What are the common side effects of Donepezil (Aricept) and how are they managed?

From the Guidelines

Donepezil (Aricept) commonly causes gastrointestinal side effects, including nausea, vomiting, diarrhea, and loss of appetite, which can be managed by taking the medication with food and gradually increasing the dose. These side effects typically occur when starting the medication or increasing the dose, as reported in studies such as 1 and 1. The most common side effects of Donepezil include:

• Nausea
• Vomiting
• Diarrhea
• Loss of appetite
• Insomnia
• Vivid dreams
• Headaches
• Dizziness
• Muscle cramps
• Fatigue
• Urinary frequency Most side effects are mild to moderate and often diminish over time as the body adjusts to the medication, as noted in 1. For persistent gastrointestinal symptoms, anti-nausea medications or antidiarrheals may be prescribed temporarily. If side effects remain intolerable, dose reduction or switching to another cholinesterase inhibitor like rivastigmine or galantamine may be necessary, as suggested in 1. Patients should be monitored for less common but serious side effects such as bradycardia (slow heart rate), syncope (fainting), or gastrointestinal bleeding, which require immediate medical attention. Donepezil works by inhibiting acetylcholinesterase, increasing acetylcholine levels in the brain to improve cognitive function, but this mechanism also explains many of its side effects due to increased cholinergic activity throughout the body, as explained in 1. It is essential to follow the recommended dosage and administration guidelines to minimize the risk of side effects, as outlined in 1 and 1. By understanding the potential side effects of Donepezil and taking steps to manage them, patients can maximize the benefits of this medication while minimizing its risks.

From the FDA Drug Label

Donepezil hydrochloride tablets may cause the following serious side effects: slow heartbeat and fainting. This happens more often in people with heart problems. more stomach acid. This raises the chance of ulcers and bleeding, especially when taking donepezil hydrochloride tablets 23 mg The most common side effects of donepezil hydrochloride tablets are: nausea diarrhea not sleeping well vomiting muscle cramps feeling tired not wanting to eat

The common side effects of Donepezil (Aricept) include nausea, diarrhea, vomiting, muscle cramps, feeling tired, and not wanting to eat. These side effects may get better after you take donepezil hydrochloride tablets for a while. Serious side effects include slow heartbeat and fainting, especially in people with heart problems, and more stomach acid, which raises the chance of ulcers and bleeding. If you experience any of these side effects, you should talk to your doctor. Key points to manage side effects:

• Call your doctor right away if you feel faint or lightheaded while taking donepezil hydrochloride tablets.
• Call your doctor right away if you have heartburn or stomach pain that is new or won’t go away.
• Report any side effects to FDA at 1-800-FDA-1088 2.

From the Research

Common Side Effects of Donepezil

• The most common adverse events reported in clinical trials have been gastrointestinal, typically nausea, vomiting, diarrhoea and constipation 3
• Headache, dizziness and sleep disturbance have also been reported 3
• Cholinergic adverse events, such as nausea, diarrhea, anorexia, and vomiting, are most likely to occur during dose initiation or adjustment 4
• Donepezil has been associated with a low incidence of serious adverse events, with no evidence of hepatotoxicity 3, 5, 4

Management of Side Effects

• The incidence of adverse events can be minimised by increasing the dose after a longer period, such as 6 weeks 5
• Patients who experience side effects may need to have their dose adjusted or discontinued 5, 6
• Donepezil is generally well tolerated, with most adverse events being mild and transient 5
• The drug's safety profile is relatively favourable compared to other cholinesterase inhibitors, such as tacrine 4

Special Considerations

• Donepezil may trigger mania in some patients, particularly those with a history of bipolar disorder 7
• The drug's effects on cognitive function and global clinical state may be modest, and its practical importance to patients and carers is unclear 6
• Donepezil's long-term efficacy and safety have been demonstrated in clinical trials, with improvements in cognitive function and global clinical state maintained for up to 1 year 5, 6