Enablex Adverse Reactions

Consistent with the pharmacological profile, the most commonly reported adverse drug reactions were dry mouth (20.2% and 35% for the 7.5 mg and 15 mg dose, respectively vs. 8% placebo) and constipation (14.8% and 21% for the 7.5 mg and 15 mg dose, respectively vs. 5.4% placebo). Anticholinergic effects, in general, are dose-dependent.
However, the patient discontinuation rates due to these adverse reactions were low (dry mouth: 0% and 0.9% for the 7.5 mg and 15 mg dose, respectively vs. 0% for placebo; constipation: 0.6% and 1.2% for the 7.5 mg and 15 mg dose, respectively vs. 0.3% for placebo). (See Table 2.)

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In the pivotal clinical trials with doses of ENABLEX 7.5 mg and 15 mg, adverse drug reactions were reported as presented in Table 2. Most of the adverse drug reactions were of mild or moderate intensity and did not result in discontinuation in the majority of the patients.
Treatment with ENABLEX may possibly mask symptoms associated with gallbladder disease.
However, there was no association between the occurrence of adverse events related to the biliary system in darifenacin-treated patients and increasing age.
The incidence of adverse events with the doses of ENABLEX 7.5 mg and 15 mg decreased during the treatment period up to 6 months. A similar trend is also seen for the discontinuation rates.