Home FDA labels d76dc06e-e796-414c-87b3-0bf34fce34fc FDA label d76dc06e-e796-414c-87b3-0bf34fce34fc openFDA label record# This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
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warnings and cautions 5. WARNINGS AND PRECAUTIONS Cholinesterase inhibitors are likely to exaggerate succinylcholine-type muscle relaxation during anesthesia ( 5.1 ). Cholinesterase inhibitors may have vagotonic effects on the sinoatrial and atrioventricular nodes manifesting as bradycardia or heart block ( 5.2 ). ARICEPT can cause vomiting. Patients should be observed closely at initiation of treatment and after dose increases ( 5.3 ). Patients should be monitored closely for symptoms of active or occult gastrointestinal (GI) bleeding, especially those at increased risk for developing ulcers ( 5.4 ). The use of ARICEPT in a dose of 23 mg once daily is associated with weight loss ( 5.5 ). Cholinomimetics may cause bladder outflow obstructions ( 5.6 ). Cholinomimetics are believed to have some potential to cause generalized convulsions ( 5.7 ). Cholinesterase inhibitors should be prescribed with care to patients with a history of asthma or obstructive pulmonary disease ( 5.8 ). 5.1. Anesthesia ARICEPT, as a cholinesterase inhibitor, is likely to exaggerate succinylcholine-type muscle relaxation during anesthesia. 5.2. Cardiovascular Conditions Because of their pharmacological action, cholinesterase inhibitors may have vagotonic effects on the sinoatrial and atrioventricular nodes. This effect may manifest as bradycardia or heart block in patients both with and without known underlying cardiac conduction abnormalities. Syncopal episodes have been reported in association with the use of ARICEPT. 5.3. Nausea and Vomiting ARICEPT, as a predictable consequence of its pharmacological properties, has been shown to produce diarrhea, nausea, and vomiting. These effects, when they occur, appear more frequently with the 10 mg/day dose than with the 5 mg/day dose, and more frequently with the 23 mg dose than with the 10 mg dose. Specifically, in a controlled trial that compared a dose of 23 mg/day to 10 mg/day in patients who had been treated with donepezil 10 mg/day for at least three months, the incidence of nausea in the 23 mg group was markedly greater than in the patients who continued on 10 mg/day (11.8% vs. 3.4%, respectively), and the incidence of vomiting in the 23 mg group was markedly greater than in the 10 mg group (9.2% vs. 2.5%, respectively). The percent of patients who discontinued treatment due to vomiting in the 23 mg group was markedly higher than in the 10 mg group (2.9% vs. 0.4%, respectively). Although in most cases, these effects have been mild and transient, sometimes lasting one to three weeks, and have resolved during continued use of ARICEPT, patients should be observed closely at the initiation of treatment and after dose increases. 5.4. Peptic Ulcer Disease and GI Bleeding Through their primary action, cholinesterase inhibitors may be expected to increase gastric acid secretion due to increased cholinergic activity. Therefore, patients should be monitored closely for symptoms of active or occult gastrointestinal bleeding, especially those at increased risk for developing ulcers, e.g., those with a history of ulcer disease or those receiving concurrent nonsteroidal anti-inflammatory drugs (NSAIDs). Clinical studies of ARICEPT in a dose of 5 mg/day to 10 mg/day have shown no increase, relative to placebo, in the incidence of either peptic ulcer disease or gastrointestinal bleeding. Results of a controlled clinical study with 23 mg/day showed an increase, relative to 10 mg/day, in the incidence of peptic ulcer disease (0.4% vs. 0.2%) and gastrointestinal bleeding from any site (1.1% vs. 0.6%) 5.5. Weight Loss Weight loss was reported as an adverse event in 4.7% of patients assigned to ARICEPT in a dose of 23 mg/day compared to 2.5% of patients assigned to 10 mg/day. Compared to their baseline weights, 8.4% of patients taking 23 mg/day were found to have a weight decrease of ≥ 7% by the end of the study, while 4.9% of patients taking 10 mg/day were found to have weight loss of ≥ 7% at the end of the study. 5.6. Genitourinary Conditions Although not observed in clinical trials of ARICEPT, cholinomimetics may cause bladder outflow obstruction. 5.7. Neurological Conditions: Seizures Cholinomimetics are believed to have some potential to cause generalized convulsions. However, seizure activity also may be a manifestation of Alzheimer's disease. 5.8. Pulmonary Conditions Because of their cholinomimetic actions, cholinesterase inhibitors should be prescribed with care to patients with a history of asthma or obstructive pulmonary disease.
