donepezil ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
946 120014-06-4

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • aricept
  • donepezil
  • donepezil hydrochloride
  • donepezil HCl
  • donezpil hydrochloride
  • donezpil
  • donezpil HCl
  • donepezilium oxalate trihydrate
  • donepezilium oxalate
  • donepezil oxalate
  • E2020
  • E-2020
An indan and piperidine derivative that acts as a selective and reversible inhibitor of ACETYLCHOLINESTERASE. Donepezil is highly selective for the central nervous system and is used in the management of mild to moderate DEMENTIA in ALZHEIMER DISEASE.
  • Molecular weight: 379.50
  • Formula: C24H29NO3
  • CLOGP: 4.40
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 0
  • TPSA: 38.77
  • ALOGS: -4.93
  • ROTB: 6

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
7.50 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.00 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 10.60 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.38 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 99 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

DateAgencyCompanyOrphan
Nov. 25, 1996 FDA EISAI INC

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Bradycardia 545.21 13.12 394 31385 64032 50509313
Fall 430.17 13.12 759 31020 334173 50239172
Syncope 313.74 13.12 354 31425 102648 50470697
Electrocardiogram QT prolonged 256.61 13.12 232 31547 51654 50521691
Dementia 255.10 13.12 146 31633 15851 50557494
Sinus bradycardia 222.82 13.12 125 31654 13058 50560287
Confusional state 205.63 13.12 396 31383 185532 50387813
Drug interaction 200.10 13.12 408 31371 199213 50374132
Hallucination 196.78 13.12 191 31588 46466 50526879
Torsade de pointes 175.35 13.12 103 31676 11732 50561613
Agitation 170.05 13.12 188 31591 53196 50520149
Aggression 162.19 13.12 122 31657 20994 50552351
Delusion 146.19 13.12 88 31691 10481 50562864
Cognitive disorder 136.39 13.12 153 31626 43970 50529375
Parkinsonism 133.71 13.12 78 31701 8769 50564576
Neuroleptic malignant syndrome 126.99 13.12 82 31697 11048 50562297
Drug ineffective 126.16 13.12 201 31578 819132 49754213
Abnormal behaviour 125.87 13.12 102 31677 19556 50553789
Delirium 120.72 13.12 134 31645 38058 50535287
Pleurothotonus 112.60 13.12 39 31740 1262 50572083
Seizure 109.75 13.12 234 31545 117640 50455705
Arthralgia 99.69 13.12 78 31701 438624 50134721
Somnolence 98.21 13.12 265 31514 154720 50418625
Sinus node dysfunction 93.71 13.12 47 31732 3908 50569437
Hallucination, visual 93.61 13.12 80 31699 16502 50556843
Pain 92.68 13.12 138 31641 578765 49994580
Cholinergic syndrome 91.41 13.12 25 31754 357 50572988
Altered state of consciousness 89.14 13.12 88 31691 21822 50551523
Loss of consciousness 85.64 13.12 197 31582 104156 50469189
Femoral neck fracture 84.99 13.12 55 31724 7435 50565910
Joint swelling 82.04 13.12 26 31753 245260 50328085
Electrocardiogram PR prolongation 81.92 13.12 26 31753 637 50572708
Hypersensitivity 81.05 13.12 18 31761 215143 50358202
Decreased appetite 80.47 13.12 293 31486 200630 50372715
Tremor 80.44 13.12 204 31575 114699 50458646
Urinary retention 79.50 13.12 90 31689 26100 50547245
Extrapyramidal disorder 79.44 13.12 63 31716 11707 50561638
Alopecia 78.42 13.12 28 31751 245019 50328326
Rash 78.29 13.12 96 31683 437375 50135970
Muscle rigidity 78.16 13.12 58 31721 9771 50563574
Atrioventricular block first degree 76.49 13.12 48 31731 6153 50567192
Myoclonus 76.00 13.12 67 31712 14403 50558942
Dehydration 74.80 13.12 238 31541 152211 50421134
Torticollis 73.88 13.12 31 31748 1705 50571640
Hypokalaemia 73.16 13.12 167 31612 87825 50485520
Rheumatoid arthritis 72.26 13.12 19 31760 202531 50370814
Depressed level of consciousness 70.34 13.12 121 31658 51832 50521513
Treatment failure 70.25 13.12 4 31775 137633 50435712
Hypothermia 69.92 13.12 59 31720 11957 50561388
Systemic lupus erythematosus 69.06 13.12 5 31774 140617 50432728
Infusion related reaction 68.42 13.12 12 31767 169545 50403800
Dementia Alzheimer's type 66.93 13.12 25 31754 1009 50572336
Mania 66.42 13.12 55 31724 10861 50562484
Sinusitis 62.75 13.12 15 31764 170543 50402802
Hypophagia 62.54 13.12 82 31697 27646 50545699
Immobile 62.03 13.12 39 31740 5015 50568330
Arthropathy 61.94 13.12 12 31767 157894 50415451
Nightmare 60.64 13.12 62 31717 16024 50557321
Mental status changes 57.89 13.12 91 31688 36181 50537164
Swelling 57.68 13.12 27 31752 200845 50372500
Urinary incontinence 56.89 13.12 79 31700 28129 50545216
Lethargy 55.31 13.12 106 31673 49326 50524019
Drug intolerance 54.85 13.12 35 31744 219069 50354276
Urinary tract infection 54.41 13.12 281 31498 223739 50349606
Pemphigus 54.35 13.12 6 31773 120160 50453185
Glossodynia 54.27 13.12 5 31774 115564 50457781
Disorientation 53.85 13.12 87 31692 35397 50537948
Dyskinesia 53.18 13.12 76 31703 27785 50545560
Sudden death 52.01 13.12 44 31735 8947 50564398
Drug hypersensitivity 49.26 13.12 51 31728 250959 50322386
Restlessness 48.53 13.12 69 31710 25104 50548241
Wandering pacemaker 48.44 13.12 8 31771 3 50573342
Atrioventricular block complete 45.07 13.12 37 31742 7218 50566127
Pruritus 44.80 13.12 68 31711 283500 50289845
Anal incontinence 44.61 13.12 45 31734 11445 50561900
Sexually inappropriate behaviour 44.46 13.12 11 31768 103 50573242
Hypocapnia 44.42 13.12 14 31765 335 50573010
Reduced facial expression 43.92 13.12 21 31758 1573 50571772
Medication error 43.59 13.12 80 31699 36024 50537321
Pain in extremity 43.53 13.12 65 31714 272800 50300545
Gastrointestinal haemorrhage 43.01 13.12 122 31657 73199 50500146
Psychomotor hyperactivity 42.82 13.12 40 31739 9261 50564084
Circulatory collapse 41.81 13.12 57 31722 19943 50553402
Encephalopathy 41.08 13.12 75 31704 33636 50539709
Therapeutic product effect decreased 41.06 13.12 17 31762 136033 50437312
Lower respiratory tract infection 40.04 13.12 6 31773 95195 50478150
Epilepsy 39.94 13.12 58 31721 21509 50551836
Hyponatraemia 39.93 13.12 142 31637 95997 50477348
Hip fracture 39.92 13.12 64 31715 25867 50547478
Apathy 39.73 13.12 35 31744 7513 50565832
Cerebral atrophy 38.49 13.12 28 31751 4573 50568772
Unresponsive to stimuli 38.45 13.12 69 31710 30540 50542805
Pericarditis 38.04 13.12 3 31776 78686 50494659
Pneumonia aspiration 37.81 13.12 69 31710 30935 50542410
Neuropsychiatric symptoms 37.48 13.12 14 31765 565 50572780
