Safety established over two decades of use
Deflux has been used for more than two decades to treat vesicoureteral reflux (VUR) grades II-IV in children.
|Incidence of adverse events occurring >1% of patients1|
|Adverse Event Category||Pivotal study N=39||Supportive Studies N=170||Post-Approval Study N=165|
|UTI||6 (15.4%)||13 (7.6%)||3 (1.8%)|
|Ureteral Dilatation||1 (2.6%)||6 (3.5%)||0 (0%)|
|Nausea, Vomiting, or Abdominal Pain||0 (0%)||2 (1.2%)||0 (0%)|
UTI = urinary tract infection.
The following adverse events have been reported with Deflux (occurring ≤ 1%): ureteral obstruction (some cases requiring temporary placement of a ureteric stent), dysuria, hematuria, urgency, frequency, hydronephrosis, pyelonephritis, urinary tract infection, foreign body reaction, calcification and pyrexia.