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adverse reactions table <table width="80%" ID="if9d3af51-00f4-4aa7-807c-2c5dfa5e2d61"> <col width="40%" align="left"/> <col width="30%" align="center"/> <col width="30%" align="center"/> <thead> <tr> <th colspan="3" styleCode="Botrule Lrule Rrule" align="center"> <content styleCode="bold">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</content> </th> </tr> <tr> <th styleCode="Botrule Lrule Rrule" align="center"> <content styleCode="bold">Body System/Adverse Event</content> </th> <th styleCode="Botrule Lrule Rrule" align="center"> <content styleCode="bold">Placebo</content> <content styleCode="bold">(n=392)</content> </th> <th styleCode="Botrule Lrule Rrule" align="center"> <content styleCode="bold">ARICEPT</content> <content styleCode="bold">(n=501)</content> </th> </tr> </thead> <tbody> <tr> <td styleCode="Botrule Lrule Rrule"> <content styleCode="bold">Percent of Patients with any Adverse Event</content> </td> <td styleCode="Botrule Lrule Rrule"> <content styleCode="bold">73</content> </td> <td styleCode="Botrule Lrule Rrule"> <content styleCode="bold">81</content> </td> </tr> <tr> <td colspan="3" styleCode="Botrule Lrule Rrule"> <content styleCode="bold">Body as a Whole</content> </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> Accident </td> <td styleCode="Botrule Lrule Rrule"> 12 </td> <td styleCode="Botrule Lrule Rrule"> 13 </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> Infection </td> <td styleCode="Botrule Lrule Rrule"> 9 </td> <td styleCode="Botrule Lrule Rrule"> 11 </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> Headache </td> <td styleCode="Botrule Lrule Rrule"> 3 </td> <td styleCode="Botrule Lrule Rrule"> 4 </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> Pain </td> <td styleCode="Botrule Lrule Rrule"> 2 </td> <td styleCode="Botrule Lrule Rrule"> 3 </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> Back Pain </td> <td styleCode="Botrule Lrule Rrule"> 2 </td> <td styleCode="Botrule Lrule Rrule"> 3 </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> Fever </td> <td styleCode="Botrule Lrule Rrule"> 1 </td> <td styleCode="Botrule Lrule Rrule"> 2 </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> Chest Pain </td> <td styleCode="Botrule Lrule Rrule"> <1 </td> <td styleCode="Botrule Lrule Rrule"> 2 </td> </tr> <tr> <td colspan="3" styleCode="Botrule Lrule Rrule"> <content styleCode="bold">Cardiovascular System</content> </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> Hypertension </td> <td styleCode="Botrule Lrule Rrule"> 2 </td> <td styleCode="Botrule Lrule Rrule"> 3 </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> Hemorrhage </td> <td styleCode="Botrule Lrule Rrule"> 1 </td> <td styleCode="Botrule Lrule Rrule"> 2 </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> Syncope </td> <td styleCode="Botrule Lrule Rrule"> 1 </td> <td styleCode="Botrule Lrule Rrule"> 2 </td> </tr> <tr> <td colspan="3" styleCode="Botrule Lrule Rrule"> <content styleCode="bold">Digestive System</content> </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> Diarrhea </td> <td styleCode="Botrule Lrule Rrule"> 4 </td> <td styleCode="Botrule Lrule Rrule"> 10 </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> Vomiting </td> <td styleCode="Botrule Lrule Rrule"> 4 </td> <td styleCode="Botrule Lrule Rrule"> 8 </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> Anorexia </td> <td styleCode="Botrule Lrule Rrule"> 4 </td> <td styleCode="Botrule Lrule Rrule"> 8 </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> Nausea </td> <td styleCode="Botrule Lrule Rrule"> 2 </td> <td styleCode="Botrule Lrule Rrule"> 6 </td> </tr> <tr> <td colspan="3" styleCode="Botrule Lrule Rrule"> <content styleCode="bold">Hemic and Lymphatic System</content> </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> Ecchymosis </td> <td styleCode="Botrule Lrule Rrule"> 2 </td> <td styleCode="Botrule Lrule Rrule"> 5 </td> </tr> <tr> <td colspan="3" styleCode="Botrule Lrule Rrule"> <content styleCode="bold">Metabolic and Nutritional Systems</content> </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> Creatine Phosphokinase Increased </td> <td styleCode="Botrule Lrule Rrule"> 1 </td> <td styleCode="Botrule Lrule Rrule"> 3 </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> Dehydration </td> <td styleCode="Botrule Lrule Rrule"> 1 </td> <td styleCode="Botrule