rivastigmine 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| acetylcholinesterase inhibitors | 2392 | 123441-03-2 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
A carbamate-derived reversible CHOLINESTERASE INHIBITOR that is selective for the CENTRAL NERVOUS SYSTEM and is used for the treatment of DEMENTIA in ALZHEIMER DISEASE and PARKINSON DISEASE.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 9 | mg | O |
| 9.50 | mg | TD |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 1 | Benet LZ, Broccatelli F, Oprea TI |
| EoM (Fraction excreted unchanged in urine) | 0.10 % | Benet LZ, Broccatelli F, Oprea TI |
| MRTD (Maximum Recommended Therapeutic Daily Dose) | 0.80 µM/kg/day | Contrera JF, Matthews EJ, Kruhlak NL, Benz RD |
| BA (Bioavailability) | 72 % | Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H |
| Vd (Volume of distribution) | 1.30 L/kg | Lombardo F, Berellini G, Obach RS |
| CL (Clearance) | 12 mL/min/kg | Lombardo F, Berellini G, Obach RS |
| fu (Fraction unbound in plasma) | 0.60 % | Lombardo F, Berellini G, Obach RS |
| t_half (Half-life) | 1.40 hours | Lombardo F, Berellini G, Obach RS |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| May 12, 1998 | EMA | ||
| April 21, 2000 | FDA | NOVARTIS |
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 |
|---|---|---|---|---|---|---|
| Product adhesion issue | 452.58 | 17.99 | 129 | 19269 | 4590 | 63465034 |
| Application site erythema | 378.90 | 17.99 | 113 | 19285 | 4722 | 63464902 |
| Hallucination | 346.40 | 17.99 | 213 | 19185 | 54604 | 63415020 |
| Dementia | 284.83 | 17.99 | 131 | 19267 | 18663 | 63450961 |
| Application site pruritus | 281.57 | 17.99 | 86 | 19312 | 3898 | 63465726 |
| Fall | 280.14 | 17.99 | 459 | 18939 | 391875 | 63077749 |
| Death | 235.25 | 17.99 | 414 | 18984 | 373967 | 63095657 |
| On and off phenomenon | 193.29 | 17.99 | 54 | 19344 | 1781 | 63467843 |
| Agitation | 188.85 | 17.99 | 152 | 19246 | 59605 | 63410019 |
| Confusional state | 186.59 | 17.99 | 290 | 19108 | 236090 | 63233534 |
| Hallucination, visual | 177.95 | 17.99 | 96 | 19302 | 19202 | 63450422 |
| Application site rash | 164.13 | 17.99 | 51 | 19347 | 2447 | 63467177 |
| Disorientation | 163.54 | 17.99 | 118 | 19280 | 39334 | 63430290 |
| Stoma site discharge | 154.59 | 17.99 | 44 | 19354 | 1554 | 63468070 |
| Aggression | 144.93 | 17.99 | 90 | 19308 | 23408 | 63446216 |
| Freezing phenomenon | 127.45 | 17.99 | 36 | 19362 | 1236 | 63468388 |
| Bradykinesia | 120.77 | 17.99 | 49 | 19349 | 5139 | 63464485 |
| Stoma site erythema | 119.12 | 17.99 | 34 | 19364 | 1213 | 63468411 |
| Cognitive disorder | 117.98 | 17.99 | 113 | 19285 | 55702 | 63413922 |
| Blood cholinesterase decreased | 117.71 | 17.99 | 22 | 19376 | 104 | 63469520 |
| Application site hypersensitivity | 114.77 | 17.99 | 24 | 19374 | 219 | 63469405 |
| Delusion | 114.18 | 17.99 | 61 | 19337 | 11956 | 63457668 |
| Abnormal behaviour | 112.13 | 17.99 | 74 | 19324 | 21352 | 63448272 |
| Dyskinesia | 110.91 | 17.99 | 86 | 19312 | 31916 | 63437708 |
| Wrong technique in product usage process | 107.47 | 17.99 | 113 | 19285 | 62227 | 63407397 |
| Memory impairment | 106.94 | 17.99 | 145 | 19253 | 104113 | 63365511 |
| Bradycardia | 105.86 | 17.99 | 121 | 19277 | 73106 | 63396518 |
| Arthralgia | 91.86 | 17.99 | 30 | 19368 | 569680 | 62899944 |
| Product administration error | 90.52 | 17.99 | 66 | 19332 | 22331 | 63447293 |
| Muscle rigidity | 86.34 | 17.99 | 50 | 19348 | 11450 | 63458174 |
| Syncope | 82.74 | 17.99 | 137 | 19261 | 117248 | 63352376 |
| Restlessness | 82.69 | 17.99 | 70 | 19328 | 29383 | 63440241 |
| Pain | 80.88 | 17.99 | 65 | 19333 | 740563 | 62729061 |
| Application site irritation | 79.45 | 17.99 | 27 | 19371 | 1723 | 63467901 |
| Application site reaction | 78.66 | 17.99 | 22 | 19376 | 728 | 63468896 |
| Tremor | 78.42 | 17.99 | 143 | 19255 | 132096 | 63337528 |
| Mini mental status examination abnormal | 78.03 | 17.99 | 11 | 19387 | 0 | 63469624 |
| Alopecia | 77.54 | 17.99 | 7 | 19391 | 337529 | 63132095 |
| Dysphagia | 77.19 | 17.99 | 114 | 19284 | 88471 | 63381153 |
| Cholinergic syndrome | 76.95 | 17.99 | 20 | 19378 | 498 | 63469126 |
| Cerebral atrophy | 75.72 | 17.99 | 35 | 19363 | 5031 | 63464593 |
| Lack of application site rotation | 68.32 | 17.99 | 10 | 19388 | 3 | 63469621 |
| Speech disorder | 65.32 | 17.99 | 71 | 19327 | 40558 | 63429066 |
| Rheumatoid arthritis | 64.94 | 17.99 | 3 | 19395 | 253816 | 63215808 |
| Hyperkinesia | 64.66 | 17.99 | 23 | 19375 | 1681 | 63467943 |
| Skin irritation | 64.35 | 17.99 | 39 | 19359 | 9702 | 63459922 |
| Delirium | 63.87 | 17.99 | 78 | 19320 | 50463 | 63419161 |
| Vomiting | 63.36 | 17.99 | 337 | 19061 | 559280 | 62910344 |
| Loss of consciousness | 62.88 | 17.99 | 122 | 19276 | 117999 | 63351625 |
| Joint swelling | 62.86 | 17.99 | 12 | 19386 | 327654 | 63141970 |
| Drug hypersensitivity | 60.40 | 17.99 | 11 | 19387 | 310676 | 63158948 |
| Stoma site irritation | 60.20 | 17.99 | 14 | 19384 | 216 | 63469408 |
| Pneumonia aspiration | 60.19 | 17.99 | 63 | 19335 | 34477 | 63435147 |
| Somnolence | 59.51 | 17.99 | 153 | 19245 | 178532 | 63291092 |
| Infusion related reaction | 59.42 | 17.99 | 4 | 19394 | 245517 | 63224107 |
| Cerebrovascular accident | 59.24 | 17.99 | 113 | 19285 | 107911 | 63361713 |
| Femur fracture | 58.63 | 17.99 | 68 | 19330 | 41688 | 63427936 |
| Akinesia | 54.81 | 17.99 | 20 | 19378 | 1573 | 63468051 |
| Dysstasia | 54.73 | 17.99 | 48 | 19350 | 21118 | 63448506 |
| Arthropathy | 53.53 | 17.99 | 5 | 19393 | 234787 | 63234837 |
| Swelling | 52.98 | 17.99 | 10 | 19388 | 275368 | 63194256 |
| Decreased appetite | 52.25 | 17.99 | 182 | 19216 | 250870 | 63218754 |
