donepezil 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| 946 | 120014-06-4 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
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.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 7.50 | mg | O |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| 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 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Nov. 25, 1996 | FDA | EISAI INC |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Bradycardia | 545.21 | 13.12 | 394 | 31385 | 64032 | 50509313 |
| Fall | 430.17 | 13.12 | 759 | 31020 | 334173 | 50239172 |
| Syncope | 313.74 | 13.12 | 354 | 31425 | 102648 | 50470697 |
| Electrocardiogram QT prolonged | 256.61 | 13.12 | 232 | 31547 | 51654 | 50521691 |
| Dementia | 255.10 | 13.12 | 146 | 31633 | 15851 | 50557494 |
| Sinus bradycardia | 222.82 | 13.12 | 125 | 31654 | 13058 | 50560287 |
| Confusional state | 205.63 | 13.12 | 396 | 31383 | 185532 | 50387813 |
| Drug interaction | 200.10 | 13.12 | 408 | 31371 | 199213 | 50374132 |
| Hallucination | 196.78 | 13.12 | 191 | 31588 | 46466 | 50526879 |
| Torsade de pointes | 175.35 | 13.12 | 103 | 31676 | 11732 | 50561613 |
| Agitation | 170.05 | 13.12 | 188 | 31591 | 53196 | 50520149 |
| Aggression | 162.19 | 13.12 | 122 | 31657 | 20994 | 50552351 |
| Delusion | 146.19 | 13.12 | 88 | 31691 | 10481 | 50562864 |
| Cognitive disorder | 136.39 | 13.12 | 153 | 31626 | 43970 | 50529375 |
| Parkinsonism | 133.71 | 13.12 | 78 | 31701 | 8769 | 50564576 |
| Neuroleptic malignant syndrome | 126.99 | 13.12 | 82 | 31697 | 11048 | 50562297 |
| Drug ineffective | 126.16 | 13.12 | 201 | 31578 | 819132 | 49754213 |
| Abnormal behaviour | 125.87 | 13.12 | 102 | 31677 | 19556 | 50553789 |
| Delirium | 120.72 | 13.12 | 134 | 31645 | 38058 | 50535287 |
| Pleurothotonus | 112.60 | 13.12 | 39 | 31740 | 1262 | 50572083 |
| Seizure | 109.75 | 13.12 | 234 | 31545 | 117640 | 50455705 |
| Arthralgia | 99.69 | 13.12 | 78 | 31701 | 438624 | 50134721 |
| Somnolence | 98.21 | 13.12 | 265 | 31514 | 154720 | 50418625 |
| Sinus node dysfunction | 93.71 | 13.12 | 47 | 31732 | 3908 | 50569437 |
| Hallucination, visual | 93.61 | 13.12 | 80 | 31699 | 16502 | 50556843 |
| Pain | 92.68 | 13.12 | 138 | 31641 | 578765 | 49994580 |
| Cholinergic syndrome | 91.41 | 13.12 | 25 | 31754 | 357 | 50572988 |
| Altered state of consciousness | 89.14 | 13.12 | 88 | 31691 | 21822 | 50551523 |
| Loss of consciousness | 85.64 | 13.12 | 197 | 31582 | 104156 | 50469189 |
| Femoral neck fracture | 84.99 | 13.12 | 55 | 31724 | 7435 | 50565910 |
| Joint swelling | 82.04 | 13.12 | 26 | 31753 | 245260 | 50328085 |
| Electrocardiogram PR prolongation | 81.92 | 13.12 | 26 | 31753 | 637 | 50572708 |
| Hypersensitivity | 81.05 | 13.12 | 18 | 31761 | 215143 | 50358202 |
| Decreased appetite | 80.47 | 13.12 | 293 | 31486 | 200630 | 50372715 |
| Tremor | 80.44 | 13.12 | 204 | 31575 | 114699 | 50458646 |
| Urinary retention | 79.50 | 13.12 | 90 | 31689 | 26100 | 50547245 |
| Extrapyramidal disorder | 79.44 | 13.12 | 63 | 31716 | 11707 | 50561638 |
| Alopecia | 78.42 | 13.12 | 28 | 31751 | 245019 | 50328326 |
| Rash | 78.29 | 13.12 | 96 | 31683 | 437375 | 50135970 |
| Muscle rigidity | 78.16 | 13.12 | 58 | 31721 | 9771 | 50563574 |
| Atrioventricular block first degree | 76.49 | 13.12 | 48 | 31731 | 6153 | 50567192 |
| Myoclonus | 76.00 | 13.12 | 67 | 31712 | 14403 | 50558942 |
| Dehydration | 74.80 | 13.12 | 238 | 31541 | 152211 | 50421134 |
| Torticollis | 73.88 | 13.12 | 31 | 31748 | 1705 | 50571640 |
| Hypokalaemia | 73.16 | 13.12 | 167 | 31612 | 87825 | 50485520 |
| Rheumatoid arthritis | 72.26 | 13.12 | 19 | 31760 | 202531 | 50370814 |
| Depressed level of consciousness | 70.34 | 13.12 | 121 | 31658 | 51832 | 50521513 |
| Treatment failure | 70.25 | 13.12 | 4 | 31775 | 137633 | 50435712 |
| Hypothermia | 69.92 | 13.12 | 59 | 31720 | 11957 | 50561388 |
| Systemic lupus erythematosus | 69.06 | 13.12 | 5 | 31774 | 140617 | 50432728 |
| Infusion related reaction | 68.42 | 13.12 | 12 | 31767 | 169545 | 50403800 |
| Dementia Alzheimer's type | 66.93 | 13.12 | 25 | 31754 | 1009 | 50572336 |
| Mania | 66.42 | 13.12 | 55 | 31724 | 10861 | 50562484 |
| Sinusitis | 62.75 | 13.12 | 15 | 31764 | 170543 | 50402802 |
| Hypophagia | 62.54 | 13.12 | 82 | 31697 | 27646 | 50545699 |
| Immobile | 62.03 | 13.12 | 39 | 31740 | 5015 | 50568330 |
| Arthropathy | 61.94 | 13.12 | 12 | 31767 | 157894 | 50415451 |
| Nightmare | 60.64 | 13.12 | 62 | 31717 | 16024 | 50557321 |
| Mental status changes | 57.89 | 13.12 | 91 | 31688 | 36181 | 50537164 |
| Swelling | 57.68 | 13.12 | 27 | 31752 | 200845 | 50372500 |
| Urinary incontinence | 56.89 | 13.12 | 79 | 31700 | 28129 | 50545216 |
| Lethargy | 55.31 | 13.12 | 106 | 31673 | 49326 | 50524019 |
| Drug intolerance | 54.85 | 13.12 | 35 | 31744 | 219069 | 50354276 |
| Urinary tract infection | 54.41 | 13.12 | 281 | 31498 | 223739 | 50349606 |
| Pemphigus | 54.35 | 13.12 | 6 | 31773 | 120160 | 50453185 |
| Glossodynia | 54.27 | 13.12 | 5 | 31774 | 115564 | 50457781 |
| Disorientation | 53.85 | 13.12 | 87 | 31692 | 35397 | 50537948 |
| Dyskinesia | 53.18 | 13.12 | 76 | 31703 | 27785 | 50545560 |
| Sudden death | 52.01 | 13.12 | 44 | 31735 | 8947 | 50564398 |
| Drug hypersensitivity | 49.26 | 13.12 | 51 | 31728 | 250959 | 50322386 |
| Restlessness | 48.53 | 13.12 | 69 | 31710 | 25104 | 50548241 |
| Wandering pacemaker | 48.44 | 13.12 | 8 | 31771 | 3 | 50573342 |
| Atrioventricular block complete | 45.07 | 13.12 | 37 | 31742 | 7218 | 50566127 |
| Pruritus | 44.80 | 13.12 | 68 | 31711 | 283500 | 50289845 |
| Anal incontinence | 44.61 | 13.12 | 45 | 31734 | 11445 | 50561900 |
| Sexually inappropriate behaviour | 44.46 | 13.12 | 11 | 31768 | 103 | 50573242 |
| Hypocapnia | 44.42 | 13.12 | 14 | 31765 | 335 | 50573010 |
| Reduced facial expression | 43.92 | 13.12 | 21 | 31758 | 1573 | 50571772 |
| Medication error | 43.59 | 13.12 | 80 | 31699 | 36024 | 50537321 |
| Pain in extremity | 43.53 | 13.12 | 65 | 31714 | 272800 | 50300545 |
| Gastrointestinal haemorrhage | 43.01 | 13.12 | 122 | 31657 | 73199 | 50500146 |
| Psychomotor hyperactivity | 42.82 | 13.12 | 40 | 31739 | 9261 | 50564084 |
| Circulatory collapse | 41.81 | 13.12 | 57 | 31722 | 19943 | 50553402 |
| Encephalopathy | 41.08 | 13.12 | 75 | 31704 | 33636 | 50539709 |
| Therapeutic product effect decreased | 41.06 | 13.12 | 17 | 31762 | 136033 | 50437312 |
| Lower respiratory tract infection | 40.04 | 13.12 | 6 | 31773 | 95195 | 50478150 |
| Epilepsy | 39.94 | 13.12 | 58 | 31721 | 21509 | 50551836 |
| Hyponatraemia | 39.93 | 13.12 | 142 | 31637 | 95997 | 50477348 |
| Hip fracture | 39.92 | 13.12 | 64 | 31715 | 25867 | 50547478 |
| Apathy | 39.73 | 13.12 | 35 | 31744 | 7513 | 50565832 |
| Cerebral atrophy | 38.49 | 13.12 | 28 | 31751 | 4573 | 50568772 |
| Unresponsive to stimuli | 38.45 | 13.12 | 69 | 31710 | 30540 | 50542805 |
| Pericarditis | 38.04 | 13.12 | 3 | 31776 | 78686 | 50494659 |
| Pneumonia aspiration | 37.81 | 13.12 | 69 | 31710 | 30935 | 50542410 |
| Neuropsychiatric symptoms | 37.48 | 13.12 | 14 | 31765 | 565 | 50572780 |
| Febrile neutropenia | 37.08 | 13.12 | 8 | 31771 | 97659 | 50475686 |
| Dizziness | 35.73 | 13.12 | 353 | 31426 | 346016 | 50227329 |
| Generalised tonic-clonic seizure | 35.23 | 13.12 | 61 | 31718 | 26249 | 50547096 |
| Off label use | 35.12 | 13.12 | 166 | 31613 | 474260 | 50099085 |
| Dementia with Lewy bodies | 34.37 | 13.12 | 11 | 31768 | 277 | 50573068 |
| Weight increased | 34.25 | 13.12 | 46 | 31733 | 201845 | 50371500 |
| Cough | 34.24 | 13.12 | 62 | 31717 | 241202 | 50332143 |
| Long QT syndrome | 34.18 | 13.12 | 22 | 31757 | 2945 | 50570400 |