Lrule Rrule"> 2 </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> Hyperlipemia </td> <td styleCode="Botrule Lrule Rrule"> <1 </td> <td styleCode="Botrule Lrule Rrule"> 2 </td> </tr> <tr> <td colspan="3" styleCode="Botrule Lrule Rrule"> <content styleCode="bold">Nervous System</content> </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> Insomnia </td> <td styleCode="Botrule Lrule Rrule"> 4 </td> <td styleCode="Botrule Lrule Rrule"> 5 </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> Hostility </td> <td styleCode="Botrule Lrule Rrule"> 2 </td> <td styleCode="Botrule Lrule Rrule"> 3 </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> Nervousness </td> <td styleCode="Botrule Lrule Rrule"> 2 </td> <td styleCode="Botrule Lrule Rrule"> 3 </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> Hallucinations </td> <td styleCode="Botrule Lrule Rrule"> 1 </td> <td styleCode="Botrule Lrule Rrule"> 3 </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> Somnolence </td> <td styleCode="Botrule Lrule Rrule"> 1 </td> <td styleCode="Botrule Lrule Rrule"> 2 </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> Dizziness </td> <td styleCode="Botrule Lrule Rrule"> 1 </td> <td styleCode="Botrule Lrule Rrule"> 2 </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> Depression </td> <td styleCode="Botrule Lrule Rrule"> 1 </td> <td styleCode="Botrule Lrule Rrule"> 2 </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> Confusion </td> <td styleCode="Botrule Lrule Rrule"> 1 </td> <td styleCode="Botrule Lrule Rrule"> 2 </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> Emotional Lability </td> <td styleCode="Botrule Lrule Rrule"> 1 </td> <td styleCode="Botrule Lrule Rrule"> 2 </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> Personality Disorder </td> <td styleCode="Botrule Lrule Rrule"> 1 </td> <td styleCode="Botrule Lrule Rrule"> 2 </td> </tr> <tr> <td colspan="3" styleCode="Botrule Lrule Rrule"> <content styleCode="bold">Skin And Appendages</content> </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> Eczema </td> <td styleCode="Botrule Lrule Rrule"> 2 </td> <td styleCode="Botrule Lrule Rrule"> 3 </td> </tr> <tr> <td colspan="3" styleCode="Botrule Lrule Rrule"> <content styleCode="bold">Urogenital System</content> </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> Urinary Incontinence </td> <td styleCode="Botrule Lrule Rrule"> 1 </td> <td styleCode="Botrule Lrule Rrule"> 2 </td> </tr> </tbody> </table>
adverse reactions table <table width="80%" ID="iec433dfa-9ee1-46ec-88aa-1c578713b4c4"> <col width="40%" align="left"/> <col width="30%" align="center"/> <col width="30%" align="center"/> <thead> <tr> <th colspan="3" styleCode="Botrule Lrule Rrule" align="center"> <content styleCode="bold">Table 5. Most Frequent Adverse Events Leading to Discontinuation from a Controlled Clinical Trial by Treatment Group</content> </th> </tr> <tr> <th styleCode="Botrule Lrule Rrule" align="center"> <content styleCode="bold">Dose Group</content> </th> <th styleCode="Botrule Lrule Rrule" align="center"> <content styleCode="bold">23 mg/day</content> <content styleCode="bold">ARICEPT</content> </th> <th styleCode="Botrule Lrule Rrule" align="center"> <content styleCode="bold">10 mg/day</content> <content styleCode="bold">ARICEPT</content> </th> </tr> </thead> <tbody> <tr> <td styleCode="Botrule Lrule Rrule"> <content styleCode="bold">Safety Population</content> </td> <td styleCode="Botrule Lrule Rrule"> 963 </td> <td styleCode="Botrule Lrule Rrule"> 471 </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> <content styleCode="bold">Event/%Discontinuing</content> </td> <td styleCode="Botrule Lrule Rrule"/> <td styleCode="Botrule Lrule Rrule"/> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> Vomiting </td> <td styleCode="Botrule Lrule Rrule"> 3 </td> <td styleCode="Botrule Lrule Rrule"> 0 </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> Diarrhea </td> <td styleCode="Botrule Lrule Rrule"> 2 </td> <td styleCode="Botrule Lrule Rrule"> 0 </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> Nausea </td> <td styleCode="Botrule Lrule Rrule"> 2 </td> <td styleCode="Botrule Lrule Rrule"> 0 </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> Dizziness </td> <td styleCode="Botrule Lrule Rrule"> 1 </td> <td styleCode="Botrule Lrule Rrule"> 0 </td> </tr> </tbody> </table>