| Therapeutic product effect variable | 52.13 | 17.99 | 18 | 19380 | 1205 | 63468419 |
| Abnormal dreams | 51.82 | 17.99 | 35 | 19363 | 10481 | 63459143 |
| Stoma site pain | 51.47 | 17.99 | 17 | 19381 | 993 | 63468631 |
| Dementia with Lewy bodies | 49.97 | 17.99 | 13 | 19385 | 325 | 63469299 |
| Marasmus | 48.73 | 17.99 | 14 | 19384 | 511 | 63469113 |
| Sinusitis | 48.68 | 17.99 | 6 | 19392 | 226647 | 63242977 |
| Malaise | 48 | 17.99 | 252 | 19146 | 415702 | 63053922 |
| Posture abnormal | 47.42 | 17.99 | 20 | 19378 | 2312 | 63467312 |
| Gait disturbance | 46.37 | 17.99 | 142 | 19256 | 183036 | 63286588 |
| Off label use | 46.18 | 17.99 | 85 | 19313 | 674377 | 62795247 |
| Pemphigus | 44.42 | 17.99 | 3 | 19395 | 183723 | 63285901 |
| Femoral neck fracture | 43.52 | 17.99 | 29 | 19369 | 8494 | 63461130 |
| Dehydration | 43.51 | 17.99 | 134 | 19264 | 173220 | 63296404 |
| Fibroma | 42.30 | 17.99 | 14 | 19384 | 823 | 63468801 |
| Application site dermatitis | 41.76 | 17.99 | 10 | 19388 | 176 | 63469448 |
| Gait inability | 40.24 | 17.99 | 64 | 19334 | 52895 | 63416729 |
| Drug ineffective | 40.18 | 17.99 | 174 | 19224 | 1044591 | 62425033 |
| Concomitant disease aggravated | 39.43 | 17.99 | 28 | 19370 | 9084 | 63460540 |
| Dementia Alzheimer's type | 39.06 | 17.99 | 14 | 19384 | 1046 | 63468578 |
| Arrhythmia | 38.98 | 17.99 | 53 | 19345 | 38087 | 63431537 |
| Accessory cardiac pathway | 38.93 | 17.99 | 6 | 19392 | 5 | 63469619 |
| Hypokinesia | 38.85 | 17.99 | 33 | 19365 | 13903 | 63455721 |
| Treatment failure | 38.76 | 17.99 | 7 | 19391 | 199036 | 63270588 |
| Application site discolouration | 38.58 | 17.99 | 13 | 19385 | 808 | 63468816 |
| Subileus | 38.48 | 17.99 | 19 | 19379 | 3160 | 63466464 |
| Fatigue | 37.82 | 17.99 | 142 | 19256 | 887886 | 62581738 |
| Product prescribing error | 37.21 | 17.99 | 43 | 19355 | 26246 | 63443378 |
| General physical health deterioration | 35.96 | 17.99 | 139 | 19259 | 201263 | 63268361 |
| Eating disorder | 35.50 | 17.99 | 36 | 19362 | 18980 | 63450644 |
| Aphasia | 35.47 | 17.99 | 47 | 19351 | 32953 | 63436671 |
| Application site swelling | 34.63 | 17.99 | 11 | 19387 | 567 | 63469057 |
| Vascular encephalopathy | 33.21 | 17.99 | 10 | 19388 | 431 | 63469193 |
| Fracture | 32.83 | 17.99 | 35 | 19363 | 19549 | 63450075 |
| Pleurothotonus | 32.28 | 17.99 | 13 | 19385 | 1336 | 63468288 |
| Stoma site inflammation | 32.11 | 17.99 | 10 | 19388 | 483 | 63469141 |
| Extrapyramidal disorder | 32.10 | 17.99 | 29 | 19369 | 13255 | 63456369 |
| Dyspnoea | 31.99 | 17.99 | 100 | 19298 | 661213 | 62808411 |
| Nightmare | 31.64 | 17.99 | 34 | 19364 | 19160 | 63450464 |
| Unresponsive to stimuli | 31.58 | 17.99 | 45 | 19353 | 33771 | 63435853 |
| Completed suicide | 30.91 | 17.99 | 4 | 19394 | 145669 | 63323955 |
| Resting tremor | 30.82 | 17.99 | 11 | 19387 | 812 | 63468812 |
| Orthostatic hypotension | 30.69 | 17.99 | 46 | 19352 | 36114 | 63433510 |
| Abdominal discomfort | 30.33 | 17.99 | 32 | 19366 | 320853 | 63148771 |
| Stoma site discomfort | 30.28 | 17.99 | 7 | 19391 | 105 | 63469519 |
| Balance disorder | 29.85 | 17.99 | 74 | 19324 | 84348 | 63385276 |
| Screaming | 29.42 | 17.99 | 16 | 19382 | 3246 | 63466378 |
| Pain in extremity | 29.21 | 17.99 | 35 | 19363 | 331451 | 63138173 |
| Stoma site reaction | 29.13 | 17.99 | 8 | 19390 | 247 | 63469377 |
| Headache | 29.06 | 17.99 | 98 | 19300 | 633143 | 62836481 |
| Stomatitis | 28.98 | 17.99 | 4 | 19394 | 138721 | 63330903 |
| Hypersensitivity | 27.86 | 17.99 | 29 | 19369 | 292656 | 63176968 |
| Urinary retention | 27.82 | 17.99 | 40 | 19358 | 30261 | 63439363 |
| Stoma site hypergranulation | 27.29 | 17.99 | 8 | 19390 | 314 | 63469310 |
| Wound | 27.29 | 17.99 | 8 | 19390 | 163255 | 63306369 |
| Psychotic symptom | 27.18 | 17.99 | 12 | 19386 | 1549 | 63468075 |
| Dizziness | 27.14 | 17.99 | 224 | 19174 | 429701 | 63039923 |
| Rash | 26.96 | 17.99 | 85 | 19313 | 560786 | 62908838 |
| Nasopharyngitis | 26.77 | 17.99 | 23 | 19375 | 254234 | 63215390 |
| Cough | 26.76 | 17.99 | 30 | 19368 | 292713 | 63176911 |
| Neutropenia | 26.75 | 17.99 | 10 | 19388 | 174995 | 63294629 |
| Weight decreased | 26.73 | 17.99 | 160 | 19238 | 276638 | 63192986 |
| Parkinson's disease | 26.62 | 17.99 | 11 | 19387 | 1208 | 63468416 |
| Back pain | 26.49 | 17.99 | 25 | 19373 | 264120 | 63205504 |
| Therapeutic product effect decreased | 26.41 | 17.99 | 13 | 19385 | 193174 | 63276450 |
| Apparent death | 26.25 | 17.99 | 11 | 19387 | 1251 | 63468373 |
| Feeding disorder | 26.23 | 17.99 | 26 | 19372 | 13336 | 63456288 |
| Depressed level of consciousness | 25.84 | 17.99 | 58 | 19340 | 62020 | 63407604 |
| Febrile neutropenia | 25.75 | 17.99 | 3 | 19395 | 118446 | 63351178 |
| Hip fracture | 25.74 | 17.99 | 38 | 19360 | 29436 | 63440188 |
| Senile dementia | 25.04 | 17.99 | 7 | 19391 | 231 | 63469393 |
| Arthritis | 25.04 | 17.99 | 3 | 19395 | 115918 | 63353706 |
| Application site vesicles | 24.89 | 17.99 | 11 | 19387 | 1424 | 63468200 |
| Discomfort | 24.86 | 17.99 | 10 | 19388 | 167364 | 63302260 |
| Peripheral swelling | 24.58 | 17.99 | 27 | 19371 | 265915 | 63203709 |
| Product administered at inappropriate site | 24.45 | 17.99 | 14 | 19384 | 3135 | 63466489 |
| Agnosia | 24.29 | 17.99 | 6 | 19392 | 121 | 63469503 |
| Hepatic enzyme increased | 24.25 | 17.99 | 16 | 19382 | 202312 | 63267312 |
| Intentional product use issue | 23.83 | 17.99 | 5 | 19393 | 127887 | 63341737 |
| Dystonia | 23.70 | 17.99 | 25 | 19373 | 13794 | 63455830 |
| Psychotic disorder | 23.69 | 17.99 | 34 | 19364 | 25678 | 63443946 |
| Parkinsonian gait | 23.53 | 17.99 | 8 | 19390 | 511 | 63469113 |
| Psychomotor hyperactivity | 23.29 | 17.99 | 22 | 19376 | 10641 | 63458983 |
| Salivary hypersecretion | 23.12 | 17.99 | 19 | 19379 | 7647 | 63461977 |
