Duloxetine for the treatment of stress urinary incontinence in women: an integrated analysis of safety

Eur J Obstet Gynecol Reprod Biol. 2006 Mar 1;125(1):120-8. doi: 10.1016/j.ejogrb.2005.08.006. Epub 2005 Sep 26.


Objective: The objective was to characterize the safety of duloxetine for treatment of stress urinary incontinence (SUI) in women, using an integrated database generated from four published placebo-controlled clinical trials.

Methods: The database included 1913 women randomized to duloxetine (N=958) or placebo (N=955), examining adverse events (AEs), serious adverse events (SAEs), vital signs, electrocardiograms, and laboratory analytes. AEs occurring initially or worsening during the double-blind treatment period were considered treatment-emergent (TEAE). Differences between duloxetine-treated and placebo-treated groups were compared statistically.

Results: Common TEAEs included: nausea (23.2%), dry mouth (13.4%), fatigue (12.7%), insomnia (12.6%), constipation (11.0%), headache (9.7%), dizziness (9.5%), somnolence (6.8%), and diarrhea (5.1%). Most TEAEs that emerged early were mild to moderate, rarely worsened, and resolved quickly. Overall AE discontinuation rates were 20.5% for duloxetine and 3.9% for placebo (P<.001). Most discontinuations (83%) occurred within the first month of treatment. SAEs were uncommon and did not differ between treatments. Statistically significant, but clinically unimportant mean increases in heart rate (2.4 bpm) and systolic and diastolic blood pressure (<or=2 mmHg) occurred. No arrhythmogenic potential was observed and any rare, transient, asymptomatic increases in hepatocellular enzymes normalized.

Conclusions: Duloxetine was safe and tolerable, although transient AEs were not uncommon.

Publication types

  • Clinical Trial, Phase II
  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Constipation / chemically induced
  • Diarrhea / chemically induced
  • Disorders of Excessive Somnolence / chemically induced
  • Dizziness / chemically induced
  • Double-Blind Method
  • Drug-Related Side Effects and Adverse Reactions*
  • Duloxetine Hydrochloride
  • Fatigue / chemically induced
  • Female
  • Headache / chemically induced
  • Humans
  • Liver / drug effects
  • Liver / enzymology
  • Middle Aged
  • Nausea / chemically induced
  • Sleep Initiation and Maintenance Disorders / chemically induced
  • Thiophenes / adverse effects
  • Thiophenes / therapeutic use*
  • Urinary Incontinence, Stress / drug therapy*
  • Xerostomia / chemically induced


  • Thiophenes
  • Duloxetine Hydrochloride