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
Dec. 23, 2022 PMDA Teikoku Seiyaku Co., Ltd.

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 631.23 13.55 427 33815 72800 63381980
Fall 469.91 13.55 792 33450 391542 63063238
Syncope 417.25 13.55 408 33834 116977 63337803
Dementia 311.41 13.55 167 34075 18627 63436153
Sinus bradycardia 286.01 13.55 145 34097 14406 63440374
Electrocardiogram QT prolonged 267.48 13.55 236 34006 59294 63395486
Drug interaction 237.44 13.55 435 33807 228696 63226084
Hallucination 210.42 13.55 199 34043 54618 63400162
Confusional state 195.25 13.55 408 33834 235972 63218808
Torsade de pointes 194.52 13.55 109 34133 13242 63441538
Aggression 180.87 13.55 128 34114 23370 63431410
Agitation 179.68 13.55 190 34052 59567 63395213
Delusion 153.36 13.55 90 34152 11927 63442853
Cognitive disorder 152.96 13.55 169 34073 55646 63399134
Parkinsonism 151.46 13.55 85 34157 10354 63444426
Neuroleptic malignant syndrome 142.66 13.55 86 34156 11970 63442810
Abnormal behaviour 131.81 13.55 102 34140 21324 63433456
Delirium 129.86 13.55 148 34094 50393 63404387
Drug ineffective 127.23 13.55 232 34010 1044533 62410247
Seizure 124.90 13.55 242 34000 132392 63322388
Pleurothotonus 117.03 13.55 39 34203 1310 63453470
Sinus node dysfunction 113.92 13.55 54 34188 4631 63450149
Muscle rigidity 110.79 13.55 72 34170 11428 63443352
Somnolence 110.19 13.55 275 33967 178410 63276370
Atrioventricular block first degree 107.62 13.55 60 34182 7213 63447567
Hallucination, visual 106.10 13.55 86 34156 19212 63435568
Pain 105.44 13.55 148 34094 740480 62714300
Arthralgia 105.00 13.55 92 34150 569618 62885162
Urinary retention 101.23 13.55 102 34140 30199 63424581
Hypersensitivity 101.06 13.55 18 34224 292667 63162113
Tremor 99.46 13.55 220 34022 132019 63322761
Altered state of consciousness 97.53 13.55 92 34150 25138 63429642
Amyloid related imaging abnormality-oedema/effusion 96.93 13.55 22 34220 162 63454618
Extrapyramidal disorder 94.50 13.55 69 34173 13215 63441565
Joint swelling 93.84 13.55 30 34212 327636 63127144
Systemic lupus erythematosus 92.27 13.55 5 34237 208913 63245867
Cholinergic syndrome 92.16 13.55 26 34216 492 63454288
Loss of consciousness 91.64 13.55 199 34043 117922 63336858
Femoral neck fracture 91.15 13.55 57 34185 8466 63446314
Rash 88.04 13.55 104 34138 560767 62894013
Infusion related reaction 87.17 13.55 14 34228 245507 63209273
Dehydration 85.82 13.55 246 33996 173108 63281672
Arthropathy 84.23 13.55 13 34229 234779 63220001
Electrocardiogram PR prolongation 83.56 13.55 26 34216 698 63454082
Decreased appetite 81.80 13.55 309 33933 250743 63204037
Myoclonus 81.55 13.55 68 34174 15800 63438980
Alopecia 80.22 13.55 41 34201 337495 63117285
Rheumatoid arthritis 78.63 13.55 20 34222 253799 63200981
Hypokalaemia 78.37 13.55 173 34069 103631 63351149
Depressed level of consciousness 77.27 13.55 128 34114 61950 63392830
Glossodynia 76.80 13.55 5 34237 178871 63275909
Pemphigus 76.39 13.55 6 34236 183720 63271060
Drug intolerance 75.60 13.55 36 34206 308625 63146155
Torticollis 74.97 13.55 31 34211 1918 63452862
Swelling 74.02 13.55 28 34214 275350 63179430
Hypothermia 73.55 13.55 60 34182 13521 63441259
Lethargy 73.11 13.55 118 34124 55889 63398891
Nightmare 72.29 13.55 69 34173 19125 63435655
Sinusitis 71.87 13.55 17 34225 226636 63228144
Dementia Alzheimer's type 70.03 13.55 25 34217 1035 63453745
Treatment failure 69.19 13.55 12 34230 199031 63255749
Mania 67.74 13.55 55 34187 12312 63442468
Immobile 66.73 13.55 41 34201 5902 63448878
Hypophagia 66.22 13.55 83 34159 31176 63423604
Mental status changes 63.79 13.55 92 34150 39507 63415273
Urinary incontinence 63.08 13.55 82 34160 31932 63422848
Urinary tract infection 60.77 13.55 293 33949 264391 63190389
Pericarditis 58.54 13.55 3 34239 131576 63323204
Disorientation 58.27 13.55 88 34154 39364 63415416
Therapeutic product effect decreased 56.48 13.55 17 34225 193170 63261610
Dyskinesia 55.46 13.55 77 34165 31925 63422855
Drug hypersensitivity 54.91 13.55 52 34190 310635 63144145
Atrioventricular block complete 54.52 13.55 41 34201 8210 63446570
Restlessness 54.26 13.55 73 34169 29380 63425400
Sudden death 54.15 13.55 45 34197 10404 63444376
Hyponatraemia 52.63 13.55 156 34086 111744 63343036
Unresponsive to stimuli 52.19 13.55 77 34165 33739 63421041
Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits 51.15 13.55 11 34231 61 63454719
Gastrointestinal haemorrhage 51.07 13.55 126 34116 81050 63373730
Cerebral infarction 49.90 13.55 63 34179 23830 63430950
Wandering pacemaker 49.66 13.55 8 34234 3 63454777
Reduced facial expression 48.84 13.55 23 34219 1943 63452837
Medication error 48.65 13.55 95 34147 52189 63402591
Abdominal discomfort 48.64 13.55 61 34181 320824 63133956
Lower respiratory tract infection 48.17 13.55 7 34235 132300 63322480
Dizziness 47.14 13.55 394 33848 429531 63025249
Anal incontinence 45.88 13.55 46 34196 13530 63441250
Encephalopathy 45.86 13.55 78 34164 38542 63416238
Apathy 45.83 13.55 38 34204 8756 63446024
Off label use 45.13 13.55 199 34043 674263 62780517
Sexually inappropriate behaviour 45.02 13.55 11 34231 115 63454665
Hypocapnia 44.95 13.55 14 34228 377 63454403
Circulatory collapse 44.48 13.55 57 34185 21881 63432899
Pain in extremity 44.27 13.55 69 34173 331417 63123363
Pneumonia aspiration 44.01 13.55 72 34170 34468 63420312
Hypotension 43.83 13.55 274 33968 272330 63182450