Febrile neutropenia 37.08 13.12 8 31771 97659 50475686
Dizziness 35.73 13.12 353 31426 346016 50227329
Generalised tonic-clonic seizure 35.23 13.12 61 31718 26249 50547096
Off label use 35.12 13.12 166 31613 474260 50099085
Dementia with Lewy bodies 34.37 13.12 11 31768 277 50573068
Weight increased 34.25 13.12 46 31733 201845 50371500
Cough 34.24 13.12 62 31717 241202 50332143
Long QT syndrome 34.18 13.12 22 31757 2945 50570400
Atrioventricular block 34.02 13.12 30 31749 6448 50566897
Listless 33.30 13.12 20 31759 2370 50570975
Infection 32.94 13.12 36 31743 172918 50400427
Tardive dyskinesia 32.92 13.12 31 31748 7248 50566097
Atrial tachycardia 32.74 13.12 19 31760 2113 50571232
Miosis 32.69 13.12 29 31750 6281 50567064
Accidental overdose 32.55 13.12 50 31729 19483 50553862
Rhabdomyolysis 32.32 13.12 74 31705 38953 50534392
Gait disturbance 32.18 13.12 182 31597 149823 50423522
Hypotension 32.01 13.12 255 31524 235214 50338131
Abdominal discomfort 31.57 13.12 61 31718 231580 50341765
Lack of spontaneous speech 31.39 13.12 9 31770 154 50573191
Sialoadenitis 31.31 13.12 16 31763 1384 50571961
Wrong patient received product 31.13 13.12 17 31762 1683 50571662
Fracture 30.78 13.12 45 31734 16788 50556557
Dyspnoea 30.10 13.12 211 31568 547397 50025948
Stomatitis 30.03 13.12 13 31766 101331 50472014
Incontinence 29.76 13.12 34 31745 9951 50563394
Paratonia 29.01 13.12 6 31773 22 50573323
Nasopharyngitis 28.80 13.12 48 31731 192879 50380466
Fluid intake reduced 28.42 13.12 20 31759 3102 50570243
Headache 28.41 13.12 194 31585 506341 50067004
Sinus arrest 28.40 13.12 16 31763 1682 50571663
Hepatic enzyme increased 27.96 13.12 27 31752 137353 50435992
Dysarthria 27.80 13.12 68 31711 37335 50536010
Product administration interrupted 26.67 13.12 13 31766 1016 50572329
Cerebrovascular accident 26.67 13.12 124 31655 94556 50478789
Fatigue 26.44 13.12 301 31478 707300 49866045
Colitis microscopic 26.16 13.12 26 31753 6494 50566851
Atrial fibrillation 25.60 13.12 129 31650 101616 50471729
Death 25.43 13.12 314 31465 325065 50248280
Memory impairment 25.42 13.12 108 31671 79252 50494093
Therapeutic product effect incomplete 25.18 13.12 13 31766 91502 50481843
Suspiciousness 25.10 13.12 9 31770 323 50573022
Hyperhidrosis 25.10 13.12 117 31662 89309 50484036
Hypernatraemia 24.98 13.12 25 31754 6296 50567049
Anger 24.75 13.12 33 31746 11300 50562045
Oropharyngeal pain 24.66 13.12 9 31770 77792 50495553
Vomiting 24.64 13.12 416 31363 460342 50113003
Pelvic fracture 24.33 13.12 33 31746 11487 50561858
Impaired healing 24.01 13.12 7 31772 69779 50503566
Wound 23.69 13.12 19 31760 105775 50467570
Speech disorder 23.68 13.12 62 31717 35486 50537859
Psoriasis 23.59 13.12 7 31772 68993 50504352
Chorea 23.43 13.12 13 31766 1327 50572018
Cerebral infarction 22.54 13.12 45 31734 21559 50551786
Grandiosity 22.53 13.12 8 31771 279 50573066
Product use issue 22.47 13.12 37 31742 149438 50423907
Discomfort 22.40 13.12 21 31758 108359 50464986
Hypersexuality 22.36 13.12 9 31770 445 50572900
Salivary hypersecretion 22.33 13.12 24 31755 6567 50566778
Irritable bowel syndrome 22.19 13.12 3 31776 51438 50521907
Hypoglycaemia 22.11 13.12 79 31700 53502 50519843
Cerebral haemorrhage 22.07 13.12 51 31728 27001 50546344
Skull fracture 21.92 13.12 11 31768 915 50572430
Herbal interaction 21.92 13.12 6 31773 86 50573259
Muscle contracture 21.90 13.12 12 31767 1195 50572150
Food refusal 21.63 13.12 8 31771 314 50573031
Brain compression 21.20 13.12 8 31771 332 50573013
Drug level increased 21.15 13.12 41 31738 19227 50554118
Social avoidant behaviour 21.11 13.12 16 31763 2781 50570564
Intentional product use issue 21.05 13.12 11 31768 76907 50496438
Non-24-hour sleep-wake disorder 20.79 13.12 4 31775 9 50573336
Hyponatraemic syndrome 20.78 13.12 9 31770 535 50572810
Sinoatrial block 20.72 13.12 10 31769 765 50572580
Posture abnormal 20.46 13.12 14 31765 2075 50571270
Chest discomfort 20.33 13.12 17 31762 92705 50480640
Injection site pain 20.16 13.12 24 31755 111000 50462345
Bedridden 20.03 13.12 27 31752 9340 50564005
Abnormal dreams 20.01 13.12 27 31752 9350 50563995
Sedation 19.99 13.12 53 31726 30557 50542788
Upper gastrointestinal haemorrhage 19.94 13.12 36 31743 15999 50557346
Psoriatic arthropathy 19.69 13.12 3 31776 47029 50526316
Peripheral swelling 19.67 13.12 65 31714 205871 50367474
Adams-Stokes syndrome 19.65 13.12 5 31774 53 50573292
Amyloid related imaging abnormality-oedema/effusion 19.49 13.12 4 31775 14 50573331
Parkinson's disease 19.29 13.12 11 31768 1184 50572161
Neutropenia 19.25 13.12 40 31739 147925 50425420
Overconfidence 19.12 13.12 3 31776 0 50573345
Incoherent 19.10 13.12 18 31761 4212 50569133
Ventricular tachycardia 19.02 13.12 35 31744 15786 50557559
Cholesteatoma 18.98 13.12 6 31773 145 50573200
Foreign body 18.81 13.12 13 31766 1958 50571387
Psychotic disorder 18.77 13.12 42 31737 21770 50551575
Urticaria 18.62 13.12 33 31746 129528 50443817
Blood pressure orthostatic decreased 18.57 13.12 5 31774 67 50573278
Executive dysfunction 18.49 13.12 6 31773 158 50573187
Antisocial behaviour 18.32 13.12 7 31772 301 50573044
Pyrexia 18.24 13.12 152 31627 380051 50193294
Emotional poverty 18.21 13.12 7 31772 306 50573039
Orthostatic hypotension 18.21 13.12 50 31729 29431 50543914
Hypertonia 18.12 13.12 17 31762 3956 50569389
Prescription drug used without a prescription 18.10 13.12 12 31767 1688 50571657
Obsessive thoughts 18.08 13.12 8 31771 501 50572844
Liver function test abnormal 17.97 13.12 65 31714 44274 50529071
Leukaemoid reaction 17.85 13.12 6 31773 177 50573168
Affect lability 17.83 13.12 25 31754 8973 50564372
Anaphylactic reaction 17.56 13.12 6 31773 54049 50519296
Pressure of speech 17.43 13.12 8 31771 546 50572799
Anorgasmia 17.42 13.12 8 31771 547 50572798
Injection site erythema 17.35 13.12 13 31766 74923 50498422
Haematoma 17.14 13.12 50 31729 30460 50542885
Intercepted product dispensing error 17.05 13.12 5 31774 93 50573252
Myalgia 16.69 13.12 33 31746 124286 50449059
Dysphagia 16.57 13.12 94 31685 77424 50495921
Arthritis 16.55 13.12 18 31761 86703 50486642
Drooling 16.44 13.12 15 31764 3369 50569976
Aphasia 16.30 13.12 47 31732 28447 50544898
Haematemesis 16.12 13.12 46 31733 27679 50545666
Drop attacks 16.07 13.12 8 31771 654 50572691
