Ceptia Adverse Reactions

The most common adverse events are diarrhoea, 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 as follows reflects the incidence of adverse events in patients receiving treatment with donepezil hydrochloride 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 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from available data). (See Table 9.)

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Vascular Dementia: A comparison of the Alzheimer's disease and vascular dementia studies show 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%) (Precautions).
Dementia with Lewis Bodies: The safety profile observed in the Phase 3 study in patients with Dementia with Lewis Body was similar to the safety 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.