ropinirole 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| 2402 | 91374-21-9 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Ropinirole is a non-ergoline dopamine agonist. The precise mechanism of action of ropinirole as a treatment for Parkinson’s disease is unknown, although it is thought to be related to its ability to stimulate dopamine D2 receptors within the caudate-putamen in the brain.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 6 | mg | O |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 1 | Benet LZ, Broccatelli F, Oprea TI |
| S (Water solubility) | 133 mg/mL | Benet LZ, Broccatelli F, Oprea TI |
| EoM (Fraction excreted unchanged in urine) | 5 % | Benet LZ, Broccatelli F, Oprea TI |
| MRTD (Maximum Recommended Therapeutic Daily Dose) | 1.32 µM/kg/day | Contrera JF, Matthews EJ, Kruhlak NL, Benz RD |
| BA (Bioavailability) | 55 % | Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H |
| Vd (Volume of distribution) | 7.70 L/kg | Lombardo F, Berellini G, Obach RS |
| CL (Clearance) | 30 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) | 6 hours | Lombardo F, Berellini G, Obach RS |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Sept. 19, 1997 | FDA | GLAXOSMITHKLINE LLC | |
| Sept. 20, 2019 | PMDA | Hisamitsu Pharmaceutical Co., 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 |
|---|---|---|---|---|---|---|
| Dyskinesia | 249.27 | 12.79 | 154 | 24018 | 31848 | 63433002 |
| On and off phenomenon | 225.90 | 12.79 | 64 | 24108 | 1771 | 63463079 |
| Compulsive shopping | 192.64 | 12.79 | 47 | 24125 | 712 | 63464138 |
| Hallucination | 177.03 | 12.79 | 155 | 24017 | 54662 | 63410188 |
| Hallucination, visual | 160.81 | 12.79 | 97 | 24075 | 19201 | 63445649 |
| Dopamine dysregulation syndrome | 152.54 | 12.79 | 30 | 24142 | 150 | 63464700 |
| Restless legs syndrome | 114.19 | 12.79 | 77 | 24095 | 18454 | 63446396 |
| Impulse-control disorder | 103.81 | 12.79 | 29 | 24143 | 761 | 63464089 |
| Full blood count abnormal | 96.99 | 12.79 | 87 | 24085 | 31630 | 63433220 |
| Bradykinesia | 94.57 | 12.79 | 44 | 24128 | 5144 | 63459706 |
| Freezing phenomenon | 90.18 | 12.79 | 29 | 24143 | 1243 | 63463607 |
| Tremor | 89.97 | 12.79 | 172 | 24000 | 132067 | 63332783 |
| Stoma site discharge | 87.57 | 12.79 | 30 | 24142 | 1568 | 63463282 |
| Fall | 84.85 | 12.79 | 334 | 23838 | 392000 | 63072850 |
| Stoma site erythema | 82.59 | 12.79 | 27 | 24145 | 1220 | 63463630 |
| Gait disturbance | 77.65 | 12.79 | 197 | 23975 | 182981 | 63281869 |
| Parkinsonism hyperpyrexia syndrome | 73.91 | 12.79 | 16 | 24156 | 137 | 63464713 |
| Hyperglycaemia | 66.70 | 12.79 | 81 | 24091 | 41786 | 63423064 |
| Gambling | 66.35 | 12.79 | 16 | 24156 | 230 | 63464620 |
| Hyperkinesia | 63.32 | 12.79 | 24 | 24148 | 1680 | 63463170 |
| Gambling disorder | 58.98 | 12.79 | 21 | 24151 | 1231 | 63463619 |
| Jealous delusion | 54.89 | 12.79 | 10 | 24162 | 30 | 63464820 |
| Product dose omission issue | 51.75 | 12.79 | 201 | 23971 | 234112 | 63230738 |
| Memory impairment | 48.21 | 12.79 | 116 | 24056 | 104142 | 63360708 |
| Treatment failure | 47.70 | 12.79 | 9 | 24163 | 199034 | 63265816 |
| Gastrooesophageal reflux disease | 45.94 | 12.79 | 108 | 24064 | 95531 | 63369319 |
