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Aricept

"The U.S. Food and Drug Administration approved the first generic versions of Aricept (donepezil hydrochloride) orally disintegrating tablet s on Dec. 11. Donepezil hydrochloride is indicated for the treatment of dementia related to Alzheimer's d"...

Aricept

Aricept

Aricept Side Effects Center

Medical Editor: Charles Patrick Davis, MD, PhD

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. The drug is not a cure; it reduces symptoms. Aricept is available as a generic named donepezil. Some side effects of Aricept are malaise, appetite loss, insomnia, muscle cramps, itchy skin and GI symptoms of 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: slow/irregular heartbeat, fainting, trouble urinating, severe stomach/abdominal pain, black stools, vomit that looks like coffee grounds, seizures.

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

Clinical Studies Experience

ARICEPT 5 mg/day and 10 mg/day

Mild to Moderate Alzheimer's Disease

Adverse Events Leading to Discontinuation

The rates of discontinuation from controlled clinical trials of ARICEPT due to adverse events 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 events 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 Frequent Adverse Events Leading to Discontinuation from Controlled Clinical Trials by Dose Group

Dose Group Placebo 5 mg/day ARICEPT 10 mg/day ARICEPT
Patients Randomized 355 350 315
Event/%Discontinuing
  Nausea 1% 1% 3%
  Diarrhea 0% < 1% 3%
  Vomiting < 1% < 1% 2%

Most Frequent Adverse Events Seen in Association with the Use of ARICEPT

The most common adverse events, 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 events were often of mild intensity and transient, resolving during continued ARICEPT treatment without the need for dose modification.

There is evidence to suggest that the frequency of these common adverse events 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 events 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 events following one and six week titration regimens.

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

Adverse Event 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%

Adverse Events Reported in Controlled Trials

The events cited reflect experience gained under closely monitored conditions of clinical trials in a highly selected patient population. In actual clinical practice or in other clinical trials, these frequency estimates may not apply, as the conditions of use, reporting behavior, and the kinds of patients treated may differ. Table 3 lists treatment emergent signs and symptoms that were reported in at least 2% of patients in placebo-controlled trials who received ARICEPT and for which the rate of occurrence was greater for patients treated with ARICEPT than with placebo. In general, adverse events occurred more frequently in female patients and with advancing age.

Table 3: Adverse Events Reported in Controlled Clinical Trials in Mild to Moderate Alzheimer's Disease in at Least 2% of Patients Receiving ARICEPT and at a Higher Frequency than Placebo Treated Patients

Body System/Adverse Event Placebo
(n=355)
ARICEPT
(n=747)
Percent of Patients with any Adverse Event 72 74
Body as a Whole
  Headache 9 10
  Pain, various locations 8 9
  Accident 6 7
  Fatigue 3 5
Cardiovascular System
  Syncope 1 2
Digestive System
  Nausea 6 11
  Diarrhea 5 10
  Vomiting 3 5
  Anorexia 2 4
Hemic and Lymphatic System
  Ecchymosis 3 4
Metabolic and Nutritional Systems
  Weight Decrease 1 3
Musculoskeletal System
  Muscle Cramps 2 6
  Arthritis 1 2
Nervous System
  Insomnia 6 9
  Dizziness 6 8
  Depression < 1 3
  Abnormal Dreams   0 3
  Somnolence < 1 2
Urogenital System
  Frequent Urination 1 2

Other Adverse Events Observed During Clinical Trials

ARICEPT has been administered to over 1700 individuals during clinical trials worldwide. Approximately 1200 of these patients have been treated for at least 3 months and more than 1000 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 1214 days.