| Dermatitis contact | 22.69 | 17.99 | 22 | 19376 | 10986 | 63458638 |
| Fear | 22.66 | 17.99 | 26 | 19372 | 15740 | 63453884 |
| Fluid intake reduced | 22.57 | 17.99 | 14 | 19384 | 3627 | 63465997 |
| Faecaloma | 22.54 | 17.99 | 19 | 19379 | 7922 | 63461702 |
| Anxiety | 22.45 | 17.99 | 128 | 19270 | 217413 | 63252211 |
| Urinary tract infection | 22.43 | 17.99 | 148 | 19250 | 264536 | 63205088 |
| Incorrect product administration duration | 21.81 | 17.99 | 22 | 19376 | 11524 | 63458100 |
| Parkinsonism | 21.78 | 17.99 | 21 | 19377 | 10418 | 63459206 |
| Medical device site dryness | 21.76 | 17.99 | 5 | 19393 | 73 | 63469551 |
| Atrioventricular block second degree | 21.64 | 17.99 | 14 | 19384 | 3900 | 63465724 |
| Paranoia | 21.59 | 17.99 | 22 | 19376 | 11657 | 63457967 |
| Myalgia | 21.36 | 17.99 | 9 | 19389 | 146520 | 63323104 |
| Medical device site injury | 21.28 | 17.99 | 3 | 19395 | 0 | 63469624 |
| Product administration interrupted | 21.25 | 17.99 | 15 | 19383 | 4821 | 63464803 |
| Drug interaction | 20.56 | 17.99 | 130 | 19268 | 229001 | 63240623 |
| Cerebral haemorrhage | 20.46 | 17.99 | 35 | 19363 | 30694 | 63438930 |
| Pyrexia | 20.08 | 17.99 | 75 | 19323 | 470403 | 62999221 |
| Neuropathy peripheral | 20.06 | 17.99 | 5 | 19393 | 113662 | 63355962 |
| Hypophagia | 20.02 | 17.99 | 35 | 19363 | 31224 | 63438400 |
| Mental impairment | 19.78 | 17.99 | 23 | 19375 | 14128 | 63455496 |
| Abnormal faeces | 19.57 | 17.99 | 15 | 19383 | 5465 | 63464159 |
| Lower respiratory tract infection | 19.49 | 17.99 | 8 | 19390 | 132299 | 63337325 |
| Tension | 19.16 | 17.99 | 12 | 19386 | 3163 | 63466461 |
| Apathy | 18.93 | 17.99 | 18 | 19380 | 8776 | 63460848 |
| Transient ischaemic attack | 18.86 | 17.99 | 38 | 19360 | 37715 | 63431909 |
| Platelet count decreased | 18.84 | 17.99 | 6 | 19392 | 116116 | 63353508 |
| Gastrointestinal sounds abnormal | 18.81 | 17.99 | 13 | 19385 | 4038 | 63465586 |
| Cardiac failure | 18.81 | 17.99 | 65 | 19333 | 89077 | 63380547 |
| Stoma site extravasation | 18.71 | 17.99 | 6 | 19392 | 319 | 63469305 |
| Altered state of consciousness | 18.49 | 17.99 | 30 | 19368 | 25200 | 63444424 |
| Paraesthesia | 18.02 | 17.99 | 13 | 19385 | 156953 | 63312671 |
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 | 485.08 | 17.81 | 303 | 16377 | 51195 | 34889056 |
| Product adhesion issue | 398.35 | 17.81 | 102 | 16578 | 1498 | 34938753 |
| Confusional state | 297.20 | 17.81 | 354 | 16326 | 143806 | 34796445 |
| Application site erythema | 258.91 | 17.81 | 79 | 16601 | 2257 | 34937994 |
| Aggression | 257.18 | 17.81 | 184 | 16496 | 38780 | 34901471 |
| Fall | 238.87 | 17.81 | 380 | 16300 | 202505 | 34737746 |
| On and off phenomenon | 224.65 | 17.81 | 72 | 16608 | 2425 | 34937826 |
| Freezing phenomenon | 213.99 | 17.81 | 62 | 16618 | 1474 | 34938777 |
| Dementia | 195.80 | 17.81 | 106 | 16574 | 13642 | 34926609 |
| Stoma site discharge | 182.56 | 17.81 | 52 | 16628 | 1161 | 34939090 |
| Abnormal behaviour | 178.77 | 17.81 | 124 | 16556 | 24845 | 34915406 |
| Application site pruritus | 165.23 | 17.81 | 50 | 16630 | 1387 | 34938864 |
| Agitation | 159.27 | 17.81 | 165 | 16515 | 57234 | 34883017 |
| Bradykinesia | 143.54 | 17.81 | 58 | 16622 | 3835 | 34936416 |
| Hallucination, visual | 138.33 | 17.81 | 93 | 16587 | 17698 | 34922553 |
| Gait disturbance | 136.71 | 17.81 | 185 | 16495 | 84955 | 34855296 |
| Stoma site erythema | 134.84 | 17.81 | 38 | 16642 | 815 | 34939436 |
| Cognitive disorder | 126.95 | 17.81 | 107 | 16573 | 28586 | 34911665 |
| Dyskinesia | 121.22 | 17.81 | 94 | 16586 | 22319 | 34917932 |
| Blood cholinesterase decreased | 115.18 | 17.81 | 24 | 16656 | 129 | 34940122 |
| Death | 114.72 | 17.81 | 432 | 16248 | 397617 | 34542634 |
| Muscle rigidity | 109.18 | 17.81 | 66 | 16614 | 10452 | 34929799 |
| Application site rash | 103.61 | 17.81 | 31 | 16649 | 826 | 34939425 |
| Somnolence | 99.74 | 17.81 | 185 | 16495 | 110931 | 34829320 |
| General physical health deterioration | 91.54 | 17.81 | 194 | 16486 | 128075 | 34812176 |
| Device dislocation | 88.42 | 17.81 | 48 | 16632 | 6201 | 34934050 |
| Memory impairment | 84.91 | 17.81 | 104 | 16576 | 43214 | 34897037 |
| Akinesia | 82.10 | 17.81 | 33 | 16647 | 2151 | 34938100 |
| Restlessness | 81.13 | 17.81 | 79 | 16601 | 25403 | 34914848 |
| Disorientation | 80.64 | 17.81 | 89 | 16591 | 33099 | 34907152 |
| Mobility decreased | 80.58 | 17.81 | 85 | 16595 | 30043 | 34910208 |
| Fibroma | 78.55 | 17.81 | 21 | 16659 | 367 | 34939884 |
| Dementia with Lewy bodies | 78.44 | 17.81 | 24 | 16656 | 691 | 34939560 |
| Pneumonia aspiration | 74.78 | 17.81 | 96 | 16584 | 41807 | 34898444 |
| Delusion | 70.49 | 17.81 | 54 | 16626 | 12581 | 34927670 |
| Delirium | 66.58 | 17.81 | 93 | 16587 | 43898 | 34896353 |
| Speech disorder | 66.08 | 17.81 | 71 | 16609 | 25615 | 34914636 |
| Stoma site inflammation | 64.38 | 17.81 | 19 | 16661 | 482 | 34939769 |
| Hyperkinesia | 64.00 | 17.81 | 26 | 16654 | 1742 | 34938509 |
| Dysphagia | 58.57 | 17.81 | 106 | 16574 | 62275 | 34877976 |
| Stoma site reaction | 58.00 | 17.81 | 15 | 16665 | 229 | 34940022 |
| Abnormal dreams | 57.40 | 17.81 | 39 | 16641 | 7539 | 34932712 |
| Reduced facial expression | 57.18 | 17.81 | 21 | 16659 | 1070 | 34939181 |
| Gait inability | 56.26 | 17.81 | 59 | 16621 | 20699 | 34919552 |
| Tremor | 55.48 | 17.81 | 122 | 16558 | 82465 | 34857786 |
| Application site irritation | 54.24 | 17.81 | 18 | 16662 | 677 | 34939574 |
| Febrile neutropenia | 53.17 | 17.81 | 3 | 16677 | 136846 | 34803405 |
| Arthralgia | 52.50 | 17.81 | 9 | 16671 | 170032 | 34770219 |
| Paranoia | 49.25 | 17.81 | 43 | 16637 | 12025 | 34928226 |
| Parkinson's disease | 48.33 | 17.81 | 20 | 16660 | 1404 | 34938847 |