| Parkinsonian gait | 45.85 | 12.79 | 14 | 24158 | 505 | 63464345 |
| Insomnia | 45.37 | 12.79 | 182 | 23990 | 215070 | 63249780 |
| Glossodynia | 45.26 | 12.79 | 7 | 24165 | 178869 | 63285981 |
| Delusion | 44.94 | 12.79 | 37 | 24135 | 11980 | 63452870 |
| Illusion | 43.14 | 12.79 | 16 | 24156 | 1054 | 63463796 |
| Systemic lupus erythematosus | 43.09 | 12.79 | 13 | 24159 | 208905 | 63255945 |
| Joint swelling | 42.94 | 12.79 | 37 | 24135 | 327629 | 63137221 |
| Behaviour disorder | 42.89 | 12.79 | 22 | 24150 | 3177 | 63461673 |
| Muscle rigidity | 42.15 | 12.79 | 35 | 24137 | 11465 | 63453385 |
| Infusion related reaction | 41.23 | 12.79 | 21 | 24151 | 245500 | 63219350 |
| Stoma site pain | 40.35 | 12.79 | 15 | 24157 | 995 | 63463855 |
| Hepatic enzyme increased | 39.24 | 12.79 | 14 | 24158 | 202314 | 63262536 |
| Asthma | 39.05 | 12.79 | 122 | 24050 | 127439 | 63337411 |
| Hypersexuality | 37.41 | 12.79 | 12 | 24160 | 510 | 63464340 |
| Muscle spasms | 36.95 | 12.79 | 137 | 24035 | 156013 | 63308837 |
| Abnormal dreams | 36.47 | 12.79 | 31 | 24141 | 10485 | 63454365 |
| Exposure during pregnancy | 35.26 | 12.79 | 8 | 24164 | 155539 | 63309311 |
| Binge eating | 34.21 | 12.79 | 11 | 24161 | 471 | 63464379 |
| Psychotic symptom | 34.03 | 12.79 | 15 | 24157 | 1546 | 63463304 |
| Drug withdrawal syndrome | 32.98 | 12.79 | 46 | 24126 | 27148 | 63437702 |
| Type 2 diabetes mellitus | 32.72 | 12.79 | 74 | 24098 | 63794 | 63401056 |
| Withdrawal syndrome | 32.35 | 12.79 | 39 | 24133 | 19958 | 63444892 |
| Balance disorder | 31.84 | 12.79 | 87 | 24085 | 84335 | 63380515 |
| Drug intolerance | 31.40 | 12.79 | 43 | 24129 | 308618 | 63156232 |
| Dystonia | 31.05 | 12.79 | 32 | 24140 | 13787 | 63451063 |
| Feeling abnormal | 30.86 | 12.79 | 125 | 24047 | 148267 | 63316583 |
| Oromandibular dystonia | 29.29 | 12.79 | 10 | 24162 | 517 | 63464333 |
| Mental impairment | 28.65 | 12.79 | 31 | 24141 | 14120 | 63450730 |
| Posture abnormal | 28.30 | 12.79 | 15 | 24157 | 2317 | 63462533 |
| Multiple sclerosis relapse | 28.06 | 12.79 | 59 | 24113 | 48419 | 63416431 |
| Arthropathy | 27.82 | 12.79 | 29 | 24143 | 234763 | 63230087 |
| Anxiety | 27.64 | 12.79 | 159 | 24013 | 217382 | 63247468 |
| Alopecia | 26.95 | 12.79 | 55 | 24117 | 337481 | 63127369 |
| Parkinsonism | 26.82 | 12.79 | 26 | 24146 | 10413 | 63454437 |
| Tension | 26.54 | 12.79 | 16 | 24156 | 3159 | 63461691 |
| Eczema eyelids | 26.27 | 12.79 | 7 | 24165 | 153 | 63464697 |
| Wound | 25.88 | 12.79 | 15 | 24157 | 163248 | 63301602 |
| Depression | 25.87 | 12.79 | 145 | 24027 | 196347 | 63268503 |
| Rapid eye movement sleep behaviour disorder | 25.45 | 12.79 | 8 | 24164 | 318 | 63464532 |
| Limbic encephalitis | 25.33 | 12.79 | 8 | 24164 | 323 | 63464527 |
| Multiple sclerosis | 24.87 | 12.79 | 38 | 24134 | 24334 | 63440516 |
| Fibroma | 24.78 | 12.79 | 10 | 24162 | 827 | 63464023 |
| Lower respiratory tract infection | 24.24 | 12.79 | 10 | 24162 | 132297 | 63332553 |
| Toxicity to various agents | 23.60 | 12.79 | 36 | 24136 | 247214 | 63217636 |
| Rheumatoid arthritis | 23.24 | 12.79 | 38 | 24134 | 253781 | 63211069 |
| Pleurothotonus | 23.22 | 12.79 | 11 | 24161 | 1338 | 63463512 |
