Home FDA labels a83a04b0-5409-3065-e053-2995a90a4e55 FDA label a83a04b0-5409-3065-e053-2995a90a4e55 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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SPL ID a83a04b0-5409-3065-e053-2995a90a4e55
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Effective date 2020-06-16
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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). • Donepezil hydrochloride 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 donepezil hydrochloride 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 Donepezil hydrochloride, 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 donepezil hydrochloride. 5.3. Nausea and Vomiting Donepezil hydrochloride, 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 donepezil hydrochloride, 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 donepezil hydrochloridein 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 reaction in 4.7% of patients assigned to donepezil hydrochloride 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 donepezil hydrochloride, 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 cellspacing="0" cellpadding="0" border="0" width="598.5"> <col width="52.5%"/> <col width="15.5%"/> <col width="32%"/> <tbody> <tr styleCode="Botrule"> <td colspan="3" align="center" styleCode="Lrule Rrule" valign="top"> <content styleCode="bold">Table 4. Adverse Reactions in Pooled Controlled Clinical Trials in Severe Alzheimer’s Disease </content> </td> </tr> <tr styleCode="Botrule"> <td align="justify" styleCode="Lrule Rrule" valign="top"> <content styleCode="bold">Body System/Adverse Reaction</content> </td> <td align="center" styleCode="Rrule" valign="top"> <content styleCode="bold">Placebo (n=392) </content> <content styleCode="bold">%</content> </td> <td align="center" styleCode="Rrule" valign="top"> <content styleCode="bold">Donepezil Hydrochloride (n=501) </content> <content styleCode="bold">%</content> </td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule" valign="top"> <content styleCode="bold">Percent of Patients with any Adverse Reaction</content> </td> <td align="center" styleCode="Rrule" valign="top"> <content styleCode="bold">73</content> </td> <td align="center" styleCode="Rrule" valign="top"> <content styleCode="bold">81</content> </td> </tr> <tr styleCode="Botrule"> <td align="justify" styleCode="Lrule Rrule" valign="top"> Accident <content styleCode="bold"/> </td> <td align="center" styleCode="Rrule" valign="top">12 </td> <td align="center" styleCode="Rrule" valign="top">13 </td> </tr> <tr styleCode="Botrule"> <td align="justify" styleCode="Lrule Rrule" valign="top"> Infection </td> <td align="center" styleCode="Rrule" valign="top">9 </td> <td align="center" styleCode="Rrule" valign="top">11 </td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule" valign="middle"> Diarrhea </td> <td align="center" styleCode="Rrule" valign="top">4 </td> <td align="center" styleCode="Rrule" valign="top">10 </td> </tr> <tr styleCode="Botrule"> <td align="justify" styleCode="Lrule Rrule" valign="top"> Anorexia </td> <td align="center" styleCode="Rrule" valign="top">4 </td> <td align="center" styleCode="Rrule" valign="top">8 </td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule" valign="middle"> Vomiting </td> <td align="center" styleCode="Rrule" valign="top">4 </td> <td align="center" styleCode="Rrule" valign="top">8 </td> </tr> <tr styleCode="Botrule"> <td align="justify" styleCode="Lrule Rrule" valign="top"> Nausea </td> <td align="center" styleCode="Rrule" valign="top">2 </td> <td align="center" styleCode="Rrule" valign="top">6 </td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule" valign="top"> Insomnia </td> <td align="center" styleCode="Rrule" valign="top">4 </td> <td align="center" styleCode="Rrule" valign="top">5 </td> </tr> <tr styleCode="Botrule"> <td align="justify" styleCode="Lrule Rrule" valign="top"> Ecchymosis </td> <td align="center" styleCode="Rrule" valign="top">2 </td> <td align="center" styleCode="Rrule" valign="top">5 </td> </tr> <tr styleCode="Botrule"> <td align="justify" styleCode="Lrule Rrule" valign="top"> Headache </td> <td align="center" styleCode="Rrule" valign="top">3 </td> <td align="center" styleCode="Rrule" valign="top">4 </td> </tr> <tr styleCode="Botrule"> <td align="justify" styleCode="Lrule Rrule" valign="top"> Hypertension </td> <td align="center" styleCode="Rrule" valign="top">2 </td> <td align="center" styleCode="Rrule" valign="top">3 </td> </tr> <tr styleCode="Botrule"> <td align="justify" styleCode="Lrule Rrule" valign="top"> Pain </td> <td align="center" styleCode="Rrule" valign="top">2 </td> <td align="center" styleCode="Rrule" valign="top">3 </td> </tr> <tr styleCode="Botrule"> <td align="justify" styleCode="Lrule Rrule" valign="top"> Back Pain </td> <td align="center" styleCode="Rrule" valign="top">2 </td> <td align="center" styleCode="Rrule" valign="top">3 </td> </tr> <tr styleCode="Botrule"> <td align="justify" styleCode="Lrule Rrule" valign="top"> Eczema </td> <td align="center" styleCode="Rrule" valign="top">2 </td> <td align="center" styleCode="Rrule" valign="top">3 </td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule" valign="top"> Hallucinations </td> <td align="center" styleCode="Rrule" valign="top">1 </td> <td align="center" styleCode="Rrule" valign="top">3 </td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule" valign="top"> Hostility </td> <td align="center" styleCode="Rrule" valign="top">2 </td> <td align="center" styleCode="Rrule" valign="top">3 </td> </tr> <tr styleCode="Botrule"> <td align="justify" styleCode="Lrule Rrule" valign="top"> Increase in Creatine Phosphokinase </td> <td align="center" styleCode="Rrule" valign="top">1 </td> <td align="center" styleCode="Rrule" valign="top">3 </td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule" valign="top"> Nervousness </td> <td align="center" styleCode="Rrule" valign="top">2 </td> <td align="center" styleCode="Rrule" valign="top">3 </td> </tr> <tr styleCode="Botrule"> <td align="justify" styleCode="Lrule Rrule" valign="top"> Fever </td> <td align="center" styleCode="Rrule" valign="top">1 </td> <td align="center" styleCode="Rrule" valign="top">2 </td> </tr> <tr styleCode="Botrule"> <td align="justify" styleCode="Lrule Rrule" valign="top"> Chest Pain </td> <td align="center" styleCode="Rrule" valign="top"><1 </td> <td align="center" styleCode="Rrule" valign="top">2 </td> </tr> <tr styleCode="Botrule"> <td align="justify" styleCode="Lrule Rrule" valign="top"> Confusion </td> <td align="center" styleCode="Rrule" valign="top">1 </td> <td align="center" styleCode="Rrule" valign="top">2 </td> </tr> <tr styleCode="Botrule"> <td align="justify" styleCode="Lrule Rrule" valign="top"> Dehydration </td> <td align="center" styleCode="Rrule" valign="top">1 </td> <td align="center" styleCode="Rrule" valign="top">2 </td> </tr> <tr styleCode="Botrule"> <td align="justify" styleCode="Lrule Rrule" valign="top"> Depression </td> <td align="center" styleCode="Rrule" valign="top">1 </td> <td align="center" styleCode="Rrule" valign="top">2 </td> </tr> <tr styleCode="Botrule"> <td align="justify" styleCode="Lrule Rrule" valign="top"> Dizziness </td> <td align="center" styleCode="Rrule" valign="top">1 </td> <td align="center" styleCode="Rrule" valign="top">2 </td> </tr> <tr styleCode="Botrule"> <td align="justify" styleCode="Lrule Rrule" valign="top"> Emotional Lability </td> <td align="center" styleCode="Rrule" valign="top">1 </td> <td align="center" styleCode="Rrule" valign="top">2 </td> </tr> <tr styleCode="Botrule"> <td align="justify" styleCode="Lrule