Aricept - Side Effects & Drug Interactions

[donepezil hydrochloride]

• Aricept - Drug Description
• Aricept - Warnings & Precautions
• Aricept - Clinical Pharmacology
• Aricept - Overdosage & Contraindications
• Aricept - Indications & Dosage
• Aricept - Patient Info

ADVERSE REACTIONS

Adverse Events Leading to Discontinuation

The rates of discontinuation from controlled clinical trials of ARICEPT® due to adverse events for the ARICEPT 5 mg/day treatment groups were comparable to those of placebo-treatment groups at approximately 5%. The rate of discontinuation of patients who received 7-day escalations from 5 mg/day to 10 mg/day, was higher at 13%.

The most common adverse events leading to discontinuation, defined as those occurring in at least 2% of patients and at twice the incidence seen in placebo patients, are shown in Table 1.

Table 1. Most Frequent Adverse Events Leading to Withdrawal

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from Controlled Clinical Trials by Dose Group

Dose Group

Placebo

5 mg/day ARICEPT®

10 mg/day ARICEPT®

Patients Randomized

355

350

315

Event/%Discontinuing

Nausea

1%

1%

3%

Diarrhea

0%

<1%

3%

Vomiting

<1%

<1%

2%

Most Frequent Adverse Clinical Events Seen in Association with the Use of ARICEPT®

The most common adverse events, defined as those occurring at a frequency of at least 5% in patients receiving 10 mg/day and twice the placebo rate, are largely predicted by ARICEPT®’s cholinomimetic effects. These include nausea, diarrhea, insomnia, vomiting, muscle cramp, fatigue and anorexia. These adverse events were often of mild intensity and transient, resolving during continued ARICEPT® treatment without the need for dose modification.

There is evidence to suggest that the frequency of these common adverse events may be affected by the rate of titration. An open-label study was conducted with 269 patients who received placebo in the 15 and 30-week studies. These patients were titrated to a dose of 10 mg/day over a 6-week period. The rates of common adverse events were lower than those seen in patients titrated to 10 mg/day over one week in the controlled clinical trials and were comparable to those seen in patients on 5 mg/day.

See Table 2 for a comparison of the most common adverse events following one and six week titration regimens.

Table 2. Comparison of rates of adverse events in patients