| Atrioventricular block | 34.02 | 13.12 | 30 | 31749 | 6448 | 50566897 |
| Listless | 33.30 | 13.12 | 20 | 31759 | 2370 | 50570975 |
| Infection | 32.94 | 13.12 | 36 | 31743 | 172918 | 50400427 |
| Tardive dyskinesia | 32.92 | 13.12 | 31 | 31748 | 7248 | 50566097 |
| Atrial tachycardia | 32.74 | 13.12 | 19 | 31760 | 2113 | 50571232 |
| Miosis | 32.69 | 13.12 | 29 | 31750 | 6281 | 50567064 |
| Accidental overdose | 32.55 | 13.12 | 50 | 31729 | 19483 | 50553862 |
| Rhabdomyolysis | 32.32 | 13.12 | 74 | 31705 | 38953 | 50534392 |
| Gait disturbance | 32.18 | 13.12 | 182 | 31597 | 149823 | 50423522 |
| Hypotension | 32.01 | 13.12 | 255 | 31524 | 235214 | 50338131 |
| Abdominal discomfort | 31.57 | 13.12 | 61 | 31718 | 231580 | 50341765 |
| Lack of spontaneous speech | 31.39 | 13.12 | 9 | 31770 | 154 | 50573191 |
| Sialoadenitis | 31.31 | 13.12 | 16 | 31763 | 1384 | 50571961 |
| Wrong patient received product | 31.13 | 13.12 | 17 | 31762 | 1683 | 50571662 |
| Fracture | 30.78 | 13.12 | 45 | 31734 | 16788 | 50556557 |
| Dyspnoea | 30.10 | 13.12 | 211 | 31568 | 547397 | 50025948 |
| Stomatitis | 30.03 | 13.12 | 13 | 31766 | 101331 | 50472014 |
| Incontinence | 29.76 | 13.12 | 34 | 31745 | 9951 | 50563394 |
| Paratonia | 29.01 | 13.12 | 6 | 31773 | 22 | 50573323 |
| Nasopharyngitis | 28.80 | 13.12 | 48 | 31731 | 192879 | 50380466 |
| Fluid intake reduced | 28.42 | 13.12 | 20 | 31759 | 3102 | 50570243 |
| Headache | 28.41 | 13.12 | 194 | 31585 | 506341 | 50067004 |
| Sinus arrest | 28.40 | 13.12 | 16 | 31763 | 1682 | 50571663 |
| Hepatic enzyme increased | 27.96 | 13.12 | 27 | 31752 | 137353 | 50435992 |
| Dysarthria | 27.80 | 13.12 | 68 | 31711 | 37335 | 50536010 |
| Product administration interrupted | 26.67 | 13.12 | 13 | 31766 | 1016 | 50572329 |
| Cerebrovascular accident | 26.67 | 13.12 | 124 | 31655 | 94556 | 50478789 |
| Fatigue | 26.44 | 13.12 | 301 | 31478 | 707300 | 49866045 |
| Colitis microscopic | 26.16 | 13.12 | 26 | 31753 | 6494 | 50566851 |
| Atrial fibrillation | 25.60 | 13.12 | 129 | 31650 | 101616 | 50471729 |
| Death | 25.43 | 13.12 | 314 | 31465 | 325065 | 50248280 |
| Memory impairment | 25.42 | 13.12 | 108 | 31671 | 79252 | 50494093 |
| Therapeutic product effect incomplete | 25.18 | 13.12 | 13 | 31766 | 91502 | 50481843 |
| Suspiciousness | 25.10 | 13.12 | 9 | 31770 | 323 | 50573022 |
| Hyperhidrosis | 25.10 | 13.12 | 117 | 31662 | 89309 | 50484036 |
| Hypernatraemia | 24.98 | 13.12 | 25 | 31754 | 6296 | 50567049 |
| Anger | 24.75 | 13.12 | 33 | 31746 | 11300 | 50562045 |
| Oropharyngeal pain | 24.66 | 13.12 | 9 | 31770 | 77792 | 50495553 |
| Vomiting | 24.64 | 13.12 | 416 | 31363 | 460342 | 50113003 |
| Pelvic fracture | 24.33 | 13.12 | 33 | 31746 | 11487 | 50561858 |
| Impaired healing | 24.01 | 13.12 | 7 | 31772 | 69779 | 50503566 |
| Wound | 23.69 | 13.12 | 19 | 31760 | 105775 | 50467570 |
| Speech disorder | 23.68 | 13.12 | 62 | 31717 | 35486 | 50537859 |
| Psoriasis | 23.59 | 13.12 | 7 | 31772 | 68993 | 50504352 |
| Chorea | 23.43 | 13.12 | 13 | 31766 | 1327 | 50572018 |
| Cerebral infarction | 22.54 | 13.12 | 45 | 31734 | 21559 | 50551786 |
| Grandiosity | 22.53 | 13.12 | 8 | 31771 | 279 | 50573066 |
| Product use issue | 22.47 | 13.12 | 37 | 31742 | 149438 | 50423907 |
| Discomfort | 22.40 | 13.12 | 21 | 31758 | 108359 | 50464986 |
| Hypersexuality | 22.36 | 13.12 | 9 | 31770 | 445 | 50572900 |
| Salivary hypersecretion | 22.33 | 13.12 | 24 | 31755 | 6567 | 50566778 |
| Irritable bowel syndrome | 22.19 | 13.12 | 3 | 31776 | 51438 | 50521907 |
| Hypoglycaemia | 22.11 | 13.12 | 79 | 31700 | 53502 | 50519843 |
| Cerebral haemorrhage | 22.07 | 13.12 | 51 | 31728 | 27001 | 50546344 |
| Skull fracture | 21.92 | 13.12 | 11 | 31768 | 915 | 50572430 |
| Herbal interaction | 21.92 | 13.12 | 6 | 31773 | 86 | 50573259 |
| Muscle contracture | 21.90 | 13.12 | 12 | 31767 | 1195 | 50572150 |
| Food refusal | 21.63 | 13.12 | 8 | 31771 | 314 | 50573031 |
| Brain compression | 21.20 | 13.12 | 8 | 31771 | 332 | 50573013 |
| Drug level increased | 21.15 | 13.12 | 41 | 31738 | 19227 | 50554118 |
| Social avoidant behaviour | 21.11 | 13.12 | 16 | 31763 | 2781 | 50570564 |
| Intentional product use issue | 21.05 | 13.12 | 11 | 31768 | 76907 | 50496438 |
| Non-24-hour sleep-wake disorder | 20.79 | 13.12 | 4 | 31775 | 9 | 50573336 |
| Hyponatraemic syndrome | 20.78 | 13.12 | 9 | 31770 | 535 | 50572810 |
| Sinoatrial block | 20.72 | 13.12 | 10 | 31769 | 765 | 50572580 |
| Posture abnormal | 20.46 | 13.12 | 14 | 31765 | 2075 | 50571270 |
| Chest discomfort | 20.33 | 13.12 | 17 | 31762 | 92705 | 50480640 |
| Injection site pain | 20.16 | 13.12 | 24 | 31755 | 111000 | 50462345 |
| Bedridden | 20.03 | 13.12 | 27 | 31752 | 9340 | 50564005 |
| Abnormal dreams | 20.01 | 13.12 | 27 | 31752 | 9350 | 50563995 |
| Sedation | 19.99 | 13.12 | 53 | 31726 | 30557 | 50542788 |
| Upper gastrointestinal haemorrhage | 19.94 | 13.12 | 36 | 31743 | 15999 | 50557346 |
| Psoriatic arthropathy | 19.69 | 13.12 | 3 | 31776 | 47029 | 50526316 |
| Peripheral swelling | 19.67 | 13.12 | 65 | 31714 | 205871 | 50367474 |
| Adams-Stokes syndrome | 19.65 | 13.12 | 5 | 31774 | 53 | 50573292 |
| Amyloid related imaging abnormality-oedema/effusion | 19.49 | 13.12 | 4 | 31775 | 14 | 50573331 |
| Parkinson's disease | 19.29 | 13.12 | 11 | 31768 | 1184 | 50572161 |
| Neutropenia | 19.25 | 13.12 | 40 | 31739 | 147925 | 50425420 |
| Overconfidence | 19.12 | 13.12 | 3 | 31776 | 0 | 50573345 |
| Incoherent | 19.10 | 13.12 | 18 | 31761 | 4212 | 50569133 |
| Ventricular tachycardia | 19.02 | 13.12 | 35 | 31744 | 15786 | 50557559 |
| Cholesteatoma | 18.98 | 13.12 | 6 | 31773 | 145 | 50573200 |
| Foreign body | 18.81 | 13.12 | 13 | 31766 | 1958 | 50571387 |
| Psychotic disorder | 18.77 | 13.12 | 42 | 31737 | 21770 | 50551575 |
| Urticaria | 18.62 | 13.12 | 33 | 31746 | 129528 | 50443817 |
| Blood pressure orthostatic decreased | 18.57 | 13.12 | 5 | 31774 | 67 | 50573278 |
| Executive dysfunction | 18.49 | 13.12 | 6 | 31773 | 158 | 50573187 |
| Antisocial behaviour | 18.32 | 13.12 | 7 | 31772 | 301 | 50573044 |
| Pyrexia | 18.24 | 13.12 | 152 | 31627 | 380051 | 50193294 |
| Emotional poverty | 18.21 | 13.12 | 7 | 31772 | 306 | 50573039 |
| Orthostatic hypotension | 18.21 | 13.12 | 50 | 31729 | 29431 | 50543914 |
| Hypertonia | 18.12 | 13.12 | 17 | 31762 | 3956 | 50569389 |
| Prescription drug used without a prescription | 18.10 | 13.12 | 12 | 31767 | 1688 | 50571657 |
| Obsessive thoughts | 18.08 | 13.12 | 8 | 31771 | 501 | 50572844 |
| Liver function test abnormal | 17.97 | 13.12 | 65 | 31714 | 44274 | 50529071 |
| Leukaemoid reaction | 17.85 | 13.12 | 6 | 31773 | 177 | 50573168 |
| Affect lability | 17.83 | 13.12 | 25 | 31754 | 8973 | 50564372 |
| Anaphylactic reaction | 17.56 | 13.12 | 6 | 31773 | 54049 | 50519296 |
| Pressure of speech | 17.43 | 13.12 | 8 | 31771 | 546 | 50572799 |
| Anorgasmia | 17.42 | 13.12 | 8 | 31771 | 547 | 50572798 |
| Injection site erythema | 17.35 | 13.12 | 13 | 31766 | 74923 | 50498422 |
| Haematoma | 17.14 | 13.12 | 50 | 31729 | 30460 | 50542885 |
| Intercepted product dispensing error | 17.05 | 13.12 | 5 | 31774 | 93 | 50573252 |
| Myalgia | 16.69 | 13.12 | 33 | 31746 | 124286 | 50449059 |
| Dysphagia | 16.57 | 13.12 | 94 | 31685 | 77424 | 50495921 |
| Arthritis | 16.55 | 13.12 | 18 | 31761 | 86703 | 50486642 |
| Drooling | 16.44 | 13.12 | 15 | 31764 | 3369 | 50569976 |
| Aphasia | 16.30 | 13.12 | 47 | 31732 | 28447 | 50544898 |
| Haematemesis | 16.12 | 13.12 | 46 | 31733 | 27679 | 50545666 |
| Drop attacks | 16.07 | 13.12 | 8 | 31771 | 654 | 50572691 |
| Normal pressure hydrocephalus | 15.90 | 13.12 | 6 | 31773 | 249 | 50573096 |
