donepezil 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | 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 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 99 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 2.247 High 1
caco2-efflux Caco-2 efflux ratio (BA/AB) 0.780 High 1
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 16.904 10^-6 cm/s High 1
dh-clint Dog hepatocyte intrinsic clearance 11.940 uL/min/10^6 cells High 1
dppb Dog plasma protein binding (% unbound) 29.470 % High 1
fcs-ppb Fetal calf serum protein binding (% unbound) 51.500 % High 1
herg hERG pIC50 5.918 pIC50 High 1
hh-clint Human hepatocyte intrinsic clearance 2.851 uL/min/10^6 cells High 1
hlm-clint Human liver microsomal intrinsic clearance 22.284 uL/min/mg protein High 1
hppb Human plasma protein binding (% unbound) 23.280 % High 1
kinase-safety-class ACVR2B,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK5,CDK9,DDR1,EGFR,EIF2AK3,EPHB4,ERBB2,GRK2,ITK,JAK2,MAP3K7,MAPK10,MAPK7,MAPKAPK2,MET,MTOR,NTRK2,PDK2,PDK4,PDPK1,PIK3CB,PIK3CD,PIM2,PRKDC,SIK2,SIK3,TEK,TTK 34
kinase-selectivity-class AKT3,AXL,EPHB4,ERBB2,GRK2,PDK4,PRKDC,SIK2 8
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 0.817 High 1
mh-clint Mouse hepatocyte intrinsic clearance 39.264 High 1
mppb Mouse plasma protein binding (% unbound) 23.190 High 1
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 3.656 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pld-class Phospholipidosis risk class (1 = positive, 0 = negative) 1 High 1
pppb Pig plasma protein binding (% unbound) 35.890 % High 1
rh-clint Rat hepatocyte intrinsic clearance 32.810 uL/min/10^6 cells High 1
rh-fuinc Rat hepatocyte fraction unbound in incubation 59.550 % High 1
rppb Rat plasma protein binding (% unbound) 23.320 % High 1
solubility-dd Solubility at pH 7.4 in DMSO 799.834 uM High 1

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 749.56 14.25 462 38983 83385 90505617
Fall 609.24 14.25 888 38557 480922 90108080
Syncope 515.21 14.25 441 39004 132222 90456780
Dementia 438.34 14.25 212 39233 23649 90565353
Sinus bradycardia 300.44 14.25 147 39298 16805 90572197
Drug interaction 286.81 14.25 466 38979 275987 90313015
Electrocardiogram QT prolonged 285.30 14.25 243 39202 72213 90516789
Hallucination 284.11 14.25 233 39212 65726 90523276
Amyloid related imaging abnormality-oedema/effusion 264.62 14.25 65 39380 879 90588123
Cognitive disorder 227.81 14.25 210 39235 69197 90519805
Agitation 222.13 14.25 204 39241 66894 90522108
Parkinsonism 211.12 14.25 109 39336 13956 90575046
Torsade de pointes 208.91 14.25 111 39334 15071 90573931
Aggression 205.59 14.25 134 39311 26534 90562468
Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits 202.19 14.25 49 39396 624 90588378
Muscle rigidity 197.97 14.25 105 39340 14204 90574798
Seizure 182.65 14.25 275 39170 152354 90436648
Delusion 178.69 14.25 97 39348 13743 90575259
Pleurothotonus 177.83 14.25 51 39394 1284 90587718
Atrioventricular block first degree 166.51 14.25 79 39366 8432 90580570
Confusional state 163.23 14.25 451 38994 385754 90203248
Abnormal behaviour 153.46 14.25 105 39340 22523 90566479
Neuroleptic malignant syndrome 152.21 14.25 90 39355 15006 90573996
Hallucination, visual 151.53 14.25 105 39340 22987 90566015
Somnolence 147.04 14.25 298 39147 208786 90380216
Urinary retention 141.20 14.25 123 39322 37621 90551381
Tremor 140.95 14.25 245 39200 152928 90436074
Systemic lupus erythematosus 135.56 14.25 5 39440 361891 90227111
Dehydration 135.36 14.25 276 39169 194171 90394831
Sinus node dysfunction 133.42 14.25 59 39386 5353 90583649
Hypersensitivity 130.18 14.25 21 39424 454656 90134346
Delirium 126.15 14.25 189 39256 104170 90484832
Pemphigus 117.50 14.25 6 39439 326858 90262144
Glossodynia 115.38 14.25 6 39439 321773 90267229
Altered state of consciousness 114.41 14.25 101 39344 31431 90557571
Arthropathy 114.09 14.25 13 39432 366229 90222773
Femoral neck fracture 113.74 14.25 65 39380 10168 90578834
Contraindicated product administered 111.62 14.25 7 39438 320132 90268870
Joint swelling 109.75 14.25 41 39404 503259 90085743
Pain 109.16 14.25 166 39279 996175 89592827
Loss of consciousness 107.10 14.25 207 39238 140031 90448971
Extrapyramidal disorder 106.65 14.25 74 39371 16229 90572773
Dyskinesia 99.87 14.25 100 39345 36434 90552568
Lethargy 99.64 14.25 130 39315 63009 90525993
Cholinergic syndrome 99.05 14.25 28 39417 668 90588334
Hypokalaemia 98.25 14.25 192 39253 130924 90458078
Depressed level of consciousness 95.44 14.25 137 39308 72647 90516355
Urinary tract infection 94.36 14.25 320 39125 305312 90283690
Nightmare 94.00 14.25 77 39368 21648 90567354
Decreased appetite 93.29 14.25 367 39078 376173 90212829
Alopecia 92.78 14.25 50 39395 495021 90093981
Rash 92.64 14.25 127 39318 795973 89793029
Swelling 91.56 14.25 34 39411 419024 90169978
Arthralgia 90.78 14.25 124 39321 778398 89810604
Drug intolerance 90.21 14.25 41 39404 447550 90141452
Mania 89.80 14.25 63 39382 14061 90574941
Myoclonus 89.43 14.25 71 39374 19097 90569905
Rheumatoid arthritis 88.85 14.25 24 39421 362590 90226412
Hyponatraemia 86.37 14.25 184 39261 133354 90455648
Pericarditis 85.60 14.25 9 39436 270142 90318860
Electrocardiogram PR prolongation 84.35 14.25 26 39419 844 90588158
Sinusitis 83.50 14.25 23 39422 343065 90245937
Psoriatic arthropathy 82.65 14.25 4 39441 228331 90360671
Hypothermia 82.04 14.25 62 39383 15513 90573489
Infusion related reaction 81.18 14.25 40 39405 416740 90172262
Drug ineffective 78.51 14.25 324 39121 1383974 89205028
Hepatic enzyme increased 77.56 14.25 30 39415 360706 90228296
Immobile 77.50 14.25 43 39402 6355 90582647
Irritable bowel syndrome 77.17 14.25 3 39442 207445 90381557
Dementia Alzheimer's type 76.69 14.25 25 39420 976 90588026
Torticollis 76.59 14.25 32 39413 2526 90586476
Treatment failure 76.58 14.25 19 39426 303909 90285093
Impaired healing 76.30 14.25 7 39438 234192 90354810
Atrial fibrillation 75.02 14.25 174 39271 133437 90455565
Restlessness 75.01 14.25 85 39360 35635 90553367
Hypophagia 74.59 14.25 85 39360 35852 90553150
Cerebral infarction 73.06 14.25 73 39372 26523 90562479
Dropped head syndrome 73.02 14.25 18 39427 247 90588755
Death 72.84 14.25 391 39054 456160 90132842
Wound 72.44 14.25 21 39424 302959 90286043
Peripheral circulatory failure 72.40 14.25 27 39418 1577 90587425
Mental status changes 72.06 14.25 93 39352 44586 90544416
Urinary incontinence 71.53 14.25 85 39360 37481 90551521
Stomatitis 71.52 14.25 16 39429 274682 90314320
Lower respiratory tract infection 70.73 14.25 12 39433 250647 90338355
Drug hypersensitivity 70.49 14.25 59 39386 463550 90125452
