Home FDA labels a640f331-d5e2-5039-e053-2995a90a3d78 FDA label a640f331-d5e2-5039-e053-2995a90a3d78 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 set ID 54b278c6-3bbb-5008-e054-00144ff8d46c
SPL ID a640f331-d5e2-5039-e053-2995a90a3d78
Version 2
Effective date 2020-05-22
Source export date 2026-10-12
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Source file https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-10-12/b939c18fdf51df171cf60ce5558819d08ac66bb16bb9991d48cbec91028d783e/drug-label-0004-of-0014.json.zip
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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 tablets 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) 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 tablets. 5.3 Nausea and Vomiting Donepezil hydrochloride tablets, as a predictable consequence of their pharmacological properties, have 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. Although in most cases, these effects have been transient, sometimes lasting one to three weeks, and have resolved during continued use of donepezil hydrochloride tablets, 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 hydrochloride tablets 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. 5.6 Genitourinary Conditions Although not observed in clinical trials of donepezil hydrochloride tablets, 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 ID="ID71" width="100%"> <col width="54%"/> <col width="24%"/> <col width="22%"/> <tbody> <tr> <td align="justify" colspan="3" styleCode=" Lrule Rrule Botrule Toprule" valign="top"> <content styleCode="bold">Table </content> <content styleCode="bold">4</content> <content styleCode="bold">. </content> <content styleCode="bold">Adverse </content> <content styleCode="bold">Reactions </content> <content styleCode="bold">in </content> <content styleCode="bold">Pooled </content> <content styleCode="bold">Controlled </content> <content styleCode="bold">Clinical </content> <content styleCode="bold">Trials </content> <content styleCode="bold">in </content> <content styleCode="bold">Severe </content> <content styleCode="bold">Alzheimer’s </content> <content styleCode="bold">Disease </content> <content styleCode="bold"> </content> </td> </tr> <tr> <td align="left" styleCode=" Lrule Rrule Botrule Toprule" valign="top"> <content styleCode="bold">Body </content> <content styleCode="bold">System</content> <content styleCode="bold">/</content> <content styleCode="bold">Adverse </content> <content styleCode="bold">Reaction </content> </td> <td align="center" styleCode=" Lrule Rrule Botrule Toprule" valign="top"> <content styleCode="bold">Placebo</content> <content styleCode="bold"> </content> <content styleCode="bold">(</content> <content styleCode="bold">n</content> <content styleCode="bold">=</content> <content styleCode="bold">392</content> <content styleCode="bold">)</content> <content styleCode="bold"> </content> <content styleCode="bold">%</content> </td> <td align="center" styleCode=" Lrule Rrule Botrule Toprule" valign="top"> <content styleCode="bold">Donepezil </content> <content styleCode="bold">Hydrochloride </content> <content styleCode="bold">Tablets</content> <content styleCode="bold"> </content> <content styleCode="bold">(</content> <content styleCode="bold">n</content> <content styleCode="bold">=</content> <content styleCode="bold">501</content> <content styleCode="bold">)</content> <content styleCode="bold"> </content> <content styleCode="bold">% </content> </td> </tr> <tr> <td align="left" styleCode=" Lrule Rrule Botrule Toprule" valign="top"> <content styleCode="bold">Percent </content> <content styleCode="bold">of </content> <content styleCode="bold">Patients </content> <content styleCode="bold">with </content> <content styleCode="bold">any </content> <content styleCode="bold">Adverse </content> <content styleCode="bold">Reaction </content> </td> <td align="center" styleCode=" Lrule Rrule Botrule Toprule" valign="top"> <content styleCode="bold">73 </content> </td> <td