Rrule" valign="top"> Hemorrhage </td> <td align="center" styleCode="Rrule" valign="top">1 </td> <td align="center" styleCode="Rrule" valign="top">2 </td> </tr> <tr styleCode="Botrule"> <td align="justify" styleCode="Lrule Rrule" valign="top"> Hyperlipemia </td> <td align="center" styleCode="Rrule" valign="top"><1 </td> <td align="center" styleCode="Rrule" valign="top">2 </td> </tr> <tr styleCode="Botrule"> <td align="justify" styleCode="Lrule Rrule" valign="top"> Personality Disorder </td> <td align="center" styleCode="Rrule" valign="top">1 </td> <td align="center" styleCode="Rrule" valign="top">2 </td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule" valign="top"> Somnolence </td> <td align="center" styleCode="Rrule" valign="top">1 </td> <td align="center" styleCode="Rrule" valign="top">2 </td> </tr> <tr styleCode="Botrule"> <td align="justify" styleCode="Lrule Rrule" valign="top"> Syncope </td> <td align="center" styleCode="Rrule" valign="top">1 </td> <td align="center" styleCode="Rrule" valign="top">2 </td> </tr> <tr> <td align="justify" styleCode="Lrule Rrule" valign="top"> Urinary Incontinence </td> <td align="center" styleCode="Rrule" valign="top">1 </td> <td align="center" styleCode="Rrule" valign="top">2 </td> </tr> </tbody> </table>
adverse reactions table <table cellspacing="0" cellpadding="0" border="0" width="596.7045"> <col width="29.3324417697537%"/> <col width="40.2540956201939%"/> <col width="30.4134626100524%"/> <tbody> <tr styleCode="Botrule"> <td colspan="3" align="center" styleCode="Lrule Rrule" valign="top"> <content styleCode="bold">Table 5. </content> <content styleCode="bold">Most Common Adverse Reactions Leading to Discontinuation in Patients with Moderate to Severe Alzheimer’s Disease</content> <content styleCode="bold"/> </td> </tr> <tr styleCode="Botrule"> <td align="justify" styleCode="Lrule Rrule" valign="top"> <content styleCode="bold">Adverse Reaction</content> </td> <td align="center" styleCode="Rrule" valign="top"> <content styleCode="bold">23 mg/day </content> <content styleCode="bold">Donepezil Hydrochloride </content> <content styleCode="bold">(n=963)</content> <content styleCode="bold">%</content> </td> <td align="center" styleCode="Rrule" valign="top"> <content styleCode="bold">10 mg/day </content> <content styleCode="bold">Donepezil Hydrochloride </content> <content styleCode="bold">(n=471)</content> <content styleCode="bold">%</content> <content styleCode="bold"/> </td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule" valign="middle"> Vomiting </td> <td align="center" styleCode="Rrule" valign="top">3 </td> <td align="center" styleCode="Rrule" valign="top">0 </td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule" valign="middle"> Diarrhea </td> <td align="center" styleCode="Rrule" valign="top">2 </td> <td align="center" styleCode="Rrule" valign="top">0 </td> </tr> <tr styleCode="Botrule"> <td align="justify" styleCode="Lrule Rrule" valign="top"> Nausea </td> <td align="center" styleCode="Rrule" valign="top">2 </td> <td align="center" styleCode="Rrule" valign="top">0 </td> </tr> <tr> <td align="justify" styleCode="Lrule Rrule" valign="top"> Dizziness </td> <td align="center" styleCode="Rrule" valign="top">1 </td> <td align="center" styleCode="Rrule" valign="top">0 </td> </tr> </tbody> </table>