Neuroglycopenia 70.12 14.25 24 39421 1091 90587911
Atrioventricular block complete 70.02 14.25 47 39398 9764 90579238
Reduced facial expression 70.00 14.25 30 39415 2523 90586479
Disorientation 68.30 14.25 90 39355 44024 90544978
Infection 67.17 14.25 37 39408 362057 90226945
Therapeutic product effect decreased 66.80 14.25 19 39426 277552 90311450
Miosis 66.65 14.25 45 39400 9439 90579563
Gastrointestinal haemorrhage 66.18 14.25 131 39314 90117 90498885
Sudden death 65.51 14.25 47 39398 10862 90578140
Fibromyalgia 65.00 14.25 7 39438 206262 90382740
Stupor 64.10 14.25 36 39409 5446 90583556
Unresponsive to stimuli 64.07 14.25 81 39364 38040 90550962
Hypotension 62.66 14.25 294 39151 325103 90263899
Dizziness 61.66 14.25 453 38992 588831 90000171
Blood cholesterol decreased 60.67 14.25 25 39420 1906 90587096
Apathy 60.49 14.25 45 39400 10995 90578007
Dementia with Lewy bodies 59.81 14.25 17 39428 414 90588588
Bradykinesia 59.49 14.25 37 39408 6751 90582251
Weight increased 58.95 14.25 57 39388 417870 90171132
Accidental overdose 58.89 14.25 67 39378 28206 90560796
Abdominal discomfort 58.63 14.25 73 39372 477255 90111747
Rhabdomyolysis 57.90 14.25 90 39355 51166 90537836
Melaena 57.00 14.25 73 39372 34724 90554278
Hypoglycaemia 56.87 14.25 106 39339 69742 90519260
Orthostatic hypotension 56.68 14.25 80 39365 41747 90547255
Initial insomnia 55.66 14.25 40 39405 9270 90579732
Cerebral atrophy 55.18 14.25 33 39412 5613 90583389
Hip fracture 55.14 14.25 70 39375 33007 90555995
Off label use 55.10 14.25 270 39175 1101982 89487020
Pneumonia aspiration 55.03 14.25 78 39367 40862 90548140
Sedation 55.00 14.25 85 39360 48086 90540916
Encephalopathy 54.50 14.25 83 39362 46361 90542641
Blood cholesterol increased 54.36 14.25 12 39433 208000 90381002
Listless 54.06 14.25 27 39418 3222 90585780
Cerebral haemorrhage 52.78 14.25 70 39375 34452 90554550
Sexually inappropriate behaviour 52.72 14.25 12 39433 114 90588888
Psychomotor hyperactivity 52.48 14.25 44 39401 12769 90576233
Nasopharyngitis 52.39 14.25 60 39385 407044 90181958
Intentional product use issue 51.89 14.25 15 39430 216877 90372125
Circulatory collapse 51.84 14.25 59 39386 24845 90564157
Wandering pacemaker 51.38 14.25 8 39437 3 90588999
Anal incontinence 51.06 14.25 48 39397 16182 90572820
Medication error 50.56 14.25 113 39332 84539 90504463
Pain in extremity 49.19 14.25 75 39370 450454 90138548
Superficial siderosis of central nervous system 48.71 14.25 10 39435 55 90588947
Urticaria 48.49 14.25 39 39406 312695 90276307
Ill-defined disorder 47.64 14.25 11 39434 184880 90404122
Blister 47.34 14.25 26 39419 254972 90334030
Fracture 47.14 14.25 53 39392 22023 90566979
Generalised tonic-clonic seizure 46.17 14.25 66 39379 34837 90554165
Tardive dyskinesia 45.73 14.25 38 39407 10892 90578110
Bursitis 45.49 14.25 3 39442 131651 90457351
Cerebrovascular accident 45.00 14.25 137 39308 123396 90465606
Gastric polyps 44.87 14.25 27 39418 4645 90584357
Wheezing 44.60 14.25 24 39421 238056 90350946
Hypocapnia 43.95 14.25 14 39431 507 90588495
Febrile neutropenia 43.74 14.25 8 39437 158341 90430661
Neuropsychiatric symptoms 43.74 14.25 15 39430 686 90588316
Type 2 diabetes mellitus 43.49 14.25 17 39428 203227 90385775
Inflammation 43.37 14.25 12 39433 178580 90410422
Hypoaesthesia 42.97 14.25 44 39401 314166 90274836
Blood urea increased 42.44 14.25 59 39386 30354 90558648
Bedridden 42.25 14.25 38 39407 12110 90576892
Atrioventricular block 41.86 14.25 33 39412 8782 90580220
Multiple drug therapy 41.64 14.25 30 39415 6979 90582023
Liver function test abnormal 41.18 14.25 77 39368 50768 90538234
Salivary hypersecretion 40.96 14.25 33 39412 9059 90579943
Duodenal ulcer perforation 40.44 14.25 23 39422 221265 90367737
Pelvic fracture 40.38 14.25 41 39404 15178 90573824
Blood pressure decreased 40.34 14.25 96 39349 74799 90514203
Discomfort 40.33 14.25 36 39409 274299 90314703
Hypotonia 40.25 14.25 36 39409 11390 90577612
Osteoarthritis 39.27 14.25 18 39427 195712 90393290
Hyperkalaemia 37.98 14.25 86 39359 64878 90524124
Long QT syndrome 37.92 14.25 23 39422 4014 90584988
Liver injury 36.93 14.25 14 39431 170553 90418449
Foreign body 36.48 14.25 19 39426 2475 90586527
Atrial tachycardia 36.41 14.25 26 39419 5964 90583038
Gait disturbance 36.09 14.25 215 39230 260281 90328721
Drug level increased 35.99 14.25 52 39393 27710 90561292
Motor dysfunction 35.76 14.25 43 39402 19187 90569815
Speech disorder 35.63 14.25 68 39377 45517 90543485
Posture abnormal 34.99 14.25 19 39426 2692 90586310
Therapeutic product effect incomplete 34.23 14.25 21 39424 193875 90395127
Dysarthria 33.96 14.25 74 39371 54408 90534594
Musculoskeletal pain 33.96 14.25 16 39429 171235 90417767
Psoriasis 33.92 14.25 11 39434 147743 90441259
Hyperhidrosis 33.77 14.25 133 39312 136172 90452830
Hiatus hernia 33.61 14.25 48 39397 25313 90563689
Incontinence 33.49 14.25 35 39410 13400 90575602
Sialoadenitis 33.00 14.25 17 39428 2165 90586837
Dyspepsia 32.90 14.25 23 39422 198137 90390865
Anger 32.88 14.25 35 39410 13685 90575317
Lack of spontaneous speech 32.75 14.25 9 39436 193 90588809
Wound infection 32.54 14.25 4 39441 106398 90482604
Fluid intake reduced 32.32 14.25 21 39424 4131 90584871
Pruritus 32.21 14.25 124 39321 541401 90047601
Product use issue 32.21 14.25 59 39386 329860 90259142
Peripheral swelling 31.99 14.25 84 39361 413022 90175980
Head injury 31.43 14.25 52 39393 31136 90557866
Injury 31.34 14.25 24 39421 197325 90391677
Lung disorder 31.30 14.25 13 39432 149870 90439132
Paratonia 31.21 14.25 6 39439 22 90588980
Upper gastrointestinal haemorrhage 31.21 14.25 44 39401 22932 90566070
Completed suicide 30.80 14.25 135 39310 144923 90444079
Asthma 30.79 14.25 36 39409 242124 90346878
Sinus arrest 30.39 14.25 16 39429 2130 90586872
Hypernatraemia 29.99 14.25 28 39417 9359 90579643
Dysphagia 29.81 14.25 112 39333 112166 90476836
Grip strength decreased 29.52 14.25 3 39442 92573 90496429
Prescription drug used without a prescription 29.18 14.25 18 39427 3237 90585765
Psychotic disorder 28.74 14.25 50 39395 31180 90557822
Movement disorder 28.73 14.25 48 39397 28971 90560031
Diabetes mellitus inadequate control 28.73 14.25 38 39407 18646 90570356
Urea cycle disorder 28.64 14.25 6 39439 37 90588965
Skull fracture 28.27 14.25 13 39432 1292 90587710
Wrong patient received product 28.09 14.25 18 39427 3459 90585543
Hypercholesterolaemia 28.07 14.25 5 39440 100887 90488115
Paraesthesia 27.94 14.25 41 39404 250285 90338717
Hyponatraemic syndrome 27.15 14.25 10 39435 564 90588438
Arthritis 27.01 14.25 20 39425 167295 90421707
Suspiciousness 26.66 14.25 9 39436 392 90588610
Musculoskeletal stiffness 26.37 14.25 56 39389 296476 90292526
