The safety and effectiveness of tegaserod in men have not been established.
Tegaserod increases the movement of stools (fecal matter) through the bowels.
However, it does not cure IBS, nor does it treat diarrhea-predominant IBS.
Tegaserod reduces pain and discomfort in the abdominal area, and reduces bloating and constipation.
FDA based its decision to approve tegaserod on the results of 3 randomized, double blind, placebo-controlled clinical studies, each lasting 12 weeks.
During the studies, patients were asked each week to rate their overall well being, symptoms of abdominal discomfort and pain, and altered bowel habits.
At the end of the third month of the studies, the proportion of patients responding favorably to tegaserod was greater than the proportion of patients responding to placebo.
| Most common side effect associated with tegaserod was diarrhea.
The differences in response rates for tegaserod versus placebo were greater at month 1 than month 3, suggesting that efficacy may decrease over time.
The efficacy of tegaserod beyond 12 weeks has not been studied.
The adverse event reported most often in association with tegaserod compared to placebo was diarrhea (9% of patients receiving tegaserod compared to 4% of patients receiving placebo).
The majority of the patients treated with tegaserod who reported diarrhea had a single episode, and in most cases, diarrhea occurred within the first week of treatment.
Typically, diarrhea resolved without patients having to discontinue tegaserod therapy.
The discontinuation rate from the studies due to diarrhea was 1.6%.
In addition, an increase in abdominal surgeries was observed in patients on tegaserod (0.3%) compared to placebo (0.2%) in the clinical studies.
The increase was primarily due to gall bladder removals reported in patients treated with tegaserod (0.17%) compared to placebo (0.06%).
A causal relationship between abdominal surgeries and tegaserod has not been established.