Treatment emergent signs and symptoms that occurred during three controlled clinical trials and two open-label trials in the United States were recorded as adverse events by the clinical investigators using terminology of their own choosing. To provide an overall estimate of the proportion of individuals having similar types of events, the events were grouped into a smaller number of standardized categories using a modified COSTART dictionary, and event frequencies were calculated across all studies. These categories are used in the listing below. The frequencies represent the proportion of 900 patients from these trials who experienced that event while receiving ARICEPT. All adverse events occurring at least twice are included, except for those already listed in Tables 2 or 3, COSTART terms too general to be informative, or events less likely to be drug related. Events are classified by body system and listed using the following definitions: Frequent adverse events - those occurring in at least 1/100 patients; Infrequent adverse events - those occurring in 1/100 to 1/1000 patients. These adverse events are not necessarily related to ARICEPT treatment and in most cases were observed at a similar frequency in placebo treated patients in the controlled studies. No important additional adverse events were seen in studies conducted outside the United States.

Body as a Whole: Frequent: influenza, chest pain, toothache; Infrequent: fever, edema face, periorbital edema, hernia hiatal, abscess, cellulitis, chills, generalized coldness, head fullness, listlessness.

Cardiovascular System: Frequent: hypertension, vasodilation, atrial fibrillation, hot flashes, hypotension; Infrequent: angina pectoris, postural hypotension, myocardial infarction, AV block (first degree), congestive heart failure, arteritis, bradycardia, peripheral vascular disease, supraventricular tachycardia, deep vein thrombosis.

Digestive System: Frequent: fecal incontinence, gastrointestinal bleeding, bloating, epigastric pain; Infrequent: eructation, gingivitis, increased appetite, flatulence, periodontal abscess, cholelithiasis, diverticulitis, drooling, dry mouth, fever sore, gastritis, irritable colon, tongue edema, epigastric distress, gastroenteritis, increased transaminases, hemorrhoids, ileus, increased thirst, jaundice, melena, polydipsia, duodenal ulcer, stomach ulcer.

Endocrine System: Infrequent: diabetes mellitus, goiter.

Hemic and Lymphatic System: Infrequent: anemia, thrombocythemia, thrombocytopenia, eosinophilia, erythrocytopenia.

Metabolic and Nutritional Disorders: Frequent: dehydration; Infrequent: gout, hypokalemia, increased creatine kinase, hyperglycemia, weight increase, increased lactate dehydrogenase.

Musculoskeletal System: Frequent: bone fracture; Infrequent: muscle weakness, muscle fasciculation.

Nervous System: Frequent: delusions, tremor, irritability, paresthesia, aggression, vertigo, ataxia, increased libido, restlessness, abnormal crying, nervousness, aphasia; Infrequent: cerebrovascular accident, intracranial hemorrhage, transient ischemic attack, emotional lability, neuralgia, coldness (localized), muscle spasm, dysphoria, gait abnormality, hypertonia, hypokinesia, neurodermatitis, numbness (localized), paranoia, dysarthria, dysphasia, hostility, decreased libido, melancholia, emotional withdrawal, nystagmus, pacing.

Respiratory System: Frequent: dyspnea, sore throat, bronchitis; Infrequent: epistaxis, post nasal drip, pneumonia, hyperventilation, pulmonary congestion, wheezing, hypoxia, pharyngitis, pleurisy, pulmonary collapse, sleep apnea, snoring.

Skin and Appendages: Frequent: pruritus, diaphoresis, urticaria; Infrequent: dermatitis, erythema, skin discoloration, hyperkeratosis, alopecia, fungal dermatitis, herpes zoster, hirsutism, skin striae, night sweats, skin ulcer.

Special Senses: Frequent: cataract, eye irritation, vision blurred; Infrequent: dry eyes, glaucoma, earache, tinnitus, blepharitis, decreased hearing, retinal hemorrhage, otitis externa, otitis media, bad taste, conjunctival hemorrhage, ear buzzing, motion sickness, spots before eyes.

Urogenital System: Frequent: urinary incontinence, nocturia; Infrequent: dysuria, hematuria, urinary urgency, metrorrhagia, cystitis, enuresis, prostate hypertrophy, pyelonephritis, inability to empty bladder, breast fibroadenosis, fibrocystic breast, mastitis, pyuria, renal failure, vaginitis.

