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


Xiapex must be administered by a physician appropriately trained in the correct administration of the product and experienced in the diagnosis and treatment of male urological diseases.


  Xiapex (N=551)
n (%)
Placebo (N=281)
n (%)
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



  1. Xiapex Summary of Product Characteristics.
  2. Gelbard et al. J Urology 2013;190:199-207.