September 4, 2015
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Aricept

"Today, the U.S. Food and Drug Administration issued a proposal designed to assist companies developing new treatments for patients in the early stages of Alzheimer's disease, before the onset of noticeable (overt) dementia.

Alzheimer’"...

Aricept




Aricept Side Effects Center

Medical Editor: Charles Patrick Davis, MD, PhD

Last reviewed on RxList 4/29/2015

Aricept (donepezil hydrochloride) is a cholinesterase inhibitor that reduces or prevents acetylcholine breakdown in brain tissue. Aricept is used to treat mild to moderate dementia like that found in patients with Alzheimer's disease. Aricept is not a cure; it reduces symptoms. Aricept is available as a generic named donepezil. Some side effects of Aricept are malaise, appetite loss, weight loss, sleep problems (insomnia), muscle cramps, tiredness, drowsiness, dizziness, weakness, shakiness (tremor), itchy skin, nausea, vomiting, or diarrhea.

Aricept (donepezil hydrochloride) is available for oral administration in film-coated tablets containing 5, 10, or 23 mg of donepezil hydrochloride. Serious side effects of Aricept include painful urination, seizures, chest pain, and GI symptoms of tarry or bloody stools and vomiting blood or material that resembles "coffee grounds". Aricept may interact with many drugs; tell the physician if you have a history of breathing problems, heart disease, fainting, seizures, GI diseases or urinary problems because they may get worst with this drug. Aricept is not recommended for use in pregnant or breastfeeding women. Aricept safety and effectiveness has not been studied in the pediatric population.

Our Aricept Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Aricept in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using donepezil and call your doctor at once if you have any of these serious side effects:

  • black, bloody, or tarry stools;
  • coughing up blood or vomit that looks like blood or coffee grounds;
  • painful or difficult urination;
  • seizure (black-out or convulsions);

Less serious side effects may include:

  • nausea, vomiting, diarrhea;
  • loss of appetite;
  • muscle cramps;
  • tired feeling; or
  • sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Aricept (Donepezil Hydrochloride)

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Aricept Overview - Patient Information: Side Effects

SIDE EFFECTS: Nausea, vomiting, diarrhea, loss of appetite/weight loss, dizziness, drowsiness, weakness, trouble sleeping, shakiness (tremor), or muscle cramps may occur as your body adjusts to the drug. These effects usually last 1-3 weeks and then lessen. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these serious side effects occur: trouble urinating, severe stomach/abdominal pain, black stools, vomit that looks like coffee grounds, seizures.

Get medical help right away if you have any very serious side effects, including: slow/fast/irregular heartbeat, severe dizziness, fainting.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Aricept (Donepezil Hydrochloride)

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Aricept FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following serious adverse reactions are described below and elsewhere in the labeling:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

ARICEPT has been administered to over 1,700 individuals during clinical trials worldwide. Approximately 1200 of these patients have been treated for at least 3 months and more than 1,000 patients have been treated for at least 6 months. Controlled and uncontrolled trials in the United States included approximately 900 patients. In regards to the highest dose of 10 mg/day, this population includes 650 patients treated for 3 months, 475 patients treated for 6 months, and 116 patients treated for over 1 year. The range of patient exposure is from 1 to 1,214 days

Mild to Moderate Alzheimer's Disease

Adverse Reactions Leading to Discontinuation

The rates of discontinuation from controlled clinical trials of ARICEPT due to adverse reactions for the ARICEPT 5 mg/day treatment groups were comparable to those of placebo treatment groups at approximately 5%. The rate of discontinuation of patients who received 7-day escalations from 5 mg/day to 10 mg/day was higher at 13%.

The most common adverse reactions leading to discontinuation, defined as those occurring in at least 2% of patients and at twice or more the incidence seen in placebo patients, are shown in Table 1.