| Stereotypy | 23.06 | 12.79 | 8 | 24164 | 434 | 63464416 |
| Urinary tract infection | 23.03 | 12.79 | 176 | 23996 | 264508 | 63200342 |
| Discomfort | 23.01 | 12.79 | 18 | 24154 | 167356 | 63297494 |
| Therapy interrupted | 23.00 | 12.79 | 43 | 24129 | 32412 | 63432438 |
| Therapeutic response unexpected | 21.66 | 12.79 | 31 | 24141 | 18728 | 63446122 |
| Stoma site infection | 21.65 | 12.79 | 9 | 24163 | 803 | 63464047 |
| Tardive dyskinesia | 21.51 | 12.79 | 21 | 24151 | 8481 | 63456369 |
| Dizziness | 21.46 | 12.79 | 254 | 23918 | 429671 | 63035179 |
| Therapeutic product effect variable | 21.14 | 12.79 | 10 | 24162 | 1213 | 63463637 |
| Pyrexia | 20.96 | 12.79 | 100 | 24072 | 470378 | 62994472 |
| Somatic delusion | 20.78 | 12.79 | 8 | 24164 | 584 | 63464266 |
| Therapeutic response shortened | 20.57 | 12.79 | 24 | 24148 | 11864 | 63452986 |
| Stomatitis | 18.96 | 12.79 | 15 | 24157 | 138710 | 63326140 |
| Stoma site reaction | 18.84 | 12.79 | 6 | 24166 | 249 | 63464601 |
| Irritability | 18.83 | 12.79 | 39 | 24133 | 31655 | 63433195 |
| Impulsive behaviour | 18.69 | 12.79 | 10 | 24162 | 1573 | 63463277 |
| Febrile neutropenia | 18.60 | 12.79 | 11 | 24161 | 118438 | 63346412 |
| Extra dose administered | 18.58 | 12.79 | 17 | 24155 | 6333 | 63458517 |
| Abnormal behaviour | 18.56 | 12.79 | 31 | 24141 | 21395 | 63443455 |
| Resting tremor | 18.23 | 12.79 | 8 | 24164 | 815 | 63464035 |
| Teeth brittle | 17.96 | 12.79 | 7 | 24165 | 528 | 63464322 |
| Living in residential institution | 17.90 | 12.79 | 7 | 24165 | 533 | 63464317 |
| Hypersensitivity | 17.66 | 12.79 | 55 | 24117 | 292630 | 63172220 |
| Abdominal discomfort | 17.52 | 12.79 | 63 | 24109 | 320822 | 63144028 |
| Somnolence | 17.35 | 12.79 | 122 | 24050 | 178563 | 63286287 |
| Labelled drug-disease interaction issue | 17.33 | 12.79 | 4 | 24168 | 47 | 63464803 |
| Major depression | 17.00 | 12.79 | 18 | 24154 | 8000 | 63456850 |
| Logorrhoea | 16.83 | 12.79 | 11 | 24161 | 2499 | 63462351 |
| Acute psychosis | 16.77 | 12.79 | 11 | 24161 | 2514 | 63462336 |
| Pre-existing condition improved | 16.58 | 12.79 | 18 | 24154 | 8226 | 63456624 |
| Hyperhidrosis | 16.52 | 12.79 | 83 | 24089 | 107753 | 63357097 |
| Acquired haemophilia | 16.51 | 12.79 | 8 | 24164 | 1023 | 63463827 |
| Dropped head syndrome | 16.28 | 12.79 | 5 | 24167 | 184 | 63464666 |
| Akinesia | 15.88 | 12.79 | 9 | 24163 | 1584 | 63463266 |
| Apathy | 15.63 | 12.79 | 18 | 24154 | 8776 | 63456074 |
| Muscle injury | 15.54 | 12.79 | 3 | 24169 | 65342 | 63399508 |
| Primary myelofibrosis | 15.49 | 12.79 | 4 | 24168 | 77 | 63464773 |
| Dermatitis contact | 15.45 | 12.79 | 20 | 24152 | 10988 | 63453862 |
| Impaired healing | 15.44 | 12.79 | 10 | 24162 | 102532 | 63362318 |
| Thrombocytopenia | 15.41 | 12.79 | 21 | 24151 | 151136 | 63313714 |
| Stoma site irritation | 15.31 | 12.79 | 5 | 24167 | 225 | 63464625 |
| Off label use | 15.21 | 12.79 | 174 | 23998 | 674288 | 62790562 |
| Occipital neuralgia | 15.07 | 12.79 | 6 | 24166 | 479 | 63464371 |
| Nocturia | 15.04 | 12.79 | 17 | 24155 | 8124 | 63456726 |
| Sleep attacks | 15.03 | 12.79 | 4 | 24168 | 87 | 63464763 |
| Periodic limb movement disorder | 14.83 | 12.79 | 5 | 24167 | 249 | 63464601 |