| Sinus bradycardia | 46.60 | 17.81 | 43 | 16637 | 12920 | 34927331 |
| Syncope | 45.20 | 17.81 | 120 | 16560 | 91331 | 34848920 |
| Bradycardia | 44.65 | 17.81 | 106 | 16574 | 75312 | 34864939 |
| Urinary incontinence | 43.06 | 17.81 | 49 | 16631 | 18825 | 34921426 |
| Neutropenia | 42.84 | 17.81 | 11 | 16669 | 156767 | 34783484 |
| Device kink | 41.15 | 17.81 | 13 | 16667 | 417 | 34939834 |
| Prescribed underdose | 40.89 | 17.81 | 34 | 16646 | 8899 | 34931352 |
| Intentional medical device removal by patient | 40.79 | 17.81 | 12 | 16668 | 301 | 34939950 |
| Stoma site pain | 38.96 | 17.81 | 14 | 16666 | 670 | 34939581 |
| Balance disorder | 38.03 | 17.81 | 69 | 16611 | 40585 | 34899666 |
| Stoma site extravasation | 37.94 | 17.81 | 9 | 16671 | 94 | 34940157 |
| Psychotic disorder | 37.43 | 17.81 | 52 | 16628 | 24400 | 34915851 |
| Application site discolouration | 36.76 | 17.81 | 11 | 16669 | 293 | 34939958 |
| Stoma site infection | 36.65 | 17.81 | 14 | 16666 | 796 | 34939455 |
| Product administration error | 36.55 | 17.81 | 42 | 16638 | 16302 | 34923949 |
| Hangover | 36.48 | 17.81 | 15 | 16665 | 1036 | 34939215 |
| Loss of consciousness | 36.40 | 17.81 | 104 | 16576 | 82563 | 34857688 |
| Urinary tract infection | 36.27 | 17.81 | 105 | 16575 | 83976 | 34856275 |
| Drug abuse | 36.07 | 17.81 | 3 | 16677 | 99093 | 34841158 |
| Application site hypersensitivity | 35.66 | 17.81 | 9 | 16671 | 124 | 34940127 |
| Disturbance in attention | 35.06 | 17.81 | 52 | 16628 | 25893 | 34914358 |
| Motor dysfunction | 34.98 | 17.81 | 28 | 16652 | 6946 | 34933305 |
| Tension | 34.41 | 17.81 | 18 | 16662 | 2157 | 34938094 |
| Mini mental status examination abnormal | 34.01 | 17.81 | 6 | 16674 | 10 | 34940241 |
| Marasmus | 33.16 | 17.81 | 12 | 16668 | 586 | 34939665 |
| Stoma site hypergranulation | 32.33 | 17.81 | 9 | 16671 | 184 | 34940067 |
| Off label use | 30.38 | 17.81 | 101 | 16579 | 419423 | 34520828 |
| Sleep disorder | 29.91 | 17.81 | 54 | 16626 | 31634 | 34908617 |
| Parkinsonism | 29.26 | 17.81 | 27 | 16653 | 8111 | 34932140 |
| Application site reaction | 29.19 | 17.81 | 10 | 16670 | 415 | 34939836 |
| Dyspnoea | 29.17 | 17.81 | 88 | 16592 | 376694 | 34563557 |
| Nonspecific reaction | 29.16 | 17.81 | 14 | 16666 | 1397 | 34938854 |
| Acute kidney injury | 29.15 | 17.81 | 64 | 16616 | 304924 | 34635327 |
| Hypokinesia | 29.13 | 17.81 | 28 | 16652 | 8852 | 34931399 |
| Device issue | 28.67 | 17.81 | 29 | 16651 | 9748 | 34930503 |
| Stoma site odour | 28.38 | 17.81 | 6 | 16674 | 35 | 34940216 |
| Malaise | 27.58 | 17.81 | 167 | 16513 | 185658 | 34754593 |
| Therapeutic product effect variable | 27.00 | 17.81 | 16 | 16664 | 2440 | 34937811 |
| Cholinergic syndrome | 26.04 | 17.81 | 10 | 16670 | 577 | 34939674 |
| Dyschezia | 25.59 | 17.81 | 13 | 16667 | 1465 | 34938786 |
| Screaming | 25.54 | 17.81 | 13 | 16667 | 1471 | 34938780 |
| White blood cell count decreased | 25.48 | 17.81 | 7 | 16673 | 95438 | 34844813 |
| Application site vesicles | 25.47 | 17.81 | 10 | 16670 | 612 | 34939639 |
| Underdose | 25.23 | 17.81 | 32 | 16648 | 13748 | 34926503 |
| Aspiration | 25.04 | 17.81 | 30 | 16650 | 12164 | 34928087 |
| Myalgia | 24.76 | 17.81 | 5 | 16675 | 84105 | 34856146 |
| Salivary hypersecretion | 24.19 | 17.81 | 25 | 16655 | 8619 | 34931632 |
| Stoma site irritation | 23.85 | 17.81 | 7 | 16673 | 174 | 34940077 |
| Embedded device | 23.56 | 17.81 | 8 | 16672 | 323 | 34939928 |
| Pancytopenia | 23.56 | 17.81 | 8 | 16672 | 95149 | 34845102 |
| Parkinsonian gait | 23.47 | 17.81 | 9 | 16671 | 517 | 34939734 |
| Aphasia | 23.43 | 17.81 | 39 | 16641 | 21415 | 34918836 |
| Middle insomnia | 23.36 | 17.81 | 22 | 16658 | 6780 | 34933471 |
| Hypersomnia | 23.02 | 17.81 | 29 | 16651 | 12378 | 34927873 |
| Apathy | 23.00 | 17.81 | 22 | 16658 | 6910 | 34933341 |
| Orthostatic hypotension | 22.98 | 17.81 | 43 | 16637 | 25876 | 34914375 |
| Neuroleptic malignant syndrome | 22.88 | 17.81 | 35 | 16645 | 17899 | 34922352 |
| Miosis | 22.16 | 17.81 | 25 | 16655 | 9510 | 34930741 |
| Device difficult to use | 22.15 | 17.81 | 15 | 16665 | 2882 | 34937369 |
| Platelet count decreased | 22.12 | 17.81 | 15 | 16665 | 119702 | 34820549 |
| Pain | 22.06 | 17.81 | 40 | 16640 | 204635 | 34735616 |
| Dysstasia | 21.82 | 17.81 | 28 | 16652 | 12167 | 34928084 |
| Headache | 21.81 | 17.81 | 39 | 16641 | 200596 | 34739655 |
| Concomitant disease progression | 21.58 | 17.81 | 14 | 16666 | 2504 | 34937747 |
| Back pain | 21.53 | 17.81 | 16 | 16664 | 121773 | 34818478 |
| Incorrect product administration duration | 21.37 | 17.81 | 18 | 16662 | 4793 | 34935458 |
| Depressed level of consciousness | 20.92 | 17.81 | 56 | 16624 | 42785 | 34897466 |
| Condition aggravated | 20.90 | 17.81 | 160 | 16520 | 192036 | 34748215 |
| Psychomotor hyperactivity | 20.30 | 17.81 | 24 | 16656 | 9598 | 34930653 |
| Toxicity to various agents | 19.98 | 17.81 | 41 | 16639 | 200321 | 34739930 |
| Urinary retention | 19.32 | 17.81 | 49 | 16631 | 36239 | 34904012 |
| Confusional arousal | 19.27 | 17.81 | 4 | 16676 | 21 | 34940230 |
| Hip fracture | 19.21 | 17.81 | 26 | 16654 | 11899 | 34928352 |
| Neuropathy peripheral | 18.94 | 17.81 | 8 | 16672 | 83255 | 34856996 |
| Choking | 18.73 | 17.81 | 17 | 16663 | 4998 | 34935253 |
| Wrong technique in product usage process | 18.54 | 17.81 | 48 | 16632 | 35938 | 34904313 |
| Incorrect product dosage form administered | 18.38 | 17.81 | 6 | 16674 | 214 | 34940037 |
| Oesophageal dilatation | 18.35 | 17.81 | 6 | 16674 | 215 | 34940036 |
| Dystonia | 18.01 | 17.81 | 24 | 16656 | 10821 | 34929430 |
| Application site inflammation | 17.97 | 17.81 | 5 | 16675 | 102 | 34940149 |
| Hypophagia | 17.84 | 17.81 | 37 | 16643 | 23985 | 34916266 |