Normal pressure hydrocephalus 15.90 13.12 6 31773 249 50573096
Dyspepsia 15.73 13.12 14 31765 74083 50499262
Blood glucose fluctuation 15.66 13.12 16 31763 4130 50569215
Injection site reaction 15.50 13.12 6 31773 50026 50523319
Duodenal ulcer haemorrhage 15.49 13.12 12 31767 2154 50571191
Product use in unapproved indication 15.32 13.12 31 31748 115788 50457557
Progressive supranuclear palsy 15.27 13.12 4 31775 48 50573297
Disease progression 15.09 13.12 23 31756 95843 50477502
Head injury 15.09 13.12 41 31738 23979 50549366
Communication disorder 15.03 13.12 12 31767 2249 50571096
Delusion of grandeur 14.86 13.12 5 31774 148 50573197
Acute abdomen 14.84 13.12 10 31769 1446 50571899
Heart rate increased 14.78 13.12 16 31763 77234 50496111
Subdural haematoma 14.76 13.12 28 31751 12919 50560426
Injection site swelling 14.72 13.12 4 31775 41769 50531576
Product blister packaging issue 14.67 13.12 5 31774 154 50573191
Fibromyalgia 14.60 13.12 5 31774 44973 50528372
Inappropriate affect 14.58 13.12 8 31771 799 50572546
Hypoaesthesia 14.45 13.12 37 31742 127220 50446125
Nasal congestion 14.45 13.12 7 31772 51113 50522232
Opisthotonus 14.42 13.12 6 31773 323 50573022
Paraesthesia 14.41 13.12 34 31745 120209 50453136
Hepatic function abnormal 14.18 13.12 49 31730 32632 50540713
Pemphigoid 14.14 13.12 18 31761 5889 50567456
Melaena 14.11 13.12 43 31736 26821 50546524
Gastric ulcer 14.03 13.12 37 31742 21268 50552077
Delusional disorder, persecutory type 14.01 13.12 5 31774 177 50573168
Paranoia 13.86 13.12 24 31755 10324 50563021
Flushing 13.83 13.12 13 31766 67002 50506343
Theft 13.82 13.12 4 31775 71 50573274
Libido increased 13.79 13.12 9 31770 1234 50572111
Thalamus haemorrhage 13.72 13.12 7 31772 603 50572742
Neuropathy peripheral 13.58 13.12 25 31754 96732 50476613
Lower gastrointestinal haemorrhage 13.47 13.12 19 31760 6860 50566485
Visuospatial deficit 13.44 13.12 3 31776 17 50573328
Discoloured vomit 13.29 13.12 7 31772 644 50572701
Ill-defined disorder 13.29 13.12 9 31770 54645 50518700

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Hallucination 368.42 13.68 290 22083 44422 29507732
Fall 316.91 13.68 516 21857 176662 29375492
Bradycardia 288.90 13.68 299 22074 65330 29486824
Dementia 253.50 13.68 139 22234 11519 29540635
Confusional state 245.39 13.68 385 21988 127492 29424662
Delusion 178.00 13.68 109 22264 11107 29541047
Agitation 157.53 13.68 194 22179 51110 29501044
Delirium 137.39 13.68 159 22214 39238 29512916
Pleurothotonus 129.95 13.68 43 22330 995 29551159
Aggression 128.23 13.68 146 22227 35395 29516759
Abnormal behaviour 121.14 13.68 116 22257 23011 29529143
Cognitive disorder 117.70 13.68 115 22258 23384 29528770
Cholinergic syndrome 102.44 13.68 30 22343 456 29551698
Depressed level of consciousness 93.43 13.68 127 22246 36815 29515339
Mania 90.77 13.68 65 22308 8598 29543556
Somnolence 81.51 13.68 203 22170 93752 29458402
Hallucination, visual 79.91 13.68 76 22297 14939 29537215
Neuroleptic malignant syndrome 77.07 13.68 77 22296 16071 29536083
Urinary incontinence 73.94 13.68 76 22297 16405 29535749
Sinus bradycardia 71.99 13.68 64 22309 11539 29540615
Syncope 71.80 13.68 177 22196 81194 29470960
Febrile neutropenia 58.14 13.68 8 22365 112232 29439922
Nightmare 57.37 13.68 56 22317 11361 29540793
Balance disorder 57.08 13.68 100 22273 36070 29516084
Gait disturbance 56.87 13.68 152 22221 73197 29478957
Blood cholinesterase decreased 56.75 13.68 14 22359 105 29552049
Sinus node dysfunction 55.94 13.68 35 22338 3699 29548455
Memory impairment 48.92 13.68 94 22279 36376 29515778
Death 46.77 13.68 428 21945 341656 29210498
Poriomania 44.65 13.68 11 22362 82 29552072
Prescribed underdose 44.47 13.68 41 22332 7745 29544409
Orthostatic hypotension 44.36 13.68 69 22304 22560 29529594
Libido increased 42.02 13.68 17 22356 704 29551450
Pneumonia aspiration 41.30 13.68 88 22285 36649 29515505
Parkinsonism 40.94 13.68 38 22335 7240 29544914
Unresponsive to stimuli 40.32 13.68 70 22303 25056 29527098
Tremor 37.82 13.68 132 22241 73406 29478748
Hyperhidrosis 36.85 13.68 120 22253 64420 29487734
Neutropenia 34.96 13.68 29 22344 131682 29420472
Loss of consciousness 34.74 13.68 129 22244 73927 29478227
Paranoia 34.61 13.68 40 22333 9837 29542317
Anal incontinence 34.27 13.68 33 22340 6582 29545572
Product prescribing issue 34.17 13.68 17 22356 1150 29551004
Serotonin syndrome 33.77 13.68 53 22320 17459 29534695
Automatism 33.74 13.68 9 22364 95 29552059
Dyskinesia 33.65 13.68 57 22316 20004 29532150
Dementia Alzheimer's type 33.38 13.68 12 22361 358 29551796
Myoclonus 32.47 13.68 45 22328 13264 29538890
Arthralgia 32.07 13.68 35 22338 139582 29412572
Intestinal haemorrhage 32.01 13.68 23 22350 3056 29549098
Rhabdomyolysis 31.99 13.68 110 22263 60698 29491456
Extrapyramidal disorder 31.64 13.68 40 22333 10791 29541363
Jealous delusion 31.58 13.68 10 22363 200 29551954
Blood glucose fluctuation 30.98 13.68 24 22349 3573 29548581
Bradyarrhythmia 30.73 13.68 19 22354 1966 29550188
Salivary hypersecretion 29.37 13.68 32 22341 7377 29544777
Electrocardiogram QT prolonged 29.10 13.68 76 22297 36061 29516093
Sexually inappropriate behaviour 28.78 13.68 11 22362 391 29551763
Hypersomnia 28.73 13.68 38 22335 10716 29541438
Nonspecific reaction 28.57 13.68 15 22358 1136 29551018
Disorientation 27.90 13.68 66 22307 29449 29522705
Drooling 27.87 13.68 21 22352 3000 29549154
Altered state of consciousness 27.56 13.68 52 22321 19837 29532317
Drug abuse 27.51 13.68 13 22360 79870 29472284
Restlessness 27.17 13.68 55 22318 22090 29530064
Dizziness 27.15 13.68 240 22133 189444 29362710
Dementia with Lewy bodies 27.05 13.68 12 22361 626 29551528
Psychomotor hyperactivity 26.68 13.68 32 22341 8181 29543973
Flight of ideas 26.58 13.68 10 22363 340 29551814
Miosis 25.68 13.68 31 22342 7978 29544176
Muscle contractions involuntary 25.40 13.68 16 22357 1711 29550443
Hypothermia 25.23 13.68 33 22340 9206 29542948
Dysstasia 24.93 13.68 35 22338 10439 29541715
Abdominal pain 24.89 13.68 40 22333 135317 29416837
Gastrointestinal haemorrhage 23.79 13.68 121 22252 79412 29472742
Dehydration 23.55 13.68 158 22215 114590 29437564
Daydreaming 23.48 13.68 10 22363 472 29551682
Hip fracture 23.42 13.68 34 22339 10458 29541696
Cold sweat 23.24 13.68 31 22342 8811 29543343
Muscle rigidity 23.23 13.68 32 22341 9379 29542775