| Spinal operation | 14.82 | 12.79 | 17 | 24155 | 8254 | 63456596 |
| Palatal swelling | 14.74 | 12.79 | 4 | 24168 | 94 | 63464756 |
| Somnambulism | 14.60 | 12.79 | 14 | 24158 | 5529 | 63459321 |
| Stoma complication | 14.50 | 12.79 | 6 | 24166 | 529 | 63464321 |
| Movement disorder | 14.48 | 12.79 | 28 | 24144 | 21633 | 63443217 |
| Anaemia | 14.48 | 12.79 | 60 | 24112 | 293370 | 63171480 |
| Serotonin syndrome | 14.43 | 12.79 | 33 | 24139 | 28649 | 63436201 |
| Nightmare | 14.31 | 12.79 | 26 | 24146 | 19168 | 63445682 |
| Sudden onset of sleep | 14.31 | 12.79 | 6 | 24166 | 547 | 63464303 |
| Basophil percentage increased | 14.21 | 12.79 | 4 | 24168 | 108 | 63464742 |
| Hospitalisation | 14.11 | 12.79 | 67 | 24105 | 85014 | 63379836 |
| Camptocormia | 13.87 | 12.79 | 5 | 24167 | 304 | 63464546 |
| Device issue | 13.82 | 12.79 | 29 | 24143 | 23752 | 63441098 |
| Ill-defined disorder | 13.69 | 12.79 | 7 | 24165 | 81748 | 63383102 |
| Clavicle fracture | 13.68 | 12.79 | 11 | 24161 | 3444 | 63461406 |
| Energy increased | 13.63 | 12.79 | 10 | 24162 | 2737 | 63462113 |
| Stoma site extravasation | 13.62 | 12.79 | 5 | 24167 | 320 | 63464530 |
| Poor quality sleep | 13.61 | 12.79 | 26 | 24146 | 19909 | 63444941 |
| Limb injury | 13.58 | 12.79 | 30 | 24142 | 25447 | 63439403 |
| Neutropenia | 13.54 | 12.79 | 29 | 24143 | 174976 | 63289874 |
| Speech disorder | 13.48 | 12.79 | 40 | 24132 | 40589 | 63424261 |
| Dreamy state | 13.44 | 12.79 | 3 | 24169 | 30 | 63464820 |
| Insurance issue | 13.44 | 12.79 | 14 | 24158 | 6107 | 63458743 |
| Cross sensitivity reaction | 13.35 | 12.79 | 9 | 24163 | 2153 | 63462697 |
| Hypertension | 13.23 | 12.79 | 58 | 24114 | 279245 | 63185605 |
| Underdose | 13.16 | 12.79 | 31 | 24141 | 27425 | 63437425 |
| Device occlusion | 12.93 | 12.79 | 15 | 24157 | 7372 | 63457478 |
| Complement factor C4 increased | 12.87 | 12.79 | 4 | 24168 | 153 | 63464697 |
| Respiratory dyskinesia | 12.87 | 12.79 | 3 | 24169 | 37 | 63464813 |
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 | 350.58 | 15.99 | 229 | 13369 | 51269 | 34892064 |
| Hypersexuality | 295.23 | 15.99 | 76 | 13522 | 1417 | 34941916 |
| Impulse-control disorder | 265.91 | 15.99 | 68 | 13530 | 1233 | 34942100 |
| Dyskinesia | 214.41 | 15.99 | 124 | 13474 | 22289 | 34921044 |
| Hallucination, visual | 204.35 | 15.99 | 111 | 13487 | 17680 | 34925653 |
| On and off phenomenon | 196.80 | 15.99 | 62 | 13536 | 2435 | 34940898 |
| Gambling disorder | 194.67 | 15.99 | 56 | 13542 | 1604 | 34941729 |
| Freezing phenomenon | 180.94 | 15.99 | 52 | 13546 | 1484 | 34941849 |
| Dopamine dysregulation syndrome | 176.97 | 15.99 | 40 | 13558 | 416 | 34942917 |
| Sudden onset of sleep | 117.58 | 15.99 | 28 | 13570 | 372 | 34942961 |
| Muscle rigidity | 110.75 | 15.99 | 62 | 13536 | 10456 | 34932877 |
| Somnolence | 93.14 | 15.99 | 160 | 13438 | 110956 | 34832377 |
| Bradykinesia | 89.26 | 15.99 | 39 | 13559 | 3854 | 34939479 |
| Jealous delusion | 87.29 | 15.99 | 21 | 13577 | 292 | 34943041 |
| Compulsive shopping | 81.97 | 15.99 | 21 | 13577 | 383 | 34942950 |
| Stoma site discharge | 78.74 | 15.99 | 26 | 13572 | 1187 | 34942146 |
| Fall | 76.07 | 15.99 | 211 | 13387 | 202674 | 34740659 |
| Stoma site erythema | 70.62 | 15.99 | 22 | 13576 | 831 | 34942502 |