Severe Alzheimer's Disease

Adverse Events Leading to Discontinuation

The rates of discontinuation from controlled clinical trials of ARICEPT due to adverse events for the ARICEPT patients were approximately 12% compared to 7% for placebo patients. The most common adverse events 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 Frequent Adverse Events Seen in Association with the Use of ARICEPT

The most common adverse events, 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 events were often of mild intensity and transient, resolving during continued ARICEPT treatment without the need for dose modification.

Adverse Events Reported in Controlled Trials

Table 4 lists adverse events that were reported in at least 2% of patients in placebo-controlled trials who received ARICEPT and for which the rate of occurrence was greater for patients treated with ARICEPT than with placebo.

Table 4: Adverse Events Reported in Controlled Clinical Trials in Severe Alzheimer's Disease in at Least 2% of Patients Receiving ARICEPT and at a Higher Frequency than Placebo Treated Patients

Body System/Adverse Event Placebo (n=392) ARICEPT (n=501)
Percent of Patients with any Adverse Event 73 81
Body as a Whole
  Accident 12 13
  Infection 9 11
  Headache 3 4
  Pain 2 3
  Back Pain 2 3
  Fever 1 2
  Chest Pain <1 2
Cardiovascular System
  Hypertension 2 3
  Hemorrhage 1 2
  Syncope 1 2
Digestive System
  Diarrhea 4 10
  Vomiting 4 8
  Anorexia 4 8
  Nausea 2 6
Hemic and Lymphatic System
  Ecchymosis 2 5
Metabolic and Nutritional Systems
  Creatine Phosphokinase Increased 1 3
  Dehydration 1 2
  Hyperlipemia < 1 2
Nervous System
  Insomnia 4 5
  Hostility 2 3
  Nervousness 2 3
  Hallucinations 1 3
  Somnolence 1 2
  Dizziness 1 2
  Depression 1 2
  Confusion 1 2
  Emotional Lability 1 2
  Personality Disorder 1 2
Skin And Appendages
  Eczema 2 3
Urogenital System
  Urinary Incontinence 1 2

Other Adverse Events Observed During Clinical Trials

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. All adverse events occurring at least twice are included, except for those already listed in Table 4, COSTART terms too general to be informative, or events less likely to be drug related. Events are classified by body system using the COSTART dictionary and listed using the following definitions: Frequent adverse events - those occurring in at least 1/100 patients; Infrequent adverse events - those occurring in 1/100 to 1/1000 patients. These adverse events are not necessarily related to

ARICEPT treatment and in most cases were observed at a similar frequency in placebo treated patients in the controlled studies.

Body as a Whole: Frequent: abdominal pain, asthenia, fungal infection, flu syndrome; Infrequent: allergic reaction, cellulitis, malaise, sepsis, face edema, hernia.

Cardiovascular System: Frequent: hypotension, bradycardia, ECG abnormal, heart failure; Infrequent: myocardial infarction, angina pectoris, atrial fibrillation, congestive heart failure, peripheral vascular disorder, supraventricular extrasystoles, ventricular extrasystoles, cardiomegaly.

Digestive System: Frequent: constipation, gastroenteritis, fecal incontinence, dyspepsia; Infrequent: gamma glutamyl transpeptidase increase, gastritis, dysphagia, periodontitis, stomach ulcer, periodontal abscess, flatulence, liver function tests abnormal, eructation, esophagitis, rectal hemorrhage.

Endocrine System: Infrequent: diabetes mellitus.

Hemic and Lymphatic System: Frequent: anemia; Infrequent: leukocytosis.

Metabolic and Nutritional Disorders: Frequent: weight loss, peripheral edema, edema, lactic dehydrogenase increased, alkaline phosphatase increased; Infrequent hypercholesteremia, hypokalemia, hypoglycemia, weight gain, bilirubinemia, BUN increased, B12 deficiency anemia, cachexia, creatinine increased, gout, hyponatremia, hypoproteinemia, iron deficiency anemia, SGOT increased, SGPT increased.