adverse reactions table <table width="80%" ID="i2f522589-9613-4823-874f-415df1e6892c"> <col width="40%" align="left"/> <col width="30%" align="center"/> <col width="30%" align="center"/> <thead> <tr> <th colspan="3" styleCode="Botrule Lrule Rrule" align="center"> <content styleCode="bold">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</content> </th> </tr> <tr> <th styleCode="Botrule Lrule Rrule" align="center"> <content styleCode="bold">Body System/Adverse Event</content> </th> <th styleCode="Botrule Lrule Rrule" align="center"> <content styleCode="bold">23 mg/day</content> <content styleCode="bold">ARICEPT</content> </th> <th styleCode="Botrule Lrule Rrule" align="center"> <content styleCode="bold">10 mg/day</content> <content styleCode="bold">ARICEPT</content> </th> </tr> </thead> <tbody> <tr> <td styleCode="Botrule Lrule Rrule"> <content styleCode="bold">Safety Population</content> </td> <td styleCode="Botrule Lrule Rrule"> <content styleCode="bold">963</content> </td> <td styleCode="Botrule Lrule Rrule"> <content styleCode="bold">471</content> </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> <content styleCode="bold">Percent of Patients with any Adverse Event</content> </td> <td styleCode="Botrule Lrule Rrule"> 74 </td> <td styleCode="Botrule Lrule Rrule"> 64 </td> </tr> <tr> <td colspan="3" styleCode="Botrule Lrule Rrule"> <content styleCode="bold">Gastrointestinal disorders</content> </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> Nausea </td> <td styleCode="Botrule Lrule Rrule"> 12 </td> <td styleCode="Botrule Lrule Rrule"> 3 </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> Vomiting </td> <td styleCode="Botrule Lrule Rrule"> 9 </td> <td styleCode="Botrule Lrule Rrule"> 3 </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> Diarrhea </td> <td styleCode="Botrule Lrule Rrule"> 8 </td> <td styleCode="Botrule Lrule Rrule"> 5 </td> </tr> <tr> <td colspan="3" styleCode="Botrule Lrule Rrule"> <content styleCode="bold">General disorders and administration site conditions</content> </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> Fatigue </td> <td styleCode="Botrule Lrule Rrule"> 2 </td> <td styleCode="Botrule Lrule Rrule"> 1 </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> Asthenia </td> <td styleCode="Botrule Lrule Rrule"> 2 </td> <td styleCode="Botrule Lrule Rrule"> 1 </td> </tr> <tr> <td colspan="3" styleCode="Botrule Lrule Rrule"> <content styleCode="bold">Injury, poisoning and procedural complications</content> </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> Contusion </td> <td styleCode="Botrule Lrule Rrule"> 2 </td> <td styleCode="Botrule Lrule Rrule"> 0 </td> </tr> <tr> <td colspan="3" styleCode="Botrule Lrule Rrule"> <content styleCode="bold">Investigations</content> </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> Weight decreased </td> <td styleCode="Botrule Lrule Rrule"> 5 </td> <td styleCode="Botrule Lrule Rrule"> 3 </td> </tr> <tr> <td colspan="3" styleCode="Botrule Lrule Rrule"> <content styleCode="bold">Metabolism and nutrition disorders</content> </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> Anorexia </td> <td styleCode="Botrule Lrule Rrule"> 5 </td> <td styleCode="Botrule Lrule Rrule"> 2 </td> </tr> <tr> <td colspan="3" styleCode="Botrule Lrule Rrule"> <content styleCode="bold">Nervous system</content> </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> Dizziness </td> <td styleCode="Botrule Lrule Rrule"> 5 </td> <td styleCode="Botrule Lrule Rrule"> 3 </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> Headache </td> <td styleCode="Botrule Lrule Rrule"> 4 </td> <td styleCode="Botrule Lrule Rrule"> 3 </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> Somnolence </td> <td styleCode="Botrule Lrule Rrule"> 2 </td> <td styleCode="Botrule Lrule Rrule"> 1 </td> </tr> <tr> <td colspan="3" styleCode="Botrule Lrule Rrule"> <content styleCode="bold">Psychiatric disorders</content> </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> Insomnia </td> <td styleCode="Botrule Lrule Rrule"> 3 </td> <td styleCode="Botrule Lrule Rrule"> 2 </td> </tr> <tr> <td colspan="3" styleCode="Botrule Lrule Rrule"> <content styleCode="bold">Renal and urinary disorders</content> </td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> Urinary incontinence </td> <td styleCode="Botrule Lrule Rrule"> 3 </td> <td styleCode="Botrule Lrule Rrule"> 1 </td> </tr> </tbody> </table>
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.