Peripheral venous disease 26.04 14.25 3 39442 83918 90505084
Social avoidant behaviour 25.93 14.25 17 39428 3396 90585606
Abnormal dreams 25.71 14.25 28 39417 11229 90577773
Bradyarrhythmia 25.66 14.25 15 39430 2446 90586556
Night sweats 25.57 14.25 12 39433 128754 90460248
Oedema 25.22 14.25 30 39415 200265 90388737
Grandiosity 24.82 14.25 8 39437 301 90588701
Pyrexia 24.79 14.25 177 39268 660308 89928694
Haematemesis 24.76 14.25 49 39396 33677 90555325
Ventricular tachycardia 24.64 14.25 41 39404 24667 90564335
Blood creatine increased 24.64 14.25 22 39423 6945 90582057
Subdural haematoma 24.29 14.25 33 39412 16612 90572390
Sciatica 24.26 14.25 7 39438 101375 90487627
Colitis microscopic 24.18 14.25 27 39418 11132 90577870
Parkinson's disease 24.06 14.25 11 39434 1079 90587923
Headache 24.00 14.25 250 39195 862496 89726506
Poriomania 23.91 14.25 6 39439 89 90588913
Drooling 23.73 14.25 18 39427 4528 90584474
Gastric ulcer 22.76 14.25 42 39403 27406 90561596
Hypersexuality 22.75 14.25 9 39436 617 90588385
Chorea 22.37 14.25 13 39432 2097 90586905
Incoherent 22.28 14.25 18 39427 4959 90584043
Adams-Stokes syndrome 22.11 14.25 5 39440 46 90588956
Haematoma 22.05 14.25 51 39394 38997 90550005
Cardio-respiratory arrest 22.03 14.25 69 39376 63071 90525931
Cardiac failure 21.81 14.25 100 39345 109396 90479606
Cardiac arrest 21.77 14.25 97 39348 104838 90484164
Sinoatrial block 21.73 14.25 10 39435 995 90588007
Freezing phenomenon 21.46 14.25 12 39433 1800 90587202
Joint stiffness 21.42 14.25 4 39441 78038 90510964
Non-24-hour sleep-wake disorder 21.42 14.25 4 39441 12 90588990
Supraventricular extrasystoles 21.42 14.25 18 39427 5239 90583763
Muscle contracture 21.40 14.25 12 39433 1809 90587193
Balance disorder 21.10 14.25 91 39354 96989 90492013
Dyspnoea 21.08 14.25 264 39181 880691 89708311
Overdose 21.08 14.25 129 39316 157580 90431422
Anaphylactic reaction 21.02 14.25 6 39439 87518 90501484
Herbal interaction 20.63 14.25 6 39439 159 90588843
Brain compression 20.53 14.25 8 39437 527 90588475
Arrhythmia 20.39 14.25 52 39393 42280 90546722
Adverse event 20.33 14.25 13 39432 117405 90471597
Vomiting 20.28 14.25 467 38978 787826 89801176
Overconfidence 20.22 14.25 3 39442 0 90589002
Electrocardiogram T wave inversion 20.15 14.25 15 39430 3668 90585334
Lower limb fracture 20.10 14.25 6 39439 85007 90503995
Fatigue 20.03 14.25 368 39077 1153655 89435347
Road traffic accident 19.92 14.25 11 39434 107615 90481387
Blood glucose fluctuation 19.88 14.25 17 39428 5066 90583936
Cholesteatoma 19.79 14.25 6 39439 184 90588818
Hypertonia 19.67 14.25 17 39428 5138 90583864
Dystonia 19.64 14.25 30 39415 16789 90572213
Dysuria 19.61 14.25 49 39396 39352 90549650
Obsessive thoughts 19.54 14.25 8 39437 600 90588402
Prescribed overdose 19.54 14.25 9 39436 97616 90491386
Paranoia 19.46 14.25 26 39419 12882 90576120
Ataxia 19.43 14.25 31 39414 18011 90570991
Hepatic function abnormal 19.40 14.25 54 39391 46234 90542768
Affect lability 19.40 14.25 31 39414 18032 90570970
Food refusal 19.20 14.25 8 39437 627 90588375
Injection site reaction 19.20 14.25 8 39437 92072 90496930
Lacunar infarction 19.03 14.25 14 39431 3363 90585639
Aphasia 19.00 14.25 51 39394 42761 90546241
Emotional poverty 18.97 14.25 7 39438 397 90588605
Head discomfort 18.89 14.25 29 39416 16304 90572698
Migraine 18.61 14.25 34 39411 190358 90398644
Leukaemoid reaction 18.58 14.25 6 39439 227 90588775
Femur fracture 18.57 14.25 53 39392 46029 90542973
Drop attacks 18.52 14.25 8 39437 686 90588316
Anorgasmia 18.45 14.25 8 39437 692 90588310
Hyperglycaemia 18.05 14.25 56 39389 50914 90538088
Obesity 17.83 14.25 12 39433 105495 90483507
Pressure of speech 17.72 14.25 8 39437 762 90588240
Duodenal ulcer haemorrhage 17.65 14.25 12 39433 2544 90586458
Hypoacusis 17.55 14.25 38 39407 27812 90561190
Cough 17.40 14.25 92 39353 368870 90220132
Hypocoagulable state 17.35 14.25 10 39435 1589 90587413
Drug dependence 17.33 14.25 39 39406 29288 90559714
Gastric ulcer haemorrhage 17.27 14.25 16 39429 5295 90583707
Executive dysfunction 17.22 14.25 6 39439 288 90588714
Behaviour disorder 17.11 14.25 15 39430 4620 90584382
Acute abdomen 16.98 14.25 10 39435 1653 90587349
Normal pressure hydrocephalus 16.96 14.25 6 39439 301 90588701
Product use in unapproved indication 16.90 14.25 82 39363 336154 90252848
Lower gastrointestinal haemorrhage 16.72 14.25 20 39425 8872 90580130
Labelled drug-drug interaction issue 16.55 14.25 11 39434 2247 90586755
Libido increased 16.54 14.25 10 39435 1734 90587268
Pemphigoid 16.48 14.25 20 39425 9006 90579996
Intercepted product dispensing error 16.47 14.25 5 39440 154 90588848
Potentiating drug interaction 16.40 14.25 16 39429 5646 90583356
Antisocial behaviour 16.37 14.25 7 39438 585 90588417
Hyperammonaemia 16.37 14.25 17 39428 6458 90582544
Product quality issue 16.36 14.25 7 39438 79318 90509684
Haemorrhagic stroke 16.33 14.25 17 39428 6479 90582523
Crying 16.17 14.25 35 39410 25610 90563392
Use of accessory respiratory muscles 15.98 14.25 6 39439 357 90588645
Red blood cell sedimentation rate increased 15.94 14.25 8 39437 82587 90506415
Product dispensing error 15.93 14.25 23 39422 12250 90576752
Visuospatial deficit 15.83 14.25 3 39442 10 90588992
Opisthotonus 15.61 14.25 6 39439 381 90588621
Inappropriate affect 15.54 14.25 8 39437 1017 90587985
Irritability 15.34 14.25 42 39403 35620 90553382
Neurodegenerative disorder 15.10 14.25 6 39439 416 90588586
Gastrointestinal disorder 15.09 14.25 59 39386 256628 90332374
Hepatorenal syndrome 15.07 14.25 10 39435 2038 90586964
Communication disorder 15.02 14.25 12 39433 3254 90585748
Duodenal perforation 15.02 14.25 8 39437 1090 90587912
Myalgia 14.80 14.25 34 39411 175091 90413911
Thalamus haemorrhage 14.76 14.25 7 39438 746 90588256
Decreased activity 14.71 14.25 18 39427 8174 90580828
Therapy non-responder 14.66 14.25 23 39422 136681 90452321
Nonspecific reaction 14.39 14.25 11 39434 2798 90586204
Failure to thrive 14.33 14.25 18 39427 8393 90580609
Injection site pruritus 14.27 14.25 3 39442 53831 90535171

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
Fall 397.44 14.84 607 26534 233913 42360281
Dementia 391.81 14.84 197 26944 16283 42577911
Bradycardia 355.50 14.84 349 26792 85135 42509059
Confusional state 346.47 14.84 477 26664 167120 42427074
Hallucination 343.75 14.84 288 26853 57219 42536975
Delirium 193.44 14.84 201 26940 52318 42541876
Agitation 186.36 14.84 217 26924 64097 42530097
Delusion 185.30 14.84 116 27025 14618 42579576
Cholinergic syndrome 183.83 14.84 49 27092 622 42593572
Pleurothotonus 172.02 14.84 53 27088 1158 42593036
Cognitive disorder 171.40 14.84 155 26986 34017 42560177