| Serotonin syndrome | 66.56 | 15.99 | 58 | 13540 | 19875 | 34923458 |
| Hyperkinesia | 65.54 | 15.99 | 25 | 13573 | 1743 | 34941590 |
| Delusion | 64.10 | 15.99 | 47 | 13551 | 12588 | 34930745 |
| Aggression | 61.83 | 15.99 | 76 | 13522 | 38888 | 34904445 |
| Psychotic disorder | 58.28 | 15.99 | 59 | 13539 | 24393 | 34918940 |
| Confusional state | 53.99 | 15.99 | 150 | 13448 | 144010 | 34799323 |
| Balance disorder | 53.07 | 15.99 | 72 | 13526 | 40582 | 34902751 |
| Device dislocation | 52.94 | 15.99 | 32 | 13566 | 6217 | 34937116 |
| Stereotypy | 52.23 | 15.99 | 17 | 13581 | 741 | 34942592 |
| Dropped head syndrome | 51.74 | 15.99 | 12 | 13586 | 141 | 34943192 |
| Orthostatic hypotension | 48.47 | 15.99 | 55 | 13543 | 25864 | 34917469 |
| Abnormal dreams | 47.29 | 15.99 | 32 | 13566 | 7546 | 34935787 |
| Abnormal behaviour | 43.35 | 15.99 | 51 | 13547 | 24918 | 34918415 |
| Gambling | 43.23 | 15.99 | 11 | 13587 | 195 | 34943138 |
| Therapeutic product effect variable | 41.80 | 15.99 | 20 | 13578 | 2436 | 34940897 |
| Parkinsonism hyperpyrexia syndrome | 41.08 | 15.99 | 9 | 13589 | 80 | 34943253 |
| Compulsive sexual behaviour | 41.07 | 15.99 | 11 | 13587 | 240 | 34943093 |
| Insomnia | 40.73 | 15.99 | 110 | 13488 | 103797 | 34839536 |
| Tremor | 40.27 | 15.99 | 95 | 13503 | 82492 | 34860841 |
| Restless legs syndrome | 39.96 | 15.99 | 30 | 13568 | 8324 | 34935009 |
| Memory impairment | 38.34 | 15.99 | 64 | 13534 | 43254 | 34900079 |
| Fibroma | 36.33 | 15.99 | 11 | 13587 | 377 | 34942956 |
| Alien limb syndrome | 34.26 | 15.99 | 5 | 13593 | 0 | 34943333 |
| Stoma site pain | 33.98 | 15.99 | 12 | 13586 | 672 | 34942661 |
| Gait disturbance | 32.21 | 15.99 | 89 | 13509 | 85051 | 34858282 |
| Compulsions | 32.14 | 15.99 | 9 | 13589 | 233 | 34943100 |
| Febrile neutropenia | 32.11 | 15.99 | 7 | 13591 | 136842 | 34806491 |
| Reduced facial expression | 31.92 | 15.99 | 13 | 13585 | 1078 | 34942255 |
| Libido increased | 31.42 | 15.99 | 12 | 13586 | 839 | 34942494 |
| Anticholinergic syndrome | 30.02 | 15.99 | 13 | 13585 | 1256 | 34942077 |
| Stress cardiomyopathy | 29.76 | 15.99 | 15 | 13583 | 2044 | 34941289 |
| Stoma site hypergranulation | 29.43 | 15.99 | 8 | 13590 | 185 | 34943148 |
| Impulsive behaviour | 29.07 | 15.99 | 15 | 13583 | 2147 | 34941186 |
| Tension | 28.98 | 15.99 | 15 | 13583 | 2160 | 34941173 |
| Drug withdrawal syndrome | 28.75 | 15.99 | 37 | 13561 | 19797 | 34923536 |
| Nonspecific reaction | 28.70 | 15.99 | 13 | 13585 | 1398 | 34941935 |
| Irritability | 28.15 | 15.99 | 41 | 13557 | 24649 | 34918684 |
| Stoma site reaction | 27.57 | 15.99 | 8 | 13590 | 236 | 34943097 |
| Cognitive disorder | 27.56 | 15.99 | 44 | 13554 | 28649 | 34914684 |
| Dystonia | 27.36 | 15.99 | 27 | 13571 | 10818 | 34932515 |
| Middle insomnia | 27.26 | 15.99 | 22 | 13576 | 6780 | 34936553 |
| Obsessive-compulsive disorder | 26.65 | 15.99 | 20 | 13578 | 5544 | 34937789 |
| Behaviour disorder | 26.57 | 15.99 | 19 | 13579 | 4891 | 34938442 |
| Mobility decreased | 25.97 | 15.99 | 44 | 13554 | 30084 | 34913249 |
| Paraphilia | 25.46 | 15.99 | 6 | 13592 | 76 | 34943257 |
| Disturbance in attention | 25.21 | 15.99 | 40 | 13558 | 25905 | 34917428 |