Psychomotor hyperactivity 43.35 13.55 40 34202 10623 63444157
Hip fracture 42.47 13.55 65 34177 29409 63425371
Cerebral atrophy 42.25 13.55 29 34213 5037 63449743
Infection 42.08 13.55 37 34205 229136 63225644
Pruritus 41.26 13.55 83 34159 361370 63093410
Listless 40.70 13.55 23 34219 2837 63451943
Hepatic enzyme increased 40.48 13.55 30 34212 202298 63252482
Death 40.42 13.55 342 33900 374039 63080741
Wound 39.99 13.55 19 34223 163244 63291536
Fracture 39.89 13.55 51 34191 19533 63435247
Febrile neutropenia 39.31 13.55 8 34234 118441 63336339
Generalised tonic-clonic seizure 39.04 13.55 62 34180 28954 63425826
Miosis 38.80 13.55 32 34210 7321 63447459
Dementia with Lewy bodies 38.43 13.55 12 34230 326 63454454
Weight increased 38.03 13.55 51 34191 260741 63194039
Psoriatic arthropathy 37.99 13.55 3 34239 91517 63363263
Accidental overdose 37.31 13.55 54 34188 23255 63431525
Tardive dyskinesia 36.73 13.55 33 34209 8469 63446311
Epilepsy 36.64 13.55 58 34184 27007 63427773
Gait disturbance 36.52 13.55 195 34047 182983 63271797
Rhabdomyolysis 36.29 13.55 76 34166 43875 63410905
Stomatitis 35.77 13.55 15 34227 138710 63316070
Neuropsychiatric symptoms 35.62 13.55 14 34228 759 63454021
Dysarthria 35.43 13.55 74 34168 42637 63412143
Long QT syndrome 35.24 13.55 22 34220 3257 63451523
Nasopharyngitis 34.81 13.55 52 34190 254205 63200575
Atrial fibrillation 34.19 13.55 139 34103 116497 63338283
Impaired healing 33.87 13.55 7 34235 102535 63352245
Sialoadenitis 33.83 13.55 17 34225 1655 63453125
Atrioventricular block 33.66 13.55 30 34212 7617 63447163
Irritable bowel syndrome 33.39 13.55 3 34239 82409 63372371
Incontinence 33.19 13.55 36 34206 11596 63443184
Intentional product use issue 32.70 13.55 14 34228 127878 63326902
Lack of spontaneous speech 32.43 13.55 9 34233 160 63454620
Hypoglycaemia 32.38 13.55 88 34154 59977 63394803
Discomfort 31.97 13.55 26 34216 167348 63287432
Cerebrovascular accident 31.87 13.55 129 34113 107895 63346885
Headache 31.66 13.55 206 34036 633035 62821745
Dropped head syndrome 31.43 13.55 9 34233 180 63454600
Pelvic fracture 30.78 13.55 37 34205 13311 63441469
Fatigue 30.68 13.55 319 33923 887709 62567071
Upper gastrointestinal haemorrhage 30.64 13.55 44 34198 18808 63435972
Neuroglycopenia 30.55 13.55 11 34231 467 63454313
Therapeutic product effect incomplete 29.94 13.55 15 34227 125041 63329739
Paratonia 29.92 13.55 6 34236 22 63454758
Wrong patient received product 29.40 13.55 17 34225 2190 63452590
Peripheral circulatory failure 29.32 13.55 13 34229 955 63453825
Product use issue 29.32 13.55 46 34196 220474 63234306
Speech disorder 28.71 13.55 66 34176 40563 63414217
Cough 28.68 13.55 73 34169 292670 63162110
Sinus arrest 28.62 13.55 16 34226 1933 63452847
Posture abnormal 28.53 13.55 17 34225 2315 63452465
Sedation 28.49 13.55 64 34178 38745 63416035
Fluid intake reduced 28.39 13.55 20 34222 3621 63451159
Hypernatraemia 27.98 13.55 27 34215 7582 63447198
Stupor 27.70 13.55 21 34221 4254 63450526
Fibromyalgia 27.59 13.55 5 34237 80415 63374365
Cerebral haemorrhage 27.57 13.55 55 34187 30674 63424106
Orthostatic hypotension 26.96 13.55 60 34182 36100 63418680
Anger 26.26 13.55 33 34209 12423 63442357
Bedridden 26.09 13.55 31 34211 11020 63443760
Foreign body 25.92 13.55 16 34226 2322 63452458
Liver function test abnormal 25.38 13.55 70 34172 48111 63406669
Suspiciousness 25.27 13.55 9 34233 370 63454410
Dyspnoea 25.12 13.55 232 34010 661081 62793699
Motor dysfunction 25.09 13.55 30 34212 10731 63444049
Bradykinesia 24.13 13.55 21 34221 5167 63449613
Salivary hypersecretion 24.13 13.55 25 34217 7641 63447139
Vomiting 23.91 13.55 429 33813 559188 62895592
Multiple drug therapy 23.83 13.55 18 34224 3628 63451152
Memory impairment 23.56 13.55 115 34127 104143 63350637
Atrial tachycardia 23.52 13.55 19 34223 4221 63450559
Colitis microscopic 23.38 13.55 27 34215 9312 63445468
Grandiosity 23.37 13.55 8 34234 292 63454488
Melaena 23.33 13.55 51 34191 30314 63424466
Peripheral swelling 23.30 13.55 70 34172 265872 63188908
Prescription drug used without a prescription 23.13 13.55 15 34227 2371 63452409
Hyperhidrosis 22.99 13.55 117 34125 107719 63347061
Chorea 22.95 13.55 13 34229 1611 63453169
Urticaria 22.59 13.55 34 34208 165768 63289012
Hypersexuality 22.47 13.55 9 34233 513 63454267
Social avoidant behaviour 22.34 13.55 16 34226 2972 63451808
Arthritis 22.14 13.55 18 34224 115903 63338877
Pyrexia 22.00 13.55 156 34086 470322 62984458
Hyponatraemic syndrome 21.93 13.55 9 34233 546 63454234
Muscle contracture 21.86 13.55 12 34230 1399 63453381
Skull fracture 21.76 13.55 11 34231 1084 63453696
Food refusal 21.63 13.55 8 34234 367 63454413
Duodenal ulcer perforation 21.57 13.55 10 34232 87199 63367581
Psoriasis 21.47 13.55 10 34232 86947 63367833
Blood cholesterol increased 21.44 13.55 12 34230 94020 63360760
Non-24-hour sleep-wake disorder 21.39 13.55 4 34238 9 63454771
Hyperkalaemia 21.26 13.55 71 34171 54132 63400648
Herbal interaction 21.14 13.55 6 34236 116 63454664
Initial insomnia 21.06 13.55 21 34221 6136 63448644
Brain compression 20.93 13.55 8 34234 402 63454378
Sinoatrial block 20.87 13.55 10 34232 878 63453902
Ill-defined disorder 20.81 13.55 9 34233 81746 63373034
Abnormal dreams 20.81 13.55 27 34215 10489 63444291
Drug level increased 20.76 13.55 41 34201 22695 63432085
Drooling 20.75 13.55 17 34225 3851 63450929