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 |
|---|---|---|---|---|---|---|
| Hallucination | 601.64 | 15.59 | 356 | 23986 | 85389 | 79634657 |
| Fall | 390.89 | 15.59 | 601 | 23741 | 487028 | 79233018 |
| Confusional state | 336.78 | 15.59 | 448 | 23894 | 317549 | 79402497 |
| On and off phenomenon | 303.64 | 15.59 | 87 | 24255 | 3153 | 79716893 |
| Dementia | 274.20 | 15.59 | 139 | 24203 | 24520 | 79695526 |
| Freezing phenomenon | 256.15 | 15.59 | 68 | 24274 | 1846 | 79718200 |
| Hallucination, visual | 255.94 | 15.59 | 146 | 24196 | 32583 | 79687463 |
| Aggression | 243.04 | 15.59 | 166 | 24176 | 50792 | 79669254 |
| Stoma site discharge | 237.29 | 15.59 | 66 | 24276 | 2143 | 79717903 |
| Blood cholinesterase decreased | 224.46 | 15.59 | 43 | 24299 | 238 | 79719808 |
| Agitation | 213.25 | 15.59 | 203 | 24139 | 99512 | 79620534 |
| Application site erythema | 197.93 | 15.59 | 70 | 24272 | 5040 | 79715006 |
| Bradykinesia | 190.88 | 15.59 | 77 | 24265 | 7966 | 79712080 |
| Stoma site erythema | 177.45 | 15.59 | 50 | 24292 | 1703 | 79718343 |
| Product adhesion issue | 176.84 | 15.59 | 55 | 24287 | 2649 | 79717397 |
| Cognitive disorder | 172.03 | 15.59 | 154 | 24188 | 69772 | 79650274 |
| Dyskinesia | 163.38 | 15.59 | 124 | 24218 | 44649 | 79675397 |
| Abnormal behaviour | 160.36 | 15.59 | 113 | 24229 | 36308 | 79683738 |
| Application site pruritus | 154.47 | 15.59 | 54 | 24288 | 3756 | 79716290 |
| Delusion | 148.69 | 15.59 | 87 | 24255 | 20336 | 79699710 |
| Disorientation | 148.00 | 15.59 | 135 | 24207 | 62641 | 79657405 |
| Death | 124.21 | 15.59 | 417 | 23925 | 566097 | 79153949 |
| Somnolence | 122.95 | 15.59 | 243 | 24099 | 238738 | 79481308 |
| Akinesia | 119.31 | 15.59 | 43 | 24299 | 3269 | 79716777 |
| Gait disturbance | 119.02 | 15.59 | 221 | 24121 | 207285 | 79512761 |
| Pneumonia aspiration | 116.60 | 15.59 | 122 | 24220 | 66845 | 79653201 |
| Muscle rigidity | 107.32 | 15.59 | 70 | 24272 | 19812 | 79700234 |
| Restlessness | 105.70 | 15.59 | 98 | 24244 | 46394 | 79673652 |
| Bradycardia | 100.78 | 15.59 | 162 | 24180 | 135395 | 79584651 |
| Delirium | 98.12 | 15.59 | 125 | 24217 | 84502 | 79635544 |
| Application site rash | 97.23 | 15.59 | 33 | 24309 | 2099 | 79717947 |
| Arthralgia | 93.93 | 15.59 | 29 | 24313 | 571774 | 79148272 |
| Cholinergic syndrome | 87.74 | 15.59 | 26 | 24316 | 1061 | 79718985 |
| Tremor | 87.45 | 15.59 | 173 | 24169 | 169910 | 79550136 |
| Syncope | 82.18 | 15.59 | 174 | 24168 | 179275 | 79540771 |
| General physical health deterioration | 79.10 | 15.59 | 223 | 24119 | 275015 | 79445031 |
| Dysphagia | 78.79 | 15.59 | 137 | 24205 | 121999 | 79598047 |
| Abnormal dreams | 76.23 | 15.59 | 46 | 24296 | 11366 | 79708680 |
| Stoma site inflammation | 75.69 | 15.59 | 21 | 24321 | 675 | 79719371 |
| Memory impairment | 75.57 | 15.59 | 128 | 24214 | 111606 | 79608440 |
| Cerebral atrophy | 73.96 | 15.59 | 40 | 24302 | 8035 | 79712011 |
| Mini mental status examination abnormal | 73.26 | 15.59 | 11 | 24331 | 6 | 79720040 |
| Loss of consciousness | 72.48 | 15.59 | 159 | 24183 | 167784 | 79552262 |
| Therapeutic product effect variable | 72.05 | 15.59 | 26 | 24316 | 1983 | 79718063 |
| Hyperkinesia | 67.77 | 15.59 | 27 | 24315 | 2702 | 79717344 |
| Pain | 66.77 | 15.59 | 70 | 24272 | 703732 | 79016314 |
| Speech disorder | 62.42 | 15.59 | 80 | 24262 | 54365 | 79665681 |
| Paranoia | 60.43 | 15.59 | 49 | 24293 | 19383 | 79700663 |
| Drug hypersensitivity | 59.27 | 15.59 | 10 | 24332 | 298906 | 79421140 |
| Fibroma | 57.66 | 15.59 | 18 | 24324 | 877 | 79719169 |
| Stoma site pain | 56.56 | 15.59 | 20 | 24322 | 1438 | 79718608 |
| Stoma site hypergranulation | 55.71 | 15.59 | 15 | 24327 | 430 | 79719616 |
| Device dislocation | 55.67 | 15.59 | 53 | 24289 | 25917 | 79694129 |
| Alopecia | 55.23 | 15.59 | 4 | 24338 | 231351 | 79488695 |
| Marasmus | 55.21 | 15.59 | 18 | 24324 | 1010 | 79719036 |
| Wrong technique in product usage process | 54.46 | 15.59 | 88 | 24254 | 73787 | 79646259 |
| Pleurothotonus | 52.59 | 15.59 | 22 | 24320 | 2494 | 79717552 |
| Febrile neutropenia | 52.37 | 15.59 | 5 | 24337 | 230994 | 79489052 |
| Stoma site irritation | 52.36 | 15.59 | 13 | 24329 | 268 | 79719778 |
| Infusion related reaction | 52.15 | 15.59 | 5 | 24337 | 230232 | 79489814 |
| Rheumatoid arthritis | 51.55 | 15.59 | 3 | 24339 | 208467 | 79511579 |
| Psychotic disorder | 50.90 | 15.59 | 63 | 24279 | 41339 | 79678707 |
| Dementia with Lewy bodies | 50.29 | 15.59 | 16 | 24326 | 830 | 79719216 |
| Application site hypersensitivity | 50.13 | 15.59 | 13 | 24329 | 321 | 79719725 |
| Stoma site reaction | 47.55 | 15.59 | 13 | 24329 | 395 | 79719651 |
| Reduced facial expression | 47.35 | 15.59 | 21 | 24321 | 2744 | 79717302 |
| Balance disorder | 46.53 | 15.59 | 97 | 24245 | 98760 | 79621286 |
| Orthostatic hypotension | 45.68 | 15.59 | 70 | 24272 | 56094 | 79663952 |
| Joint swelling | 44.92 | 15.59 | 16 | 24326 | 288630 | 79431416 |
| Stoma site extravasation | 44.27 | 15.59 | 12 | 24330 | 353 | 79719693 |
| Sinus bradycardia | 43.92 | 15.59 | 46 | 24296 | 25201 | 79694845 |
| Dysstasia | 43.77 | 15.59 | 48 | 24294 | 27698 | 79692348 |
| Stoma site odour | 43.06 | 15.59 | 9 | 24333 | 82 | 79719964 |
| Neuroleptic malignant syndrome | 42.30 | 15.59 | 47 | 24295 | 27512 | 79692534 |
| Product administration error | 41.64 | 15.59 | 50 | 24292 | 31796 | 79688250 |
| Headache | 41.44 | 15.59 | 86 | 24256 | 653686 | 79066360 |
| Application site dermatitis | 41.35 | 15.59 | 10 | 24332 | 184 | 79719862 |
| Stoma site infection | 41.12 | 15.59 | 16 | 24326 | 1504 | 79718542 |
| Urinary tract infection | 40.85 | 15.59 | 179 | 24163 | 274333 | 79445713 |
| Extrapyramidal disorder | 40.67 | 15.59 | 42 | 24300 | 22637 | 79697409 |