| Suspiciousness | 24.98 | 15.99 | 8 | 13590 | 331 | 34943002 |
| Diarrhoea | 24.79 | 15.99 | 74 | 13524 | 389838 | 34553495 |
| Speech disorder | 24.13 | 15.99 | 39 | 13559 | 25647 | 34917686 |
| Tic | 24.04 | 15.99 | 13 | 13585 | 2045 | 34941288 |
| Incorrect product dosage form administered | 23.92 | 15.99 | 7 | 13591 | 213 | 34943120 |
| Agitation | 23.71 | 15.99 | 62 | 13536 | 57337 | 34885996 |
| Paranoia | 23.22 | 15.99 | 26 | 13572 | 12042 | 34931291 |
| Mania | 22.74 | 15.99 | 23 | 13575 | 9488 | 34933845 |
| Progressive supranuclear palsy | 22.48 | 15.99 | 5 | 13593 | 48 | 34943285 |
| Hypokinesia | 22.20 | 15.99 | 22 | 13576 | 8858 | 34934475 |
| Torsade de pointes | 22.11 | 15.99 | 20 | 13578 | 7189 | 34936144 |
| Thunderclap headache | 22.06 | 15.99 | 6 | 13592 | 139 | 34943194 |
| Stoma site inflammation | 21.92 | 15.99 | 8 | 13590 | 493 | 34942840 |
| Sexually inappropriate behaviour | 21.75 | 15.99 | 8 | 13590 | 504 | 34942829 |
| Embedded device | 21.10 | 15.99 | 7 | 13591 | 324 | 34943009 |
| Neutropenia | 21.09 | 15.99 | 18 | 13580 | 156760 | 34786573 |
| Generalised onset non-motor seizure | 20.98 | 15.99 | 4 | 13594 | 16 | 34943317 |
| Hypersomnia | 20.96 | 15.99 | 25 | 13573 | 12382 | 34930951 |
| Akinesia | 20.63 | 15.99 | 12 | 13586 | 2172 | 34941161 |
| Product dispensing error | 20.42 | 15.99 | 18 | 13580 | 6256 | 34937077 |
| Mydriasis | 20.10 | 15.99 | 19 | 13579 | 7218 | 34936115 |
| Multiple organ dysfunction syndrome | 19.92 | 15.99 | 3 | 13595 | 76563 | 34866770 |
| Hypomania | 19.77 | 15.99 | 12 | 13586 | 2347 | 34940986 |
| Bipolar disorder | 19.40 | 15.99 | 14 | 13584 | 3655 | 34939678 |
| Dysphagia | 18.63 | 15.99 | 60 | 13538 | 62321 | 34881012 |
| Parkinsonian crisis | 18.48 | 15.99 | 3 | 13595 | 3 | 34943330 |
| Urinary tract infection | 18.38 | 15.99 | 73 | 13525 | 84008 | 34859325 |
| Hallucinations, mixed | 18.33 | 15.99 | 12 | 13586 | 2677 | 34940656 |
| Salivary gland cancer stage IV | 18.31 | 15.99 | 4 | 13594 | 35 | 34943298 |
| Sleep disorder | 18.27 | 15.99 | 39 | 13559 | 31649 | 34911684 |
| Medical device discomfort | 18.21 | 15.99 | 4 | 13594 | 36 | 34943297 |
| Nocturia | 17.96 | 15.99 | 21 | 13577 | 10189 | 34933144 |
| Malignant neoplasm progression | 17.83 | 15.99 | 6 | 13592 | 88040 | 34855293 |
| Depressive symptom | 17.66 | 15.99 | 12 | 13586 | 2847 | 34940486 |
| Gait inability | 17.47 | 15.99 | 30 | 13568 | 20728 | 34922605 |
| Psychomotor hyperactivity | 17.27 | 15.99 | 20 | 13578 | 9602 | 34933731 |
| Sleep attacks | 17.25 | 15.99 | 5 | 13593 | 147 | 34943186 |
| Suicidal ideation | 17.05 | 15.99 | 44 | 13554 | 40344 | 34902989 |
| Logorrhoea | 16.96 | 15.99 | 11 | 13587 | 2415 | 34940918 |
| Hyperphagia | 16.65 | 15.99 | 9 | 13589 | 1414 | 34941919 |
| Toxicity to various agents | 16.65 | 15.99 | 33 | 13565 | 200329 | 34743004 |
| Pyrexia | 16.59 | 15.99 | 70 | 13528 | 332943 | 34610390 |
| Oedema peripheral | 16.57 | 15.99 | 91 | 13507 | 119721 | 34823612 |
| Movement disorder | 16.43 | 15.99 | 22 | 13576 | 12226 | 34931107 |
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 | 398.14 | 12.92 | 297 | 29437 | 85448 | 79629206 |
| Hallucination, visual | 352.62 | 12.92 | 193 | 29541 | 32536 | 79682118 |