adverse reactions table <table cellspacing="0" cellpadding="0" border="0" width="599.4975"> <col width="35.4076539101497%"/> <col width="33.8546866333888%"/> <col width="30.7376594564615%"/> <tbody> <tr styleCode="Botrule"> <td colspan="3" align="center" styleCode="Lrule Rrule" valign="top"> <content styleCode="bold">Table 6. </content> <content styleCode="bold">Adverse Reactions in a Controlled Clinical Trial in Moderate to Severe Alzheimer’s Disease</content> <content styleCode="bold"/> </td> </tr> <tr styleCode="Botrule"> <td align="justify" styleCode="Lrule Rrule" valign="top"> <content styleCode="bold">Adverse Reaction</content> </td> <td align="center" styleCode="Rrule" valign="top"> <content styleCode="bold">23 mg/day </content> <content styleCode="bold">Donepezil Hydrochloride </content> <content styleCode="bold">(n=963)</content> <content styleCode="bold">%</content> </td> <td align="center" styleCode="Rrule" valign="top"> <content styleCode="bold">10 mg/day </content> <content styleCode="bold">Donepezil Hydrochloride </content> <content styleCode="bold">(n=471)</content> <content styleCode="bold">%</content> <content styleCode="bold"/> </td> </tr> <tr styleCode="Botrule"> <td align="justify" styleCode="Lrule Rrule" valign="top"> <content styleCode="bold">Percent of Patients with any Adverse Reaction</content> </td> <td align="center" styleCode="Rrule" valign="top">74 </td> <td align="center" styleCode="Rrule" valign="top">64 </td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule" valign="middle"> Nausea </td> <td align="center" styleCode="Rrule" valign="top">12 </td> <td align="center" styleCode="Rrule" valign="top">3 </td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule" valign="middle"> Vomiting </td> <td align="center" styleCode="Rrule" valign="top">9 </td> <td align="center" styleCode="Rrule" valign="top">3 </td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule" valign="middle"> Diarrhea </td> <td align="center" styleCode="Rrule" valign="top">8 </td> <td align="center" styleCode="Rrule" valign="top">5 </td> </tr> <tr styleCode="Botrule"> <td align="justify" styleCode="Lrule Rrule" valign="top"> Anorexia </td> <td align="center" styleCode="Rrule" valign="top">5 </td> <td align="center" styleCode="Rrule" valign="top">2 </td> </tr> <tr styleCode="Botrule"> <td align="justify" styleCode="Lrule Rrule" valign="top"> Dizziness </td> <td align="center" styleCode="Rrule" valign="top">5 </td> <td align="center" styleCode="Rrule" valign="top">3 </td> </tr> <tr styleCode="Botrule"> <td align="justify" styleCode="Lrule Rrule" valign="top"> Weight Loss </td> <td align="center" styleCode="Rrule" valign="top">5 </td> <td align="center" styleCode="Rrule" valign="top">3 </td> </tr> <tr styleCode="Botrule"> <td align="justify" styleCode="Lrule Rrule" valign="top"> Headache </td> <td align="center" styleCode="Rrule" valign="top">4 </td> <td align="center" styleCode="Rrule" valign="top">3 </td> </tr> <tr styleCode="Botrule"> <td align="justify" styleCode="Lrule Rrule" valign="top"> Insomnia </td> <td align="center" styleCode="Rrule" valign="top">3 </td> <td align="center" styleCode="Rrule" valign="top">2 </td> </tr> <tr styleCode="Botrule"> <td align="justify" styleCode="Lrule Rrule" valign="top"> Urinary Incontinence </td> <td align="center" styleCode="Rrule" valign="top">3 </td> <td align="center" styleCode="Rrule" valign="top">1 </td> </tr> <tr styleCode="Botrule"> <td align="justify" styleCode="Lrule Rrule" valign="top"> Asthenia </td> <td align="center" styleCode="Rrule" valign="top">2 </td> <td align="center" styleCode="Rrule" valign="top">1 </td> </tr> <tr styleCode="Botrule"> <td align="justify" styleCode="Lrule Rrule" valign="top"> Contusion </td> <td align="center" styleCode="Rrule" valign="top">2 </td> <td align="center" styleCode="Rrule" valign="top">0 </td> </tr> <tr styleCode="Botrule"> <td align="justify" styleCode="Lrule Rrule" valign="top"> Fatigue </td> <td align="center" styleCode="Rrule" valign="top">2 </td> <td align="center" styleCode="Rrule" valign="top">1 </td> </tr> <tr> <td align="justify" styleCode="Lrule Rrule" valign="top"> Somnolence </td> <td align="center" styleCode="Rrule" valign="top">2 </td> <td align="center" styleCode="Rrule" valign="top">1 </td> </tr> </tbody> </table>
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.