| Dyspepsia | 15.73 | 13.12 | 14 | 31765 | 74083 | 50499262 |
| Blood glucose fluctuation | 15.66 | 13.12 | 16 | 31763 | 4130 | 50569215 |
| Injection site reaction | 15.50 | 13.12 | 6 | 31773 | 50026 | 50523319 |
| Duodenal ulcer haemorrhage | 15.49 | 13.12 | 12 | 31767 | 2154 | 50571191 |
| Product use in unapproved indication | 15.32 | 13.12 | 31 | 31748 | 115788 | 50457557 |
| Progressive supranuclear palsy | 15.27 | 13.12 | 4 | 31775 | 48 | 50573297 |
| Disease progression | 15.09 | 13.12 | 23 | 31756 | 95843 | 50477502 |
| Head injury | 15.09 | 13.12 | 41 | 31738 | 23979 | 50549366 |
| Communication disorder | 15.03 | 13.12 | 12 | 31767 | 2249 | 50571096 |
| Delusion of grandeur | 14.86 | 13.12 | 5 | 31774 | 148 | 50573197 |
| Acute abdomen | 14.84 | 13.12 | 10 | 31769 | 1446 | 50571899 |
| Heart rate increased | 14.78 | 13.12 | 16 | 31763 | 77234 | 50496111 |
| Subdural haematoma | 14.76 | 13.12 | 28 | 31751 | 12919 | 50560426 |
| Injection site swelling | 14.72 | 13.12 | 4 | 31775 | 41769 | 50531576 |
| Product blister packaging issue | 14.67 | 13.12 | 5 | 31774 | 154 | 50573191 |
| Fibromyalgia | 14.60 | 13.12 | 5 | 31774 | 44973 | 50528372 |
| Inappropriate affect | 14.58 | 13.12 | 8 | 31771 | 799 | 50572546 |
| Hypoaesthesia | 14.45 | 13.12 | 37 | 31742 | 127220 | 50446125 |
| Nasal congestion | 14.45 | 13.12 | 7 | 31772 | 51113 | 50522232 |
| Opisthotonus | 14.42 | 13.12 | 6 | 31773 | 323 | 50573022 |
| Paraesthesia | 14.41 | 13.12 | 34 | 31745 | 120209 | 50453136 |
| Hepatic function abnormal | 14.18 | 13.12 | 49 | 31730 | 32632 | 50540713 |
| Pemphigoid | 14.14 | 13.12 | 18 | 31761 | 5889 | 50567456 |
| Melaena | 14.11 | 13.12 | 43 | 31736 | 26821 | 50546524 |
| Gastric ulcer | 14.03 | 13.12 | 37 | 31742 | 21268 | 50552077 |
| Delusional disorder, persecutory type | 14.01 | 13.12 | 5 | 31774 | 177 | 50573168 |
| Paranoia | 13.86 | 13.12 | 24 | 31755 | 10324 | 50563021 |
| Flushing | 13.83 | 13.12 | 13 | 31766 | 67002 | 50506343 |
| Theft | 13.82 | 13.12 | 4 | 31775 | 71 | 50573274 |
| Libido increased | 13.79 | 13.12 | 9 | 31770 | 1234 | 50572111 |
| Thalamus haemorrhage | 13.72 | 13.12 | 7 | 31772 | 603 | 50572742 |
| Neuropathy peripheral | 13.58 | 13.12 | 25 | 31754 | 96732 | 50476613 |
| Lower gastrointestinal haemorrhage | 13.47 | 13.12 | 19 | 31760 | 6860 | 50566485 |
| Visuospatial deficit | 13.44 | 13.12 | 3 | 31776 | 17 | 50573328 |
| Discoloured vomit | 13.29 | 13.12 | 7 | 31772 | 644 | 50572701 |
| Ill-defined disorder | 13.29 | 13.12 | 9 | 31770 | 54645 | 50518700 |
FDA Adverse Event Reporting System (Male)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Hallucination | 368.42 | 13.68 | 290 | 22083 | 44422 | 29507732 |
| Fall | 316.91 | 13.68 | 516 | 21857 | 176662 | 29375492 |
| Bradycardia | 288.90 | 13.68 | 299 | 22074 | 65330 | 29486824 |
| Dementia | 253.50 | 13.68 | 139 | 22234 | 11519 | 29540635 |
| Confusional state | 245.39 | 13.68 | 385 | 21988 | 127492 | 29424662 |
| Delusion | 178.00 | 13.68 | 109 | 22264 | 11107 | 29541047 |
| Agitation | 157.53 | 13.68 | 194 | 22179 | 51110 | 29501044 |
| Delirium | 137.39 | 13.68 | 159 | 22214 | 39238 | 29512916 |
| Pleurothotonus | 129.95 | 13.68 | 43 | 22330 | 995 | 29551159 |
| Aggression | 128.23 | 13.68 | 146 | 22227 | 35395 | 29516759 |
| Abnormal behaviour | 121.14 | 13.68 | 116 | 22257 | 23011 | 29529143 |
| Cognitive disorder | 117.70 | 13.68 | 115 | 22258 | 23384 | 29528770 |
| Cholinergic syndrome | 102.44 | 13.68 | 30 | 22343 | 456 | 29551698 |
| Depressed level of consciousness | 93.43 | 13.68 | 127 | 22246 | 36815 | 29515339 |
| Mania | 90.77 | 13.68 | 65 | 22308 | 8598 | 29543556 |
| Somnolence | 81.51 | 13.68 | 203 | 22170 | 93752 | 29458402 |
| Hallucination, visual | 79.91 | 13.68 | 76 | 22297 | 14939 | 29537215 |
| Neuroleptic malignant syndrome | 77.07 | 13.68 | 77 | 22296 | 16071 | 29536083 |
| Urinary incontinence | 73.94 | 13.68 | 76 | 22297 | 16405 | 29535749 |
| Sinus bradycardia | 71.99 | 13.68 | 64 | 22309 | 11539 | 29540615 |
| Syncope | 71.80 | 13.68 | 177 | 22196 | 81194 | 29470960 |
| Febrile neutropenia | 58.14 | 13.68 | 8 | 22365 | 112232 | 29439922 |
| Nightmare | 57.37 | 13.68 | 56 | 22317 | 11361 | 29540793 |
| Balance disorder | 57.08 | 13.68 | 100 | 22273 | 36070 | 29516084 |
| Gait disturbance | 56.87 | 13.68 | 152 | 22221 | 73197 | 29478957 |
| Blood cholinesterase decreased | 56.75 | 13.68 | 14 | 22359 | 105 | 29552049 |
| Sinus node dysfunction | 55.94 | 13.68 | 35 | 22338 | 3699 | 29548455 |
| Memory impairment | 48.92 | 13.68 | 94 | 22279 | 36376 | 29515778 |
| Death | 46.77 | 13.68 | 428 | 21945 | 341656 | 29210498 |
| Poriomania | 44.65 | 13.68 | 11 | 22362 | 82 | 29552072 |
| Prescribed underdose | 44.47 | 13.68 | 41 | 22332 | 7745 | 29544409 |
| Orthostatic hypotension | 44.36 | 13.68 | 69 | 22304 | 22560 | 29529594 |
| Libido increased | 42.02 | 13.68 | 17 | 22356 | 704 | 29551450 |
| Pneumonia aspiration | 41.30 | 13.68 | 88 | 22285 | 36649 | 29515505 |
| Parkinsonism | 40.94 | 13.68 | 38 | 22335 | 7240 | 29544914 |
| Unresponsive to stimuli | 40.32 | 13.68 | 70 | 22303 | 25056 | 29527098 |
| Tremor | 37.82 | 13.68 | 132 | 22241 | 73406 | 29478748 |
| Hyperhidrosis | 36.85 | 13.68 | 120 | 22253 | 64420 | 29487734 |
| Neutropenia | 34.96 | 13.68 | 29 | 22344 | 131682 | 29420472 |
| Loss of consciousness | 34.74 | 13.68 | 129 | 22244 | 73927 | 29478227 |
| Paranoia | 34.61 | 13.68 | 40 | 22333 | 9837 | 29542317 |
| Anal incontinence | 34.27 | 13.68 | 33 | 22340 | 6582 | 29545572 |
| Product prescribing issue | 34.17 | 13.68 | 17 | 22356 | 1150 | 29551004 |
| Serotonin syndrome | 33.77 | 13.68 | 53 | 22320 | 17459 | 29534695 |
| Automatism | 33.74 | 13.68 | 9 | 22364 | 95 | 29552059 |
| Dyskinesia | 33.65 | 13.68 | 57 | 22316 | 20004 | 29532150 |
| Dementia Alzheimer's type | 33.38 | 13.68 | 12 | 22361 | 358 | 29551796 |
| Myoclonus | 32.47 | 13.68 | 45 | 22328 | 13264 | 29538890 |
| Arthralgia | 32.07 | 13.68 | 35 | 22338 | 139582 | 29412572 |
| Intestinal haemorrhage | 32.01 | 13.68 | 23 | 22350 | 3056 | 29549098 |
| Rhabdomyolysis | 31.99 | 13.68 | 110 | 22263 | 60698 | 29491456 |
| Extrapyramidal disorder | 31.64 | 13.68 | 40 | 22333 | 10791 | 29541363 |
| Jealous delusion | 31.58 | 13.68 | 10 | 22363 | 200 | 29551954 |
| Blood glucose fluctuation | 30.98 | 13.68 | 24 | 22349 | 3573 | 29548581 |
| Bradyarrhythmia | 30.73 | 13.68 | 19 | 22354 | 1966 | 29550188 |
| Salivary hypersecretion | 29.37 | 13.68 | 32 | 22341 | 7377 | 29544777 |
| Electrocardiogram QT prolonged | 29.10 | 13.68 | 76 | 22297 | 36061 | 29516093 |
| Sexually inappropriate behaviour | 28.78 | 13.68 | 11 | 22362 | 391 | 29551763 |
| Hypersomnia | 28.73 | 13.68 | 38 | 22335 | 10716 | 29541438 |
| Nonspecific reaction | 28.57 | 13.68 | 15 | 22358 | 1136 | 29551018 |
| Disorientation | 27.90 | 13.68 | 66 | 22307 | 29449 | 29522705 |
| Drooling | 27.87 | 13.68 | 21 | 22352 | 3000 | 29549154 |
| Altered state of consciousness | 27.56 | 13.68 | 52 | 22321 | 19837 | 29532317 |
| Drug abuse | 27.51 | 13.68 | 13 | 22360 | 79870 | 29472284 |
| Restlessness | 27.17 | 13.68 | 55 | 22318 | 22090 | 29530064 |
| Dizziness | 27.15 | 13.68 | 240 | 22133 | 189444 | 29362710 |
| Dementia with Lewy bodies | 27.05 | 13.68 | 12 | 22361 | 626 | 29551528 |
| Psychomotor hyperactivity | 26.68 | 13.68 | 32 | 22341 | 8181 | 29543973 |
| Flight of ideas | 26.58 | 13.68 | 10 | 22363 | 340 | 29551814 |
| Miosis | 25.68 | 13.68 | 31 | 22342 | 7978 | 29544176 |
| Muscle contractions involuntary | 25.40 | 13.68 | 16 | 22357 | 1711 | 29550443 |
| Hypothermia | 25.23 | 13.68 | 33 | 22340 | 9206 | 29542948 |
| Dysstasia | 24.93 | 13.68 | 35 | 22338 | 10439 | 29541715 |