Musculoskeletal System: Frequent: arthritis; Infrequent: arthrosis, bone fracture, arthralgia, leg cramps, osteoporosis, myalgia.

Nervous System: Frequent: agitation, anxiety, tremor, convulsion, wandering, abnormal gait; Infrequent: apathy, vertigo, delusions, abnormal dreams, cerebrovascular accident, increased salivation, ataxia, euphoria, vasodilatation, cerebral hemorrhage, cerebral infarction, cerebral ischemia, dementia, extrapyramidal syndrome, grand mal convulsion, hemiplegia, hypertonia, hypokinesia.

Respiratory System: Frequent: pharyngitis, pneumonia, cough increased, bronchitis; Infrequent: dyspnea, rhinitis, asthma.

Skin and Appendages: Frequent: rash, skin ulcer, pruritus; Infrequent: psoriasis, skin discoloration, herpes zoster, dry skin, sweating, urticaria, vesiculobullous rash.

Special Senses: Infrequent: conjunctivitis, glaucoma, abnormal vision, ear pain, lacrimation disorder.

Urogenital System: Frequent: urinary tract infection, cystitis, hematuria, glycosuria; Infrequent: vaginitis, dysuria, urinary frequency, albuminuria.

ARICEPT 23 mg/day

Moderate to Severe Alzheimer's Disease

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 Events Leading to Discontinuation

The rate of discontinuation from a controlled clinical trial of ARICEPT 23 mg/day due to adverse events was higher (18.6%) than for the 10 mg/day treatment group (7.9%). The most common adverse events 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 Frequent Adverse Events Leading to Discontinuation from a Controlled Clinical Trial by Treatment Group

Dose Group 23 mg/day ARICEPT 10 mg/day ARICEPT
Safety Population 963 471
Event/ %Discontinuing
  Vomiting 3 0
  Diarrhea 2 0
  Nausea   2 0
  Dizziness 1 0

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

Most Frequent Adverse Events Seen in Association with the Use of 23 mg

The most common adverse events, defined as those occurring at a frequency of at least 5%, include nausea, diarrhea, vomiting, and anorexia. These adverse events were often of mild to moderate intensity.

Adverse Events Reported in Controlled Trials

The events cited reflect experience gained under closely monitored conditions of a controlled clinical trial in a highly selected patient population. In actual clinical practice or in other clinical trials, these frequency estimates may not apply, as the conditions of use, reporting behavior, and the kinds of patients treated may differ. Table 6 lists adverse events that were reported 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 events in patients taking ARICEPT with or without memantine.

Table 6: Adverse Events Reported in a Controlled Clinical Trial in Moderate to Severe Alzheimer's Disease in at Least 2% of Patients and Higher in the 23 mg/day Group

Body System/Adverse Event 23 mg/day ARICEPT 10 mg/day ARICEPT
Safety Population 963 471
Percent of Patients with any Adverse Event 74 64
Gastrointestinal disorders
  Nausea 12 3
  Vomiting 9 3
  Diarrhea 8 5
General disorders and administration site conditions
  Fatigue 2 1
  Asthenia 2 1
Injury, poisoning and procedural complications
  Contusion 2 0
Investigations
  Weight decreased 5 3
Metabolism and nutrition disorders
  Anorexia 5 2
Nervous system
  Dizziness 5 3
  Headache 4 3
  Somnolence 2 1
Psychiatric disorders
  Insomnia 3 2
Renal and urinary disorders
  Urinary incontinence 3 1

Postmarketing Experience

Voluntary reports of adverse events temporally associated with ARICEPT that have been received since market introduction that are not listed above, and for which there are inadequate data to determine the causal relationship with the drug include the following: abdominal pain, agitation, cholecystitis, confusion, convulsions, hallucinations, heart block (all types), hemolytic anemia, hepatitis, hyponatremia, neuroleptic malignant syndrome, pancreatitis, and rash.

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

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Aricept - User Reviews

Aricept User Reviews

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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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