Atrioventricular block first degree 22.89 13.68 24 22349 5295 29546859
Thrombocytopenia 22.81 13.68 42 22331 134781 29417373
Femoral neck fracture 22.62 13.68 18 22355 2785 29549369
Contusion 22.62 13.68 63 22310 31032 29521122
Atrioventricular block complete 22.47 13.68 29 22344 7982 29544172
Dyspnoea 22.47 13.68 150 22223 326582 29225572
Lethargy 22.45 13.68 71 22302 37509 29514645
Inappropriate antidiuretic hormone secretion 22.35 13.68 34 22339 10898 29541256
Hangover 22.19 13.68 12 22361 965 29551189
Pain 22.04 13.68 62 22311 171370 29380784
Blood glucose abnormal 21.99 13.68 23 22350 5060 29547094
Skin swelling 21.51 13.68 12 22361 1026 29551128
Gastrointestinal ulcer 21.18 13.68 14 22359 1625 29550529
Drug interaction 21.06 13.68 235 22138 197150 29355004
Subdural haematoma 20.92 13.68 44 22329 18149 29534005
Neutrophil count decreased 20.54 13.68 4 22369 43563 29508591
Intention tremor 20.06 13.68 8 22365 319 29551835
Gait inability 19.48 13.68 43 22330 18332 29533822
Duodenal ulcer 19.27 13.68 29 22344 9209 29542945
Pruritus 19.23 13.68 37 22336 116812 29435342
Multiple drug therapy 19.17 13.68 8 22365 359 29551795
Atrioventricular block 19.16 13.68 25 22348 6957 29545197
Potentiating drug interaction 19.06 13.68 20 22353 4418 29547736
Defect conduction intraventricular 18.98 13.68 7 22366 225 29551929
Executive dysfunction 18.98 13.68 7 22366 225 29551929
Malignant neoplasm progression 18.68 13.68 17 22356 73842 29478312
Neuropathy peripheral 18.38 13.68 16 22357 71011 29481143
Gastroenteritis pseudomonas 18.33 13.68 4 22369 16 29552138
Decreased appetite 17.81 13.68 178 22195 145164 29406990
Seizure 17.78 13.68 126 22247 92997 29459157
Underdose 17.66 13.68 32 22341 11837 29540317
Septic shock 17.56 13.68 13 22360 62547 29489607
Hiccups 17.35 13.68 27 22346 8826 29543328
Irritability 17.23 13.68 46 22327 22106 29530048
Infusion related reaction 16.95 13.68 6 22367 43880 29508274
Urinary tract infection 16.91 13.68 103 22270 72251 29479903
Foaming at mouth 16.87 13.68 9 22364 704 29551450
Paraesthesia 16.71 13.68 10 22363 53835 29498319
Multiple organ dysfunction syndrome 16.60 13.68 14 22359 63102 29489052
Speech disorder 16.47 13.68 47 22326 23469 29528685
Mental status changes 15.66 13.68 60 22313 34867 29517287
Incontinence 15.36 13.68 19 22354 5013 29547141
Behaviour disorder 15 13.68 16 22357 3600 29548554
Sudden death 14.93 13.68 33 22340 14077 29538077
Leukopenia 14.82 13.68 12 22361 55191 29496963
Impulsive behaviour 14.67 13.68 12 22361 1931 29550223
Posture abnormal 14.65 13.68 12 22361 1935 29550219
Respiratory symptom 14.50 13.68 9 22364 937 29551217
Stomatitis 14.46 13.68 5 22368 37108 29515046
Pyrexia 14.27 13.68 144 22229 287478 29264676
Fracture 14.07 13.68 20 22353 6033 29546121
Chest pain 14.00 13.68 41 22332 111932 29440222
Parkinson's disease 13.77 13.68 10 22363 1351 29550803
Hypernatraemia 13.75 13.68 22 22351 7364 29544790
Drug hypersensitivity 13.74 13.68 19 22354 68387 29483767

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Bradycardia 777.89 12.87 659 45825 117560 64334688
Fall 635.10 12.87 1100 45384 415726 64036522
Hallucination 416.17 12.87 375 46109 72413 64379835
Dementia 394.84 12.87 223 46261 20543 64431705
Confusional state 353.68 12.87 656 45828 260488 64191760
Syncope 329.66 12.87 482 46002 157153 64295095
Agitation 280.65 12.87 332 46152 88035 64364213
Delusion 262.64 12.87 163 46321 17851 64434397
Sinus bradycardia 262.15 12.87 178 46306 22715 64429533
Aggression 257.82 12.87 235 46249 45997 64406251
Delirium 248.38 12.87 277 46207 68917 64383331
Electrocardiogram QT prolonged 243.21 12.87 293 46191 79155 64373093
Pleurothotonus 220.21 12.87 77 46407 2225 64450023
Abnormal behaviour 195.48 12.87 175 46309 33447 64418801
Cognitive disorder 195.03 12.87 219 46265 54868 64397380
Cholinergic syndrome 184.47 12.87 53 46431 790 64451458
Neuroleptic malignant syndrome 173.51 12.87 144 46340 24852 64427396
Parkinsonism 148.65 12.87 105 46379 14268 64437980
Drug interaction 146.91 12.87 582 45902 361501 64090747
Somnolence 145.50 12.87 397 46087 203248 64249000
Mania 141.31 12.87 107 46377 16179 64436069
Sinus node dysfunction 137.01 12.87 76 46408 6752 64445496
Depressed level of consciousness 135.00 12.87 224 46260 81212 64371036
Torsade de pointes 128.83 12.87 104 46380 17259 64434989
Hallucination, visual 123.88 12.87 125 46359 27709 64424539
Arthralgia 116.77 12.87 89 46395 442171 64010077
Myoclonus 110.31 12.87 112 46372 25006 64427242
Urinary incontinence 106.74 12.87 131 46353 36020 64416228
Seizure 103.21 12.87 309 46175 166583 64285665
Nightmare 100.30 12.87 98 46386 20895 64431353
Femoral neck fracture 100.23 12.87 68 46416 8656 64443592
Loss of consciousness 98.73 12.87 282 46202 148083 64304165
Pain 97.09 12.87 156 46328 553355 63898893
Drug ineffective 88.94 12.87 310 46174 839937 63612311
Muscle rigidity 88.05 12.87 84 46400 17389 64434859
Extrapyramidal disorder 87.35 12.87 88 46396 19464 64432784
Hypothermia 86.21 12.87 88 46396 19768 64432480
Tremor 85.61 12.87 268 46216 147962 64304286
Febrile neutropenia 85.25 12.87 16 46468 187641 64264607
Altered state of consciousness 83.53 12.87 119 46365 37783 64414465
Dehydration 82.57 12.87 342 46142 216421 64235827
Atrioventricular block first degree 79.00 12.87 64 46420 10670 64441578
Anal incontinence 78.38 12.87 74 46410 15122 64437126
Joint swelling 74.45 12.87 31 46453 215351 64236897
Decreased appetite 74.31 12.87 399 46085 280890 64171358
Death 73.97 12.87 597 45887 482108 63970140
Electrocardiogram PR prolongation 73.06 12.87 30 46454 1357 64450891
Dyskinesia 71.57 12.87 113 46371 39275 64412973
Gait disturbance 70.61 12.87 278 46206 171877 64280371
Infusion related reaction 70.60 12.87 16 46468 164451 64287797
Disorientation 68.75 12.87 135 46349 55693 64396555
Sexually inappropriate behaviour 66.10 12.87 21 46463 447 64451801
Lethargy 65.77 12.87 155 46329 72439 64379809
Pneumonia aspiration 64.31 12.87 136 46348 59135 64393113
Restlessness 63.97 12.87 108 46376 39677 64412571
Mental status changes 63.67 12.87 138 46346 61024 64391224
Hyperhidrosis 63.23 12.87 216 46268 124704 64327544
Dementia Alzheimer's type 61.05 12.87 24 46460 968 64451280
Unresponsive to stimuli 61.02 12.87 121 46363 50272 64401976
Pruritus 59.54 12.87 83 46401 312317 64139931
Psychomotor hyperactivity 59.05 12.87 62 46422 14389 64437859