Aggression 151.88 14.84 163 26978 44000 42550194
Amyloid related imaging abnormality-oedema/effusion 149.28 14.84 42 27099 660 42593534
Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits 140.07 14.84 40 27101 665 42593529
Abnormal behaviour 130.70 14.84 119 27022 26332 42567862
Neuroleptic malignant syndrome 114.78 14.84 101 27040 21371 42572823
Syncope 110.39 14.84 214 26927 99192 42495002
Mania 105.59 14.84 72 27069 10475 42583719
Urinary incontinence 94.56 14.84 91 27050 21577 42572617
Hallucination, visual 89.33 14.84 87 27054 20933 42573261
Depressed level of consciousness 87.56 14.84 129 27012 47841 42546353
Sinus bradycardia 83.67 14.84 72 27069 14781 42579413
Anal incontinence 77.60 14.84 57 27084 9324 42584870
Balance disorder 74.12 14.84 119 27022 47526 42546668
Somnolence 73.58 14.84 227 26914 140878 42453316
Febrile neutropenia 72.48 14.84 15 27126 185688 42408506
Death 70.85 14.84 527 26614 470658 42123536
Gait disturbance 70.17 14.84 177 26964 97823 42496371
Sinus node dysfunction 68.44 14.84 41 27100 4771 42589423
Memory impairment 63.01 14.84 114 27027 50108 42544086
Neurodegenerative disorder 62.05 14.84 19 27122 406 42593788
Loss of consciousness 61.16 14.84 162 26979 92192 42502002
Poriomania 60.12 14.84 14 27127 97 42594097
Blood cholinesterase decreased 57.27 14.84 15 27126 177 42594017
Pneumonia aspiration 55.74 14.84 108 27033 49970 42544224
Parkinsonism 52.85 14.84 48 27093 10575 42583619
Orthostatic hypotension 52.60 14.84 80 27061 30490 42563704
Diabetic hyperosmolar coma 50.10 14.84 17 27124 509 42593685
Neutropenia 49.69 14.84 33 27108 199398 42394796
Disorientation 47.42 14.84 84 27057 36305 42557889
Dyskinesia 47.34 14.84 69 27072 25321 42568873
Electrocardiogram QT prolonged 46.91 14.84 98 27043 47847 42546347
Libido increased 46.57 14.84 19 27122 959 42593235
Unresponsive to stimuli 45.53 14.84 76 27065 31327 42562867
Dementia with Lewy bodies 44.76 14.84 18 27123 875 42593319
Nightmare 42.38 14.84 65 27076 24947 42569247
Salivary hypersecretion 42.24 14.84 43 27098 10900 42583294
Dehydration 41.85 14.84 190 26951 141577 42452617
Tremor 41.55 14.84 146 26995 96783 42497411
Flight of ideas 40.16 14.84 13 27128 335 42593859
Paranoia 40.00 14.84 47 27094 13979 42580215
Intestinal haemorrhage 39.60 14.84 27 27114 3924 42590270
Rhabdomyolysis 39.20 14.84 124 27017 77895 42516299
Drug interaction 38.99 14.84 297 26844 266702 42327492
Prescribed underdose 38.96 14.84 40 27101 10242 42583952
Blood glucose fluctuation 38.22 14.84 28 27113 4559 42589635
Psychomotor hyperactivity 36.84 14.84 40 27101 10918 42583276
Bradyarrhythmia 36.00 14.84 22 27119 2653 42591541
Myoclonus 35.69 14.84 49 27092 17016 42577178
Dementia Alzheimer's type 35.63 14.84 12 27129 351 42593843
Muscle rigidity 35.38 14.84 41 27100 12018 42582176
Hypersomnia 35.24 14.84 45 27096 14573 42579621
Dizziness 34.56 14.84 274 26867 248980 42345214
Superficial siderosis of central nervous system 33.80 14.84 8 27133 60 42594134
Atrioventricular block first degree 33.61 14.84 30 27111 6461 42587733
Automatism 32.88 14.84 9 27132 127 42594067
Abnormal dreams 32.84 14.84 33 27108 8238 42585956
Altered state of consciousness 32.42 14.84 63 27078 29196 42564998
Atrioventricular block complete 32.28 14.84 38 27103 11326 42582868
Hyperhidrosis 31.86 14.84 128 27013 90384 42503810
Multiple drug therapy 31.29 14.84 15 27126 1114 42593080
Contusion 31.23 14.84 77 27064 41908 42552286
Off label use 31.16 14.84 259 26882 638076 41956118
Gastrointestinal haemorrhage 31.10 14.84 134 27007 97592 42496602
Drooling 30.85 14.84 24 27117 4275 42589919
Jealous delusion 30.33 14.84 11 27130 402 42593792
Seizure 30.08 14.84 154 26987 120407 42473787
Arthralgia 29.07 14.84 54 27087 205184 42389010
Restlessness 28.85 14.84 60 27081 29189 42565005
Substance dependence 28.61 14.84 12 27129 650 42593544
Extrapyramidal disorder 28.29 14.84 43 27098 16369 42577825
Hypersexuality 28.16 14.84 16 27125 1686 42592508
Muscle contractions involuntary 28.07 14.84 17 27124 2017 42592177
Serotonin syndrome 27.84 14.84 55 27086 25790 42568404
Blood glucose abnormal 27.74 14.84 28 27113 7025 42587169
Hip fracture 27.15 14.84 38 27103 13434 42580760
Subdural haematoma 27.08 14.84 51 27090 23087 42571107
Drug abuse 26.52 14.84 17 27124 104754 42489440
Nonspecific reaction 26.35 14.84 15 27126 1586 42592608
Sexually inappropriate behaviour 25.95 14.84 11 27130 612 42593582
Eosinophilic pneumonia chronic 25.66 14.84 9 27132 298 42593896
Atrioventricular block 25.42 14.84 31 27110 9584 42584610
Duodenal ulcer 25.29 14.84 35 27106 12244 42581950
Hangover 25.26 14.84 13 27128 1125 42593069
Product prescribing issue 25.03 14.84 26 27115 6747 42587447
Atrioventricular block second degree 25.01 14.84 21 27120 4166 42590028
Lethargy 24.90 14.84 76 27065 46814 42547380
Pruritus 24.72 14.84 52 27089 188719 42405475
Pain 24.71 14.84 77 27064 244771 42349423
Dyspnoea 24.64 14.84 173 26968 442448 42151746
Trifascicular block 24.47 14.84 7 27134 117 42594077
Speech disorder 24.46 14.84 56 27085 29065 42565129
Septic shock 24.42 14.84 14 27127 91658 42502536
Dysstasia 24.42 14.84 37 27104 14049 42580145
Cold sweat 24.40 14.84 33 27108 11297 42582897
Athetosis 23.81 14.84 6 27135 60 42594134
Decreased appetite 23.37 14.84 206 26935 192931 42401263
Neutrophil count decreased 22.96 14.84 6 27135 63409 42530785
Gait inability 22.70 14.84 47 27094 22786 42571408
Neuropathy peripheral 22.57 14.84 19 27122 101834 42492360
Irritability 22.43 14.84 53 27088 28075 42566119
Chorea 22.36 14.84 13 27128 1431 42592763
Mental status changes 22.12 14.84 68 27073 42047 42552147
Thrombocytopenia 22.03 14.84 56 27085 190223 42403971
Drug ineffective 21.91 14.84 277 26864 629920 41964274
Hypothermia 21.87 14.84 33 27108 12482 42581712
Bifascicular block 21.76 14.84 8 27133 304 42593890
Gastrointestinal ulcer 21.56 14.84 14 27127 1876 42592318
Incontinence 21.35 14.84 24 27117 6806 42587388
Daydreaming 21.24 14.84 10 27131 713 42593481
Intention tremor 21.22 14.84 9 27132 501 42593693
Malignant neoplasm progression 20.79 14.84 23 27118 108377 42485817
Foaming at mouth 20.73 14.84 11 27130 1013 42593181
Behaviour disorder 20.72 14.84 24 27117 7030 42587164
Eye movement disorder 20.13 14.84 20 27121 4925 42589269
Miosis 20.10 14.84 33 27108 13413 42580781
Urinary tract infection 19.54 14.84 119 27022 99165 42495029
Leukopenia 19.09 14.84 12 27129 74734 42519460
Accidental overdose 19.03 14.84 50 27091 28280 42565914
Paradoxical drug reaction 18.98 14.84 19 27122 4719 42589475
Femoral neck fracture 18.97 14.84 18 27123 4191 42590003
Psoriasis 18.78 14.84 4 27137 48600 42545594
