Exelon Adverse Reactions

Summary of the safety profile: The most commonly reported adverse reactions (ADRs) are gastrointestinal, including nausea (38%) and vomiting (23%), especially during titration. Female patients in clinical studies were found to be more susceptible than male patients to gastrointestinal adverse reactions and weight loss.
Tabulated list of adverse reactions: Adverse reactions in Table 4 and Table 5 are listed according to MedDRA system organ class and frequency category. Frequency categories are defined using the following convention: 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); not known (cannot be estimated from the available data).
The following adverse reactions, listed in Table 4 as follows, have been accumulated in patients with Alzheimer's dementia treated with Exelon. (See Table 4.)

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The following additional adverse reactions have been observed with Exelon transdermal patches: delirium, pyrexia, decreased appetite, urinary incontinence (common), psychomotor hyperactivity (uncommon), erythema, urticaria, vesicles, allergic dermatitis (not known).
Table 5 shows the adverse reactions reported during clinical studies conducted in patients with dementia associated with Parkinson's disease treated with Exelon capsules. (See Table 5.)

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The following additional adverse reaction has been observed in a study of patients with dementia associated with Parkinson's disease treated with Exelon transdermal patches: agitation (common).
Table 6 lists the number and percentage of patients from the specific 24-week clinical study conducted with Exelon in patients with dementia associated with Parkinson's disease with pre-defined adverse events that may reflect worsening of parkinsonian symptoms. (See Table 6.)

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Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions.