Aricept Evess Adverse Reactions

Clinical Studies: Mild to Moderately Severe Alzheimer's Disease: The most common adverse events (incidence ≥5% and twice the frequency of placebo in patients receiving 10 mg/day) were diarrhea, muscle cramps, fatigue, nausea, vomiting and insomnia (see Table 8).
Other common adverse events (incidence ≥5% and ≥ placebo) were headache, pain, accident, common cold, abdominal disturbance and dizziness. Cases of syncope, bradycardia, sinoatrial block and atrioventricular block were observed. No notable abnormalities in laboratory values associated with treatment were observed except for minor increases in serum concentrations of muscle creatinine kinase. (See Table 8.)

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Severe Alzheimer's Disease: The most common adverse events (incidence ≥5% and twice the frequency of placebo) were diarrhea, nausea, and aggression (see Table 9).

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Vascular Dementia: A comparison of the Alzheimer's disease and vascular dementia studies shows that the types of and relative proportions of adverse events associated with donepezil hydrochloride were similar in the two populations. In the combined vascular dementia studies the mortality rate in the donepezil hydrochloride group (1.7%) was numerically higher than in the placebo group (1.1%) (see Precautions).
Dementia with Lewy Bodies: The safety profile observed in the Phase 3 study in patients with Dementia with Lewy Bodies was similar to the profile observed in the studies in Alzheimer's Disease with the exception of a higher rate of Parkinsonism.
Post-Marketing Experience: There have been post-marketing reports of hallucinations, agitation, aggressive behavior, seizure, hepatitis, gastric ulcer, duodenal ulcer, and gastrointestinal hemorrhage.