Executive dysfunction 18.68 14.84 7 27134 281 42593913
Pyrexia 18.63 14.84 161 26980 393881 42200313
Living in residential institution 18.59 14.84 9 27132 683 42593511
Hypernatraemia 18.31 14.84 27 27114 10005 42584189
Melaena 18.01 14.84 60 27081 38686 42555508
Stomatitis 17.77 14.84 5 27136 50324 42543870
Sinus arrest 17.60 14.84 13 27128 2143 42592051
Underdose 17.39 14.84 35 27106 16631 42577563
Neuromuscular blockade 17.33 14.84 7 27134 344 42593850
Potentiating drug interaction 17.33 14.84 21 27120 6447 42587747
Pressure of speech 17.12 14.84 8 27133 561 42593633
Multiple organ dysfunction syndrome 17.10 14.84 22 27119 97013 42497181
Drug hypersensitivity 17.04 14.84 23 27118 99366 42494828
Hiccups 17.03 14.84 29 27112 12142 42582052
Cholinesterase inhibition 17.00 14.84 3 27138 3 42594191
Dysphagia 16.82 14.84 91 27050 72628 42521566
Skin swelling 16.46 14.84 14 27127 2828 42591366
Accidental exposure to product by child 16.40 14.84 11 27130 1556 42592638
Inappropriate antidiuretic hormone secretion 16.39 14.84 34 27107 16507 42577687
Stress 16.36 14.84 4 27137 44208 42549986
Tardive dyskinesia 16.19 14.84 21 27120 6903 42587291
Urticaria 16.17 14.84 14 27127 74022 42520172
Circulatory collapse 16.17 14.84 42 27099 23594 42570600
Sedation complication 16.13 14.84 14 27127 2905 42591289
Nodal rhythm 16.09 14.84 11 27130 1606 42592588
Medication error 16.00 14.84 52 27089 33102 42561092
Duodenal ulcer haemorrhage 15.80 14.84 19 27122 5789 42588405
Parkinson's disease 15.59 14.84 10 27131 1312 42592882
Defect conduction intraventricular 15.21 14.84 7 27134 474 42593720
Gastroenteritis pseudomonas 15.13 14.84 4 27137 49 42594145
Sudden death 15.11 14.84 33 27108 16596 42577598
Product use complaint 15.03 14.84 12 27129 2219 42591975

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 1034.41 13.66 769 57877 154748 110375905
Fall 869.04 13.66 1313 57333 602169 109928484
Dementia 688.31 13.66 336 58310 31337 110499316
Syncope 569.55 13.66 616 58030 201920 110328733
Hallucination 481.69 13.66 412 58234 101020 110429633
Amyloid related imaging abnormality-oedema/effusion 393.85 13.66 103 58543 1472 110529181
Confusional state 379.30 13.66 794 57852 467886 110062767
Agitation 358.70 13.66 367 58279 112684 110417969
Sinus bradycardia 346.26 13.66 208 58438 29275 110501378
Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits 330.37 13.66 87 58559 1279 110529374
Pleurothotonus 329.49 13.66 99 58547 2399 110528254
Aggression 327.83 13.66 263 58383 58947 110471706
Cognitive disorder 318.14 13.66 306 58340 87205 110443448
Delusion 306.23 13.66 178 58468 23577 110507076
Electrocardiogram QT prolonged 301.67 13.66 329 58317 108631 110422022
Delirium 300.20 13.66 364 58282 134661 110395992
Cholinergic syndrome 275.64 13.66 75 58571 1257 110529396
Drug interaction 258.99 13.66 713 57933 499470 110031183
Neuroleptic malignant syndrome 242.97 13.66 176 58470 33883 110496770
Parkinsonism 236.13 13.66 147 58499 22040 110508613
Abnormal behaviour 228.04 13.66 179 58467 38860 110491793
Muscle rigidity 210.81 13.66 141 58505 23890 110506763
Somnolence 200.62 13.66 469 58177 296980 110233673
Hallucination, visual 190.13 13.66 162 58484 39443 110491210
Sinus node dysfunction 184.60 13.66 92 58554 8955 110521698
Mania 182.37 13.66 122 58524 20674 110509979
Atrioventricular block first degree 176.49 13.66 104 58542 14121 110516532
Seizure 166.03 13.66 364 58282 220821 110309832
Death 160.63 13.66 764 57882 698105 109832548
Depressed level of consciousness 157.17 13.66 242 58404 112036 110418617
Dehydration 154.93 13.66 409 58237 279102 110251551
Torsade de pointes 154.87 13.66 114 58532 22486 110508167
Loss of consciousness 148.38 13.66 324 58322 195982 110334671
Urinary incontinence 140.14 13.66 150 58496 48437 110482216
Tremor 135.27 13.66 318 58328 201914 110328739
Anal incontinence 128.88 13.66 101 58545 21863 110508790
Myoclonus 128.63 13.66 120 58526 32878 110497775
Pain 128.08 13.66 193 58453 954762 109575891
Altered state of consciousness 127.37 13.66 155 58491 57471 110473182
Dyskinesia 121.29 13.66 143 58503 51303 110479350
Femoral neck fracture 120.58 13.66 78 58568 12489 110518164
Joint swelling 114.16 13.66 46 58600 442799 110087854
Nightmare 113.87 13.66 121 58525 38742 110491911
Extrapyramidal disorder 106.82 13.66 102 58544 28765 110501888
Arthropathy 105.21 13.66 14 58632 287508 110243145
Systemic lupus erythematosus 104.42 13.66 8 58638 254330 110276323
Lethargy 104.29 13.66 182 58464 93394 110437259
Disorientation 104.07 13.66 156 58490 70515 110460138
Hypersensitivity 102.44 13.66 43 58603 403955 110126698
Febrile neutropenia 99.43 13.66 23 58623 316744 110213909
Arthralgia 99.27 13.66 163 58483 779469 109751184
Pneumonia aspiration 98.45 13.66 164 58482 81069 110449584
Decreased appetite 96.85 13.66 503 58143 475343 110055310
Drug hypersensitivity 94.95 13.66 62 58584 454028 110076625
Glossodynia 93.98 13.66 6 58640 221998 110308655
Dementia with Lewy bodies 93.71 13.66 31 58615 1035 110529618
Hypothermia 93.67 13.66 91 58555 26211 110504442
Drug ineffective 93.22 13.66 453 58193 1520087 109010566
Orthostatic hypotension 92.97 13.66 143 58503 66106 110464547
Atrioventricular block complete 92.01 13.66 80 58566 20002 110510651
Unresponsive to stimuli 91.36 13.66 139 58507 63651 110467002
Psoriatic arthropathy 90.78 13.66 3 58643 196758 110333895
Stomatitis 90.21 13.66 17 58629 270225 110260428
Pericarditis 89.63 13.66 7 58639 219107 110311546
Rhabdomyolysis 88.96 13.66 197 58449 120204 110410449
Swelling 87.96 13.66 38 58608 351003 110179650
Dizziness 87.30 13.66 651 57995 697542 109833111
Drug intolerance 87.05 13.66 54 58592 406458 110124195
Restlessness 86.88 13.66 127 58519 56132 110474521
Rheumatoid arthritis 85.98 13.66 26 58620 299587 110231066
Rash 85.86 13.66 193 58453 820771 109709882
Urinary retention 84.86 13.66 141 58505 69542 110461111
Sinusitis 84.68 13.66 26 58620 296662 110233991
Urinary tract infection 83.82 13.66 369 58277 325913 110204740
Gait disturbance 83.48 13.66 330 58316 277878 110252775
Mental status changes 83.45 13.66 147 58499 75975 110454678
Helicobacter infection 83.11 13.66 3 58643 181874 110348779
Pemphigus 82.05 13.66 9 58637 214561 110316092
Salivary hypersecretion 81.03 13.66 70 58576 17351 110513302
Hepatic enzyme increased 79.98 13.66 35 58611 320857 110209796
Psychomotor hyperactivity 79.52 13.66 74 58572 20203 110510450
Cerebral infarction 78.57 13.66 116 58530 51722 110478931
Superficial siderosis of central nervous system 77.97 13.66 18 58628 147 110530506
Off label use 77.52 13.66 473 58173 1499712 109030941
Gastrointestinal haemorrhage 76.63 13.66 227 58419 165291 110365362
