Pletal (Cilostazol) and Diarrhea
Yes, diarrhea is a well-documented adverse effect of Pletal (cilostazol), occurring significantly more frequently than placebo, and should be managed through patient counseling, dose adjustment, or discontinuation if severe.
Incidence and Characteristics
Diarrhea is one of the most commonly reported adverse events with cilostazol, along with headache, abnormal stools, and palpitations. 1
In clinical trials, diarrhea was reported significantly more often with cilostazol compared to placebo, though specific incidence rates for cilostazol monotherapy vary across studies. 1
When compared directly to pentoxifylline, cilostazol caused significantly more diarrhea. 1
Approximately 20% of patients discontinue cilostazol within the first 3 months due to adverse effects, which include gastrointestinal symptoms like diarrhea. 2, 3
Severity and Time Course
Adverse events with cilostazol are generally mild to moderate in intensity, transient, or resolve after symptomatic treatment. 1
Most gastrointestinal side effects are self-limited and rarely require treatment withdrawal. 1
The diarrhea associated with cilostazol does not typically lead to serious adverse events in the peripheral arterial disease population. 1
Management Strategies
Initial Counseling
Counsel patients before starting cilostazol that diarrhea is a common side effect to set appropriate expectations and improve adherence. 3
Inform patients that gastrointestinal symptoms are usually mild and often resolve with continued use. 1
Dose Adjustment
If diarrhea is intolerable at the standard dose of 100 mg twice daily, consider dose reduction to 50 mg twice daily. 2
Evaluate patient tolerance at 2-4 weeks after initiation to assess whether dose adjustment is needed. 2, 4
Discontinuation Criteria
Discontinue cilostazol if diarrhea is severe, persistent, or leads to dehydration, particularly in elderly patients who are more prone to dehydration complications. 1
If symptoms do not improve with dose reduction or symptomatic treatment, discontinuation may be necessary. 1
Clinical Benefit Assessment
- Assess clinical benefit within 3-6 months of starting therapy to determine if the improvement in claudication symptoms justifies continuing despite side effects. 2, 4
Important Caveats
Elderly patients require special attention as they are more prone to dehydration from gastrointestinal side effects, which could result in hospitalization. 1
The tolerability profile of cilostazol limits its use despite proven efficacy for intermittent claudication. 3
Drug interactions with CYP3A4 or CYP2C19 inhibitors may increase cilostazol levels and potentially worsen side effects, requiring dose adjustment or avoidance. 1