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 drug reactions from clinical trials in table 7 and table 8 are listed by MedDRA system organ class. Within each system organ class, the adverse drug reactions are ranked by frequency, with the most frequent reactions first. Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness. In addition, the corresponding frequency category for each adverse drug reaction is based on the following convention (CIOMS III): 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). (See Tables 7 and 8.)

Click on icon to see table/diagram/image


Click on icon to see table/diagram/image

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, visual hallucination (common).
In patients with dementia associated with 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, dermatitis allergic.
Very rarely reported: tachycardia, atrioventricular block, atrial fibrillation, pancreatitis, seizure. Parkinson's disease (worsening) 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, allergic dermatitis (disseminated), extrapyramidal symptoms in patients with Alzheimer's dementia, tremor, nightmares.
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: 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.)

Click on icon to see table/diagram/image

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.)

Click on icon to see table/diagram/image

Application site reactions (skin irritation): In double-blind controlled clinical trials, application site reactions were mostly mild to moderate in severity. The incidence of application site skin reactions leading to discontinuation was observed in ≤2.3% of Exelon Patch patients. This number was 4.9% and 8.4% in the Chinese population and Japanese population, respectively.
Cases of skin irritation were captured separately on an investigator-rated skin irritation scale. Skin irritation, when observed, was mostly slight or mild in severity and was rated as severe in ≤2.2% of Exelon Patch patients, in a double-blind controlled study and in ≤3.7% of Exelon Patch patients in a double-blind controlled study in Japanese patients.
See Application site reactions and skin reactions under PRECAUTIONS.