Sudden death 57.98 12.87 72 46412 20024 64432224
Rheumatoid arthritis 57.82 12.87 23 46461 164271 64287977
Immobile 57.73 12.87 42 46442 5973 64446275
Rash 57.70 12.87 156 46328 458393 63993855
Atrioventricular block complete 57.39 12.87 61 46423 14357 64437891
Drug hypersensitivity 55.17 12.87 54 46430 237761 64214487
Hypersensitivity 55.05 12.87 37 46447 196415 64255833
Urinary tract infection 54.14 12.87 318 46166 231278 64220970
Dizziness 53.82 12.87 509 45975 429654 64022594
Sinusitis 53.74 12.87 19 46465 145909 64306339
Hypophagia 52.76 12.87 99 46385 39488 64412760
Miosis 52.57 12.87 56 46428 13210 64439038
Pain in extremity 52.46 12.87 86 46398 302999 64149249
Neutropenia 51.56 12.87 58 46426 239566 64212682
Alopecia 50.89 12.87 28 46456 165662 64286586
Gastrointestinal haemorrhage 50.50 12.87 209 46275 132103 64320145
Rhabdomyolysis 50.31 12.87 163 46321 91563 64360685
Dementia with Lewy bodies 50.27 12.87 19 46465 688 64451560
Atrioventricular block 49.90 12.87 52 46432 11963 64440285
Swelling 49.32 12.87 27 46457 160191 64292057
Orthostatic hypotension 49.26 12.87 106 46378 46632 64405616
Torticollis 48.58 12.87 26 46458 2151 64450097
Circulatory collapse 48.28 12.87 87 46397 33645 64418603
Dyspnoea 47.75 12.87 313 46171 718361 63733887
Memory impairment 47.66 12.87 153 46331 85529 64366719
Arthropathy 47.63 12.87 14 46470 120953 64331295
Treatment failure 46.96 12.87 13 46471 116803 64335445
Hip fracture 46.83 12.87 76 46408 27023 64425225
Salivary hypersecretion 46.01 12.87 50 46434 12063 64440185
Poriomania 45.48 12.87 13 46471 190 64452058
Wandering pacemaker 45.42 12.87 8 46476 6 64452242
Medication error 44.50 12.87 106 46378 49860 64402388
Jealous delusion 44.04 12.87 13 46471 214 64452034
Blood cholinesterase decreased 43.71 12.87 13 46471 220 64452028
Accidental overdose 43.57 12.87 83 46401 33474 64418774
Hypokalaemia 42.99 12.87 188 46296 121715 64330533
Cerebral atrophy 42.48 12.87 38 46446 7247 64445001
Drug intolerance 42.09 12.87 44 46440 187948 64264300
Cough 41.67 12.87 98 46386 302050 64150198
Generalised tonic-clonic seizure 41.55 12.87 90 46394 39767 64412481
Paranoia 41.53 12.87 55 46429 16297 64435951
Urinary retention 41.28 12.87 102 46382 49099 64403149
Headache 41.27 12.87 219 46265 529248 63923000
Stomatitis 40.81 12.87 14 46470 109591 64342657
Bradyarrhythmia 40.12 12.87 28 46456 3730 64448518
Epilepsy 39.97 12.87 80 46404 33451 64418797
Incontinence 39.29 12.87 46 46438 12035 64440213
Systemic lupus erythematosus 38.89 12.87 5 46479 77607 64374641
Libido increased 38.88 12.87 21 46463 1769 64450479
Apathy 38.60 12.87 44 46440 11188 64441060
Weight increased 38.34 12.87 59 46425 213289 64238959
Executive dysfunction 38.29 12.87 12 46472 244 64452004
Blood glucose fluctuation 36.59 12.87 32 46452 5923 64446325
Fracture 35.72 12.87 55 46429 18700 64433548
Reduced facial expression 35.63 12.87 21 46463 2092 64450156
Hypocapnia 35.35 12.87 14 46470 576 64451672
Contraindicated product administered 34.92 12.87 17 46467 107812 64344436
Malignant neoplasm progression 34.76 12.87 19 46465 112852 64339396
Thrombocytopenia 34.65 12.87 68 46416 223733 64228515
Encephalopathy 34.51 12.87 107 46377 58712 64393536
Nasopharyngitis 33.55 12.87 56 46428 196017 64256231
Drooling 33.52 12.87 29 46455 5290 64446958
Hypomania 31.99 12.87 29 46455 5625 64446623
Off label use 31.95 12.87 297 46187 632509 63819739
Paraesthesia 31.81 12.87 30 46454 134492 64317756
Neuropsychiatric symptoms 31.75 12.87 15 46469 951 64451297
Balance disorder 31.55 12.87 132 46352 83794 64368454
Nonspecific reaction 31.42 12.87 19 46465 1984 64450264
Pyrexia 31.39 12.87 255 46229 558389 63893859
Psoriasis 30.70 12.87 7 46477 71696 64380552
Infection 30.54 12.87 54 46430 184826 64267422
Glossodynia 30.48 12.87 5 46479 64691 64387557
Prescribed underdose 30.42 12.87 50 46434 17965 64434283
Oropharyngeal pain 30.34 12.87 13 46471 88854 64363394
Automatism 30.11 12.87 9 46475 155 64452093
Subdural haematoma 29.99 12.87 64 46420 27990 64424258
Tardive dyskinesia 29.94 12.87 35 46449 9143 64443105
Parkinson's disease 29.89 12.87 17 46467 1584 64450664
Injection site pain 29.85 12.87 22 46462 111386 64340862
Product prescribing issue 29.77 12.87 19 46465 2182 64450066
Listless 29.38 12.87 22 46462 3268 64448980
Mucosal inflammation 29.12 12.87 5 46479 62579 64389669
Social avoidant behaviour 29.03 12.87 25 46459 4532 64447716
Posture abnormal 28.71 12.87 22 46462 3384 64448864
Duodenal ulcer 28.44 12.87 43 46441 14392 64437856
Paratonia 28.19 12.87 6 46478 22 64452226
Urticaria 28.16 12.87 39 46445 147278 64304970
Abnormal dreams 28.12 12.87 36 46448 10320 64441928
Muscle contractions involuntary 27.60 12.87 21 46463 3196 64449052
Duodenal ulcer haemorrhage 27.39 12.87 28 46456 6297 64445951
Speech disorder 27.38 12.87 87 46397 48354 64403894
Cerebral infarction 27.23 12.87 78 46406 40966 64411282
Sialoadenitis 26.94 12.87 16 46468 1617 64450631
Chorea 26.39 12.87 17 46467 1983 64450265
Flight of ideas 26.36 12.87 12 46472 699 64451549
Hepatic enzyme increased 26.27 12.87 33 46451 129910 64322338
Potentiating drug interaction 25.70 12.87 30 46454 7822 64444426
Behaviour disorder 25.47 12.87 23 46461 4439 64447809
Upper gastrointestinal haemorrhage 25.41 12.87 69 46415 35151 64417097
Pressure of speech 25.31 12.87 13 46471 988 64451260
Neutrophil count decreased 25.25 12.87 12 46472 77184 64375064
Drop attacks 25.14 12.87 13 46471 1002 64451246
Lower respiratory tract infection 24.94 12.87 19 46465 94595 64357653
Daydreaming 24.86 12.87 12 46472 798 64451450
Hypersomnia 24.65 12.87 48 46436 19669 64432579
Neuropathy peripheral 24.65 12.87 29 46455 117496 64334752
Musculoskeletal pain 24.57 12.87 14 46470 81280 64370968
Multiple drug therapy 24.54 12.87 17 46467 2237 64450011
Arthritis 24.53 12.87 15 46469 83799 64368449
Chest discomfort 23.98 12.87 29 46455 116077 64336171
Pemphigus 23.93 12.87 7 46477 60694 64391554
Sedation 23.92 12.87 75 46409 41387 64410861
Impaired healing 23.80 12.87 7 46477 60466 64391782
Anaphylactic reaction 23.51 12.87 10 46474 68654 64383594
Sinoatrial block 23.45 12.87 13 46471 1153 64451095
Lack of spontaneous speech 23.42 12.87 8 46476 215 64452033
Amyloid related imaging abnormality-oedema/effusion 23.35 12.87 6 46478 57 64452191
Dysphagia 23.21 12.87 144 46340 106668 64345580
