Home FDA labels fe8e29e9-5045-4e0e-9019-e381f2f7f8ef FDA label fe8e29e9-5045-4e0e-9019-e381f2f7f8ef 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 ce5c1d5e-e51d-4765-8be6-9d7f92099049
SPL ID fe8e29e9-5045-4e0e-9019-e381f2f7f8ef
Version 4
Effective date 2019-12-12
Source export date 2026-10-12
Source partition 5
Source file https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-10-12/13cbfcd236c665f0ee69e2d9141331148dcdff45d1679c92f029cfba27dd74a2/drug-label-0005-of-0014.json.zip
Source manifest SHA-256 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run 20261013T011858Z
Imported at 2026-10-13 01:42:01 Harmonized identifier links# Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
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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 bleeding (GI), 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. 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. 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. 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.
Adverse reactions cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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adverse reactions table <table cellpadding="0pt" cellspacing="0pt" width="100%"> <col width="53%"/> <col width="15%"/> <col width="32%"/> <tbody> <tr> <td align="center" colspan="3" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> <content styleCode="bold">Table 4. Adverse Reactions in Pooled Controlled Clinical Trials in Severe Alzheimer’s Disease </content> </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">Body System/Adverse Reaction</content> </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph> <content styleCode="bold">Placebo (n=392)</content> <content styleCode="bold">%</content> </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph> <content styleCode="bold">Donepezil Hydrochloride (n=501)</content> <content styleCode="bold">%</content> </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> <content styleCode="bold">Percent of Patients with any Adverse Reaction</content> </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph> <content styleCode="bold">73</content> </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph> <content styleCode="bold">81</content> </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> Accident </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>12 </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>13 </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> Infection </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>9 </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>11 </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="middle"> <paragraph> Diarrhea </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>4 </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>10 </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> Anorexia </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>4 </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>8 </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="middle"> <paragraph> Vomiting </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>4 </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>8 </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> Nausea </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>2 </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>6 </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> Insomnia </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>4 </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>5 </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> Ecchymosis </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>2 </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>5 </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> Headache </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>3 </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>4 </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> Hypertension </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>2 </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>3 </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> Pain </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>2 </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>3 </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> Back Pain </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>2 </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>3 </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> Eczema </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>2 </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>3 </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> Hallucinations </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>1 </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>3 </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> Hostility </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>2 </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>3 </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> Increase in Creatine Phosphokinase </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>1 </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>3 </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> Nervousness </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>2 </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>3 </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> Fever </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>1 </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>2 </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> Chest Pain </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph><1 </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>2 </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> Confusion </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>1 </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>2 </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> Dehydration </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>1 </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>2 </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> Depression </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>1 </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>2 </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> Dizziness </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>1 </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>2 </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> Emotional Lability </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>1 </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>2 </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> Hemorrhage </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>1 </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>2 </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> Hyperlipemia </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph><1 </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>2 </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> Personality Disorder </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>1 </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>2 </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> Somnolence </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>1 </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>2 </paragraph> </td> </tr> <tr> <td styleCode="Rrule Lrule Botrule " valign="top"> <paragraph> Syncope </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>1 </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>2 </paragraph> </td> </tr> <tr> <td styleCode="Rrule Botrule Lrule " valign="top"> <paragraph> Urinary Incontinence </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>1 </paragraph> </td> <td align="center" styleCode="Rrule Botrule " valign="top"> <paragraph>2 </paragraph> </td> </tr> </tbody> </table>
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.