align="center" styleCode=" Lrule Rrule Botrule Toprule" valign="top"> <content styleCode="bold">81 </content> </td> </tr> <tr> <td align="left" styleCode=" Lrule Rrule Botrule Toprule" valign="top">Accident </td> <td align="center" styleCode=" Lrule Rrule Botrule Toprule" valign="top">12 </td> <td align="center" styleCode=" Lrule Rrule Botrule Toprule" valign="top">13 </td> </tr> <tr> <td align="left" styleCode=" Lrule Rrule Botrule Toprule" valign="top">Infection </td> <td align="center" styleCode=" Lrule Rrule Botrule Toprule" valign="top">9 </td> <td align="center" styleCode=" Lrule Rrule Botrule Toprule" valign="top">11 </td> </tr> <tr> <td align="left" styleCode=" Lrule Rrule Botrule Toprule" valign="top">Diarrhea </td> <td align="center" styleCode=" Lrule Rrule Botrule Toprule" valign="top">4 </td> <td align="center" styleCode=" Lrule Rrule Botrule Toprule" valign="top">10 </td> </tr> <tr> <td align="left" styleCode=" Lrule Rrule Botrule Toprule" valign="top">Anorexia </td> <td align="center" styleCode=" Lrule Rrule Botrule Toprule" valign="top">4 </td> <td align="center" styleCode=" Lrule Rrule Botrule Toprule" valign="top">8 </td> </tr> <tr> <td align="left" styleCode=" Lrule Rrule Botrule Toprule" valign="top">Vomiting </td> <td align="center" styleCode=" Lrule Rrule Botrule Toprule" valign="top">4 </td> <td align="center" styleCode=" Lrule Rrule Botrule Toprule" valign="top">8 </td> </tr> <tr> <td align="left" styleCode=" Lrule Rrule Botrule Toprule" valign="top">Nausea </td> <td align="center" styleCode=" Lrule Rrule Botrule Toprule" valign="top">2 </td> <td align="center" styleCode=" Lrule Rrule Botrule Toprule" valign="top">6 </td> </tr> <tr> <td align="left" styleCode=" Lrule Rrule Botrule Toprule" valign="top">Insomnia </td> <td align="center" styleCode=" Lrule Rrule Botrule Toprule" valign="top">4 </td> <td align="center" styleCode=" Lrule Rrule Botrule Toprule" valign="top">5 </td> </tr> <tr> <td align="left" styleCode=" Lrule Rrule Botrule Toprule" valign="top">Ecchymosis </td> <td align="center" styleCode=" Lrule Rrule Botrule Toprule" valign="top">2 </td> <td align="center" styleCode=" Lrule Rrule Botrule Toprule" valign="top">5 </td> </tr> <tr> <td align="left" styleCode=" Lrule Rrule Botrule Toprule" valign="top">Headache </td> <td align="center" styleCode=" Lrule Rrule Botrule Toprule" valign="top">3 </td> <td align="center" styleCode=" Lrule Rrule Botrule Toprule" valign="top">4 </td> </tr> <tr> <td align="left" styleCode=" Lrule Rrule Botrule Toprule" valign="top">Hypertension </td> <td align="center" styleCode=" Lrule Rrule Botrule Toprule" valign="top">2 </td> <td align="center" styleCode=" Lrule Rrule Botrule Toprule" valign="top">3 </td> </tr> <tr> <td align="left" styleCode=" Lrule Rrule Botrule Toprule" valign="top">Pain </td> <td align="center" styleCode=" Lrule Rrule Botrule Toprule" valign="top">2 </td> <td align="center" styleCode=" Lrule Rrule Botrule Toprule" valign="top">3 </td> </tr> <tr> <td align="left" styleCode=" Lrule Rrule Botrule Toprule" valign="top">Back Pain </td> <td align="center" styleCode=" Lrule Rrule Botrule Toprule" valign="top">2 </td> <td align="center" styleCode=" Lrule Rrule Botrule Toprule" valign="top">3 </td> </tr> <tr> <td align="left" styleCode=" Lrule Rrule Botrule Toprule" valign="top">Eczema </td> <td align="center" styleCode=" Lrule Rrule Botrule Toprule" valign="top">2 </td> <td align="center" styleCode=" Lrule Rrule Botrule Toprule" valign="top">3 </td> </tr> <tr> <td align="left" styleCode=" Lrule Rrule Botrule Toprule" valign="top">Hallucinations </td> <td align="center" styleCode=" Lrule Rrule Botrule Toprule" valign="top">1 </td> <td align="center" styleCode=" Lrule Rrule Botrule Toprule" valign="top">3 </td> </tr> <tr> <td align="left" styleCode=" Lrule Rrule Botrule Toprule" valign="top">Hostility </td> <td align="center" styleCode=" Lrule Rrule Botrule Toprule" valign="top">2 </td> <td align="center" styleCode=" Lrule Rrule Botrule Toprule" valign="top">3 </td> </tr> <tr> <td