| Abdominal pain | 24.89 | 13.68 | 40 | 22333 | 135317 | 29416837 |
| Gastrointestinal haemorrhage | 23.79 | 13.68 | 121 | 22252 | 79412 | 29472742 |
| Dehydration | 23.55 | 13.68 | 158 | 22215 | 114590 | 29437564 |
| Daydreaming | 23.48 | 13.68 | 10 | 22363 | 472 | 29551682 |
| Hip fracture | 23.42 | 13.68 | 34 | 22339 | 10458 | 29541696 |
| Cold sweat | 23.24 | 13.68 | 31 | 22342 | 8811 | 29543343 |
| Muscle rigidity | 23.23 | 13.68 | 32 | 22341 | 9379 | 29542775 |
| Atrioventricular block first degree | 22.89 | 13.68 | 24 | 22349 | 5295 | 29546859 |
| Thrombocytopenia | 22.81 | 13.68 | 42 | 22331 | 134781 | 29417373 |
| Femoral neck fracture | 22.62 | 13.68 | 18 | 22355 | 2785 | 29549369 |
| Contusion | 22.62 | 13.68 | 63 | 22310 | 31032 | 29521122 |
| Atrioventricular block complete | 22.47 | 13.68 | 29 | 22344 | 7982 | 29544172 |
| Dyspnoea | 22.47 | 13.68 | 150 | 22223 | 326582 | 29225572 |
| Lethargy | 22.45 | 13.68 | 71 | 22302 | 37509 | 29514645 |
| Inappropriate antidiuretic hormone secretion | 22.35 | 13.68 | 34 | 22339 | 10898 | 29541256 |
| Hangover | 22.19 | 13.68 | 12 | 22361 | 965 | 29551189 |
| Pain | 22.04 | 13.68 | 62 | 22311 | 171370 | 29380784 |
| Blood glucose abnormal | 21.99 | 13.68 | 23 | 22350 | 5060 | 29547094 |
| Skin swelling | 21.51 | 13.68 | 12 | 22361 | 1026 | 29551128 |
| Gastrointestinal ulcer | 21.18 | 13.68 | 14 | 22359 | 1625 | 29550529 |
| Drug interaction | 21.06 | 13.68 | 235 | 22138 | 197150 | 29355004 |
| Subdural haematoma | 20.92 | 13.68 | 44 | 22329 | 18149 | 29534005 |
| Neutrophil count decreased | 20.54 | 13.68 | 4 | 22369 | 43563 | 29508591 |
| Intention tremor | 20.06 | 13.68 | 8 | 22365 | 319 | 29551835 |
| Gait inability | 19.48 | 13.68 | 43 | 22330 | 18332 | 29533822 |
| Duodenal ulcer | 19.27 | 13.68 | 29 | 22344 | 9209 | 29542945 |
| Pruritus | 19.23 | 13.68 | 37 | 22336 | 116812 | 29435342 |
| Multiple drug therapy | 19.17 | 13.68 | 8 | 22365 | 359 | 29551795 |
| Atrioventricular block | 19.16 | 13.68 | 25 | 22348 | 6957 | 29545197 |
| Potentiating drug interaction | 19.06 | 13.68 | 20 | 22353 | 4418 | 29547736 |
| Defect conduction intraventricular | 18.98 | 13.68 | 7 | 22366 | 225 | 29551929 |
| Executive dysfunction | 18.98 | 13.68 | 7 | 22366 | 225 | 29551929 |
| Malignant neoplasm progression | 18.68 | 13.68 | 17 | 22356 | 73842 | 29478312 |
| Neuropathy peripheral | 18.38 | 13.68 | 16 | 22357 | 71011 | 29481143 |
| Gastroenteritis pseudomonas | 18.33 | 13.68 | 4 | 22369 | 16 | 29552138 |
| Decreased appetite | 17.81 | 13.68 | 178 | 22195 | 145164 | 29406990 |
| Seizure | 17.78 | 13.68 | 126 | 22247 | 92997 | 29459157 |
| Underdose | 17.66 | 13.68 | 32 | 22341 | 11837 | 29540317 |
| Septic shock | 17.56 | 13.68 | 13 | 22360 | 62547 | 29489607 |
| Hiccups | 17.35 | 13.68 | 27 | 22346 | 8826 | 29543328 |
| Irritability | 17.23 | 13.68 | 46 | 22327 | 22106 | 29530048 |
| Infusion related reaction | 16.95 | 13.68 | 6 | 22367 | 43880 | 29508274 |
| Urinary tract infection | 16.91 | 13.68 | 103 | 22270 | 72251 | 29479903 |
| Foaming at mouth | 16.87 | 13.68 | 9 | 22364 | 704 | 29551450 |
| Paraesthesia | 16.71 | 13.68 | 10 | 22363 | 53835 | 29498319 |
| Multiple organ dysfunction syndrome | 16.60 | 13.68 | 14 | 22359 | 63102 | 29489052 |
| Speech disorder | 16.47 | 13.68 | 47 | 22326 | 23469 | 29528685 |
| Mental status changes | 15.66 | 13.68 | 60 | 22313 | 34867 | 29517287 |
| Incontinence | 15.36 | 13.68 | 19 | 22354 | 5013 | 29547141 |
| Behaviour disorder | 15 | 13.68 | 16 | 22357 | 3600 | 29548554 |
| Sudden death | 14.93 | 13.68 | 33 | 22340 | 14077 | 29538077 |
| Leukopenia | 14.82 | 13.68 | 12 | 22361 | 55191 | 29496963 |
| Impulsive behaviour | 14.67 | 13.68 | 12 | 22361 | 1931 | 29550223 |
| Posture abnormal | 14.65 | 13.68 | 12 | 22361 | 1935 | 29550219 |
| Respiratory symptom | 14.50 | 13.68 | 9 | 22364 | 937 | 29551217 |
| Stomatitis | 14.46 | 13.68 | 5 | 22368 | 37108 | 29515046 |
| Pyrexia | 14.27 | 13.68 | 144 | 22229 | 287478 | 29264676 |
| Fracture | 14.07 | 13.68 | 20 | 22353 | 6033 | 29546121 |
| Chest pain | 14.00 | 13.68 | 41 | 22332 | 111932 | 29440222 |
| Parkinson's disease | 13.77 | 13.68 | 10 | 22363 | 1351 | 29550803 |
| Hypernatraemia | 13.75 | 13.68 | 22 | 22351 | 7364 | 29544790 |
| Drug hypersensitivity | 13.74 | 13.68 | 19 | 22354 | 68387 | 29483767 |
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Bradycardia | 777.89 | 12.87 | 659 | 45825 | 117560 | 64334688 |
| Fall | 635.10 | 12.87 | 1100 | 45384 | 415726 | 64036522 |
| Hallucination | 416.17 | 12.87 | 375 | 46109 | 72413 | 64379835 |
| Dementia | 394.84 | 12.87 | 223 | 46261 | 20543 | 64431705 |
| Confusional state | 353.68 | 12.87 | 656 | 45828 | 260488 | 64191760 |
| Syncope | 329.66 | 12.87 | 482 | 46002 | 157153 | 64295095 |
| Agitation | 280.65 | 12.87 | 332 | 46152 | 88035 | 64364213 |
| Delusion | 262.64 | 12.87 | 163 | 46321 | 17851 | 64434397 |
| Sinus bradycardia | 262.15 | 12.87 | 178 | 46306 | 22715 | 64429533 |
| Aggression | 257.82 | 12.87 | 235 | 46249 | 45997 | 64406251 |
| Delirium | 248.38 | 12.87 | 277 | 46207 | 68917 | 64383331 |
| Electrocardiogram QT prolonged | 243.21 | 12.87 | 293 | 46191 | 79155 | 64373093 |
| Pleurothotonus | 220.21 | 12.87 | 77 | 46407 | 2225 | 64450023 |
| Abnormal behaviour | 195.48 | 12.87 | 175 | 46309 | 33447 | 64418801 |
| Cognitive disorder | 195.03 | 12.87 | 219 | 46265 | 54868 | 64397380 |
| Cholinergic syndrome | 184.47 | 12.87 | 53 | 46431 | 790 | 64451458 |
| Neuroleptic malignant syndrome | 173.51 | 12.87 | 144 | 46340 | 24852 | 64427396 |
| Parkinsonism | 148.65 | 12.87 | 105 | 46379 | 14268 | 64437980 |
| Drug interaction | 146.91 | 12.87 | 582 | 45902 | 361501 | 64090747 |
| Somnolence | 145.50 | 12.87 | 397 | 46087 | 203248 | 64249000 |
| Mania | 141.31 | 12.87 | 107 | 46377 | 16179 | 64436069 |
| Sinus node dysfunction | 137.01 | 12.87 | 76 | 46408 | 6752 | 64445496 |
| Depressed level of consciousness | 135.00 | 12.87 | 224 | 46260 | 81212 | 64371036 |
| Torsade de pointes | 128.83 | 12.87 | 104 | 46380 | 17259 | 64434989 |
| Hallucination, visual | 123.88 | 12.87 | 125 | 46359 | 27709 | 64424539 |
| Arthralgia | 116.77 | 12.87 | 89 | 46395 | 442171 | 64010077 |
| Myoclonus | 110.31 | 12.87 | 112 | 46372 | 25006 | 64427242 |
| Urinary incontinence | 106.74 | 12.87 | 131 | 46353 | 36020 | 64416228 |
| Seizure | 103.21 | 12.87 | 309 | 46175 | 166583 | 64285665 |
| Nightmare | 100.30 | 12.87 | 98 | 46386 | 20895 | 64431353 |
| Femoral neck fracture | 100.23 | 12.87 | 68 | 46416 | 8656 | 64443592 |
| Loss of consciousness | 98.73 | 12.87 | 282 | 46202 | 148083 | 64304165 |
| Pain | 97.09 | 12.87 | 156 | 46328 | 553355 | 63898893 |
| Drug ineffective | 88.94 | 12.87 | 310 | 46174 | 839937 | 63612311 |
| Muscle rigidity | 88.05 | 12.87 | 84 | 46400 | 17389 | 64434859 |
| Extrapyramidal disorder | 87.35 | 12.87 | 88 | 46396 | 19464 | 64432784 |
| Hypothermia | 86.21 | 12.87 | 88 | 46396 | 19768 | 64432480 |
| Tremor | 85.61 | 12.87 | 268 | 46216 | 147962 | 64304286 |
| Febrile neutropenia | 85.25 | 12.87 | 16 | 46468 | 187641 | 64264607 |
| Altered state of consciousness | 83.53 | 12.87 | 119 | 46365 | 37783 | 64414465 |
| Dehydration | 82.57 | 12.87 | 342 | 46142 | 216421 | 64235827 |
| Atrioventricular block first degree | 79.00 | 12.87 | 64 | 46420 | 10670 | 64441578 |
| Anal incontinence | 78.38 | 12.87 | 74 | 46410 | 15122 | 64437126 |
| Joint swelling | 74.45 | 12.87 | 31 | 46453 | 215351 | 64236897 |
| Decreased appetite | 74.31 | 12.87 | 399 | 46085 | 280890 | 64171358 |
| Death | 73.97 | 12.87 | 597 | 45887 | 482108 | 63970140 |
| Electrocardiogram PR prolongation | 73.06 | 12.87 | 30 | 46454 | 1357 | 64450891 |