Table 1: Most Common Adverse Reactions Leading to Discontinuation in Patients with Mild to Moderate Alzheimer's Disease

Adverse Reaction Placebo
(n=355) %
5 mg/day ARICEPT
(n=350) %
10 mg/day ARICEPT
(n=315) %
Nausea 1 1 3
Diarrhea 0 < 1 3
Vomiting < 1 < 1 2

Most Common Adverse Reactions

The most common adverse reactions, defined as those occurring at a frequency of at least 5% in patients receiving 10 mg/day and twice the placebo rate, are largely predicted by ARICEPT's cholinomimetic effects. These include nausea, diarrhea, insomnia, vomiting, muscle cramp, fatigue, and anorexia. These adverse reactions were often transient, resolving during continued ARICEPT treatment without the need for dose modification.

There is evidence to suggest that the frequency of these common adverse reactions may be affected by the rate of titration. An open-label study was conducted with 269 patients who received placebo in the 15-and 30-week studies. These patients were titrated to a dose of 10 mg/day over a 6-week period. The rates of common adverse reactions were lower than those seen in patients titrated to 10 mg/day over one week in the controlled clinical trials and were comparable to those seen in patients on 5 mg/day.

See Table 2 for a comparison of the most common adverse reactions following one and six week titration regimens.

Table 2: Comparison of Rates of Adverse Reactions in Mild to Moderate Patients Titrated to 10 mg/day over 1 and 6 Weeks

Adverse Reaction No titration One week titration Six week titration
Placebo
(n=315) %
5 mg/day
(n=311) %
10 mg/day
(n=315) %
10 mg/day
(n=269) %
Nausea 6 5 19 6
Diarrhea 5 8 15 9
Insomnia 6 6 14 6
Fatigue 3 4 8 3
Vomiting 3 3 8 5
Muscle cramps 2 6 8 3
Anorexia 2 3 7 3

Table 3 lists adverse reactions that occurred in at least 2% of patients in pooled placebo-controlled trials who received either ARICEPT 5 mg or 10 mg and for which the rate of occurrence was greater for patients treated with ARICEPT than with placebo. In general, adverse reactions occurred more frequently in female patients and with advancing age.

Table 3: Adverse Reactions in Pooled Placebo-Controlled Clinical Trials in Mild to Moderate Alzheimer's Disease

Adverse Reaction Placebo
(n=355)%
ARICEPT
(n=747)%
Percent of Patients with any Adverse Reaction 72 74
  Nausea 6 11
  Diarrhea 5 10
  Headache 9 10
  Insomnia 6 9
  Pain, various locations 8 9
  Dizziness 6 8
  Accident 6 7
  Muscle Cramps 2 6
  Fatigue 3 5
  Vomiting 3 5
  Anorexia 2 4
  Ecchymosis 3 4
  Abnormal Dreams 0 3
  Depression < 1 3
  Weight Loss 1 3
  Arthritis 1 2
  Frequent Urination 1 2
  Somnolence < 1 2
  Syncope 1 2

Severe Alzheimer's Disease (ARICEPT 5 mg/day and 10 mg/day)

ARICEPT has been administered to over 600 patients with severe Alzheimer's disease during clinical trials of at least 6 months duration, including three double-blind, placebo-controlled trials, two of which had an open label extension.

Adverse Reactions Leading to Discontinuation

The rates of discontinuation from controlled clinical trials of ARICEPT due to adverse reactions for the ARICEPT patients were approximately 12% compared to 7% for placebo patients. The most common adverse reactions leading to discontinuation, defined as those occurring in at least 2% of ARICEPT patients and at twice or more the incidence seen in placebo, were anorexia (2% vs. 1% placebo), nausea (2% vs. < 1% placebo), diarrhea (2% vs. 0% placebo), and urinary tract infection (2% vs. 1% placebo).

Most Common Adverse Reactions

The most common adverse reactions, defined as those occurring at a frequency of at least 5% in patients receiving ARICEPT and at twice or more the placebo rate, are largely predicted by ARICEPT's cholinomimetic effects. These include diarrhea, anorexia, vomiting, nausea, and ecchymosis. These adverse reactions were often transient, resolving during continued ARICEPT treatment without the need for dose modification.

