Exelon Patch Adverse Reactions

The overall incidence of adverse events in patients treated with Exelon Patch 10 was lower than the rate in patients who received Exelon capsule treatment. Nausea and vomiting were the most common adverse events in patients who received active treatment and occurred at similar rates in both Exelon Patch 20 and capsule groups. However, the rates of both of these events were substantially lower with Exelon Patch 10 group.
The most commonly reported adverse drug reactions are gastrointestinal including nausea and vomiting, especially during titration.
Adverse reactions in Table 7 and Table 8 are ranked under headings of frequency, the most frequent first, using the following convention: Very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000), including isolated reports (see Table 7 and Table 8).

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Additional adverse reactions observed during a 76-week prospective, open-label study in patients with dementia associated with Parkinson's disease treated with Exelon transdermal patches: Dehydration, decreased weight, aggression, hallucination visual (common).
In patients with dementia associated Parkinson's disease the following adverse drug reactions have only been observed in clinical trials with Exelon capsules: Nausea, vomiting (very common); decreased appetite, restlessness, worsening of Parkinson's disease, bradycardia, diarrhoea, dyspepsia, salivary hypersecretion, increased sweating (common); dystonia, atrial fibrillation, atrioventricular block (uncommon).
Adverse Drug Reactions from Post-Marketing Spontaneous Reports: The following additional adverse drug reactions have been identified based on post-marketing spontaneous reports. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency.
Rarely Reported: Hypertension, application site hypersensitivity, pruritus, rash, erythema, urticaria, blister, allergic dermatitis.
Very Rarely Reported: Tachycardia, atrioventricular block, atrial fibrillation, pancreatitis, seizure. Worsening of Parkinson's disease has been observed in patients with Parkinson's disease who were treated with Exelon patches.
Frequency Not Known: Hepatitis, restlessness, sick sinus syndrome, abnormal liver function tests, disseminated cutaneous hypersensitivity reactions.
Additional Adverse Drug Reactions which Have Been Reported with Exelon Capsules or Oral Solution: Very Rare: Severe vomiting associated with oesophageal rupture. Rare: Angina pectoris, myocardial infarction, duodenal ulcers. Common: Tremor, confusion.
Information from Clinical Trials in Patients with Alzheimer's Dementia Treated with Exelon Patches: The following adverse drug reactions were reported in patients with Alzheimer's dementia treated with Exelon patches (see Table 9).

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Information from Clinical Trials in Patients with Severe Alzheimer's Dementia Treated with Exelon Patch 15: The following adverse drug reactions were reported in patients with severe Alzheimer's dementia treated with Exelon patch 15 (see Table 10).

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Application Site Reactions (Skin Irritation): In the 24-week placebo-controlled clinical trial, cases of skin irritation were captured separately on an investigator-rated skin irritation scale and not as adverse events unless they fulfilled the criteria for a serious adverse event. Skin irritation, when observed, was mostly slight or mild in severity and was rated as severe in ≤2.2% of Exelon Patch patients, versus ≤1% of placebo patch patients.
In the 48-week active controlled clinical trial, cases of skin irritation were captured as patient or caregiver reported adverse events. The most commonly reported skin irritation events during the first 24 weeks of the double-blind period for Exelon Patch 15 group and Exelon Patch 10 group respectively, were application site erythema (5.7% vs 4.6%) and application site pruritus (3.6% vs 2.8%). The percentages decreased in both Exelon Patch 15 and Exelon Patch 10 treatment groups over time (>24 weeks): Application site erythema (0.8% vs 1.6%) and application site pruritus (0.4% vs 1.2%), respectively. Application site pruritus led to discontinuation in 1.1% of the patients from each of the treatment groups during the total 48 week double-blind treatment phase. Application site reactions were mostly mild or moderate in severity and were rated as severe in <2% of patients.
In the 24-week double-blind, double-dummy, controlled clinical trial in patients with severe Alzheimer's disease, cases of skin irritation were captured as adverse events. The most commonly reported skin irritation events during the 24 weeks for Exelon Patch 15 and Exelon Patch 5 respectively, were application site erythema (13.2% vs 11.7%) and application site pruritus (3.7% vs 2.2%). Application site erythema led to discontinuation in only 0.8% of the patients in 15 cm² group and in 0.6% of patients in 5 cm² group. Application site erythema in both groups was mostly mild or moderate in severity.
Skin application site reactions and skin reactions (see Precautions).
A direct comparison of the rate of skin irritation events reported in each of these studies cannot be made due to the difference in data collection methods employed.