping” sound or sensation was reported, and in these cases, a diagnosis of corporal rupture cannot be excluded. These patients were managed without surgical intervention, but the long-term consequences are unknown.1,2
- Xiapex Summary of Product Characteristics.
- Gelbard et al. J Urology 2013;190:199-207.