Alopecia 75.96 13.66 50 58596 364703 110165950
Impaired healing 75.86 13.66 8 58638 196709 110333944
Miosis 74.45 13.66 74 58572 21909 110508744
Accidental overdose 74.29 13.66 113 58533 51721 110478932
Electrocardiogram PR prolongation 73.71 13.66 30 58616 1813 110528840
Neurodegenerative disorder 73.67 13.66 24 58622 763 110529890
Weight increased 72.94 13.66 69 58577 419575 110111078
Immobile 71.92 13.66 47 58599 7655 110522998
Infusion related reaction 71.90 13.66 58 58588 381104 110149549
Hyperhidrosis 70.35 13.66 239 58407 187059 110343594
Lower respiratory tract infection 69.91 13.66 21 58625 243085 110287568
Sudden death 69.78 13.66 75 58571 24320 110506333
Dementia Alzheimer's type 69.76 13.66 24 58622 905 110529748
Melaena 69.27 13.66 128 58518 68629 110462024
Sexually inappropriate behaviour 69.10 13.66 22 58624 649 110530004
Urticaria 68.73 13.66 42 58604 318815 110211838
Fibromyalgia 68.41 13.66 6 58640 170903 110359750
Peripheral circulatory failure 67.28 13.66 28 58618 1791 110528862
Infection 67.21 13.66 56 58590 362144 110168509
Poriomania 67.20 13.66 17 58629 211 110530442
Atrioventricular block 66.97 13.66 62 58584 16815 110513838
Treatment failure 66.34 13.66 32 58614 277202 110253451
Bradykinesia 66.31 13.66 51 58595 10737 110519916
Circulatory collapse 66.30 13.66 97 58549 42896 110487757
Multiple drug therapy 65.45 13.66 45 58601 7969 110522684
Neuroglycopenia 65.25 13.66 24 58622 1102 110529551
Hypophagia 64.76 13.66 107 58539 52519 110478134
Bradyarrhythmia 63.64 13.66 37 58609 4897 110525756
Hip fracture 62.65 13.66 85 58561 35066 110495587
Reduced facial expression 62.53 13.66 33 58613 3618 110527035
Nasopharyngitis 61.59 13.66 71 58575 394290 110136363
Sedation 59.54 13.66 121 58525 69562 110461091
Hypokalaemia 59.26 13.66 222 58424 182226 110348427
Intentional product use issue 58.72 13.66 29 58617 247877 110282776
Cerebral atrophy 58.15 13.66 44 58602 9041 110521612
Pain in extremity 58.10 13.66 106 58540 487012 110043641
Balance disorder 57.93 13.66 164 58482 116396 110414257
Paraesthesia 57.43 13.66 38 58608 276483 110254170
Medication error 56.07 13.66 152 58494 105214 110425439
Paranoia 55.75 13.66 64 58582 22310 110508343
Neuropsychiatric symptoms 55.08 13.66 22 58624 1266 110529387
Wound 54.66 13.66 28 58618 234409 110296244
Musculoskeletal pain 54.11 13.66 15 58631 183008 110347645
Apathy 53.77 13.66 54 58592 16185 110514468
Blood cholesterol increased 53.05 13.66 16 58630 184769 110345884
Hypoaesthesia 53.03 13.66 53 58593 314170 110216483
Therapeutic product effect decreased 52.89 13.66 32 58614 244284 110286369
Abnormal dreams 52.76 13.66 48 58598 12732 110517921
Generalised tonic-clonic seizure 50.38 13.66 98 58548 54582 110476071
Contraindicated product administered 50.37 13.66 35 58611 248232 110282421
Wandering pacemaker 49.80 13.66 8 58638 3 110530650
Torticollis 49.25 13.66 27 58619 3194 110527459
Cerebral haemorrhage 48.75 13.66 107 58539 64861 110465792
Blood glucose fluctuation 48.65 13.66 37 58609 7661 110522992
Osteoarthritis 48.61 13.66 18 58628 182605 110348048
Stupor 48.47 13.66 38 58608 8227 110522426
Dropped head syndrome 48.43 13.66 16 58630 532 110530121
Pruritus 48.36 13.66 153 58493 581407 109949246
Wheezing 47.90 13.66 39 58607 255191 110275462
Blood cholesterol decreased 47.80 13.66 25 58621 2691 110527962
Diabetic hyperosmolar coma 47.78 13.66 18 58628 884 110529769
Fracture 47.33 13.66 62 58584 24726 110505927
Incontinence 47.32 13.66 51 58595 16584 110514069
Drooling 46.64 13.66 35 58611 7104 110523549
Hypotension 46.58 13.66 453 58193 523396 110007257
Libido increased 46.49 13.66 24 58622 2515 110528138
Hypersexuality 46.41 13.66 22 58624 1918 110528735
Psoriasis 46.29 13.66 9 58637 139984 110390669
Subdural haematoma 46.04 13.66 75 58571 36379 110494274
Listless 45.73 13.66 29 58617 4486 110526167
Behaviour disorder 45.34 13.66 39 58607 9608 110521045
Encephalopathy 45.21 13.66 119 58527 80936 110449717
Inflammation 45.16 13.66 23 58623 193215 110337438
Neutropenia 45.11 13.66 81 58565 374539 110156114
Haematemesis 45.09 13.66 98 58548 59010 110471643
Duodenal ulcer perforation 44.86 13.66 19 58627 177681 110352972
Ill-defined disorder 44.27 13.66 14 58632 156839 110373814
Abdominal discomfort 44.07 13.66 89 58557 393769 110136884
Posture abnormal 43.70 13.66 28 58618 4410 110526243
Blister 43.60 13.66 34 58612 227342 110303311
Speech disorder 43.51 13.66 99 58547 61470 110469183
Blood pressure decreased 43.31 13.66 147 58499 114944 110415709
Bedridden 43.27 13.66 44 58602 13381 110517272
Tardive dyskinesia 42.85 13.66 44 58602 13535 110517118
Jealous delusion 42.56 13.66 14 58632 459 110530194
Blood cholinesterase decreased 42.47 13.66 14 58632 462 110530191
Atrial fibrillation 41.37 13.66 235 58411 229407 110301246
Initial insomnia 40.90 13.66 38 58608 10351 110520302
Irritability 40.81 13.66 83 58563 47726 110482927
Liver injury 39.74 13.66 15 58631 150398 110380255
Hyponatraemia 39.38 13.66 223 58423 217430 110313223
Arthritis 39.08 13.66 20 58626 167566 110363087
Dysphagia 38.84 13.66 173 58473 153427 110377226
Flight of ideas 38.62 13.66 15 58631 801 110529852
Lung disorder 38.38 13.66 24 58622 180023 110350630
Gastric polyps 38.15 13.66 28 58618 5495 110525158
Dyspnoea 37.05 13.66 392 58254 1106480 109424173
Substance dependence 36.72 13.66 14 58632 711 110529942
Duodenal ulcer 36.01 13.66 48 58598 19466 110511187
Asthma 35.97 13.66 48 58598 250243 110280410
Executive dysfunction 35.93 13.66 12 58634 413 110530240
Parkinson's disease 35.44 13.66 17 58629 1522 110529131
Headache 35.26 13.66 299 58347 882078 109648575
Sinus arrest 35.07 13.66 24 58622 4218 110526435
Dyspepsia 34.82 13.66 30 58616 190935 110339718
Duodenal ulcer haemorrhage 34.78 13.66 31 58615 8006 110522647
Pressure of speech 34.63 13.66 16 58630 1316 110529337
Wound infection 34.55 13.66 5 58641 96460 110434193
Movement disorder 34.46 13.66 66 58580 36338 110494315
Hypersomnia 34.45 13.66 57 58589 28004 110502649
Mucosal inflammation 34.39 13.66 5 58641 96136 110434517
Night sweats 34.34 13.66 14 58632 133969 110396684
Pyrexia 34.29 13.66 308 58338 897957 109632696
Hypoglycaemia 34.19 13.66 137 58509 115967 110414686
Obesity 34.04 13.66 9 58637 113342 110417311
Malignant neoplasm progression 33.59 13.66 26 58620 174541 110356112
Head injury 33.59 13.66 72 58574 42945 110487708
Peripheral venous disease 33.53 13.66 3 58643 84114 110446539
Hypocapnia 33.45 13.66 14 58632 908 110529745
Pelvic fracture 32.78 13.66 39 58607 14115 110516538
Memory impairment 32.53 13.66 197 58449 196747 110333906
Thrombocytopenia 32.45 13.66 87 58559 348798 110181855
Hiatus hernia 32.45 13.66 55 58591 27551 110503102
