Detrol LA

[Tolterodine]

Side Effects & Drug Interactions
ADVERSE REACTIONS

The Phase 2 and 3 clinical trial program for DETROL LA Capsules included 1073 patients who were treated with DETROL LA (n= 537) or placebo (n= 536). The patients were treated with 2, 4, 6, or 8 mg/ day for up to 15 months. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates. The data described below reflect exposure to DETROL LA 4 mg once daily every morning in 505 patients and to placebo in 507 patients exposed for 12 weeks in the Phase 3, controlled clinical study. Adverse events were reported in 52% (n= 263) of patients receiving DETROL LA and in 49% (n= 247) of patients receiving placebo.

Text Continues Below

---

The most common adverse events reported by patients receiving DETROL LA were

dry mouth,
headache,
constipation,
abdominal pain.

Dry mouth was the most frequently reported adverse event for patients treated with DETROL LA occurring in 23.4% of patients treated with DETROL LA and 7.7% of placebo-treated patients. Dry mouth, constipation, abnormal vision (accommodation abnormalities), urinary retention, and dry eyes are expected side effects of antimuscarinic agents. A serious adverse event was reported by 1.4% (n= 7) of patients receiving DETROL LA and by 3.6% (n= 18) of patients receiving placebo.

The frequency of discontinuation due to adverse events was highest during the first 4 weeks of treatment. Similar percentages of patients treated with DETROL LA or placebo discontinued treatment due to adverse events. Treatment was discontinued due to adverse events and dry mouth was reported as an adverse event in 2.4% (n= 12) of patients treated with DETROL LA and in 1.2% (n= 6) of patients treated with placebo.
Table 3 lists the adverse events reported in 1% or more of patients treated with DETROL LA 4 mg once daily in the 12-week study. The adverse events were reported regardless of causality.

Page:  1 | 2 | 3 | Next >>