Hemic and Lymphatic System: Infrequent : anemia, thrombocythemia, thrombocytopenia, eosinophilia, erythrocytopenia.
Approximay 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. The range of patient exposure is from 1 to 1214 days. ARICEPT has been administered to over 1700 individuals during clinical trials worldwide. 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. Controlled and uncontrolled trials in the United States included approximay 900 patients.
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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. The events cited reflect experience gained under closely monitored conditions of clinical trials in a highly selected patient population.
This is not a complete list of side effects and others may occur. l your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
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.
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.
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.
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Metabolic and Nutritional Disorders: Frequent : dehydration; Infrequent : gout, hypokalemia, increased creatine kinase, hyperglycemia, weight increase, increased lactate dehydrogenase.
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.
Less serious side effects may include:
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.
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There is evidence to suggest that the frequency of these common adverse events may be affected by the rate of titration. 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. An open-label study was conducted with 269 patients who received placebo in the 15 and 30-week studies.
Aricept is not recommended for use in pregnant or breastfeeding women. Aricept may interact with many drugs; l 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 (donepezil hydrochloride) is available for oral administration in film-coated tablets containing 5, 10, or 23 mg of donepezil hydrochloride. Aricept safety and effectiveness has not been studied in the pediatric population. 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".
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.
These adverse events were often of mild intensity and transient, resolving during continued ARICEPT treatment without the need for dose modification. These include nausea, diarrhea, insomnia, vomiting, muscle cramp, fatigue and anorexia. 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.
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Musculoskeletal System: Frequent : bone fracture; Infrequent : muscle weakness, muscle fasciculation.
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%
These include diarrhea, anorexia, vomiting, nausea, and ecchymosis. 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 adverse events were often of mild intensity and transient, resolving during continued ARICEPT treatment without the need for dose modification.
You may report side effects to FDA at 1-800-FDA-1088. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.
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%
You may report side effects to FDA at 1-800-FDA-1088. Many people using this medication do not have serious side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In Canada - Call your doctor for medical advice about side effects. 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. This is not a complete list of possible side effects. 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. In the US - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at. l 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. Read the entire patient information overview for Aricept (Donepezil Hydrochloride) ».
The frequencies represent the proportion of 900 patients from these trials who experienced that event while receiving ARICEPT. 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. No important additional adverse events were seen in studies conducted outside the United States. 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. 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. 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. 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.
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.
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 approximay 5%. The rate of discontinuation of patients who received 7-day escalations from 5 mg/day to 10 mg/day was higher at 13%.
< 1% placebo), diarrhea (2% vs. 0% placebo) and urinary tract infection (2% vs. 1% placebo). 1% placebo), nausea (2% vs. 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. The rates of discontinuation from controlled clinical trials of ARICEPT due to adverse events for the ARICEPT patients were approximay 12% compared to 7% for placebo patients.
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Stop using donepezil and call your doctor at once if you have any of these serious side effects:
Read the entire detailed patient monograph for Aricept (Donepezil Hydrochloride) »
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.
See Table 2 for a comparison of the most common adverse events following one and six week titration regimens.
Endocrine System: Infrequent : diabetes mellitus, goiter.
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.
Read the FDA Offers New Guidance on Developing Drugs for Alzheimer's Disease article »
Our Aricept Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
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.
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Medical Editor: Charles Patrick Davis, MD, PhD.
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.
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.
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. Some side effects of Aricept are malaise, appetite loss, insomnia, muscle cramps, itchy skin and GI symptoms of nausea, vomiting or diarrhea. Aricept is available as a generic named donepezil.
A concise overview of the drug for the patient or caregiver from First DataBank.
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Donepezil 5 mg side effects