Atrioventricular block second degree 32.36 13.66 30 58616 8151 110522502
Cerebrovascular accident 32.30 13.66 185 58461 181099 110349554
Social avoidant behaviour 32.17 13.66 25 58621 5344 110525309
Nonspecific reaction 31.77 13.66 20 58626 3054 110527599
Upper gastrointestinal haemorrhage 31.53 13.66 77 58569 50019 110480634
Blood urea increased 30.97 13.66 81 58565 54876 110475777
Injury 30.94 13.66 29 58617 177236 110353417
Anaphylactic reaction 30.86 13.66 11 58635 114289 110416364
Motor dysfunction 30.53 13.66 50 58596 24356 110506297
Sciatica 30.42 13.66 6 58640 92393 110438260
Hypernatraemia 30.09 13.66 42 58604 17791 110512862
Automatism 29.95 13.66 9 58637 218 110530435
Foreign body 29.75 13.66 19 58627 2976 110527677
Product use issue 29.54 13.66 77 58569 311618 110219035
Muscle contractions involuntary 29.50 13.66 22 58624 4422 110526231
Head discomfort 29.48 13.66 43 58603 18957 110511696
Wrong patient received product 29.39 13.66 26 58620 6648 110524005
Gastric ulcer 29.21 13.66 65 58581 39762 110490891
Grip strength decreased 29.08 13.66 4 58642 80170 110450483
Discomfort 29.03 13.66 43 58603 214664 110315989
Injection site pain 28.88 13.66 31 58615 177891 110352762
Injection site reaction 28.87 13.66 6 58640 89064 110441589
Lacunar infarction 28.71 13.66 25 58621 6261 110524392
Adams-Stokes syndrome 28.71 13.66 8 58638 147 110530506
Psychotic disorder 28.62 13.66 75 58571 50862 110479791
Fluid intake reduced 28.37 13.66 26 58620 6960 110523693
Incoherent 28.05 13.66 28 58618 8330 110522323
Drop attacks 27.62 13.66 13 58633 1115 110529538
Paratonia 27.32 13.66 6 58640 38 110530615
Freezing phenomenon 27.03 13.66 17 58629 2592 110528061
Potentiating drug interaction 26.83 13.66 32 58614 11611 110519042
Migraine 26.67 13.66 31 58615 171621 110359032
Sialoadenitis 26.65 13.66 17 58629 2656 110527997
Anger 26.61 13.66 41 58605 18966 110511687
Product use in unapproved indication 26.22 13.66 135 58511 447242 110083411
Neuropathy peripheral 26.14 13.66 34 58612 179243 110351410
Long QT syndrome 26.04 13.66 25 58621 7093 110523560
Amaurosis fugax 25.84 13.66 16 58630 2374 110528279
Obsessive thoughts 25.80 13.66 13 58633 1294 110529359
Colitis ulcerative 25.51 13.66 5 58641 77358 110453295
Peripheral swelling 25.36 13.66 119 58527 403915 110126738
Grandiosity 25.14 13.66 10 58636 569 110530084
Hypomania 25.09 13.66 29 58617 10181 110520472
Cold sweat 24.72 13.66 43 58603 21988 110508665
Sinoatrial block 24.40 13.66 13 58633 1452 110529201
Lack of spontaneous speech 24.30 13.66 8 58638 263 110530390
Atrial tachycardia 24.13 13.66 27 58619 9151 110521502
Hypercholesterolaemia 24.09 13.66 9 58637 90828 110439825
Accidental exposure to product by child 23.88 13.66 17 58629 3181 110527472
Daydreaming 23.86 13.66 12 58634 1190 110529463
Therapeutic product effect incomplete 23.81 13.66 52 58594 223753 110306900
Dysarthria 23.76 13.66 98 58548 84023 110446630
Chorea 23.71 13.66 17 58629 3218 110527435
Type 2 diabetes mellitus 23.47 13.66 36 58610 177196 110353457
Neutrophil count decreased 23.28 13.66 18 58628 120923 110409730
Dysstasia 23.26 13.66 53 58593 32933 110497720
Completed suicide 23.18 13.66 213 58433 242168 110288485
Haematoma 23.16 13.66 76 58570 58400 110472253
C-reactive protein increased 22.88 13.66 51 58595 217868 110312785
Skull fracture 22.68 13.66 14 58632 2066 110528587
Erythema 22.59 13.66 79 58567 291368 110239285
Adverse event 22.51 13.66 15 58631 108794 110421859
Cough 22.41 13.66 148 58498 461493 110069160
Hyponatraemic syndrome 22.06 13.66 10 58636 787 110529866
Taste disorder 22.04 13.66 4 58642 65383 110465270
Road traffic accident 21.96 13.66 15 58631 107383 110423270
Eosinophilic pneumonia chronic 21.89 13.66 9 58637 558 110530095
Trifascicular block 21.87 13.66 7 58639 210 110530443
Drug level increased 21.64 13.66 65 58581 47654 110482999
Pemphigoid 21.51 13.66 38 58608 19669 110510984
Oropharyngeal pain 21.48 13.66 24 58622 135252 110395401
Urea cycle disorder 21.22 13.66 5 58641 45 110530608
Pulmonary fibrosis 21.20 13.66 14 58632 102028 110428625
Bifascicular block 21.18 13.66 8 58638 396 110530257
Haemorrhagic stroke 21.09 13.66 31 58615 13758 110516895
Intention tremor 20.96 13.66 10 58636 884 110529769
Septic shock 20.85 13.66 32 58614 157496 110373157
Hypotonia 20.71 13.66 33 58613 15712 110514941
Urinary tract disorder 20.39 13.66 20 58626 5824 110524829
Food refusal 20.39 13.66 10 58636 940 110529713
Red blood cell sedimentation rate increased 20.36 13.66 8 58638 78294 110452359
Hangover 20.32 13.66 14 58632 2488 110528165
Product prescribing issue 19.95 13.66 29 58617 12743 110517910
Supraventricular extrasystoles 19.95 13.66 23 58623 8050 110522603
Gastrooesophageal reflux disease 19.83 13.66 41 58605 179935 110350718
Ventricular tachycardia 19.80 13.66 65 58581 49944 110480709
Hip arthroplasty 19.74 13.66 3 58643 55810 110474843
Gastrointestinal ulcer 19.57 13.66 17 58629 4243 110526410
Injection site erythema 19.46 13.66 13 58633 94163 110436490
Suspiciousness 19.28 13.66 9 58637 758 110529895
Blood creatine increased 19.24 13.66 27 58619 11494 110519159
Affect lability 19.15 13.66 35 58611 18602 110512051
Communication disorder 19.01 13.66 18 58628 5021 110525632
Musculoskeletal stiffness 19.01 13.66 80 58566 279742 110250911
Joint stiffness 18.97 13.66 6 58640 67237 110463416
Colitis microscopic 18.90 13.66 29 58617 13365 110517288
Gastric ulcer haemorrhage 18.89 13.66 25 58621 10069 110520584
Chest discomfort 18.82 13.66 40 58606 173808 110356845
Mental disorder 18.70 13.66 54 58592 38737 110491916
Cardio-respiratory arrest 18.57 13.66 115 58531 115721 110414932
Vomiting 18.50 13.66 622 58024 910053 109620600
Liver function test abnormal 18.44 13.66 79 58567 68871 110461782
Disease progression 18.34 13.66 67 58579 243967 110286686
Oedema 18.30 13.66 54 58592 209922 110320731
Cholesteatoma 18.29 13.66 6 58640 195 110530458
Intestinal haemorrhage 18.29 13.66 21 58625 7320 110523333
Normal pressure hydrocephalus 18.24 13.66 8 58638 582 110530071
Apraxia 18.05 13.66 15 58631 3525 110527128
Dry mouth 17.73 13.66 51 58595 199897 110330756
Vascular dementia 17.64 13.66 9 58637 920 110529733
Rapid eye movement sleep behaviour disorder 17.63 13.66 8 58638 631 110530022
Cholinesterase inhibition 17.55 13.66 3 58643 3 110530650
Stress 17.49 13.66 18 58628 105330 110425323
Marasmus 17.47 13.66 11 58635 1680 110528973
Inappropriate affect 17.43 13.66 11 58635 1688 110528965
Drug reaction with eosinophilia and systemic symptoms 17.41 13.66 11 58635 82084 110448569
Tongue dry 17.15 13.66 10 58636 1330 110529323
Presyncope 17.13 13.66 61 58585 48826 110481827