| Dyskinesia | 71.57 | 12.87 | 113 | 46371 | 39275 | 64412973 |
| Gait disturbance | 70.61 | 12.87 | 278 | 46206 | 171877 | 64280371 |
| Infusion related reaction | 70.60 | 12.87 | 16 | 46468 | 164451 | 64287797 |
| Disorientation | 68.75 | 12.87 | 135 | 46349 | 55693 | 64396555 |
| Sexually inappropriate behaviour | 66.10 | 12.87 | 21 | 46463 | 447 | 64451801 |
| Lethargy | 65.77 | 12.87 | 155 | 46329 | 72439 | 64379809 |
| Pneumonia aspiration | 64.31 | 12.87 | 136 | 46348 | 59135 | 64393113 |
| Restlessness | 63.97 | 12.87 | 108 | 46376 | 39677 | 64412571 |
| Mental status changes | 63.67 | 12.87 | 138 | 46346 | 61024 | 64391224 |
| Hyperhidrosis | 63.23 | 12.87 | 216 | 46268 | 124704 | 64327544 |
| Dementia Alzheimer's type | 61.05 | 12.87 | 24 | 46460 | 968 | 64451280 |
| Unresponsive to stimuli | 61.02 | 12.87 | 121 | 46363 | 50272 | 64401976 |
| Pruritus | 59.54 | 12.87 | 83 | 46401 | 312317 | 64139931 |
| Psychomotor hyperactivity | 59.05 | 12.87 | 62 | 46422 | 14389 | 64437859 |
| Sudden death | 57.98 | 12.87 | 72 | 46412 | 20024 | 64432224 |
| Rheumatoid arthritis | 57.82 | 12.87 | 23 | 46461 | 164271 | 64287977 |
| Immobile | 57.73 | 12.87 | 42 | 46442 | 5973 | 64446275 |
| Rash | 57.70 | 12.87 | 156 | 46328 | 458393 | 63993855 |
| Atrioventricular block complete | 57.39 | 12.87 | 61 | 46423 | 14357 | 64437891 |
| Drug hypersensitivity | 55.17 | 12.87 | 54 | 46430 | 237761 | 64214487 |
| Hypersensitivity | 55.05 | 12.87 | 37 | 46447 | 196415 | 64255833 |
| Urinary tract infection | 54.14 | 12.87 | 318 | 46166 | 231278 | 64220970 |
| Dizziness | 53.82 | 12.87 | 509 | 45975 | 429654 | 64022594 |
| Sinusitis | 53.74 | 12.87 | 19 | 46465 | 145909 | 64306339 |
| Hypophagia | 52.76 | 12.87 | 99 | 46385 | 39488 | 64412760 |
| Miosis | 52.57 | 12.87 | 56 | 46428 | 13210 | 64439038 |
| Pain in extremity | 52.46 | 12.87 | 86 | 46398 | 302999 | 64149249 |
| Neutropenia | 51.56 | 12.87 | 58 | 46426 | 239566 | 64212682 |
| Alopecia | 50.89 | 12.87 | 28 | 46456 | 165662 | 64286586 |
| Gastrointestinal haemorrhage | 50.50 | 12.87 | 209 | 46275 | 132103 | 64320145 |
| Rhabdomyolysis | 50.31 | 12.87 | 163 | 46321 | 91563 | 64360685 |
| Dementia with Lewy bodies | 50.27 | 12.87 | 19 | 46465 | 688 | 64451560 |
| Atrioventricular block | 49.90 | 12.87 | 52 | 46432 | 11963 | 64440285 |
| Swelling | 49.32 | 12.87 | 27 | 46457 | 160191 | 64292057 |
| Orthostatic hypotension | 49.26 | 12.87 | 106 | 46378 | 46632 | 64405616 |
| Torticollis | 48.58 | 12.87 | 26 | 46458 | 2151 | 64450097 |
| Circulatory collapse | 48.28 | 12.87 | 87 | 46397 | 33645 | 64418603 |
| Dyspnoea | 47.75 | 12.87 | 313 | 46171 | 718361 | 63733887 |
| Memory impairment | 47.66 | 12.87 | 153 | 46331 | 85529 | 64366719 |
| Arthropathy | 47.63 | 12.87 | 14 | 46470 | 120953 | 64331295 |
| Treatment failure | 46.96 | 12.87 | 13 | 46471 | 116803 | 64335445 |
| Hip fracture | 46.83 | 12.87 | 76 | 46408 | 27023 | 64425225 |
| Salivary hypersecretion | 46.01 | 12.87 | 50 | 46434 | 12063 | 64440185 |
| Poriomania | 45.48 | 12.87 | 13 | 46471 | 190 | 64452058 |
| Wandering pacemaker | 45.42 | 12.87 | 8 | 46476 | 6 | 64452242 |
| Medication error | 44.50 | 12.87 | 106 | 46378 | 49860 | 64402388 |
| Jealous delusion | 44.04 | 12.87 | 13 | 46471 | 214 | 64452034 |
| Blood cholinesterase decreased | 43.71 | 12.87 | 13 | 46471 | 220 | 64452028 |
| Accidental overdose | 43.57 | 12.87 | 83 | 46401 | 33474 | 64418774 |
| Hypokalaemia | 42.99 | 12.87 | 188 | 46296 | 121715 | 64330533 |
| Cerebral atrophy | 42.48 | 12.87 | 38 | 46446 | 7247 | 64445001 |
| Drug intolerance | 42.09 | 12.87 | 44 | 46440 | 187948 | 64264300 |
| Cough | 41.67 | 12.87 | 98 | 46386 | 302050 | 64150198 |
| Generalised tonic-clonic seizure | 41.55 | 12.87 | 90 | 46394 | 39767 | 64412481 |
| Paranoia | 41.53 | 12.87 | 55 | 46429 | 16297 | 64435951 |
| Urinary retention | 41.28 | 12.87 | 102 | 46382 | 49099 | 64403149 |
| Headache | 41.27 | 12.87 | 219 | 46265 | 529248 | 63923000 |
| Stomatitis | 40.81 | 12.87 | 14 | 46470 | 109591 | 64342657 |
| Bradyarrhythmia | 40.12 | 12.87 | 28 | 46456 | 3730 | 64448518 |
| Epilepsy | 39.97 | 12.87 | 80 | 46404 | 33451 | 64418797 |
| Incontinence | 39.29 | 12.87 | 46 | 46438 | 12035 | 64440213 |
| Systemic lupus erythematosus | 38.89 | 12.87 | 5 | 46479 | 77607 | 64374641 |
| Libido increased | 38.88 | 12.87 | 21 | 46463 | 1769 | 64450479 |
| Apathy | 38.60 | 12.87 | 44 | 46440 | 11188 | 64441060 |
| Weight increased | 38.34 | 12.87 | 59 | 46425 | 213289 | 64238959 |
| Executive dysfunction | 38.29 | 12.87 | 12 | 46472 | 244 | 64452004 |
| Blood glucose fluctuation | 36.59 | 12.87 | 32 | 46452 | 5923 | 64446325 |
| Fracture | 35.72 | 12.87 | 55 | 46429 | 18700 | 64433548 |
| Reduced facial expression | 35.63 | 12.87 | 21 | 46463 | 2092 | 64450156 |
| Hypocapnia | 35.35 | 12.87 | 14 | 46470 | 576 | 64451672 |
| Contraindicated product administered | 34.92 | 12.87 | 17 | 46467 | 107812 | 64344436 |
| Malignant neoplasm progression | 34.76 | 12.87 | 19 | 46465 | 112852 | 64339396 |
| Thrombocytopenia | 34.65 | 12.87 | 68 | 46416 | 223733 | 64228515 |
| Encephalopathy | 34.51 | 12.87 | 107 | 46377 | 58712 | 64393536 |
| Nasopharyngitis | 33.55 | 12.87 | 56 | 46428 | 196017 | 64256231 |
| Drooling | 33.52 | 12.87 | 29 | 46455 | 5290 | 64446958 |
| Hypomania | 31.99 | 12.87 | 29 | 46455 | 5625 | 64446623 |
| Off label use | 31.95 | 12.87 | 297 | 46187 | 632509 | 63819739 |
| Paraesthesia | 31.81 | 12.87 | 30 | 46454 | 134492 | 64317756 |
| Neuropsychiatric symptoms | 31.75 | 12.87 | 15 | 46469 | 951 | 64451297 |
| Balance disorder | 31.55 | 12.87 | 132 | 46352 | 83794 | 64368454 |
| Nonspecific reaction | 31.42 | 12.87 | 19 | 46465 | 1984 | 64450264 |
| Pyrexia | 31.39 | 12.87 | 255 | 46229 | 558389 | 63893859 |
| Psoriasis | 30.70 | 12.87 | 7 | 46477 | 71696 | 64380552 |
| Infection | 30.54 | 12.87 | 54 | 46430 | 184826 | 64267422 |
| Glossodynia | 30.48 | 12.87 | 5 | 46479 | 64691 | 64387557 |
| Prescribed underdose | 30.42 | 12.87 | 50 | 46434 | 17965 | 64434283 |
| Oropharyngeal pain | 30.34 | 12.87 | 13 | 46471 | 88854 | 64363394 |
| Automatism | 30.11 | 12.87 | 9 | 46475 | 155 | 64452093 |
| Subdural haematoma | 29.99 | 12.87 | 64 | 46420 | 27990 | 64424258 |
| Tardive dyskinesia | 29.94 | 12.87 | 35 | 46449 | 9143 | 64443105 |
| Parkinson's disease | 29.89 | 12.87 | 17 | 46467 | 1584 | 64450664 |
| Injection site pain | 29.85 | 12.87 | 22 | 46462 | 111386 | 64340862 |
| Product prescribing issue | 29.77 | 12.87 | 19 | 46465 | 2182 | 64450066 |
| Listless | 29.38 | 12.87 | 22 | 46462 | 3268 | 64448980 |
| Mucosal inflammation | 29.12 | 12.87 | 5 | 46479 | 62579 | 64389669 |
| Social avoidant behaviour | 29.03 | 12.87 | 25 | 46459 | 4532 | 64447716 |
| Posture abnormal | 28.71 | 12.87 | 22 | 46462 | 3384 | 64448864 |
| Duodenal ulcer | 28.44 | 12.87 | 43 | 46441 | 14392 | 64437856 |
| Paratonia | 28.19 | 12.87 | 6 | 46478 | 22 | 64452226 |
| Urticaria | 28.16 | 12.87 | 39 | 46445 | 147278 | 64304970 |
| Abnormal dreams | 28.12 | 12.87 | 36 | 46448 | 10320 | 64441928 |
| Muscle contractions involuntary | 27.60 | 12.87 | 21 | 46463 | 3196 | 64449052 |
| Duodenal ulcer haemorrhage | 27.39 | 12.87 | 28 | 46456 | 6297 | 64445951 |
| Speech disorder | 27.38 | 12.87 | 87 | 46397 | 48354 | 64403894 |
| Cerebral infarction | 27.23 | 12.87 | 78 | 46406 | 40966 | 64411282 |
| Sialoadenitis | 26.94 | 12.87 | 16 | 46468 | 1617 | 64450631 |
| Chorea | 26.39 | 12.87 | 17 | 46467 | 1983 | 64450265 |
| Flight of ideas | 26.36 | 12.87 | 12 | 46472 | 699 | 64451549 |
| Hepatic enzyme increased | 26.27 | 12.87 | 33 | 46451 | 129910 | 64322338 |
| Potentiating drug interaction | 25.70 | 12.87 | 30 | 46454 | 7822 | 64444426 |