Table 4 lists adverse reactions that occurred in at least 2% of patients in pooled placebo-controlled trials who received ARICEPT 5 mg or 10 mg and for which the rate of occurrence was greater for patients treated with ARICEPT than with placebo.

Table 4: Adverse Reactions in Pooled Controlled Clinical Trials in Severe Alzheimer's Disease

Body System/Adverse Reaction Placebo
(n=392) %
ARICEPT
(n=501) %
Percent of Patients with any Adverse Reaction 73 81
  Accident 12 13
  Infection 9 11
  Diarrhea 4 10
  Anorexia 4 8
  Vomiting 4 8
  Nausea 2 6
  Insomnia 4 5
  Ecchymosis 2 5
  Headache 3 4
  Hypertension 2 3
  Pain 2 3
  Back Pain 2 3
  Eczema 2 3
  Hallucinations 1 3
  Hostility 2 3
  Increase in Creatine Phosphokinase 1 3
  Nervousness 2 3
  Fever 1 2
  Chest Pain < 1 2
  Confusion 1 2
  Dehydration 1 2
  Depression 1 2
  Dizziness 1 2
  Emotional Lability 1 2
  Hemorrhage 1 2
  Hyperlipemia < 1 2
  Personality Disorder 1 2
  Somnolence 1 2
  Syncope 1 2
  Urinary Incontinence 1 2

Moderate to Severe Alzheimer's Disease (ARICEPT 23 mg/day)

ARICEPT 23 mg/day has been administered to over 1300 individuals globally in clinical trials. Approximately 1050 of these patients have been treated for at least three months and more than 950 patients have been treated for at least six months. The range of patient exposure was from 1 to over 500 days.

Adverse Reactions Leading to Discontinuation

The rate of discontinuation from a controlled clinical trial of ARICEPT 23 mg/day due to adverse reactions was higher (19%) than for the 10 mg/day treatment group (8%). The most common adverse reactions leading to discontinuation, defined as those occurring in at least 1% of patients and greater than those occurring with 10 mg/day are shown in Table 5.

Table 5: Most Common Adverse Reactions Leading to Discontinuation in Patients with Moderate to Severe Alzheimer's Disease

Adverse Reaction 23 mg/day ARICEPT
(n=963) %
10 mg/day ARICEPT
(n=471) %
Vomiting 3 0
Diarrhea 2 0
Nausea 2 0
Dizziness 1 0

The majority of discontinuations due to adverse reactions in the 23 mg group occurred during the first month of treatment.

Most Common Adverse Reactions with ARICEPT 23 mg/day

The most common adverse reactions, defined as those occurring at a frequency of at least 5%, include nausea, diarrhea, vomiting, and anorexia.

Table 6 lists adverse reactions that occurred in at least 2% of patients who received 23 mg/day of ARICEPT and at a higher frequency than those receiving 10 mg/day of ARICEPT in a controlled clinical trial that compared the two doses. In this study, there were no important differences in the type of adverse reactions in patients taking ARICEPT with or without memantine.

Table 6: Adverse Reactions in a Controlled Clinical Trial in Moderate to Severe Alzheimer's Disease

Adverse Reaction 23 mg/day ARICEPT
(n=963)%
10 mg/day ARICEPT
(n=471)%
Percent of Patients with any Adverse Reaction 74 64
  Nausea 12 3
  Vomiting 9 3
  Diarrhea 8 5
  Anorexia 5 2

Postmarketing Experience

The following adverse reactions have been identified during post-approval use ARICEPT. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Abdominal pain, agitation, aggression, cholecystitis, confusion, convulsions, hallucinations, heart block (all types), hemolytic anemia, hepatitis, hyponatremia, neuroleptic malignant syndrome, pancreatitis, rash, rhabdomyolysis, QTc prolongation, and torsade de pointes.

Read the entire FDA prescribing information for Aricept (Donepezil Hydrochloride)

Aricept - User Reviews

Aricept User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Aricept sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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