Lower gastrointestinal haemorrhage 16.86 13.66 33 58613 18453 110512200
Senile dementia 16.67 13.66 6 58640 259 110530394
Bone marrow failure 16.61 13.66 5 58641 57843 110472810
Overdose 16.44 13.66 193 58453 233601 110297052
Bone pain 16.37 13.66 7 58639 65126 110465527
Brain compression 16.30 13.66 8 58638 753 110529900
Non-24-hour sleep-wake disorder 16.17 13.66 4 58642 45 110530608
Upper respiratory tract infection 16.15 13.66 28 58618 131300 110399353
Lower limb fracture 16.11 13.66 10 58636 75338 110455315
Aphasia 16.09 13.66 68 58578 58929 110471724
Nasal congestion 16.08 13.66 17 58629 98265 110432388
Femur fracture 16.02 13.66 56 58590 44413 110486240
Serotonin syndrome 15.99 13.66 68 58578 59085 110471568
Thalamus haemorrhage 15.97 13.66 11 58635 1953 110528700
Prescription drug used without a prescription 15.90 13.66 17 58629 5479 110525174
Diabetes mellitus inadequate control 15.88 13.66 43 58603 29732 110500921
International normalised ratio increased 15.74 13.66 89 58557 86683 110443970
Decreased interest 15.66 13.66 16 58630 4892 110525761
Anaphylactic shock 15.65 13.66 4 58642 51542 110479111
Hiccups 15.61 13.66 26 58620 12843 110517810
Therapy non-responder 15.56 13.66 38 58608 157269 110373384
Blood glucose abnormal 15.54 13.66 26 58620 12890 110517763
Pain in jaw 15.49 13.66 4 58642 51173 110479480
Gastroenteritis pseudomonas 15.37 13.66 4 58642 56 110530597
Sedation complication 15.23 13.66 33 58613 19822 110510831
Euphoric mood 15.21 13.66 21 58625 8806 110521847
Asthenia 15.11 13.66 475 58171 688524 109842129
Coma scale abnormal 15.07 13.66 22 58624 9704 110520949
Eye movement disorder 15.07 13.66 22 58624 9706 110520947
Product blister packaging issue 14.91 13.66 6 58640 352 110530301
COVID-19 14.88 13.66 73 58573 244987 110285666
Amyloid related imaging abnormalities 14.87 13.66 4 58642 64 110530589
Blood creatine phosphokinase increased 14.63 13.66 77 58569 73000 110457653
Spinal compression fracture 14.61 13.66 31 58615 18361 110512292
Failure to thrive 14.59 13.66 26 58620 13548 110517105
Foaming at mouth 14.54 13.66 11 58635 2259 110528394
Neck pain 14.47 13.66 27 58619 123103 110407550
Product quality issue 14.26 13.66 12 58634 77287 110453366
Oesophageal ulcer 13.80 13.66 19 58627 7945 110522708
Intercepted product dispensing error 13.78 13.66 5 58641 221 110530432
Defect conduction intraventricular 13.73 13.66 7 58639 714 110529939
Electrocardiogram T wave inversion 13.73 13.66 16 58630 5664 110524989
Injection site pruritus 13.72 13.66 5 58641 51253 110479400
Acute psychosis 13.68 13.66 15 58631 4972 110525681

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
MeSH PA D002800 Cholinesterase Inhibitors
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D018678 Cholinergic Agents
MeSH PA D018697 Nootropic Agents
CHEBI has role CHEBI:35469 antidepressant
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:38462 EC 3.1.1.7 (acetylcholinesterase) inhibitor
FDA EPC N0000175723 Cholinesterase Inhibitor
CHEBI has role CHEBI:35474 anxiolytic drug
CHEBI has role CHEBI:35476 antipsychotic agent
CHEBI has role CHEBI:35526 hypoglycemic agent
CHEBI has role CHEBI:35705 immunosuppressive agent
CHEBI has role CHEBI:37733 EC 3.1.1.8 (cholinesterase) inhibitor
CHEBI has role CHEBI:48407 antiparkinson drug
CHEBI has role CHEBI:66980 nootropic agent
CHEBI has role CHEBI:73336 vulnerary

Related Drugs by ATC class:

N06DA Anticholinesterases 5 drugs
galantamineipidacrinememantinerivastigminetacrine

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




🐶 Veterinary Drug Use

None

🐶 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 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 DISCN SYSTEM TRANSDERMAL 12161767 Dec. 30, 2036 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 DISCN SYSTEM TRANSDERMAL 12168075 Dec. 30, 2036 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 DISCN SYSTEM TRANSDERMAL 12161767 Dec. 30, 2036 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 DISCN SYSTEM TRANSDERMAL 12168075 Dec. 30, 2036 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 DISCN 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 DISCN 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 DISCN 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 DISCN 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 DISCN 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 DISCN 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 DISCN 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 DISCN 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 DISCN 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 DISCN 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 DISCN 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 DISCN 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
cGMP-specific 3',5'-cyclic phosphodiesterase Enzyme IC50 7.96 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
MAP/microtubule affinity-regulating kinase 4 Kinase IC50 5.28 CHEMBL
Fatty-acid amide hydrolase 1 Enzyme IC50 5.28 CHEMBL
Amyloid beta A4 protein Membrane other IC50 4.06 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
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
870555-76-3 SECONDARY_CAS_RN
8SSC91326P INXIGHT DRUGS

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 19 sections
Donepezil Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-7952 TABLET, FILM COATED 10 mg ORAL ANDA 19 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 0904-6477 TABLET, FILM COATED 5 mg ORAL ANDA 26 sections
Donepezil Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-6478 TABLET, FILM COATED 10 mg ORAL ANDA 26 sections
Donepezil Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 13668-102 TABLET, FILM COATED 5 mg ORAL ANDA 26 sections
Donepezil Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 13668-103 TABLET, FILM COATED 10 mg ORAL ANDA 26 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 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 20 sections
Donepezil HUMAN PRESCRIPTION DRUG LABEL 1 31722-738 TABLET 10 mg ORAL ANDA 20 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 19 sections
Donepezil Hydrochloride Human Prescription Drug Label 1 33342-028 TABLET, FILM COATED 10 mg ORAL ANDA 19 sections
Donepezil Hydrochloride Human Prescription Drug Label 1 33342-029 TABLET, ORALLY DISINTEGRATING 5 mg ORAL ANDA 18 sections
Donepezil Hydrochloride Human Prescription Drug Label 1 33342-029 TABLET, ORALLY DISINTEGRATING 5 mg ORAL ANDA 18 sections
Donepezil Hydrochloride Human Prescription Drug Label 1 33342-030 TABLET, ORALLY DISINTEGRATING 10 mg ORAL ANDA 18 sections