| Behaviour disorder | 25.47 | 12.87 | 23 | 46461 | 4439 | 64447809 |
| Upper gastrointestinal haemorrhage | 25.41 | 12.87 | 69 | 46415 | 35151 | 64417097 |
| Pressure of speech | 25.31 | 12.87 | 13 | 46471 | 988 | 64451260 |
| Neutrophil count decreased | 25.25 | 12.87 | 12 | 46472 | 77184 | 64375064 |
| Drop attacks | 25.14 | 12.87 | 13 | 46471 | 1002 | 64451246 |
| Lower respiratory tract infection | 24.94 | 12.87 | 19 | 46465 | 94595 | 64357653 |
| Daydreaming | 24.86 | 12.87 | 12 | 46472 | 798 | 64451450 |
| Hypersomnia | 24.65 | 12.87 | 48 | 46436 | 19669 | 64432579 |
| Neuropathy peripheral | 24.65 | 12.87 | 29 | 46455 | 117496 | 64334752 |
| Musculoskeletal pain | 24.57 | 12.87 | 14 | 46470 | 81280 | 64370968 |
| Multiple drug therapy | 24.54 | 12.87 | 17 | 46467 | 2237 | 64450011 |
| Arthritis | 24.53 | 12.87 | 15 | 46469 | 83799 | 64368449 |
| Chest discomfort | 23.98 | 12.87 | 29 | 46455 | 116077 | 64336171 |
| Pemphigus | 23.93 | 12.87 | 7 | 46477 | 60694 | 64391554 |
| Sedation | 23.92 | 12.87 | 75 | 46409 | 41387 | 64410861 |
| Impaired healing | 23.80 | 12.87 | 7 | 46477 | 60466 | 64391782 |
| Anaphylactic reaction | 23.51 | 12.87 | 10 | 46474 | 68654 | 64383594 |
| Sinoatrial block | 23.45 | 12.87 | 13 | 46471 | 1153 | 64451095 |
| Lack of spontaneous speech | 23.42 | 12.87 | 8 | 46476 | 215 | 64452033 |
| Amyloid related imaging abnormality-oedema/effusion | 23.35 | 12.87 | 6 | 46478 | 57 | 64452191 |
| Dysphagia | 23.21 | 12.87 | 144 | 46340 | 106668 | 64345580 |
| Incoherent | 22.98 | 12.87 | 27 | 46457 | 7091 | 64445157 |
| Cerebral haemorrhage | 22.96 | 12.87 | 85 | 46399 | 51005 | 64401243 |
| Adams-Stokes syndrome | 22.88 | 12.87 | 7 | 46477 | 131 | 64452117 |
| Intentional product use issue | 22.86 | 12.87 | 21 | 46463 | 95343 | 64356905 |
| Wrong patient received product | 22.68 | 12.87 | 20 | 46464 | 3742 | 64448506 |
| Bedridden | 22.65 | 12.87 | 32 | 46452 | 10077 | 64442171 |
| Melaena | 22.34 | 12.87 | 87 | 46397 | 53461 | 64398787 |
| Vomiting | 22.05 | 12.87 | 536 | 45948 | 550581 | 63901667 |
| Colitis microscopic | 22.04 | 12.87 | 27 | 46457 | 7405 | 64444843 |
| Sinus arrest | 21.85 | 12.87 | 18 | 46466 | 3072 | 64449176 |
| Anger | 21.76 | 12.87 | 40 | 46444 | 15701 | 64436547 |
| Irritability | 21.69 | 12.87 | 67 | 46417 | 36679 | 64415569 |
| Injection site erythema | 21.67 | 12.87 | 12 | 46472 | 70788 | 64381460 |
| Atrial tachycardia | 21.62 | 12.87 | 19 | 46465 | 3540 | 64448708 |
| Dysstasia | 21.48 | 12.87 | 50 | 46434 | 23165 | 64429083 |
| Product use in unapproved indication | 21.47 | 12.87 | 61 | 46423 | 176557 | 64275691 |
| Myalgia | 21.40 | 12.87 | 52 | 46432 | 158565 | 64293683 |
| Food refusal | 21.14 | 12.87 | 9 | 46475 | 446 | 64451802 |
| Product administration interrupted | 21.02 | 12.87 | 12 | 46472 | 1126 | 64451122 |
| Long QT syndrome | 20.91 | 12.87 | 22 | 46462 | 5117 | 64447131 |
| Hypernatraemia | 20.81 | 12.87 | 34 | 46450 | 12155 | 64440093 |
| Therapeutic product effect decreased | 20.61 | 12.87 | 32 | 46452 | 115319 | 64336929 |
| Gastric ulcer | 20.59 | 12.87 | 58 | 46426 | 30176 | 64422072 |
| Pemphigoid | 20.53 | 12.87 | 35 | 46449 | 12951 | 64439297 |
| Cold sweat | 20.50 | 12.87 | 40 | 46444 | 16415 | 64435833 |
| Fatigue | 20.37 | 12.87 | 399 | 46085 | 748331 | 63703917 |
| Erythema | 20.33 | 12.87 | 68 | 46416 | 187002 | 64265246 |
| Gait inability | 20.32 | 12.87 | 72 | 46412 | 42296 | 64409952 |
| Back pain | 20.26 | 12.87 | 102 | 46382 | 250069 | 64202179 |
| Product use issue | 20.26 | 12.87 | 50 | 46434 | 151665 | 64300583 |
| Pelvic fracture | 20.15 | 12.87 | 31 | 46453 | 10532 | 64441716 |
| Hypoaesthesia | 20.05 | 12.87 | 44 | 46440 | 139064 | 64313184 |
| Bone marrow failure | 19.90 | 12.87 | 5 | 46479 | 47947 | 64404301 |
| Gastrointestinal ulcer | 19.86 | 12.87 | 17 | 46467 | 3058 | 64449190 |
| Cholesteatoma | 19.62 | 12.87 | 6 | 46478 | 112 | 64452136 |
| Obsessive thoughts | 19.53 | 12.87 | 11 | 46473 | 1006 | 64451242 |
| Affect lability | 19.47 | 12.87 | 28 | 46456 | 8962 | 64443286 |
| Flushing | 19.23 | 12.87 | 17 | 46467 | 78631 | 64373617 |
| Injection site reaction | 19.11 | 12.87 | 5 | 46479 | 46659 | 64405589 |
| Fluid intake reduced | 18.94 | 12.87 | 21 | 46463 | 5179 | 64447069 |
| Suspiciousness | 18.88 | 12.87 | 9 | 46475 | 582 | 64451666 |
| Dyspepsia | 18.87 | 12.87 | 18 | 46466 | 80294 | 64371954 |
| Nasal congestion | 18.42 | 12.87 | 10 | 46474 | 59648 | 64392600 |
| Drug reaction with eosinophilia and systemic symptoms | 18.40 | 12.87 | 8 | 46476 | 54209 | 64398039 |
| Septic shock | 18.13 | 12.87 | 30 | 46454 | 105407 | 64346841 |
| Helicobacter infection | 17.99 | 12.87 | 3 | 46481 | 38359 | 64413889 |
| Product blister packaging issue | 17.98 | 12.87 | 6 | 46478 | 150 | 64452098 |
| Disease progression | 17.91 | 12.87 | 48 | 46436 | 141632 | 64310616 |
| Normal pressure hydrocephalus | 17.77 | 12.87 | 8 | 46476 | 454 | 64451794 |
| Skull fracture | 17.67 | 12.87 | 12 | 46472 | 1529 | 64450719 |
| Hangover | 17.62 | 12.87 | 13 | 46471 | 1888 | 64450360 |
| Dysarthria | 17.52 | 12.87 | 87 | 46397 | 59319 | 64392929 |
| Intention tremor | 17.49 | 12.87 | 9 | 46475 | 687 | 64451561 |
| Pain in jaw | 17.40 | 12.87 | 4 | 46480 | 40751 | 64411497 |
| Blood pressure decreased | 17.36 | 12.87 | 114 | 46370 | 86085 | 64366163 |
| Gastroenteritis pseudomonas | 17.32 | 12.87 | 4 | 46480 | 23 | 64452225 |
| Abdominal pain | 17.30 | 12.87 | 143 | 46341 | 312232 | 64140016 |
| Cerebrovascular accident | 17.22 | 12.87 | 163 | 46321 | 137420 | 64314828 |
| Gastric ulcer haemorrhage | 17.10 | 12.87 | 25 | 46459 | 8118 | 64444130 |
| Ventricular tachycardia | 17.09 | 12.87 | 59 | 46425 | 34206 | 64418042 |
| Brain compression | 16.85 | 12.87 | 8 | 46476 | 513 | 64451735 |
| Hyponatraemic syndrome | 16.71 | 12.87 | 9 | 46475 | 754 | 64451494 |
| Rapid eye movement sleep behaviour disorder | 16.69 | 12.87 | 7 | 46477 | 334 | 64451914 |
| Hiccups | 16.57 | 12.87 | 25 | 46459 | 8351 | 64443897 |
| Apraxia | 16.53 | 12.87 | 14 | 46470 | 2481 | 64449767 |
| Defect conduction intraventricular | 16.33 | 12.87 | 7 | 46477 | 353 | 64451895 |
| Grandiosity | 16.23 | 12.87 | 8 | 46476 | 557 | 64451691 |
| Bone pain | 16.17 | 12.87 | 7 | 46477 | 47565 | 64404683 |
| Abdominal discomfort | 16.12 | 12.87 | 72 | 46412 | 182250 | 64269998 |
| Herpes zoster | 16.11 | 12.87 | 20 | 46464 | 79167 | 64373081 |
| Head injury | 15.91 | 12.87 | 56 | 46428 | 32786 | 64419462 |
| Injection site swelling | 15.88 | 12.87 | 5 | 46479 | 41348 | 64410900 |
| Hypotension | 15.65 | 12.87 | 372 | 46112 | 380602 | 64071646 |
| Communication disorder | 15.32 | 12.87 | 16 | 46468 | 3690 | 64448558 |
| Atrioventricular block second degree | 15.31 | 12.87 | 21 | 46463 | 6433 | 64445815 |
| Heart rate increased | 15.24 | 12.87 | 30 | 46454 | 98645 | 64353603 |
| Senile dementia | 15.24 | 12.87 | 6 | 46478 | 243 | 64452005 |
| Lower gastrointestinal haemorrhage | 15.13 | 12.87 | 32 | 46452 | 13907 | 64438341 |
| Non-24-hour sleep-wake disorder | 15.12 | 12.87 | 4 | 46480 | 43 | 64452205 |
| Thalamus haemorrhage | 14.85 | 12.87 | 11 | 46473 | 1608 | 64450640 |
| Injection site bruising | 14.70 | 12.87 | 4 | 46480 | 36369 | 64415879 |
| Intercepted product dispensing error | 14.65 | 12.87 | 5 | 46479 | 134 | 64452114 |
| Foreign body | 14.59 | 12.87 | 13 | 46471 | 2466 | 64449782 |
| Haematoma | 14.55 | 12.87 | 69 | 46415 | 46181 | 64406067 |
| Fibromyalgia | 14.31 | 12.87 | 4 | 46480 | 35727 | 64416521 |
| Lymphadenopathy | 14.16 | 12.87 | 8 | 46476 | 46678 | 64405570 |
| Inflammation | 13.81 | 12.87 | 16 | 46468 | 65284 | 64386964 |
| Leukaemoid reaction | 13.75 | 12.87 | 6 | 46478 | 316 | 64451932 |