Incoherent 22.98 12.87 27 46457 7091 64445157
Cerebral haemorrhage 22.96 12.87 85 46399 51005 64401243
Adams-Stokes syndrome 22.88 12.87 7 46477 131 64452117
Intentional product use issue 22.86 12.87 21 46463 95343 64356905
Wrong patient received product 22.68 12.87 20 46464 3742 64448506
Bedridden 22.65 12.87 32 46452 10077 64442171
Melaena 22.34 12.87 87 46397 53461 64398787
Vomiting 22.05 12.87 536 45948 550581 63901667
Colitis microscopic 22.04 12.87 27 46457 7405 64444843
Sinus arrest 21.85 12.87 18 46466 3072 64449176
Anger 21.76 12.87 40 46444 15701 64436547
Irritability 21.69 12.87 67 46417 36679 64415569
Injection site erythema 21.67 12.87 12 46472 70788 64381460
Atrial tachycardia 21.62 12.87 19 46465 3540 64448708
Dysstasia 21.48 12.87 50 46434 23165 64429083
Product use in unapproved indication 21.47 12.87 61 46423 176557 64275691
Myalgia 21.40 12.87 52 46432 158565 64293683
Food refusal 21.14 12.87 9 46475 446 64451802
Product administration interrupted 21.02 12.87 12 46472 1126 64451122
Long QT syndrome 20.91 12.87 22 46462 5117 64447131
Hypernatraemia 20.81 12.87 34 46450 12155 64440093
Therapeutic product effect decreased 20.61 12.87 32 46452 115319 64336929
Gastric ulcer 20.59 12.87 58 46426 30176 64422072
Pemphigoid 20.53 12.87 35 46449 12951 64439297
Cold sweat 20.50 12.87 40 46444 16415 64435833
Fatigue 20.37 12.87 399 46085 748331 63703917
Erythema 20.33 12.87 68 46416 187002 64265246
Gait inability 20.32 12.87 72 46412 42296 64409952
Back pain 20.26 12.87 102 46382 250069 64202179
Product use issue 20.26 12.87 50 46434 151665 64300583
Pelvic fracture 20.15 12.87 31 46453 10532 64441716
Hypoaesthesia 20.05 12.87 44 46440 139064 64313184
Bone marrow failure 19.90 12.87 5 46479 47947 64404301
Gastrointestinal ulcer 19.86 12.87 17 46467 3058 64449190
Cholesteatoma 19.62 12.87 6 46478 112 64452136
Obsessive thoughts 19.53 12.87 11 46473 1006 64451242
Affect lability 19.47 12.87 28 46456 8962 64443286
Flushing 19.23 12.87 17 46467 78631 64373617
Injection site reaction 19.11 12.87 5 46479 46659 64405589
Fluid intake reduced 18.94 12.87 21 46463 5179 64447069
Suspiciousness 18.88 12.87 9 46475 582 64451666
Dyspepsia 18.87 12.87 18 46466 80294 64371954
Nasal congestion 18.42 12.87 10 46474 59648 64392600
Drug reaction with eosinophilia and systemic symptoms 18.40 12.87 8 46476 54209 64398039
Septic shock 18.13 12.87 30 46454 105407 64346841
Helicobacter infection 17.99 12.87 3 46481 38359 64413889
Product blister packaging issue 17.98 12.87 6 46478 150 64452098
Disease progression 17.91 12.87 48 46436 141632 64310616
Normal pressure hydrocephalus 17.77 12.87 8 46476 454 64451794
Skull fracture 17.67 12.87 12 46472 1529 64450719
Hangover 17.62 12.87 13 46471 1888 64450360
Dysarthria 17.52 12.87 87 46397 59319 64392929
Intention tremor 17.49 12.87 9 46475 687 64451561
Pain in jaw 17.40 12.87 4 46480 40751 64411497
Blood pressure decreased 17.36 12.87 114 46370 86085 64366163
Gastroenteritis pseudomonas 17.32 12.87 4 46480 23 64452225
Abdominal pain 17.30 12.87 143 46341 312232 64140016
Cerebrovascular accident 17.22 12.87 163 46321 137420 64314828
Gastric ulcer haemorrhage 17.10 12.87 25 46459 8118 64444130
Ventricular tachycardia 17.09 12.87 59 46425 34206 64418042
Brain compression 16.85 12.87 8 46476 513 64451735
Hyponatraemic syndrome 16.71 12.87 9 46475 754 64451494
Rapid eye movement sleep behaviour disorder 16.69 12.87 7 46477 334 64451914
Hiccups 16.57 12.87 25 46459 8351 64443897
Apraxia 16.53 12.87 14 46470 2481 64449767
Defect conduction intraventricular 16.33 12.87 7 46477 353 64451895
Grandiosity 16.23 12.87 8 46476 557 64451691
Bone pain 16.17 12.87 7 46477 47565 64404683
Abdominal discomfort 16.12 12.87 72 46412 182250 64269998
Herpes zoster 16.11 12.87 20 46464 79167 64373081
Head injury 15.91 12.87 56 46428 32786 64419462
Injection site swelling 15.88 12.87 5 46479 41348 64410900
Hypotension 15.65 12.87 372 46112 380602 64071646
Communication disorder 15.32 12.87 16 46468 3690 64448558
Atrioventricular block second degree 15.31 12.87 21 46463 6433 64445815
Heart rate increased 15.24 12.87 30 46454 98645 64353603
Senile dementia 15.24 12.87 6 46478 243 64452005
Lower gastrointestinal haemorrhage 15.13 12.87 32 46452 13907 64438341
Non-24-hour sleep-wake disorder 15.12 12.87 4 46480 43 64452205
Thalamus haemorrhage 14.85 12.87 11 46473 1608 64450640
Injection site bruising 14.70 12.87 4 46480 36369 64415879
Intercepted product dispensing error 14.65 12.87 5 46479 134 64452114
Foreign body 14.59 12.87 13 46471 2466 64449782
Haematoma 14.55 12.87 69 46415 46181 64406067
Fibromyalgia 14.31 12.87 4 46480 35727 64416521
Lymphadenopathy 14.16 12.87 8 46476 46678 64405570
Inflammation 13.81 12.87 16 46468 65284 64386964
Leukaemoid reaction 13.75 12.87 6 46478 316 64451932
Stress 13.72 12.87 14 46470 60520 64391728
Coma scale abnormal 13.70 12.87 22 46462 7752 64444496
Dyspnoea exertional 13.61 12.87 20 46464 73710 64378538
Aphasia 13.58 12.87 62 46422 40844 64411404
Hyponatraemia 13.55 12.87 165 46319 148174 64304074
Euphoric mood 13.50 12.87 20 46464 6571 64445677
Inappropriate antidiuretic hormone secretion 13.49 12.87 41 46443 22248 64430000
Psychotic disorder 13.47 12.87 55 46429 34523 64417725
Hypersexuality 13.45 12.87 10 46474 1469 64450779
Acute psychosis 13.41 12.87 15 46469 3737 64448511
Serotonin syndrome 13.39 12.87 60 46424 39222 64413026
Antisocial behaviour 13.34 12.87 7 46477 556 64451692
Lacunar infarction 13.12 12.87 18 46466 5514 64446734
Marasmus 13.01 12.87 8 46476 860 64451388
Decreased interest 12.99 12.87 14 46470 3346 64448902
Movement disorder 12.88 12.87 40 46444 21960 64430288

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC N06DA02 NERVOUS SYSTEM
PSYCHOANALEPTICS
ANTI-DEMENTIA DRUGS
Anticholinesterases
ATC N06DA52 NERVOUS SYSTEM
PSYCHOANALEPTICS
ANTI-DEMENTIA DRUGS
Anticholinesterases
ATC N06DA53 NERVOUS SYSTEM
PSYCHOANALEPTICS
ANTI-DEMENTIA DRUGS
Anticholinesterases
FDA MoA N0000000177 Cholinesterase Inhibitors
CHEBI has role CHEBI:38462 acetylcholinesterase inhibitors
MeSH PA D002491 Central Nervous System Agents
MeSH PA D018678 Cholinergic Agents
MeSH PA D002800 Cholinesterase Inhibitors
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D018697 Nootropic Agents
FDA EPC N0000175723 Cholinesterase Inhibitor
CHEBI has role CHEBI:37733 EC 3.1.1.8 inhibitor