| Posture abnormal | 40.65 | 15.59 | 21 | 24321 | 3845 | 79716201 |
| Urinary incontinence | 40.56 | 15.59 | 56 | 24286 | 40853 | 79679193 |
| Product administration interrupted | 40.48 | 15.59 | 21 | 24321 | 3878 | 79716168 |
| Femur fracture | 39.97 | 15.59 | 54 | 24288 | 38598 | 79681448 |
| Neutropenia | 39.83 | 15.59 | 19 | 24323 | 287691 | 79432355 |
| Arthropathy | 39.70 | 15.59 | 4 | 24338 | 177107 | 79542939 |
| Hypokinesia | 39.15 | 15.59 | 38 | 24304 | 19022 | 79701024 |
| Application site irritation | 38.99 | 15.59 | 16 | 24326 | 1728 | 79718318 |
| Depressed level of consciousness | 38.85 | 15.59 | 89 | 24253 | 96563 | 79623483 |
| Toxicity to various agents | 38.70 | 15.59 | 43 | 24299 | 421497 | 79298549 |
| Disturbance in attention | 38.09 | 15.59 | 61 | 24281 | 50740 | 79669306 |
| Parkinsonism | 37.75 | 15.59 | 35 | 24307 | 16549 | 79703497 |
| Dystonia | 37.24 | 15.59 | 39 | 24303 | 21360 | 79698686 |
| Urinary retention | 37.11 | 15.59 | 64 | 24278 | 56566 | 79663480 |
| Gait inability | 36.55 | 15.59 | 65 | 24277 | 58852 | 79661194 |
| Concomitant disease aggravated | 36.36 | 15.59 | 31 | 24311 | 13136 | 79706910 |
| Salivary hypersecretion | 36.28 | 15.59 | 32 | 24310 | 14192 | 79705854 |
| Accessory cardiac pathway | 35.98 | 15.59 | 6 | 24336 | 12 | 79720034 |
| Completed suicide | 35.95 | 15.59 | 15 | 24327 | 245752 | 79474294 |
| Rash | 35.86 | 15.59 | 77 | 24265 | 578281 | 79141765 |
| Sinusitis | 35.66 | 15.59 | 8 | 24334 | 195493 | 79524553 |
| Dehydration | 35.52 | 15.59 | 160 | 24182 | 248027 | 79472019 |
| Psychomotor hyperactivity | 35.38 | 15.59 | 34 | 24308 | 16815 | 79703231 |
| Decreased appetite | 35.15 | 15.59 | 201 | 24141 | 342217 | 79377829 |
| Back pain | 35.14 | 15.59 | 25 | 24317 | 304155 | 79415891 |
| Screaming | 34.68 | 15.59 | 19 | 24323 | 3914 | 79716132 |
| Intentional medical device removal by patient | 34.51 | 15.59 | 10 | 24332 | 377 | 79719669 |
| Dyspnoea | 34.39 | 15.59 | 140 | 24202 | 856885 | 78863161 |
| Hangover | 32.85 | 15.59 | 15 | 24327 | 2097 | 79717949 |
| Swelling | 32.06 | 15.59 | 13 | 24329 | 216698 | 79503348 |
| Altered state of consciousness | 32.01 | 15.59 | 52 | 24290 | 43770 | 79676276 |
| Hip fracture | 31.84 | 15.59 | 43 | 24299 | 30718 | 79689328 |
| Miosis | 31.53 | 15.59 | 31 | 24311 | 15758 | 79704288 |
| Mobility decreased | 31.19 | 15.59 | 95 | 24247 | 122080 | 79597966 |
| Stomatitis | 31.17 | 15.59 | 4 | 24338 | 146753 | 79573293 |
| Myalgia | 31.15 | 15.59 | 9 | 24333 | 185632 | 79534414 |
| Urticaria | 31.04 | 15.59 | 9 | 24333 | 185192 | 79534854 |
| Subileus | 30.73 | 15.59 | 20 | 24322 | 5634 | 79714412 |
| Femoral neck fracture | 30.67 | 15.59 | 25 | 24317 | 9959 | 79710087 |
| Off label use | 30.56 | 15.59 | 158 | 24184 | 907057 | 78812989 |
| Vascular encephalopathy | 29.82 | 15.59 | 10 | 24332 | 613 | 79719433 |
| Hypersomnia | 29.78 | 15.59 | 36 | 24306 | 23050 | 79696996 |
| Hypersensitivity | 29.70 | 15.59 | 22 | 24320 | 262217 | 79457829 |
| Contraindicated product administered | 29.64 | 15.59 | 6 | 24336 | 157532 | 79562514 |
| Parkinson's disease | 29.61 | 15.59 | 13 | 24329 | 1658 | 79718388 |
| Aphasia | 29.55 | 15.59 | 52 | 24290 | 46680 | 79673366 |
| Amyloid related imaging abnormality-oedema/effusion | 29.25 | 15.59 | 9 | 24333 | 418 | 79719628 |
| Unresponsive to stimuli | 28.93 | 15.59 | 57 | 24285 | 55731 | 79664315 |
| Apathy | 28.79 | 15.59 | 27 | 24315 | 12950 | 79707096 |
| Prescribed underdose | 28.65 | 15.59 | 40 | 24302 | 29474 | 79690572 |
| Stoma site discomfort | 28.64 | 15.59 | 7 | 24335 | 135 | 79719911 |
| Aspiration | 28.59 | 15.59 | 33 | 24309 | 20125 | 79699921 |
| Choking | 28.44 | 15.59 | 26 | 24316 | 12075 | 79707971 |
| Abdominal discomfort | 28.44 | 15.59 | 21 | 24321 | 250706 | 79469340 |
| Drug ineffective | 28.19 | 15.59 | 204 | 24138 | 1080709 | 78639337 |
| Intentional product use issue | 28.19 | 15.59 | 6 | 24336 | 152106 | 79567940 |
| Malignant neoplasm progression | 28.18 | 15.59 | 4 | 24338 | 135986 | 79584060 |
| Incorrect product dosage form administered | 27.67 | 15.59 | 8 | 24334 | 299 | 79719747 |
| Application site reaction | 27.67 | 15.59 | 10 | 24332 | 766 | 79719280 |
| Anger | 27.61 | 15.59 | 30 | 24312 | 17132 | 79702914 |
| Tension | 27.48 | 15.59 | 17 | 24325 | 4387 | 79715659 |
| Neuropathy peripheral | 27.39 | 15.59 | 5 | 24337 | 141300 | 79578746 |
| Product prescribing error | 27.23 | 15.59 | 49 | 24293 | 44764 | 79675282 |
| Cough | 26.04 | 15.59 | 45 | 24297 | 366744 | 79353302 |
| Parkinsonian gait | 25.72 | 15.59 | 10 | 24332 | 938 | 79719108 |
| Agnosia | 25.35 | 15.59 | 7 | 24335 | 221 | 79719825 |
| Device kink | 24.97 | 15.59 | 12 | 24330 | 1883 | 79718163 |
| Oesophageal dilatation | 24.57 | 15.59 | 8 | 24334 | 447 | 79719599 |
| Medical device site injury | 24.34 | 15.59 | 4 | 24338 | 7 | 79720039 |
| Resting tremor | 24.28 | 15.59 | 11 | 24331 | 1510 | 79718536 |
| Vomiting | 23.93 | 15.59 | 309 | 24033 | 665519 | 79054527 |
| Hyporesponsive to stimuli | 23.86 | 15.59 | 12 | 24330 | 2076 | 79717970 |
| Pain in extremity | 23.85 | 15.59 | 47 | 24295 | 364491 | 79355555 |
| Platelet count decreased | 23.81 | 15.59 | 15 | 24327 | 194649 | 79525397 |
| Device issue | 23.76 | 15.59 | 35 | 24307 | 27073 | 79692973 |
| Feeding disorder | 23.71 | 15.59 | 27 | 24315 | 16227 | 79703819 |
| Nightmare | 23.56 | 15.59 | 34 | 24308 | 25827 | 79694219 |
| Bradyarrhythmia | 23.36 | 15.59 | 15 | 24327 | 4131 | 79715915 |
| Hypophagia | 23.09 | 15.59 | 46 | 24296 | 45321 | 79674725 |
| Treatment failure | 22.47 | 15.59 | 12 | 24330 | 170474 | 79549572 |
| Medical device site dryness | 22.37 | 15.59 | 5 | 24337 | 64 | 79719982 |