Parkinson's disease 20.65 13.55 11 34231 1208 63453572
Incoherent 20.39 13.55 18 34224 4512 63450268
Adams-Stokes syndrome 20.32 13.55 5 34237 54 63454726
Oropharyngeal pain 20.22 13.55 13 34229 94474 63360306
Supraventricular extrasystoles 20.19 13.55 18 34224 4571 63450209
Haematemesis 19.96 13.55 48 34194 30364 63424416
Chest discomfort 19.87 13.55 18 34224 109951 63344829
Overconfidence 19.58 13.55 3 34239 0 63454780
Affect lability 19.57 13.55 27 34215 11124 63443656
Dysphagia 19.50 13.55 97 34145 88488 63366292
Inflammation 19.49 13.55 10 34232 82263 63372517
Blood pressure decreased 19.45 13.55 78 34164 64944 63389836
Cholesteatoma 19.39 13.55 6 34236 158 63454622
Blister 19.30 13.55 25 34217 129789 63324991
Gastric ulcer 19.18 13.55 41 34201 23996 63430784
Anaphylactic reaction 18.97 13.55 6 34236 66094 63388686
Hypoaesthesia 18.89 13.55 39 34203 168354 63286426
Leukaemoid reaction 18.74 13.55 6 34236 177 63454603
Aphasia 18.44 13.55 49 34193 32951 63421829
Psychotic disorder 18.42 13.55 42 34200 25670 63429110
Executive dysfunction 18.31 13.55 6 34236 191 63454589
Emotional poverty 18.31 13.55 7 34235 352 63454428
Blood pressure orthostatic decreased 18.22 13.55 5 34237 85 63454695
Obsessive thoughts 18.10 13.55 8 34234 583 63454197
Hypertonia 18.09 13.55 17 34225 4620 63450160
Anorgasmia 17.95 13.55 8 34234 595 63454185
Paraesthesia 17.91 13.55 36 34206 156930 63297850
Haematoma 17.76 13.55 50 34192 34770 63420010
Head injury 17.72 13.55 43 34199 27353 63427427
Antisocial behaviour 17.42 13.55 7 34235 402 63454378
Injection site pain 17.31 13.55 27 34215 129773 63325007
Paranoia 17.17 13.55 26 34216 11653 63443127
Intercepted product dispensing error 17.14 13.55 5 34237 107 63454673
Subdural haematoma 17.09 13.55 29 34213 14299 63440481
Ventricular tachycardia 17.02 13.55 35 34207 19944 63434836
Drop attacks 17.01 13.55 8 34234 674 63454106
Dyspepsia 16.99 13.55 18 34224 102178 63352602
Pressure of speech 16.53 13.55 8 34234 718 63454062
Use of accessory respiratory muscles 16.44 13.55 6 34236 265 63454515
Myalgia 16.38 13.55 34 34208 146495 63308285
Blood glucose fluctuation 16.38 13.55 16 34226 4560 63450220
Heart rate increased 16.35 13.55 16 34226 94222 63360558
Labelled drug-drug interaction issue 16.06 13.55 9 34233 1092 63453688
Hepatic function abnormal 15.78 13.55 50 34192 37092 63417688
Duodenal ulcer haemorrhage 15.72 13.55 12 34230 2455 63452325
Overdose 15.63 13.55 111 34131 114967 63339813
Musculoskeletal pain 15.63 13.55 16 34226 92261 63362519
Communication disorder 15.58 13.55 12 34230 2488 63452292
Normal pressure hydrocephalus 15.58 13.55 6 34236 308 63454472
Nasal congestion 15.52 13.55 8 34234 65652 63389128
Acute abdomen 15.52 13.55 10 34232 1563 63453217
Gastric ulcer haemorrhage 15.44 13.55 16 34226 4892 63449888
Product dispensing error 15.23 13.55 23 34219 10282 63444498
Lower gastrointestinal haemorrhage 15.21 13.55 20 34222 7870 63446910
Potentiating drug interaction 15.16 13.55 15 34227 4341 63450439
Neurodegenerative disorder 15.03 13.55 6 34236 339 63454441
Progressive supranuclear palsy 14.92 13.55 4 34238 62 63454718
Opisthotonus 14.84 13.55 6 34236 350 63454430
Inappropriate affect 14.79 13.55 8 34234 906 63453874
Pemphigoid 14.76 13.55 19 34223 7325 63447455
Ataxia 14.60 13.55 28 34214 15167 63439613
Blood urea increased 14.56 13.55 39 34203 26340 63428440
Osteoarthritis 14.54 13.55 18 34224 95325 63359455
Cardiac failure 14.53 13.55 90 34152 89052 63365728
Libido increased 14.39 13.55 9 34233 1336 63453444
Product use in unapproved indication 14.37 13.55 49 34193 179031 63275749
Gastric polyps 14.28 13.55 13 34229 3392 63451388
Disease progression 14.13 13.55 28 34214 122730 63332050
Arrhythmia 14.11 13.55 49 34193 38091 63416689
Theft 14.06 13.55 4 34238 78 63454702
Heat illness 13.98 13.55 5 34237 208 63454572
Neutropenia 13.96 13.55 48 34194 174957 63279823
Asthma 13.92 13.55 30 34212 127531 63327249
Visuospatial deficit 13.90 13.55 3 34239 17 63454763
Delusional disorder, persecutory type 13.78 13.55 5 34237 217 63454563
Thalamus haemorrhage 13.73 13.55 7 34235 702 63454078
Product blister packaging issue 13.69 13.55 5 34237 221 63454559
Poriomania 13.61 13.55 4 34238 88 63454692

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 366.76 14.34 295 23783 51203 34881650
Fall 345.45 14.34 549 23529 202336 34730517
Dementia 310.81 14.34 163 23915 13585 34919268
Bradycardia 307.95 14.34 316 23762 75102 34857751
Confusional state 304.79 14.34 432 23646 143728 34789125
Delusion 177.97 14.34 110 23968 12525 34920328
Pleurothotonus 164.04 14.34 52 24026 1153 34931700
Agitation 159.43 14.34 197 23881 57202 34875651
Delirium 143.62 14.34 164 23914 43827 34889026
Cognitive disorder 136.79 14.34 131 23947 28562 34904291
Cholinergic syndrome 130.54 14.34 37 24041 550 34932303
Aggression 130.13 14.34 147 23931 38817 34894036
Abnormal behaviour 124.74 14.34 117 23961 24852 34908001
Neuroleptic malignant syndrome 91.41 14.34 85 23993 17849 34915004
Mania 90.78 14.34 65 24013 9446 34923407
Depressed level of consciousness 89.53 14.34 128 23950 42713 34890140
Urinary incontinence 87.71 14.34 85 23993 18789 34914064
Sinus bradycardia 85.22 14.34 71 24007 12892 34919961
Hallucination, visual 84.33 14.34 81 23997 17710 34915143
Somnolence 81.94 14.34 213 23865 110903 34821950
Syncope 79.79 14.34 187 23891 91264 34841589
Amyloid related imaging abnormality-oedema/effusion 74.42 14.34 20 24058 241 34932612
