Aricept 23 mg Adverse Reactions

Undesirable effects: The most common adverse events are diarrhea, muscle cramps, fatigue, nausea, vomiting and insomnia. The incidence profile for adverse events for severe Alzheimer's disease is similar to that of mild to moderately severe Alzheimer's disease. The table below reflects the incidence of adverse events in patients receiving treatment with Donepezil hydrochloride (ARICEPT) for all stages of Alzheimer's disease.
Adverse reactions reported as more than an isolated case are listed as follows, by system organ class and by frequency. Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100, < 1/10), uncommon (≥ 1/1,000, < 1/100), rare (≥ 1/10,000, < 1/1,100), very rare (< 1/10,000) and not known (cannot be estimated from available data). (See Table 1.)

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Clinical Studies Experience: Donepezil hydrochloride (ARICEPT) 23 mg tablets has been administered to over 1300 individuals globally in clinical trials. Approximately 1050 of these patients have been treated for at least three months and more than 950 patients have been treated for at least six months. The range of patient exposure was from 1 to over 500 days.
Adverse Events Leading to Discontinuation: The rate of discontinuation from a controlled clinical trial of Donepezil hydrochloride (ARICEPT) 23 mg tablets due to adverse events was higher (18.6%) than for the donepezil 10 mg/day treatment group (7.9%).
The most common adverse events leading to discontinuation, defined as those occurring in at least 1% of patients and greater than those occurring with donepezil 10 mg/day doses, are shown in Table 2. (See Table 2.)

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The majority of discontinuations due to adverse events in the Donepezil hydrochloride (ARICEPT) 23 mg tablets group occurred during the first month of treatment.
Most Frequent Adverse Clinical Events Seen in Association with the Use of Donepezil hydrochloride (ARICEPT) 23 mg tablets: The most common adverse events, defined as those occurring at a frequency of at least 5%, include nausea, diarrhea, vomiting, and anorexia. These adverse events were often of mild to moderate intensity.
Adverse Events Reported in Controlled Trials: The events cited reflect experience gained under closely monitored conditions of a controlled clinical trial in a highly selected patient population. In actual clinical practice or in other clinical trials, these frequency estimates may not apply, as the conditions of use, reporting behavior, and the kinds of patients treated may differ. Table 3 lists adverse events that were reported in at least 2% of patients who received 23 mg/day of Donepezil hydrochloride (ARICEPT) and at a higher frequency than those receiving 10 mg/day of Donepezil hydrochloride (ARICEPT) in a controlled clinical trial that compared the two doses. In this study, there were no important differences in the type of adverse events in patients taking Donepezil hydrochloride (ARICEPT) with or without memantine. (See Table 3.)

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Post-marketing Experience with 5 mg and 10 mg Donepezil Hydrochloride (ARICEPT) Tablets: Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These adverse reactions include the following: abdominal pain, agitation, cholecystitis, confusion, convulsions, hallucinations, heart block (all types), hemolytic anemia, hepatitis, hyponatremia, neuroleptic malignant syndrome, pancreatitis, and rash.