| Dyskinesia | 341.59 | 12.92 | 211 | 29523 | 44562 | 79670092 |
| Dopamine dysregulation syndrome | 331.14 | 12.92 | 68 | 29666 | 449 | 79714205 |
| On and off phenomenon | 307.96 | 12.92 | 92 | 29642 | 3148 | 79711506 |
| Impulse-control disorder | 304.39 | 12.92 | 80 | 29654 | 1694 | 79712960 |
| Hypersexuality | 223.57 | 12.92 | 62 | 29672 | 1618 | 79713036 |
| Freezing phenomenon | 220.05 | 12.92 | 63 | 29671 | 1851 | 79712803 |
| Compulsive shopping | 200.35 | 12.92 | 49 | 29685 | 767 | 79713887 |
| Gambling disorder | 190.25 | 12.92 | 57 | 29677 | 1969 | 79712685 |
| Jealous delusion | 140.54 | 12.92 | 31 | 29703 | 299 | 79714355 |
| Fall | 138.11 | 12.92 | 447 | 29287 | 487182 | 79227472 |
| Bradykinesia | 134.94 | 12.92 | 64 | 29670 | 7979 | 79706675 |
| Parkinsonism hyperpyrexia syndrome | 115.10 | 12.92 | 25 | 29709 | 223 | 79714431 |
| Hyperkinesia | 111.59 | 12.92 | 41 | 29693 | 2688 | 79711966 |
| Stoma site discharge | 108.45 | 12.92 | 38 | 29696 | 2171 | 79712483 |
| Muscle rigidity | 101.45 | 12.92 | 73 | 29661 | 19809 | 79694845 |
| Stoma site erythema | 101.03 | 12.92 | 34 | 29700 | 1719 | 79712935 |
| Restless legs syndrome | 91.76 | 12.92 | 69 | 29665 | 20023 | 79694631 |
| Delusion | 90.75 | 12.92 | 69 | 29665 | 20354 | 79694300 |
| Tremor | 88.87 | 12.92 | 196 | 29538 | 169887 | 79544767 |
| Gait disturbance | 85.53 | 12.92 | 218 | 29516 | 207288 | 79507366 |
| Gambling | 83.84 | 12.92 | 20 | 29714 | 280 | 79714374 |
| Full blood count abnormal | 78.84 | 12.92 | 86 | 29648 | 40388 | 79674266 |
| Behaviour disorder | 75.69 | 12.92 | 40 | 29694 | 6273 | 79708381 |
| Somnolence | 73.76 | 12.92 | 226 | 29508 | 238755 | 79475899 |
| Sudden onset of sleep | 73.14 | 12.92 | 21 | 29713 | 623 | 79714031 |
| Serotonin syndrome | 73.00 | 12.92 | 87 | 29647 | 44940 | 79669714 |
| Stereotypy | 65.20 | 12.92 | 21 | 29713 | 924 | 79713730 |
| Dystonia | 65.07 | 12.92 | 58 | 29676 | 21341 | 79693313 |
| Drug withdrawal syndrome | 62.84 | 12.92 | 71 | 29663 | 34647 | 79680007 |
| Aggression | 61.42 | 12.92 | 85 | 29649 | 50873 | 79663781 |
| Insomnia | 57.99 | 12.92 | 212 | 29522 | 244958 | 79469696 |
| Irritability | 54.72 | 12.92 | 72 | 29662 | 41072 | 79673582 |
| Therapeutic product effect variable | 53.12 | 12.92 | 22 | 29712 | 1987 | 79712667 |
| Dropped head syndrome | 51.91 | 12.92 | 14 | 29720 | 328 | 79714326 |
| Abnormal dreams | 51.68 | 12.92 | 39 | 29695 | 11373 | 79703281 |
| Psychotic disorder | 49.80 | 12.92 | 69 | 29665 | 41333 | 79673321 |
| Balance disorder | 47.22 | 12.92 | 110 | 29624 | 98747 | 79615907 |
| Impulsive behaviour | 45.37 | 12.92 | 22 | 29712 | 2878 | 79711776 |
| Withdrawal syndrome | 43.71 | 12.92 | 52 | 29682 | 26802 | 79687852 |
| Memory impairment | 43.52 | 12.92 | 115 | 29619 | 111619 | 79603035 |
| Abnormal behaviour | 42.76 | 12.92 | 60 | 29674 | 36361 | 79678293 |
| Illusion | 42.46 | 12.92 | 18 | 29716 | 1723 | 79712931 |
| Binge eating | 42.14 | 12.92 | 13 | 29721 | 496 | 79714158 |
| Febrile neutropenia | 40.03 | 12.92 | 18 | 29716 | 230981 | 79483673 |
| Product dose omission issue | 39.64 | 12.92 | 190 | 29544 | 247347 | 79467307 |
| Orthostatic hypotension | 39.14 | 12.92 | 73 | 29661 | 56091 | 79658563 |