Anal incontinence 71.16 14.34 52 24026 7797 34925056
Sinus node dysfunction 70.19 14.34 41 24037 4208 34928645
Balance disorder 65.92 14.34 108 23970 40546 34892307
Febrile neutropenia 59.78 14.34 11 24067 136838 34796015
Gait disturbance 58.44 14.34 159 23919 84981 34847872
Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits 56.98 14.34 15 24063 166 34932687
Blood cholinesterase decreased 54.56 14.34 14 24064 139 34932714
Nightmare 54.43 14.34 58 24020 14333 34918520
Loss of consciousness 54.37 14.34 152 23926 82515 34850338
Orthostatic hypotension 53.47 14.34 77 24001 25842 34907011
Death 52.94 14.34 460 23618 397589 34535264
Memory impairment 50.88 14.34 100 23978 43218 34889635
Pneumonia aspiration 45.94 14.34 94 23984 41809 34891044
Unresponsive to stimuli 45.71 14.34 74 24004 27495 34905358
Poriomania 44.88 14.34 11 24067 89 34932764
Prescribed underdose 44.85 14.34 42 24036 8891 34923962
Parkinsonism 44.24 14.34 40 24038 8098 34924755
Product prescribing issue 44.04 14.34 24 24054 2155 34930698
Disorientation 43.14 14.34 80 23998 33108 34899745
Tremor 41.32 14.34 138 23940 82449 34850404
Libido increased 40.84 14.34 17 24061 834 34932019
Intestinal haemorrhage 40.68 14.34 27 24051 3469 34929384
Blood glucose fluctuation 39.42 14.34 28 24050 4016 34928837
Neutropenia 38.42 14.34 31 24047 156747 34776106
Dyskinesia 38.30 14.34 61 24017 22352 34910501
Arthralgia 37.62 14.34 37 24041 170004 34762849
Dementia with Lewy bodies 36.74 14.34 15 24063 700 34932153
Salivary hypersecretion 36.57 14.34 37 24041 8607 34924246
Hyperhidrosis 36.55 14.34 125 23953 75567 34857286
Bradyarrhythmia 35.81 14.34 21 24057 2170 34930683
Drug abuse 33.76 14.34 13 24065 99083 34833770
Hypersomnia 33.44 14.34 42 24036 12365 34920488
Dementia Alzheimer's type 33.33 14.34 12 24066 396 34932457
Automatism 32.93 14.34 9 24069 116 34932737
Paranoia 32.76 14.34 41 24037 12027 34920826
Serotonin syndrome 32.35 14.34 53 24025 19880 34912973
Muscle rigidity 32.24 14.34 38 24040 10480 34922373
Myoclonus 32.22 14.34 45 24033 14680 34918173
Psychomotor hyperactivity 31.57 14.34 36 24042 9586 34923267
Drug interaction 30.86 14.34 263 23815 225683 34707170
Rhabdomyolysis 30.69 14.34 110 23968 68053 34864800
Extrapyramidal disorder 30.65 14.34 41 24037 12839 34920014
Dizziness 30.18 14.34 255 23823 218266 34714587
Drooling 29.74 14.34 22 24056 3360 34929493
Jealous delusion 28.59 14.34 10 24068 303 34932550
Altered state of consciousness 28.27 14.34 54 24024 22839 34910014
Blood glucose abnormal 28.00 14.34 27 24051 5925 34926928
Electrocardiogram QT prolonged 27.58 14.34 76 24002 40876 34891977
Sexually inappropriate behaviour 27.20 14.34 11 24067 501 34932352
Nonspecific reaction 27.03 14.34 15 24063 1396 34931457
Dehydration 26.77 14.34 167 23911 129802 34803051
Flight of ideas 26.77 14.34 10 24068 367 34932486
Duodenal ulcer 26.31 14.34 34 24044 10298 34922555
Contusion 26.01 14.34 69 24009 36295 34896558
Muscle contractions involuntary 25.72 14.34 16 24062 1840 34931013
Restlessness 25.40 14.34 55 24023 25427 34907426
Dyspnoea 25.39 14.34 154 23924 376628 34556225
Eosinophilic pneumonia chronic 25.32 14.34 9 24069 286 34932567
Gastrointestinal haemorrhage 25.11 14.34 124 23954 88353 34844500
Seizure 24.98 14.34 140 23938 104717 34828136
Lethargy 24.48 14.34 73 24005 41049 34891804
Chorea 24.31 14.34 13 24065 1124 34931729
Pain 24.25 14.34 67 24011 204608 34728245
Atrioventricular block complete 24.25 14.34 31 24047 9288 34923565
Hypothermia 23.74 14.34 33 24045 10715 34922138
Miosis 23.69 14.34 31 24047 9504 34923349
Athetosis 23.53 14.34 6 24072 58 34932795
Dysstasia 23.36 14.34 35 24043 12160 34920693
Daydreaming 22.94 14.34 10 24068 550 34932303
Thrombocytopenia 22.60 14.34 46 24032 156201 34776652
Subdural haematoma 22.59 14.34 46 24032 20375 34912478
Cold sweat 22.56 14.34 31 24047 9956 34922897
Hip fracture 22.53 14.34 34 24044 11891 34920962
Hangover 22.42 14.34 12 24066 1039 34931814
Pruritus 22.11 14.34 40 24038 141941 34790912
Atrioventricular block first degree 22.06 14.34 24 24054 6068 34926785
Gastrointestinal ulcer 21.83 14.34 14 24064 1697 34931156
Femoral neck fracture 21.49 14.34 18 24060 3289 34929564
Atrioventricular block 21.26 14.34 27 24051 8036 34924817
Neuropathy peripheral 20.96 14.34 16 24062 83247 34849606
Inappropriate antidiuretic hormone secretion 20.81 14.34 34 24044 12719 34920134
Behaviour disorder 20.74 14.34 21 24057 4889 34927964
Accidental overdose 20.68 14.34 44 24034 20096 34912757
Neutrophil count decreased 20.46 14.34 5 24073 51099 34881754
Multiple organ dysfunction syndrome 20.20 14.34 14 24064 76552 34856301
Infusion related reaction 19.72 14.34 6 24072 53051 34879802
Skin swelling 19.50 14.34 12 24066 1353 34931500
Mental status changes 19.35 14.34 64 24014 38019 34894834
Executive dysfunction 19.33 14.34 7 24071 235 34932618
Septic shock 19.13 14.34 13 24065 71821 34861032
Potentiating drug interaction 18.71 14.34 20 24058 4957 34927896
Gait inability 18.66 14.34 43 24035 20715 34912138
Speech disorder 18.63 14.34 49 24029 25637 34907216
Intention tremor 18.61 14.34 8 24070 425 34932428
Malignant neoplasm progression 18.49 14.34 20 24058 88026 34844827
Decreased appetite 18.30 14.34 185 23893 166207 34766646
Multiple drug therapy 18.13 14.34 8 24070 453 34932400
Underdose 17.63 14.34 33 24045 13747 34919106