CHEBI has role CHEBI:66980 intelligence enhancer

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Alzheimer's disease indication 26929004 DOID:10652
Moderate to Severe Alzheimer's Type Dementia indication
Diffuse Lewy body disease off-label use 80098002
Sick sinus syndrome contraindication 36083008 DOID:13884
Gastrointestinal ulcer contraindication 40845000
Sinus bradycardia contraindication 49710005
Gastrointestinal hemorrhage contraindication 74474003
Epilepsy contraindication 84757009 DOID:1826
Asthma contraindication 195967001 DOID:2841
Atrioventricular block contraindication 233917008 DOID:0050820
Bladder outflow obstruction contraindication 236645006
NSAID-Induced Gastric Ulcer contraindication
Chronic Obstructive Pulmonary Disease with Bronchospasms contraindication




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 8.4 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
10MG;14MG NAMZARIC ALLERGAN N206439 Dec. 23, 2014 RX CAPSULE, EXTENDED RELEASE ORAL 8173708 Nov. 22, 2025 MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMERS TYPE
10MG;14MG NAMZARIC ALLERGAN N206439 Dec. 23, 2014 RX CAPSULE, EXTENDED RELEASE ORAL 8283379 Nov. 22, 2025 MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMERS TYPE
10MG;14MG NAMZARIC ALLERGAN N206439 Dec. 23, 2014 RX CAPSULE, EXTENDED RELEASE ORAL 8338486 Nov. 22, 2025 MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMERS TYPE
10MG;14MG NAMZARIC ALLERGAN N206439 Dec. 23, 2014 RX CAPSULE, EXTENDED RELEASE ORAL 8362085 Nov. 22, 2025 MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMERS TYPE
10MG;14MG NAMZARIC ALLERGAN N206439 Dec. 23, 2014 RX CAPSULE, EXTENDED RELEASE ORAL 8580858 Nov. 22, 2025 MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMERS TYPE
10MG;21MG NAMZARIC ALLERGAN N206439 July 18, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 8173708 Nov. 22, 2025 MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMERS TYPE
10MG;21MG NAMZARIC ALLERGAN N206439 July 18, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 8283379 Nov. 22, 2025 MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMERS TYPE
10MG;21MG NAMZARIC ALLERGAN N206439 July 18, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 8338486 Nov. 22, 2025 MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMERS TYPE
10MG;21MG NAMZARIC ALLERGAN N206439 July 18, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 8362085 Nov. 22, 2025 MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMERS TYPE
10MG;21MG NAMZARIC ALLERGAN N206439 July 18, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 8580858 Nov. 22, 2025 MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMERS TYPE
10MG;28MG NAMZARIC ALLERGAN N206439 Dec. 23, 2014 RX CAPSULE, EXTENDED RELEASE ORAL 8173708 Nov. 22, 2025 MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMERS TYPE
10MG;28MG NAMZARIC ALLERGAN N206439 Dec. 23, 2014 RX CAPSULE, EXTENDED RELEASE ORAL 8283379 Nov. 22, 2025 MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMERS TYPE
10MG;28MG NAMZARIC ALLERGAN N206439 Dec. 23, 2014 RX CAPSULE, EXTENDED RELEASE ORAL 8338486 Nov. 22, 2025 MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMERS TYPE
10MG;28MG NAMZARIC ALLERGAN N206439 Dec. 23, 2014 RX CAPSULE, EXTENDED RELEASE ORAL 8362085 Nov. 22, 2025 MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMERS TYPE
10MG;28MG NAMZARIC ALLERGAN N206439 Dec. 23, 2014 RX CAPSULE, EXTENDED RELEASE ORAL 8580858 Nov. 22, 2025 MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMERS TYPE
10MG;7MG NAMZARIC ALLERGAN N206439 July 18, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 8173708 Nov. 22, 2025 MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMERS TYPE
10MG;7MG NAMZARIC ALLERGAN N206439 July 18, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 8283379 Nov. 22, 2025 MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMERS TYPE
10MG;7MG NAMZARIC ALLERGAN N206439 July 18, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 8338486 Nov. 22, 2025 MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMERS TYPE
10MG;7MG NAMZARIC ALLERGAN N206439 July 18, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 8362085 Nov. 22, 2025 MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMERS TYPE
10MG;7MG NAMZARIC ALLERGAN N206439 July 18, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 8580858 Nov. 22, 2025 MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMERS TYPE
10MG;14MG NAMZARIC ALLERGAN N206439 Dec. 23, 2014 RX CAPSULE, EXTENDED RELEASE ORAL 8039009 March 24, 2029 MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMERS TYPE
10MG;21MG NAMZARIC ALLERGAN N206439 July 18, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 8039009 March 24, 2029 MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMERS TYPE
10MG;28MG NAMZARIC ALLERGAN N206439 Dec. 23, 2014 RX CAPSULE, EXTENDED RELEASE ORAL 8039009 March 24, 2029 MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMERS TYPE
10MG;7MG NAMZARIC ALLERGAN N206439 July 18, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 8039009 March 24, 2029 MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMERS TYPE
10MG;14MG NAMZARIC ALLERGAN N206439 Dec. 23, 2014 RX CAPSULE, EXTENDED RELEASE ORAL 8058291 Dec. 5, 2029 MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMERS TYPE
10MG;21MG NAMZARIC ALLERGAN N206439 July 18, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 8058291 Dec. 5, 2029 MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMERS TYPE
10MG;28MG NAMZARIC ALLERGAN N206439 Dec. 23, 2014 RX CAPSULE, EXTENDED RELEASE ORAL 8058291 Dec. 5, 2029 MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMERS TYPE
10MG;7MG NAMZARIC ALLERGAN N206439 July 18, 2016 RX CAPSULE, EXTENDED RELEASE ORAL 8058291 Dec. 5, 2029 MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMERS TYPE
10MG/DAY ADLARITY CORIUM N212304 March 11, 2022 RX SYSTEM TRANSDERMAL 10016372 July 26, 2037 A METHOD OF TRANSDERMAL DELIVERY OF DONEPEZIL FOR TREATING MILD, MODERATE AND SEVERE DEMENTIA OF THE ALZHEIMERS TYPE
10MG/DAY ADLARITY CORIUM N212304 March 11, 2022 RX SYSTEM TRANSDERMAL 11103463 July 26, 2037 A METHOD OF TRANSDERMAL DELIVERY OF DONEPEZIL FOR TREATING MILD, MODERATE AND SEVERE DEMENTIA OF THE ALZHEIMERS TYPE