| Stress | 13.72 | 12.87 | 14 | 46470 | 60520 | 64391728 |
| Coma scale abnormal | 13.70 | 12.87 | 22 | 46462 | 7752 | 64444496 |
| Dyspnoea exertional | 13.61 | 12.87 | 20 | 46464 | 73710 | 64378538 |
| Aphasia | 13.58 | 12.87 | 62 | 46422 | 40844 | 64411404 |
| Hyponatraemia | 13.55 | 12.87 | 165 | 46319 | 148174 | 64304074 |
| Euphoric mood | 13.50 | 12.87 | 20 | 46464 | 6571 | 64445677 |
| Inappropriate antidiuretic hormone secretion | 13.49 | 12.87 | 41 | 46443 | 22248 | 64430000 |
| Psychotic disorder | 13.47 | 12.87 | 55 | 46429 | 34523 | 64417725 |
| Hypersexuality | 13.45 | 12.87 | 10 | 46474 | 1469 | 64450779 |
| Acute psychosis | 13.41 | 12.87 | 15 | 46469 | 3737 | 64448511 |
| Serotonin syndrome | 13.39 | 12.87 | 60 | 46424 | 39222 | 64413026 |
| Antisocial behaviour | 13.34 | 12.87 | 7 | 46477 | 556 | 64451692 |
| Lacunar infarction | 13.12 | 12.87 | 18 | 46466 | 5514 | 64446734 |
| Marasmus | 13.01 | 12.87 | 8 | 46476 | 860 | 64451388 |
| Decreased interest | 12.99 | 12.87 | 14 | 46470 | 3346 | 64448902 |
| Movement disorder | 12.88 | 12.87 | 40 | 46444 | 21960 | 64430288 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| 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|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| 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 level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 8.4 | Basic |
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 10MG;14MG | NAMZARIC | ALLERGAN | N206439 | Dec. 23, 2014 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 8173708 | Nov. 22, 2025 | MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMERS TYPE |
| 10MG;14MG | NAMZARIC | ALLERGAN | N206439 | Dec. 23, 2014 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 8283379 | Nov. 22, 2025 | MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMERS TYPE |
| 10MG;14MG | NAMZARIC | ALLERGAN | N206439 | Dec. 23, 2014 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 8338486 | Nov. 22, 2025 | MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMERS TYPE |
| 10MG;14MG | NAMZARIC | ALLERGAN | N206439 | Dec. 23, 2014 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 8362085 | Nov. 22, 2025 | MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMERS TYPE |
| 10MG;14MG | NAMZARIC | ALLERGAN | N206439 | Dec. 23, 2014 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 8580858 | Nov. 22, 2025 | MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMERS TYPE |
| 10MG;21MG | NAMZARIC | ALLERGAN | N206439 | July 18, 2016 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 8173708 | Nov. 22, 2025 | MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMERS TYPE |
| 10MG;21MG | NAMZARIC | ALLERGAN | N206439 | July 18, 2016 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 8283379 | Nov. 22, 2025 | MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMERS TYPE |
| 10MG;21MG | NAMZARIC | ALLERGAN | N206439 | July 18, 2016 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 8338486 | Nov. 22, 2025 | MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMERS TYPE |
| 10MG;21MG | NAMZARIC | ALLERGAN | N206439 | July 18, 2016 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 8362085 | Nov. 22, 2025 | MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMERS TYPE |
| 10MG;21MG | NAMZARIC | ALLERGAN | N206439 | July 18, 2016 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 8580858 | Nov. 22, 2025 | MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMERS TYPE |
| 10MG;28MG | NAMZARIC | ALLERGAN | N206439 | Dec. 23, 2014 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 8173708 | Nov. 22, 2025 | MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMERS TYPE |
| 10MG;28MG | NAMZARIC | ALLERGAN | N206439 | Dec. 23, 2014 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 8283379 | Nov. 22, 2025 | MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMERS TYPE |
| 10MG;28MG | NAMZARIC | ALLERGAN | N206439 | Dec. 23, 2014 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 8338486 | Nov. 22, 2025 | MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMERS TYPE |
| 10MG;28MG | NAMZARIC | ALLERGAN | N206439 | Dec. 23, 2014 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 8362085 | Nov. 22, 2025 | MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMERS TYPE |
| 10MG;28MG | NAMZARIC | ALLERGAN | N206439 | Dec. 23, 2014 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 8580858 | Nov. 22, 2025 | MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMERS TYPE |
| 10MG;7MG | NAMZARIC | ALLERGAN | N206439 | July 18, 2016 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 8173708 | Nov. 22, 2025 | MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMERS TYPE |
| 10MG;7MG | NAMZARIC | ALLERGAN | N206439 | July 18, 2016 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 8283379 | Nov. 22, 2025 | MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMERS TYPE |
| 10MG;7MG | NAMZARIC | ALLERGAN | N206439 | July 18, 2016 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 8338486 | Nov. 22, 2025 | MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMERS TYPE |
| 10MG;7MG | NAMZARIC | ALLERGAN | N206439 | July 18, 2016 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 8362085 | Nov. 22, 2025 | MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMERS TYPE |
| 10MG;7MG | NAMZARIC | ALLERGAN | N206439 | July 18, 2016 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 8580858 | Nov. 22, 2025 | MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMERS TYPE |
| 10MG;14MG | NAMZARIC | ALLERGAN | N206439 | Dec. 23, 2014 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 8039009 | March 24, 2029 | MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMERS TYPE |
| 10MG;21MG | NAMZARIC | ALLERGAN | N206439 | July 18, 2016 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 8039009 | March 24, 2029 | MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMERS TYPE |
| 10MG;28MG | NAMZARIC | ALLERGAN | N206439 | Dec. 23, 2014 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 8039009 | March 24, 2029 | MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMERS TYPE |
| 10MG;7MG | NAMZARIC | ALLERGAN | N206439 | July 18, 2016 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 8039009 | March 24, 2029 | MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMERS TYPE |
| 10MG;14MG | NAMZARIC | ALLERGAN | N206439 | Dec. 23, 2014 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 8058291 | Dec. 5, 2029 | MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMERS TYPE |
| 10MG;21MG | NAMZARIC | ALLERGAN | N206439 | July 18, 2016 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 8058291 | Dec. 5, 2029 | MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMERS TYPE |
| 10MG;28MG | NAMZARIC | ALLERGAN | N206439 | Dec. 23, 2014 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 8058291 | Dec. 5, 2029 | MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMERS TYPE |
| 10MG;7MG | NAMZARIC | ALLERGAN | N206439 | July 18, 2016 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 8058291 | Dec. 5, 2029 | MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMERS TYPE |
| 10MG/DAY | ADLARITY | CORIUM | N212304 | March 11, 2022 | RX | SYSTEM | TRANSDERMAL | 10016372 | July 26, 2037 | A METHOD OF TRANSDERMAL DELIVERY OF DONEPEZIL FOR TREATING MILD, MODERATE AND SEVERE DEMENTIA OF THE ALZHEIMERS TYPE |
| 10MG/DAY | ADLARITY | CORIUM | N212304 | March 11, 2022 | RX | SYSTEM | TRANSDERMAL | 11103463 | July 26, 2037 | A METHOD OF TRANSDERMAL DELIVERY OF DONEPEZIL FOR TREATING MILD, MODERATE AND SEVERE DEMENTIA OF THE ALZHEIMERS TYPE |