Pyrexia 17.57 14.34 146 23932 332867 34599986
Psoriasis 17.18 14.34 3 24075 38809 34894044
Irritability 16.80 14.34 46 24032 24644 34908209
Urinary tract infection 16.65 14.34 107 23971 83974 34848879
Hiccups 16.62 14.34 27 24051 10055 34922798
Paraesthesia 16.58 14.34 12 24066 64160 34868693
Foaming at mouth 16.44 14.34 9 24069 815 34932038
Defect conduction intraventricular 16.41 14.34 7 24071 365 34932488
Abdominal pain 16.23 14.34 58 24020 163560 34769293
Circulatory collapse 16.15 14.34 41 24037 20997 34911856
Incontinence 16.09 14.34 20 24058 5827 34927026
Leukopenia 15.92 14.34 12 24066 62844 34870009
Stomatitis 15.46 14.34 5 24073 42509 34890344
Paradoxical drug reaction 15.39 14.34 15 24063 3336 34929517
Sudden death 15.36 14.34 33 24045 15168 34917685
Abnormal dreams 14.88 14.34 22 24056 7556 34925297
Chest pain 14.62 14.34 42 24036 126720 34806133
Gastroenteritis pseudomonas 14.61 14.34 4 24074 52 34932801
Impulsive behaviour 14.53 14.34 12 24066 2150 34930703
Urticaria 14.44 14.34 13 24065 62364 34870489

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 875.75 13.19 707 49603 134850 79559228
Fall 694.55 13.19 1160 49150 486469 79207609
Dementia 499.67 13.19 264 50046 24395 79669683
Hallucination 429.69 13.19 387 49923 85358 79608720
Syncope 426.55 13.19 545 49765 178904 79515174
Confusional state 390.55 13.19 710 49600 317287 79376791
Sinus bradycardia 335.04 13.19 205 50105 25042 79669036
Agitation 288.91 13.19 335 49975 99380 79594698
Aggression 277.06 13.19 241 50069 50717 79643361
Delusion 268.85 13.19 165 50145 20258 79673820
Delirium 259.81 13.19 293 50017 84334 79609744
Pleurothotonus 259.00 13.19 86 50224 2430 79691648
Electrocardiogram QT prolonged 247.42 13.19 295 50015 90091 79603987
Cognitive disorder 228.20 13.19 250 50060 69676 79624402
Cholinergic syndrome 213.50 13.19 61 50249 1026 79693052
Neuroleptic malignant syndrome 203.87 13.19 156 50154 27403 79666675
Abnormal behaviour 203.50 13.19 175 50135 36246 79657832
Drug interaction 191.53 13.19 636 49674 414547 79279531
Sinus node dysfunction 171.83 13.19 88 50222 7613 79686465
Parkinsonism 168.85 13.19 114 50196 16470 79677608
Somnolence 155.65 13.19 414 49896 238567 79455511
Amyloid related imaging abnormality-oedema/effusion 155.32 13.19 39 50271 388 79693690
Torsade de pointes 148.74 13.19 112 50198 19200 79674878
Mania 143.09 13.19 107 50203 18153 79675925
Depressed level of consciousness 139.28 13.19 232 50078 96420 79597658
Hallucination, visual 137.38 13.19 134 50176 32595 79661483
Muscle rigidity 128.61 13.19 104 50206 19778 79674300
Arthralgia 128.05 13.19 104 50206 571699 79122379
Loss of consciousness 125.96 13.19 307 50003 167636 79526442
Urinary incontinence 124.36 13.19 141 50169 40768 79653310
Seizure 121.73 13.19 326 49984 188508 79505570
Myoclonus 115.63 13.19 113 50197 27547 79666531
Anal incontinence 113.23 13.19 93 50217 18075 79676003
Pain 111.56 13.19 170 50140 703632 78990446
Nightmare 108.76 13.19 106 50204 25755 79668323
Atrioventricular block first degree 108.73 13.19 78 50232 12413 79681665
Femoral neck fracture 104.91 13.19 70 50240 9914 79684164
Tremor 102.00 13.19 286 50024 169797 79524281
Drug ineffective 99.59 13.19 350 49960 1080563 78613515
Extrapyramidal disorder 99.21 13.19 95 50215 22584 79671494
Death 98.24 13.19 652 49658 565862 79128216
Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits 94.78 13.19 23 50287 196 79693882
Dehydration 93.38 13.19 356 49954 247831 79446247
Infusion related reaction 89.83 13.19 18 50292 230219 79463859
Joint swelling 89.60 13.19 35 50275 288611 79405467
Disorientation 89.48 13.19 150 50160 62626 79631452
Febrile neutropenia 88.19 13.19 19 50291 230980 79463098
Hypothermia 87.82 13.19 89 50221 22657 79671421
Altered state of consciousness 86.85 13.19 122 50188 43700 79650378
Lethargy 82.76 13.19 168 50142 81124 79612954
Unresponsive to stimuli 79.10 13.19 133 50177 55655 79638423
Dyskinesia 79.03 13.19 118 50192 44655 79649423
Gait disturbance 78.31 13.19 298 50012 207208 79486870
Decreased appetite 75.68 13.19 420 49890 341998 79352080
Pneumonia aspiration 74.93 13.19 144 50166 66823 79627255
Electrocardiogram PR prolongation 73.08 13.19 30 50280 1553 79692525
Mental status changes 72.50 13.19 142 50168 66817 79627261
Hypersensitivity 71.71 13.19 38 50272 262201 79431877
Arthropathy 68.75 13.19 14 50296 177097 79516981
Rheumatoid arthritis 68.53 13.19 23 50287 208447 79485631
Atrioventricular block complete 67.82 13.19 67 50243 16543 79677535
Restlessness 67.46 13.19 112 50198 46380 79647698
Orthostatic hypotension 66.84 13.19 124 50186 56040 79638038
Dizziness 65.73 13.19 561 49749 525880 79168198
Sexually inappropriate behaviour 65.70 13.19 21 50289 524 79693554
Rash 65.42 13.19 170 50140 578188 79115890
Sinusitis 65.27 13.19 21 50289 195480 79498598
Psychomotor hyperactivity 65.18 13.19 66 50244 16783 79677295
Dementia with Lewy bodies 64.10 13.19 23 50287 823 79693255
Dementia Alzheimer's type 63.53 13.19 24 50286 995 79693083
Drug hypersensitivity 62.37 13.19 58 50252 298858 79395220
Immobile 61.74 13.19 44 50266 6929 79687149
Swelling 61.33 13.19 30 50280 216681 79477397
Sudden death 60.74 13.19 73 50237 22438 79671640
Hyperhidrosis 59.99 13.19 221 50089 151271 79542807
Pruritus 59.83 13.19 98 50212 394550 79299528
Circulatory collapse 59.07 13.19 94 50216 37574 79656504
Gastrointestinal haemorrhage 58.91 13.19 216 50094 147503 79546575