| Skin irritation | 22.32 | 15.59 | 22 | 24320 | 11218 | 79708828 |
| Fluid intake reduced | 22.00 | 15.59 | 17 | 24325 | 6271 | 79713775 |
| Arrhythmia | 21.98 | 15.59 | 54 | 24288 | 61218 | 79658828 |
| Circulatory collapse | 21.38 | 15.59 | 40 | 24302 | 37628 | 79682418 |
| Device connection issue | 21.35 | 15.59 | 9 | 24333 | 1039 | 79719007 |
| Underdose | 21.10 | 15.59 | 37 | 24305 | 33114 | 79686932 |
| White blood cell count decreased | 21.05 | 15.59 | 16 | 24326 | 188272 | 79531774 |
| Oropharyngeal pain | 20.91 | 15.59 | 4 | 24338 | 109349 | 79610697 |
| Movement disorder | 20.80 | 15.59 | 33 | 24309 | 27226 | 79692820 |
| Fracture | 20.35 | 15.59 | 29 | 24313 | 21772 | 79698274 |
| Arthritis | 20.35 | 15.59 | 5 | 24337 | 114875 | 79605171 |
| Nasopharyngitis | 20.04 | 15.59 | 29 | 24313 | 253852 | 79466194 |
| Faecaloma | 19.98 | 15.59 | 21 | 24321 | 11543 | 79708503 |
| Stoma complication | 19.98 | 15.59 | 8 | 24334 | 811 | 79719235 |
| Fatigue | 19.84 | 15.59 | 185 | 24157 | 929542 | 78790504 |
| Hepatic enzyme increased | 19.80 | 15.59 | 16 | 24326 | 182594 | 79537452 |
| Hand deformity | 19.45 | 15.59 | 4 | 24338 | 103915 | 79616131 |
| Incoherent | 19.01 | 15.59 | 17 | 24325 | 7675 | 79712371 |
| Nonspecific reaction | 18.99 | 15.59 | 11 | 24331 | 2521 | 79717525 |
| Mental impairment | 18.78 | 15.59 | 26 | 24316 | 19010 | 79701036 |
| Anxiety | 18.75 | 15.59 | 135 | 24207 | 248377 | 79471669 |
| Hallucinations, mixed | 18.56 | 15.59 | 16 | 24326 | 6883 | 79713163 |
| Drooling | 18.53 | 15.59 | 15 | 24327 | 5919 | 79714127 |
| Psychotic symptom | 18.34 | 15.59 | 11 | 24331 | 2686 | 79717360 |
| Medical device site hyperaesthesia | 17.99 | 15.59 | 3 | 24339 | 6 | 79720040 |
| Stoma site induration | 17.98 | 15.59 | 4 | 24338 | 50 | 79719996 |
| Atrioventricular block second degree | 17.75 | 15.59 | 16 | 24326 | 7296 | 79712750 |
| Grimacing | 17.73 | 15.59 | 7 | 24335 | 684 | 79719362 |
| Drug dispensed to wrong patient | 17.58 | 15.59 | 7 | 24335 | 699 | 79719347 |
| Middle insomnia | 17.45 | 15.59 | 23 | 24319 | 16046 | 79704000 |
| Time perception altered | 17.27 | 15.59 | 5 | 24337 | 188 | 79719858 |
| Haematuria traumatic | 17.16 | 15.59 | 5 | 24337 | 192 | 79719854 |
| Migraine | 17.16 | 15.59 | 3 | 24339 | 87490 | 79632556 |
| Wound | 17.12 | 15.59 | 7 | 24335 | 116172 | 79603874 |
| Dyspnoea exertional | 17.05 | 15.59 | 3 | 24339 | 87070 | 79632976 |
| Epilepsy | 16.82 | 15.59 | 38 | 24304 | 40822 | 79679224 |
| Head injury | 16.79 | 15.59 | 36 | 24306 | 37333 | 79682713 |
| Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits | 16.64 | 15.59 | 5 | 24337 | 214 | 79719832 |
| Poriomania | 16.57 | 15.59 | 5 | 24337 | 217 | 79719829 |
| Urinary casts present | 16.47 | 15.59 | 4 | 24338 | 75 | 79719971 |
| Confusional arousal | 16.42 | 15.59 | 4 | 24338 | 76 | 79719970 |
| Pancytopenia | 16.20 | 15.59 | 16 | 24326 | 165729 | 79554317 |
| Facial bones fracture | 16.19 | 15.59 | 13 | 24329 | 5069 | 79714977 |
| Fear | 15.93 | 15.59 | 26 | 24316 | 21960 | 79698086 |
| Lack of application site rotation | 15.86 | 15.59 | 4 | 24338 | 88 | 79719958 |
| Libido increased | 15.82 | 15.59 | 9 | 24333 | 1992 | 79718054 |
| Senile dementia | 15.81 | 15.59 | 5 | 24337 | 254 | 79719792 |
| Concomitant disease progression | 15.80 | 15.59 | 11 | 24331 | 3462 | 79716584 |
| Neuropsychiatric symptoms | 15.79 | 15.59 | 8 | 24334 | 1407 | 79718639 |
| Lower respiratory tract infection | 15.74 | 15.59 | 10 | 24332 | 129210 | 79590836 |
| Hallucination, auditory | 15.72 | 15.59 | 25 | 24317 | 20668 | 79699378 |
| Application site vesicles | 15.65 | 15.59 | 8 | 24334 | 1432 | 79718614 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | N06DA03 | NERVOUS SYSTEM PSYCHOANALEPTICS ANTI-DEMENTIA DRUGS Anticholinesterases |
| FDA MoA | N0000000177 | Cholinesterase 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 | D018696 | Neuroprotective Agents |
| MeSH PA | D018377 | Neurotransmitter Agents |
| MeSH PA | D020011 | Protective Agents |
| CHEBI has role | CHEBI:37733 | EC 3.1.1.8 inhibitor |
| CHEBI has role | CHEBI:38323 | cholinergic drugs |
| CHEBI has role | CHEBI:63726 | neuroprotective agents |
| FDA EPC | N0000175723 | Cholinesterase Inhibitor |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Alzheimer's disease | indication | 26929004 | DOID:10652 |
| Dementia associated with Parkinson's Disease | indication | 425390006 | |
| Diffuse Lewy body disease | off-label use | 80098002 | |
| Moderate to Severe Alzheimer's Type Dementia | off-label use | ||
| Urinary tract obstruction | contraindication | 7163005 | DOID:5200 |
| Chronic obstructive lung disease | contraindication | 13645005 | DOID:3083 |
| Parkinsonism | contraindication | 32798002 | |
| Sick sinus syndrome | contraindication | 36083008 | DOID:13884 |
| Gastrointestinal ulcer | contraindication | 40845000 | |
| Conduction disorder of the heart | contraindication | 44808001 | |
| Neuromuscular block, function | contraindication | 55394004 | |
| Anorexia nervosa | contraindication | 56882008 | DOID:8689 |
| Diarrhea | contraindication | 62315008 | |
| Gastrointestinal hemorrhage | contraindication | 74474003 | |
| Extrapyramidal disease | contraindication | 76349003 | |
| Weight loss | contraindication | 89362005 | |
| Seizure disorder | contraindication | 128613002 | |
| Asthma | contraindication | 195967001 | DOID:2841 |
| Atrioventricular block | contraindication | 233917008 | DOID:0050820 |
| Vomiting | contraindication | 422400008 | |
| Nausea | contraindication | 422587007 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 8.32 | Basic |
Orange Book patent data (new drug applications)
None
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 | IC50 | 7.43 | CHEMBL | IUPHAR | |||