| 5MG/DAY | ADLARITY | CORIUM | N212304 | March 11, 2022 | RX | SYSTEM | TRANSDERMAL | 10016372 | July 26, 2037 | A METHOD OF TRANSDERMAL DELIVERY OF DONEPEZIL FOR TREATING MILD, MODERATE AND SEVERE DEMENTIA OF THE ALZHEIMERS TYPE |
| 5MG/DAY | ADLARITY | CORIUM | N212304 | March 11, 2022 | RX | SYSTEM | TRANSDERMAL | 11103463 | July 26, 2037 | A METHOD OF TRANSDERMAL DELIVERY OF DONEPEZIL FOR TREATING MILD, MODERATE AND SEVERE DEMENTIA OF THE ALZHEIMERS TYPE |
| 10MG/DAY | ADLARITY | CORIUM | N212304 | March 11, 2022 | RX | SYSTEM | TRANSDERMAL | 10835499 | May 20, 2038 | A METHOD OF TRANSDERMAL DELIVERY OF DONEPEZIL FOR TREATING MILD, MODERATE AND SEVERE DEMENTIA OF THE ALZHEIMERS TYPE |
| 5MG/DAY | ADLARITY | CORIUM | N212304 | March 11, 2022 | RX | SYSTEM | TRANSDERMAL | 10835499 | May 20, 2038 | A METHOD OF TRANSDERMAL DELIVERY OF DONEPEZIL FOR TREATING MILD, MODERATE AND SEVERE DEMENTIA OF THE ALZHEIMERS TYPE |
| 10MG/DAY | ADLARITY | CORIUM | N212304 | March 11, 2022 | RX | SYSTEM | TRANSDERMAL | 10966936 | Aug. 11, 2038 | A METHOD OF TRANSDERMAL DELIVERY OF DONEPEZIL FOR TREATING MILD, MODERATE AND SEVERE DEMENTIA OF THE ALZHEIMERS TYPE |
| 5MG/DAY | ADLARITY | CORIUM | N212304 | March 11, 2022 | RX | SYSTEM | TRANSDERMAL | 10966936 | Aug. 11, 2038 | A METHOD OF TRANSDERMAL DELIVERY OF DONEPEZIL FOR TREATING MILD, MODERATE AND SEVERE DEMENTIA OF THE ALZHEIMERS TYPE |
Orange Book exclusivity data (new drug applications)
None
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Acetylcholinesterase | Enzyme | INHIBITOR | Ki | 7.80 | WOMBAT-PK | CHEMBL | |||
| Sigma non-opioid intracellular receptor 1 | Membrane receptor | Ki | 7.84 | CHEMBL | |||||
| Potassium voltage-gated channel subfamily H member 2 | Ion channel | IC50 | 5.70 | CHEMBL | |||||
| Multidrug resistance protein 1 | Transporter | IC50 | 4.46 | CHEMBL | |||||
| Sodium-dependent serotonin transporter | Transporter | Ki | 5.05 | WOMBAT-PK | |||||
| Amine oxidase [flavin-containing] B | Enzyme | IC50 | 4.82 | CHEMBL | |||||
| Cholinesterase | Enzyme | Ki | 4.90 | CHEMBL | |||||
| Histamine H3 receptor | GPCR | IC50 | 6.46 | CHEMBL | |||||
| Beta-secretase 1 | Enzyme | IC50 | 5.49 | CHEMBL | |||||
| Acetylcholinesterase | Enzyme | IC50 | 8.24 | CHEMBL | |||||
| Acetylcholinesterase | Enzyme | IC50 | 8.24 | CHEMBL | |||||
| Butyrylcholinesterase; Protein Bche | Enzyme | IC50 | 5.56 | CHEMBL | |||||
| Acetylcholinesterase | Enzyme | IC50 | 8.77 | CHEMBL | |||||
| Acetylcholinesterase | Enzyme | Ki | 7.25 | CHEMBL | |||||
| Acetylcholinesterase | Enzyme | Ki | 8.54 | CHEMBL | |||||
| Amine oxidase [flavin-containing] B | Enzyme | IC50 | 4.82 | CHEMBL | |||||
| Cholinesterase | Enzyme | IC50 | 5.15 | CHEMBL | |||||
| Butyrylcholinesterase | Enzyme | Ki | 6.19 | CHEMBL | |||||
| Sigma non-opioid intracellular receptor 1 | Membrane other | Ki | 7.84 | CHEMBL | |||||
| Choline O-acetyltransferase | Enzyme | IC50 | 8.28 | CHEMBL | |||||
| Cholinesterase | Enzyme | IC50 | 6.08 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| D00670 | KEGG_DRUG |
| 120011-70-3 | SECONDARY_CAS_RN |
| 135446 | RXNORM |
| 4021006 | VANDF |
| 4024045 | VANDF |
| C0527316 | UMLSCUI |
| CHEBI:53289 | CHEBI |
| E20 | PDB_CHEM_ID |
| CHEMBL502 | ChEMBL_ID |
| CHEMBL1678 | ChEMBL_ID |
| DB00843 | DRUGBANK_ID |
| D000077265 | MESH_DESCRIPTOR_UI |
| 3152 | PUBCHEM_CID |
| 6599 | IUPHAR_LIGAND_ID |
| 7517 | INN_ID |
| 870555-76-3 | SECONDARY_CAS_RN |
| 8SSC91326P | UNII |
| 15004 | MMSL |
| 178540 | MMSL |
| 4631 | MMSL |
| 6432 | MMSL |
| d04099 | MMSL |
| 006295 | NDDF |
| 006296 | NDDF |
| 108497001 | SNOMEDCT_US |
| 386855006 | SNOMEDCT_US |
| 386856007 | SNOMEDCT_US |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Donepezil Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0143-9747 | TABLET, FILM COATED | 5 mg | ORAL | ANDA | 24 sections |
| Donepezil Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0143-9748 | TABLET, FILM COATED | 10 mg | ORAL | ANDA | 24 sections |
| Namzaric | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0456-1207 | CAPSULE | 10 mg | ORAL | NDA | 31 sections |
| Namzaric | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0456-1214 | CAPSULE | 10 mg | ORAL | NDA | 31 sections |
| Namzaric | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0456-1221 | CAPSULE | 10 mg | ORAL | NDA | 31 sections |
| Namzaric | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0456-1228 | CAPSULE | 10 mg | ORAL | NDA | 31 sections |
| Donepezil Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0615-7951 | TABLET, FILM COATED | 5 mg | ORAL | ANDA | 18 sections |
| Donepezil Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0615-7952 | TABLET, FILM COATED | 10 mg | ORAL | ANDA | 18 sections |
| Donepezil Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0615-8313 | TABLET, FILM COATED | 10 mg | ORAL | ANDA | 19 sections |
| Donepezil Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0781-5276 | TABLET, ORALLY DISINTEGRATING | 5 mg | ORAL | ANDA | 26 sections |
| Donepezil Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0781-5277 | TABLET, ORALLY DISINTEGRATING | 10 mg | ORAL | ANDA | 26 sections |
| Donepezil Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0904-6477 | TABLET, FILM COATED | 5 mg | ORAL | ANDA | 24 sections |
| Donepezil Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0904-6478 | TABLET, FILM COATED | 10 mg | ORAL | ANDA | 24 sections |
| Donepezil Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 13668-102 | TABLET, FILM COATED | 5 mg | ORAL | ANDA | 25 sections |
| Donepezil Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 13668-103 | TABLET, FILM COATED | 10 mg | ORAL | ANDA | 25 sections |
| Donepezil Hydrochloride | Human Prescription Drug Label | 1 | 16571-778 | TABLET, FILM COATED | 5 mg | ORAL | ANDA | 26 sections |
| Donepezil Hydrochloride | Human Prescription Drug Label | 1 | 16571-779 | TABLET, FILM COATED | 10 mg | ORAL | ANDA | 26 sections |
| DONEPEZIL HYDROCHLORIDE | Human Prescription Drug Label | 1 | 24724-028 | TABLET, FILM COATED | 5 mg | ORAL | ANDA | 25 sections |
| DONEPEZIL HYDROCHLORIDE | Human Prescription Drug Label | 1 | 24724-029 | TABLET, FILM COATED | 10 mg | ORAL | ANDA | 25 sections |
| Donepezil Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 24979-004 | TABLET, FILM COATED | 23 mg | ORAL | ANDA | 16 sections |
| donepezil hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 29300-248 | TABLET, FILM COATED | 5 mg | ORAL | ANDA | 23 sections |
| donepezil hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 29300-249 | TABLET, FILM COATED | 10 mg | ORAL | ANDA | 23 sections |
| donepezil hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 29300-250 | TABLET, ORALLY DISINTEGRATING | 5 mg | ORAL | ANDA | 23 sections |
| donepezil hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 29300-251 | TABLET, ORALLY DISINTEGRATING | 10 mg | ORAL | ANDA | 23 sections |
| Donepezil hydrochloride | Human Prescription Drug Label | 1 | 31722-139 | TABLET, FILM COATED | 5 mg | ORAL | ANDA | 25 sections |
| Donepezil hydrochloride | Human Prescription Drug Label | 1 | 31722-140 | TABLET, FILM COATED | 10 mg | ORAL | ANDA | 25 sections |
| Donepezil | Human Prescription Drug Label | 1 | 31722-737 | TABLET | 5 mg | ORAL | ANDA | 19 sections |
| Donepezil | Human Prescription Drug Label | 1 | 31722-738 | TABLET | 10 mg | ORAL | ANDA | 19 sections |
| Donepezil Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 33261-817 | TABLET, FILM COATED | 10 mg | ORAL | ANDA | 19 sections |
| Donepezil Hydrochloride | Human Prescription Drug Label | 1 | 33342-027 | TABLET, FILM COATED | 5 mg | ORAL | ANDA | 18 sections |