align="left" styleCode=" Lrule Rrule Botrule Toprule" valign="top">Increase in Creatine Phosphokinase </td> <td align="center" styleCode=" Lrule Rrule Botrule Toprule" valign="top">1 </td> <td align="center" styleCode=" Lrule Rrule Botrule Toprule" valign="top">3 </td> </tr> <tr> <td align="left" styleCode=" Lrule Rrule Botrule Toprule" valign="top">Nervousness </td> <td align="center" styleCode=" Lrule Rrule Botrule Toprule" valign="top">2 </td> <td align="center" styleCode=" Lrule Rrule Botrule Toprule" valign="top">3 </td> </tr> <tr> <td align="left" styleCode=" Lrule Rrule Botrule Toprule" valign="top">Fever </td> <td align="center" styleCode=" Lrule Rrule Botrule Toprule" valign="top">1 </td> <td align="center" styleCode=" Lrule Rrule Botrule Toprule" valign="top">2 </td> </tr> <tr> <td align="left" styleCode=" Lrule Rrule Botrule Toprule" valign="top">Chest Pain </td> <td align="center" styleCode=" Lrule Rrule Botrule Toprule" valign="top"><1 </td> <td align="center" styleCode=" Lrule Rrule Botrule Toprule" valign="top">2 </td> </tr> <tr> <td align="left" styleCode=" Lrule Rrule Botrule Toprule" valign="top">Confusion </td> <td align="center" styleCode=" Lrule Rrule Botrule Toprule" valign="top">1 </td> <td align="center" styleCode=" Lrule Rrule Botrule Toprule" valign="top">2 </td> </tr> <tr> <td align="left" styleCode=" Lrule Rrule Botrule Toprule" valign="top">Dehydration </td> <td align="center" styleCode=" Lrule Rrule Botrule Toprule" valign="top">1 </td> <td align="center" styleCode=" Lrule Rrule Botrule Toprule" valign="top">2 </td> </tr> <tr> <td align="left" styleCode=" Lrule Rrule Botrule Toprule" valign="top">Depression </td> <td align="center" styleCode=" Lrule Rrule Botrule Toprule" valign="top">1 </td> <td align="center" styleCode=" Lrule Rrule Botrule Toprule" valign="top">2 </td> </tr> <tr> <td align="left" styleCode=" Lrule Rrule Botrule Toprule" valign="top">Dizziness </td> <td align="center" styleCode=" Lrule Rrule Botrule Toprule" valign="top">1 </td> <td align="center" styleCode=" Lrule Rrule Botrule Toprule" valign="top">2 </td> </tr> <tr> <td align="left" styleCode=" Lrule Rrule Botrule Toprule" valign="top">Emotional Lability </td> <td align="center" styleCode=" Lrule Rrule Botrule Toprule" valign="top">1 </td> <td align="center" styleCode=" Lrule Rrule Botrule Toprule" valign="top">2 </td> </tr> <tr> <td align="left" styleCode=" Lrule Rrule Botrule Toprule" valign="top">Hemorrhage </td> <td align="center" styleCode=" Lrule Rrule Botrule Toprule" valign="top">1 </td> <td align="center" styleCode=" Lrule Rrule Botrule Toprule" valign="top">2 </td> </tr> <tr> <td align="left" styleCode=" Lrule Rrule Botrule Toprule" valign="top">Hyperlipemia </td> <td align="center" styleCode=" Lrule Rrule Botrule Toprule" valign="top"><1 </td> <td align="center" styleCode=" Lrule Rrule Botrule Toprule" valign="top">2 </td> </tr> <tr> <td align="left" styleCode=" Lrule Rrule Botrule Toprule" valign="top">Personality Disorder </td> <td align="center" styleCode=" Lrule Rrule Botrule Toprule" valign="top">1 </td> <td align="center" styleCode=" Lrule Rrule Botrule Toprule" valign="top">2 </td> </tr> <tr> <td align="left" styleCode=" Lrule Rrule Botrule Toprule" valign="top">Somnolence </td> <td align="center" styleCode=" Lrule Rrule Botrule Toprule" valign="top">1 </td> <td align="center" styleCode=" Lrule Rrule Botrule Toprule" valign="top">2 </td> </tr> <tr> <td align="left" styleCode=" Lrule Rrule Botrule Toprule" valign="top">Syncope </td> <td align="center" styleCode=" Lrule Rrule Botrule Toprule" valign="top">1 </td> <td align="center" styleCode=" Lrule Rrule Botrule Toprule" valign="top">2 </td> </tr> <tr> <td align="left" styleCode=" Lrule Rrule Botrule Toprule" valign="top">Urinary Incontinence </td> <td align="center" styleCode=" Lrule Rrule Botrule Toprule" valign="top">1 </td> <td align="center" styleCode=" Lrule Rrule Botrule Toprule" valign="top">2 </td> </tr> </tbody> </table>
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.