Systemic lupus erythematosus 57.85 13.19 5 50305 121144 79572934
Drug intolerance 57.79 13.19 49 50261 264070 79430008
Accidental overdose 56.95 13.19 95 50215 39486 79654592
Urinary tract infection 56.19 13.19 330 49980 274182 79419896
Miosis 55.94 13.19 59 50251 15730 79678348
Salivary hypersecretion 55.53 13.19 56 50254 14168 79679910
Hypophagia 55.03 13.19 101 50209 45266 79648812
Pain in extremity 54.81 13.19 91 50219 364447 79329631
Medication error 54.10 13.19 128 50182 68514 79625564
Urinary retention 54.06 13.19 114 50196 56516 79637562
Rhabdomyolysis 53.71 13.19 165 50145 102966 79591112
Alopecia 53.01 13.19 41 50269 231314 79462764
Atrioventricular block 52.49 13.19 54 50256 13987 79680091
Poriomania 50.61 13.19 14 50296 208 79693870
Cerebral infarction 49.60 13.19 97 50213 45579 79648499
Torticollis 49.58 13.19 26 50284 2361 79691717
Treatment failure 49.15 13.19 23 50287 170463 79523615
Hip fracture 48.56 13.19 77 50233 30684 79663394
Stomatitis 48.56 13.19 16 50294 146741 79547337
Bradyarrhythmia 48.27 13.19 31 50279 4115 79689963
Off label use 48.27 13.19 355 49955 906860 78787218
Glossodynia 47.39 13.19 5 50305 103332 79590746
Neutropenia 46.88 13.19 68 50242 287642 79406436
Weight increased 46.75 13.19 64 50246 277322 79416756
Wandering pacemaker 46.48 13.19 8 50302 6 79694072
Neuropsychiatric symptoms 46.22 13.19 21 50289 1394 79692684
Generalised tonic-clonic seizure 46.17 13.19 92 50218 43818 79650260
Headache 46.14 13.19 234 50076 653538 79040540
Cerebral atrophy 45.49 13.19 39 50271 8036 79686042
Blood glucose fluctuation 45.44 13.19 36 50274 6646 79687432
Apathy 45.10 13.19 48 50262 12929 79681149
Memory impairment 45.06 13.19 164 50146 111570 79582508
Hypokalaemia 44.87 13.19 195 50115 143845 79550233
Dyspnoea 44.79 13.19 337 49973 856688 78837390
Paranoia 44.42 13.19 58 50252 19374 79674704
Fracture 43.64 13.19 61 50249 21740 79672338
Reduced facial expression 43.31 13.19 25 50285 2740 79691338
Blood cholinesterase decreased 43.01 13.19 13 50297 268 79693810
Incontinence 41.65 13.19 48 50262 14116 79679962
Nasopharyngitis 41.36 13.19 60 50250 253821 79440257
Jealous delusion 40.96 13.19 13 50297 317 79693761
Infection 40.49 13.19 56 50254 241656 79452422
Contraindicated product administered 39.94 13.19 25 50285 157513 79536565
Epilepsy 39.86 13.19 83 50227 40777 79653301
Paraesthesia 39.43 13.19 32 50278 176291 79517787
Libido increased 39.31 13.19 21 50289 1980 79692098
Cough 39.00 13.19 111 50199 366678 79327400
Balance disorder 38.93 13.19 144 50166 98713 79595365
Pyrexia 38.76 13.19 260 50050 678449 79015629
Behaviour disorder 38.67 13.19 32 50278 6281 79687797
Hepatic enzyme increased 38.57 13.19 35 50275 182575 79511503
Pemphigus 38.37 13.19 8 50302 99574 79594504
Drooling 38.28 13.19 31 50279 5903 79688175
Encephalopathy 38.08 13.19 111 50199 67286 79626792
Executive dysfunction 37.95 13.19 12 50298 289 79693789
Product prescribing issue 36.91 13.19 26 50284 4019 79690059
Multiple drug therapy 36.72 13.19 26 50284 4052 79690026
Intentional product use issue 36.06 13.19 26 50284 152086 79541992
Hypocapnia 35.99 13.19 14 50296 629 79693449
Listless 35.66 13.19 25 50285 3836 79690242
Posture abnormal 35.63 13.19 25 50285 3841 79690237
Urticaria 35.11 13.19 39 50271 185162 79508916
Sedation 34.80 13.19 91 50219 51804 79642274
Malignant neoplasm progression 33.90 13.19 22 50288 135968 79558110
Impaired healing 33.86 13.19 7 50303 87648 79606430
Subdural haematoma 33.21 13.19 66 50244 31368 79662710
Thrombocytopenia 33.05 13.19 74 50236 265185 79428893
Speech disorder 33.02 13.19 92 50218 54353 79639725
Helicobacter infection 32.94 13.19 3 50307 69701 79624377
Psoriasis 32.90 13.19 8 50302 89579 79604499
Therapeutic product effect decreased 32.75 13.19 33 50277 163830 79530248
Abnormal dreams 32.42 13.19 38 50272 11374 79682704
Upper gastrointestinal haemorrhage 32.42 13.19 77 50233 41303 79652775
Lower respiratory tract infection 32.08 13.19 21 50289 129199 79564879
Mucosal inflammation 31.43 13.19 5 50305 75575 79618503
Tardive dyskinesia 31.38 13.19 36 50274 10535 79683543
Parkinson's disease 31.32 13.19 17 50293 1654 79692424
Melaena 31.30 13.19 97 50213 60793 79633285
Social avoidant behaviour 30.74 13.19 25 50285 4789 79689289
Hypersomnia 30.04 13.19 53 50257 23033 79671045
Automatism 29.94 13.19 9 50301 182 79693896
Nonspecific reaction 29.65 13.19 19 50291 2513 79691565
Arthritis 29.43 13.19 18 50292 114862 79579216
Musculoskeletal pain 29.20 13.19 14 50296 102340 79591738
Paratonia 28.99 13.19 6 50304 22 79694056
Neuroglycopenia 28.73 13.19 11 50299 473 79693605
Duodenal ulcer 28.67 13.19 43 50267 16326 79677752
Sialoadenitis 28.47 13.19 17 50293 1984 79692094
Bradykinesia 28.39 13.19 30 50280 8013 79686065
Peripheral circulatory failure 28.21 13.19 14 50296 1132 79692946
Oropharyngeal pain 28.20 13.19 17 50293 109336 79584742
Hypomania 28.17 13.19 29 50281 7515 79686563
Abdominal discomfort 28.04 13.19 74 50236 250653 79443425
Hypotension 27.97 13.19 411 49899 439906 79254172
Duodenal ulcer haemorrhage 27.59 13.19 28 50282 7135 79686943
Bedridden 27.53 13.19 36 50274 12043 79682035
Fibromyalgia 27.34 13.19 4 50306 64336 79629742
Injection site pain 27.28 13.19 25 50285 129813 79564265
Adams-Stokes syndrome 27.23 13.19 8 50302 149 79693929
Muscle contractions involuntary 27.15 13.19 21 50289 3744 79690334
Neuropathy peripheral 26.51 13.19 30 50280 141275 79552803