5MG/DAY ADLARITY CORIUM N212304 March 11, 2022 RX SYSTEM TRANSDERMAL 10016372 July 26, 2037 A METHOD OF TRANSDERMAL DELIVERY OF DONEPEZIL FOR TREATING MILD, MODERATE AND SEVERE DEMENTIA OF THE ALZHEIMERS TYPE
5MG/DAY ADLARITY CORIUM N212304 March 11, 2022 RX SYSTEM TRANSDERMAL 11103463 July 26, 2037 A METHOD OF TRANSDERMAL DELIVERY OF DONEPEZIL FOR TREATING MILD, MODERATE AND SEVERE DEMENTIA OF THE ALZHEIMERS TYPE
10MG/DAY ADLARITY CORIUM N212304 March 11, 2022 RX SYSTEM TRANSDERMAL 10835499 May 20, 2038 A METHOD OF TRANSDERMAL DELIVERY OF DONEPEZIL FOR TREATING MILD, MODERATE AND SEVERE DEMENTIA OF THE ALZHEIMERS TYPE
5MG/DAY ADLARITY CORIUM N212304 March 11, 2022 RX SYSTEM TRANSDERMAL 10835499 May 20, 2038 A METHOD OF TRANSDERMAL DELIVERY OF DONEPEZIL FOR TREATING MILD, MODERATE AND SEVERE DEMENTIA OF THE ALZHEIMERS TYPE
10MG/DAY ADLARITY CORIUM N212304 March 11, 2022 RX SYSTEM TRANSDERMAL 10966936 Aug. 11, 2038 A METHOD OF TRANSDERMAL DELIVERY OF DONEPEZIL FOR TREATING MILD, MODERATE AND SEVERE DEMENTIA OF THE ALZHEIMERS TYPE
5MG/DAY ADLARITY CORIUM N212304 March 11, 2022 RX SYSTEM TRANSDERMAL 10966936 Aug. 11, 2038 A METHOD OF TRANSDERMAL DELIVERY OF DONEPEZIL FOR TREATING MILD, MODERATE AND SEVERE DEMENTIA OF THE ALZHEIMERS TYPE

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Acetylcholinesterase Enzyme INHIBITOR Ki 7.80 WOMBAT-PK CHEMBL
Sigma non-opioid intracellular receptor 1 Membrane receptor Ki 7.84 CHEMBL
Potassium voltage-gated channel subfamily H member 2 Ion channel IC50 5.70 CHEMBL
Multidrug resistance protein 1 Transporter IC50 4.46 CHEMBL
Sodium-dependent serotonin transporter Transporter Ki 5.05 WOMBAT-PK
Amine oxidase [flavin-containing] B Enzyme IC50 4.82 CHEMBL
Cholinesterase Enzyme Ki 4.90 CHEMBL
Histamine H3 receptor GPCR IC50 6.46 CHEMBL
Beta-secretase 1 Enzyme IC50 5.49 CHEMBL
Acetylcholinesterase Enzyme IC50 8.24 CHEMBL
Acetylcholinesterase Enzyme IC50 8.24 CHEMBL
Butyrylcholinesterase; Protein Bche Enzyme IC50 5.56 CHEMBL
Acetylcholinesterase Enzyme IC50 8.77 CHEMBL
Acetylcholinesterase Enzyme Ki 7.25 CHEMBL
Acetylcholinesterase Enzyme Ki 8.54 CHEMBL
Amine oxidase [flavin-containing] B Enzyme IC50 4.82 CHEMBL
Cholinesterase Enzyme IC50 5.15 CHEMBL
Butyrylcholinesterase Enzyme Ki 6.19 CHEMBL
Sigma non-opioid intracellular receptor 1 Membrane other Ki 7.84 CHEMBL
Choline O-acetyltransferase Enzyme IC50 8.28 CHEMBL
Cholinesterase Enzyme IC50 6.08 CHEMBL

External reference:

IDSource
D00670 KEGG_DRUG
120011-70-3 SECONDARY_CAS_RN
135446 RXNORM
4021006 VANDF
4024045 VANDF
C0527316 UMLSCUI
CHEBI:53289 CHEBI
E20 PDB_CHEM_ID
CHEMBL502 ChEMBL_ID
CHEMBL1678 ChEMBL_ID
DB00843 DRUGBANK_ID
D000077265 MESH_DESCRIPTOR_UI
3152 PUBCHEM_CID
6599 IUPHAR_LIGAND_ID
7517 INN_ID
870555-76-3 SECONDARY_CAS_RN
8SSC91326P UNII
15004 MMSL
178540 MMSL
4631 MMSL
6432 MMSL
d04099 MMSL
006295 NDDF
006296 NDDF
108497001 SNOMEDCT_US
386855006 SNOMEDCT_US
386856007 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Donepezil Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0143-9747 TABLET, FILM COATED 5 mg ORAL ANDA 24 sections
Donepezil Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0143-9748 TABLET, FILM COATED 10 mg ORAL ANDA 24 sections
Namzaric HUMAN PRESCRIPTION DRUG LABEL 2 0456-1207 CAPSULE 10 mg ORAL NDA 31 sections
Namzaric HUMAN PRESCRIPTION DRUG LABEL 2 0456-1214 CAPSULE 10 mg ORAL NDA 31 sections
Namzaric HUMAN PRESCRIPTION DRUG LABEL 2 0456-1221 CAPSULE 10 mg ORAL NDA 31 sections
Namzaric HUMAN PRESCRIPTION DRUG LABEL 2 0456-1228 CAPSULE 10 mg ORAL NDA 31 sections
Donepezil Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-7951 TABLET, FILM COATED 5 mg ORAL ANDA 18 sections
Donepezil Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-7952 TABLET, FILM COATED 10 mg ORAL ANDA 18 sections
Donepezil Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-8313 TABLET, FILM COATED 10 mg ORAL ANDA 19 sections
Donepezil Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0781-5276 TABLET, ORALLY DISINTEGRATING 5 mg ORAL ANDA 26 sections
Donepezil Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0781-5277 TABLET, ORALLY DISINTEGRATING 10 mg ORAL ANDA 26 sections
Donepezil Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-6477 TABLET, FILM COATED 5 mg ORAL ANDA 24 sections
Donepezil Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-6478 TABLET, FILM COATED 10 mg ORAL ANDA 24 sections
Donepezil Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 13668-102 TABLET, FILM COATED 5 mg ORAL ANDA 25 sections
Donepezil Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 13668-103 TABLET, FILM COATED 10 mg ORAL ANDA 25 sections
Donepezil Hydrochloride Human Prescription Drug Label 1 16571-778 TABLET, FILM COATED 5 mg ORAL ANDA 26 sections
Donepezil Hydrochloride Human Prescription Drug Label 1 16571-779 TABLET, FILM COATED 10 mg ORAL ANDA 26 sections
DONEPEZIL HYDROCHLORIDE Human Prescription Drug Label 1 24724-028 TABLET, FILM COATED 5 mg ORAL ANDA 25 sections
DONEPEZIL HYDROCHLORIDE Human Prescription Drug Label 1 24724-029 TABLET, FILM COATED 10 mg ORAL ANDA 25 sections
Donepezil Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 24979-004 TABLET, FILM COATED 23 mg ORAL ANDA 16 sections
donepezil hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 29300-248 TABLET, FILM COATED 5 mg ORAL ANDA 23 sections
donepezil hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 29300-249 TABLET, FILM COATED 10 mg ORAL ANDA 23 sections
donepezil hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 29300-250 TABLET, ORALLY DISINTEGRATING 5 mg ORAL ANDA 23 sections
donepezil hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 29300-251 TABLET, ORALLY DISINTEGRATING 10 mg ORAL ANDA 23 sections
Donepezil hydrochloride Human Prescription Drug Label 1 31722-139 TABLET, FILM COATED 5 mg ORAL ANDA 25 sections
Donepezil hydrochloride Human Prescription Drug Label 1 31722-140 TABLET, FILM COATED 10 mg ORAL ANDA 25 sections
Donepezil Human Prescription Drug Label 1 31722-737 TABLET 5 mg ORAL ANDA 19 sections
Donepezil Human Prescription Drug Label 1 31722-738 TABLET 10 mg ORAL ANDA 19 sections
Donepezil Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 33261-817 TABLET, FILM COATED 10 mg ORAL ANDA 19 sections
Donepezil Hydrochloride Human Prescription Drug Label 1 33342-027 TABLET, FILM COATED 5 mg ORAL ANDA 18 sections