| Cholinesterase | Enzyme | INHIBITOR | IC50 | 7.52 | CHEMBL | IUPHAR | |||
| Acetylcholinesterase | Enzyme | IC50 | 5.95 | CHEMBL | |||||
| Butyrylcholinesterase; Protein Bche | Enzyme | IC50 | 6.46 | CHEMBL | |||||
| Acetylcholinesterase | Enzyme | IC50 | 5.74 | CHEMBL | |||||
| Acetylcholinesterase | Enzyme | IC50 | 5.38 | CHEMBL | |||||
| Acetylcholinesterase | Enzyme | IC50 | 6.21 | CHEMBL | |||||
| Cholinesterase | Enzyme | IC50 | 5.80 | CHEMBL | |||||
| Butyrylcholinesterase | Enzyme | IC50 | 6.80 | CHEMBL | |||||
| Cholinesterase | Enzyme | IC50 | 6.08 | CHEMBL | |||||
| Acetylcholine receptor subunit epsilon | Ion channel | IC50 | 5.05 | CHEMBL | |||||
| Cholinesterase | Enzyme | IC50 | 5.20 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| 4021219 | VUID |
| N0000148665 | NUI |
| D03822 | KEGG_DRUG |
| 129101-54-8 | SECONDARY_CAS_RN |
| 4021219 | VANDF |
| 4021220 | VANDF |
| C0649350 | UMLSCUI |
| CHEBI:8874 | CHEBI |
| CHEMBL636 | ChEMBL_ID |
| DB00989 | DRUGBANK_ID |
| CHEMBL215645 | ChEMBL_ID |
| D000068836 | MESH_DESCRIPTOR_UI |
| 77991 | PUBCHEM_CID |
| 6602 | IUPHAR_LIGAND_ID |
| 7562 | INN_ID |
| PKI06M3IW0 | UNII |
| 183379 | RXNORM |
| 174208 | MMSL |
| 23978 | MMSL |
| 31947 | MMSL |
| 79573 | MMSL |
| 8887 | MMSL |
| d04537 | MMSL |
| 007559 | NDDF |
| 007560 | NDDF |
| 126131008 | SNOMEDCT_US |
| 323368009 | SNOMEDCT_US |
| 395868008 | SNOMEDCT_US |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Exelon | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0078-0501 | PATCH, EXTENDED RELEASE | 4.60 mg | TRANSDERMAL | NDA | 30 sections |
| Exelon | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0078-0501 | PATCH, EXTENDED RELEASE | 4.60 mg | TRANSDERMAL | NDA | 30 sections |
| Exelon | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0078-0501 | PATCH, EXTENDED RELEASE | 4.60 mg | TRANSDERMAL | NDA | 30 sections |
| Exelon | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0078-0502 | PATCH, EXTENDED RELEASE | 9.50 mg | TRANSDERMAL | NDA | 30 sections |
| Exelon | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0078-0502 | PATCH, EXTENDED RELEASE | 9.50 mg | TRANSDERMAL | NDA | 30 sections |
| Exelon | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0078-0502 | PATCH, EXTENDED RELEASE | 9.50 mg | TRANSDERMAL | NDA | 30 sections |
| Exelon | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0078-0503 | PATCH, EXTENDED RELEASE | 13.30 mg | TRANSDERMAL | NDA | 30 sections |
| Exelon | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0078-0503 | PATCH, EXTENDED RELEASE | 13.30 mg | TRANSDERMAL | NDA | 30 sections |
| Exelon | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0078-0503 | PATCH, EXTENDED RELEASE | 13.30 mg | TRANSDERMAL | NDA | 30 sections |
| Rivastigmine | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0378-9070 | PATCH | 4.60 mg | TRANSDERMAL | ANDA | 27 sections |
| Rivastigmine | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0378-9071 | PATCH | 9.50 mg | TRANSDERMAL | ANDA | 27 sections |
| Rivastigmine | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0378-9072 | PATCH | 13.30 mg | TRANSDERMAL | ANDA | 27 sections |
| Rivastigmine | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0781-7304 | PATCH, EXTENDED RELEASE | 4.60 mg | TRANSDERMAL | NDA authorized generic | 27 sections |
| Rivastigmine | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0781-7309 | PATCH, EXTENDED RELEASE | 9.50 mg | TRANSDERMAL | NDA authorized generic | 27 sections |
| Rivastigmine | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0781-7313 | PATCH, EXTENDED RELEASE | 13.30 mg | TRANSDERMAL | NDA authorized generic | 27 sections |
| Rivastigmine Tartrate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0904-6587 | CAPSULE | 1.50 mg | ORAL | ANDA | 24 sections |
| Rivastigmine Tartrate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0904-7107 | CAPSULE | 1.50 mg | ORAL | ANDA | 25 sections |
| Rivastigmine Tartrate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0904-7107 | CAPSULE | 1.50 mg | ORAL | ANDA | 25 sections |
| Rivastigmine | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16714-115 | PATCH, EXTENDED RELEASE | 4.60 mg | TRANSDERMAL | ANDA | 25 sections |
| Rivastigmine | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16714-115 | PATCH, EXTENDED RELEASE | 4.60 mg | TRANSDERMAL | ANDA | 25 sections |
| Rivastigmine | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16714-116 | PATCH, EXTENDED RELEASE | 9.50 mg | TRANSDERMAL | ANDA | 25 sections |
| Rivastigmine | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16714-116 | PATCH, EXTENDED RELEASE | 9.50 mg | TRANSDERMAL | ANDA | 25 sections |
| Rivastigmine | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16714-117 | PATCH, EXTENDED RELEASE | 13.30 mg | TRANSDERMAL | ANDA | 25 sections |
| Rivastigmine | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16714-117 | PATCH, EXTENDED RELEASE | 13.30 mg | TRANSDERMAL | ANDA | 25 sections |
| Exelon | HUMAN PRESCRIPTION DRUG LABEL | 1 | 21695-357 | PATCH, EXTENDED RELEASE | 4.60 mg | TRANSDERMAL | NDA | 16 sections |
| RIVASTIGMINE TARTRATE | Human Prescription Drug Label | 1 | 27241-090 | CAPSULE | 1.50 mg | ORAL | ANDA | 25 sections |
| RIVASTIGMINE TARTRATE | Human Prescription Drug Label | 1 | 27241-091 | CAPSULE | 3 mg | ORAL | ANDA | 25 sections |
| RIVASTIGMINE TARTRATE | Human Prescription Drug Label | 1 | 27241-092 | CAPSULE | 4.50 mg | ORAL | ANDA | 25 sections |
| RIVASTIGMINE TARTRATE | Human Prescription Drug Label | 1 | 27241-093 | CAPSULE | 6 mg | ORAL | ANDA | 25 sections |
| RIVASTIGMINE TARTRATE | Human Prescription Drug Label | 1 | 33342-089 | CAPSULE | 1.50 mg | ORAL | ANDA | 25 sections |