Dysphagia 26.36 13.19 149 50161 121987 79572091
Drop attacks 26.30 13.19 13 50297 1042 79693036
Anaphylactic reaction 26.21 13.19 10 50300 83733 79610345
Potentiating drug interaction 26.12 13.19 30 50280 8789 79685289
Blood pressure decreased 26.04 13.19 128 50182 99338 79594740
Hypoaesthesia 25.79 13.19 46 50264 179306 79514772
Product use issue 25.75 13.19 59 50251 209763 79484315
Pelvic fracture 25.70 13.19 35 50275 12169 79681909
Flight of ideas 25.67 13.19 12 50298 850 79693228
Chorea 25.52 13.19 17 50293 2400 79691678
Gastric ulcer 25.39 13.19 62 50248 33843 79660235
Cerebral haemorrhage 25.25 13.19 87 50223 57586 79636492
Chest discomfort 25.15 13.19 30 50280 138014 79556064
Fluid intake reduced 24.99 13.19 25 50285 6263 79687815
Daydreaming 24.77 13.19 12 50298 921 79693157
Pressure of speech 24.44 13.19 13 50297 1215 79692863
Long QT syndrome 24.27 13.19 24 50286 5931 79688147
Fatigue 24.25 13.19 427 49883 929300 78764778
Incoherent 24.20 13.19 27 50283 7665 79686413
Lack of spontaneous speech 24.09 13.19 8 50302 226 79693852
Haematemesis 23.90 13.19 80 50230 52184 79641894
Neutrophil count decreased 23.69 13.19 15 50295 93944 79600134
Irritability 23.46 13.19 68 50242 41076 79653002
Sinoatrial block 23.28 13.19 13 50297 1338 79692740
Anger 23.11 13.19 40 50270 17122 79676956
Dysarthria 22.95 13.19 94 50216 67528 79626550
Hyponatraemia 22.87 13.19 191 50119 177657 79516421
Superficial siderosis of central nervous system 22.58 13.19 5 50305 27 79694051
Hypernatraemia 22.57 13.19 36 50274 14415 79679663
Motor dysfunction 22.05 13.19 36 50274 14697 79679381
Cerebrovascular accident 21.71 13.19 170 50140 155122 79538956
Product use in unapproved indication 21.60 13.19 83 50227 250276 79443802
Vomiting 21.57 13.19 561 49749 665267 79028811
Wrong patient received product 21.44 13.19 20 50290 4598 79689480
Sinus arrest 21.44 13.19 18 50292 3604 79690474
Myalgia 21.35 13.19 54 50256 185587 79508491
Eosinophilic pneumonia chronic 21.17 13.19 9 50301 509 79693569
Dropped head syndrome 21.12 13.19 8 50302 334 79693744
Nasal congestion 21.04 13.19 11 50299 76541 79617537
Back pain 20.75 13.19 110 50200 304070 79390008
Cold sweat 20.65 13.19 40 50270 18659 79675419
Foreign body 20.56 13.19 16 50294 2878 79691200
Food refusal 20.49 13.19 9 50301 551 79693527
Dyspepsia 20.47 13.19 23 50287 108664 79585414
Wound 20.37 13.19 26 50284 116153 79577925
Affect lability 20.33 13.19 30 50280 11229 79682849
Gastrointestinal ulcer 20.14 13.19 17 50293 3429 79690649
Prescribed underdose 20.04 13.19 52 50258 29462 79664616
Dysstasia 19.99 13.19 50 50260 27696 79666382
Erythema 19.93 13.19 73 50237 223217 79470861
Obsessive thoughts 19.80 13.19 11 50299 1121 79692957
Cholesteatoma 19.79 13.19 6 50304 125 79693953
Inflammation 19.75 13.19 18 50292 93735 79600343
Pemphigoid 19.72 13.19 35 50275 15280 79678798
Drug reaction with eosinophilia and systemic symptoms 19.56 13.19 8 50302 64236 79629842
Supraventricular extrasystoles 19.41 13.19 23 50287 6964 79687114
Suspiciousness 19.25 13.19 9 50301 638 79693440
Gastric ulcer haemorrhage 19.18 13.19 26 50284 9001 79685077
Discomfort 19.18 13.19 31 50279 125586 79568492
Blood cholesterol increased 18.95 13.19 15 50295 83705 79610373
Disease progression 18.69 13.19 57 50253 184305 79509773
Colitis microscopic 18.45 13.19 28 50282 10740 79683338
Accidental exposure to product by child 18.27 13.19 15 50295 2911 79691167
Heart rate increased 18.23 13.19 30 50280 120694 79573384
Hypersexuality 18.18 13.19 12 50298 1668 79692410
Osteoarthritis 18.11 13.19 17 50293 87292 79606786
Septic shock 18.10 13.19 31 50279 122770 79571308
Stupor 18.07 13.19 22 50288 6850 79687228
Injection site reaction 18.07 13.19 6 50304 54779 79639299
Haematoma 18.06 13.19 73 50237 52122 79641956
Intention tremor 18.03 13.19 9 50301 737 79693341
Hangover 17.95 13.19 13 50297 2099 79691979
Bone marrow failure 17.93 13.19 5 50305 51102 79642976
Head injury 17.80 13.19 58 50252 37311 79656767
Hyponatraemic syndrome 17.65 13.19 9 50301 771 79693307
Communication disorder 17.63 13.19 17 50293 4073 79690005
Intestinal haemorrhage 17.60 13.19 21 50289 6405 79687673
Skull fracture 17.55 13.19 12 50298 1768 79692310
Normal pressure hydrocephalus 17.55 13.19 8 50302 535 79693543
Duodenal ulcer perforation 17.49 13.19 10 50300 66201 79627877
Flushing 17.37 13.19 18 50292 88250 79605828
Pain in jaw 17.18 13.19 4 50306 46147 79647931
Peripheral swelling 17.03 13.19 100 50210 269517 79424561
Atrioventricular block second degree 16.98 13.19 22 50288 7290 79686788
Grandiosity 16.95 13.19 8 50302 579 79693499
Brain compression 16.94 13.19 8 50302 580 79693498
Hypoglycaemia 16.94 13.19 116 50194 101478 79592600
Bone pain 16.88 13.19 7 50303 55735 79638343
Asthma 16.56 13.19 38 50272 135057 79559021
COVID-19 16.52 13.19 48 50262 157626 79536452
Injection site erythema 16.49 13.19 15 50295 78182 79615896
Product blister packaging issue 16.48 13.19 6 50304 224 79693854
Apraxia 16.46 13.19 14 50296 2853 79691225
Herpes zoster 16.14 13.19 21 50289 93062 79601016
Lower gastrointestinal haemorrhage 16.01 13.19 33 50277 16092 79677986
Stress 15.94 13.19 16 50294 79596 79614482
Aphasia 15.88 13.19 65 50245 46667 79647411
Senile dementia 15.78 13.19 6 50304 253 79693825
Hiccups 15.68 13.19 25 50285 10006 79684072
Lacunar infarction 15.55 13.19 19 50291 5938 79688140
Rapid eye movement sleep behaviour disorder 15.49 13.19 7 50303 459 79693619
Non-24-hour sleep-wake disorder 15.48 13.19 4 50306 45 79694033
Thalamus haemorrhage 15.21 13.19 11 50299 1771 79692307
Blister 15.14 13.19 33 50277 119443 79574635
Injection site pruritus 15.09 13.19 4 50306 42279 79651799
Labelled drug-drug interaction issue 15.07 13.19 10 50300 1403 79692675
Neurodegenerative disorder 15.05 13.19 7 50303 490 79693588
Therapeutic product effect incomplete 14.93 13.19 43 50267 141602 79552476
Candida infection 14.86 13.19 3 50307 38211 79655867
Defect conduction intraventricular 14.84 13.19 7 50303 506 79693572
Serotonin syndrome 14.81 13.19 62 50248 44965 79649113
Ventricular tachycardia 14.79 13.19 59 50251 41876 79652202
Initial insomnia 14.77 13.19 20 50290 6918 79687160
Blood glucose abnormal 14.72 13.19 25 50285 10541 79683537
Abdominal pain 14.70 13.19 166 50144 389403 79304675
Atrial fibrillation 14.68 13.19 190 50120 197696 79496382
Intercepted product dispensing error 14.58 13.19 5 50305 156 79693922
Gastroenteritis pseudomonas 14.36 13.19 4 50306 61 79694017
Dry eye 14.15 13.19 3 50307 36928 79657150
Wheezing 14.15 13.19 33 50277 116631 79577447
Gait inability 14.14 13.19 74 50236 58843 79635235
Coma scale abnormal 14.08 13.19 22 50288 8656 79685422
Leukaemoid reaction 13.94 13.19 6 50304 350 79693728
Acute psychosis 13.71 13.19 15 50295 4165 79689913
Anaphylactic shock 13.64 13.19 3 50307 35993 79658085
Psychotic disorder 13.61 13.19 57 50253 41345 79652733
Hip arthroplasty 13.51 13.19 3 50307 35753 79658325
Ill-defined disorder 13.46 13.19 13 50297 65862 79628216
Decreased interest 13.42 13.19 14 50296 3683 79690395
Drug resistance 13.27 13.19 5 50305 42208 79651870
Gastric polyps 13.27 13.19 14 50296 3733 79690345
Oesophageal ulcer 13.19 13.19 19 50291 6956 79687122

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 ABBVIE 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 ABBVIE 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 ABBVIE 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 ABBVIE 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 ABBVIE 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 ABBVIE 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 ABBVIE 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 ABBVIE 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 ABBVIE 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 ABBVIE 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 ABBVIE 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 ABBVIE 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 ABBVIE 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 ABBVIE 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 ABBVIE 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 ABBVIE 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 ABBVIE 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 ABBVIE 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 ABBVIE 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 ABBVIE 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 ABBVIE 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 ABBVIE 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 ABBVIE 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 ABBVIE 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 ABBVIE 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 ABBVIE 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 ABBVIE 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 ABBVIE 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 11679086 May 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 11679086 May 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 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 11648214 Sept. 23, 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 11648214 Sept. 23, 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)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
10MG/DAY ADLARITY CORIUM N212304 March 11, 2022 RX SYSTEM TRANSDERMAL March 11, 2025 NEW PRODUCT
5MG/DAY ADLARITY CORIUM N212304 March 11, 2022 RX SYSTEM TRANSDERMAL March 11, 2025 NEW PRODUCT

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Acetylcholinesterase Enzyme INHIBITOR Ki 7.80 WOMBAT-PK 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
cAMP-specific 3',5'-cyclic phosphodiesterase 4D Enzyme IC50 4.44 CHEMBL
Acetylcholine receptor subunit epsilon Ion channel IC50 7.49 CHEMBL
Histamine H3 receptor GPCR IC50 6.46 CHEMBL
Beta-secretase 1 Enzyme IC50 5.49 CHEMBL
Sigma non-opioid intracellular receptor 1 Membrane receptor Ki 7.84 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
Choline O-acetyltransferase Enzyme IC50 8.28 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
Cholinesterase Enzyme IC50 6.08 CHEMBL

External reference:

IDSource
D00670 KEGG_DRUG
120011-70-3 SECONDARY_CAS_RN
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
135446 RXNORM
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 0456-1207 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 0456-1214 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 0456-1221 CAPSULE 10 mg ORAL NDA 31 sections
Namzaric HUMAN PRESCRIPTION DRUG LABEL 2 0456-1228 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 13668-102 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 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