| Treatment failure | 39.04 | 12.92 | 8 | 29726 | 170478 | 79544176 |
| Type 2 diabetes mellitus | 38.27 | 12.92 | 73 | 29661 | 57049 | 79657605 |
| Muscle spasms | 37.88 | 12.92 | 147 | 29587 | 174583 | 79540071 |
| Parkinsonian gait | 37.86 | 12.92 | 14 | 29720 | 934 | 79713720 |
| Psychotic symptom | 37.85 | 12.92 | 19 | 29715 | 2678 | 79711976 |
| Toxicity to various agents | 36.73 | 12.92 | 63 | 29671 | 421477 | 79293177 |
| Feeling abnormal | 36.21 | 12.92 | 136 | 29598 | 159063 | 79555591 |
| Confusional state | 35.98 | 12.92 | 222 | 29512 | 317775 | 79396879 |
| Hyperglycaemia | 35.50 | 12.92 | 80 | 29654 | 70255 | 79644399 |
| Hepatic enzyme increased | 35.31 | 12.92 | 12 | 29722 | 182598 | 79532056 |
| Stoma site pain | 35.31 | 12.92 | 15 | 29719 | 1443 | 79713211 |
| Pyrexia | 33.47 | 12.92 | 135 | 29599 | 678574 | 79036080 |
| Gastrooesophageal reflux disease | 32.49 | 12.92 | 99 | 29635 | 104147 | 79610507 |
| Logorrhoea | 31.81 | 12.92 | 20 | 29714 | 4345 | 79710309 |
| Tension | 31.64 | 12.92 | 20 | 29714 | 4384 | 79710270 |
| Product dispensing error | 30.86 | 12.92 | 31 | 29703 | 13232 | 79701422 |
| Parkinsonian crisis | 30.53 | 12.92 | 5 | 29729 | 6 | 79714648 |
| Parkinsonism | 30.15 | 12.92 | 34 | 29700 | 16550 | 79698104 |
| Oromandibular dystonia | 29.38 | 12.92 | 12 | 29722 | 1046 | 79713608 |
| Energy increased | 28.96 | 12.92 | 17 | 29717 | 3265 | 79711389 |
| Infusion related reaction | 28.85 | 12.92 | 26 | 29708 | 230211 | 79484443 |
| Akinesia | 28.82 | 12.92 | 17 | 29717 | 3295 | 79711359 |
| Progressive supranuclear palsy | 27.97 | 12.92 | 7 | 29727 | 121 | 79714533 |
| Acute psychosis | 27.60 | 12.92 | 18 | 29716 | 4162 | 79710492 |
| Speech disorder | 27.55 | 12.92 | 62 | 29672 | 54383 | 79660271 |
| Disturbance in attention | 27.00 | 12.92 | 59 | 29675 | 50742 | 79663912 |
| Tardive dyskinesia | 27.00 | 12.92 | 26 | 29708 | 10545 | 79704109 |
| Rheumatoid arthritis | 26.77 | 12.92 | 23 | 29711 | 208447 | 79506207 |
| Rapid eye movement sleep behaviour disorder | 26.70 | 12.92 | 9 | 29725 | 457 | 79714197 |
| Somatic delusion | 26.47 | 12.92 | 10 | 29724 | 708 | 79713946 |
| Obsessive-compulsive disorder | 26.27 | 12.92 | 20 | 29714 | 5907 | 79708747 |
| Middle insomnia | 25.96 | 12.92 | 31 | 29703 | 16038 | 79698616 |
| Hand deformity | 25.69 | 12.92 | 4 | 29730 | 103915 | 79610739 |
| Hallucinations, mixed | 25.67 | 12.92 | 21 | 29713 | 6878 | 79707776 |
| Asthma | 25.57 | 12.92 | 109 | 29625 | 134986 | 79579668 |
| Sleep attacks | 25.41 | 12.92 | 7 | 29727 | 178 | 79714476 |
| Drug intolerance | 25.32 | 12.92 | 37 | 29697 | 264082 | 79450572 |
| Joint swelling | 25.25 | 12.92 | 43 | 29691 | 288603 | 79426051 |
| Eczema eyelids | 25.19 | 12.92 | 7 | 29727 | 184 | 79714470 |
| Movement disorder | 24.98 | 12.92 | 40 | 29694 | 27219 | 79687435 |
| Anxiety | 24.72 | 12.92 | 168 | 29566 | 248344 | 79466310 |
| Nonspecific reaction | 24.70 | 12.92 | 14 | 29720 | 2518 | 79712136 |
| Urinary tract infection | 24.64 | 12.92 | 181 | 29553 | 274331 | 79440323 |
| Hyperphagia | 24.60 | 12.92 | 14 | 29720 | 2538 | 79712116 |
| Hypomania | 24.04 | 12.92 | 21 | 29713 | 7523 | 79707131 |
| Compulsions | 23.85 | 12.92 | 8 | 29726 | 400 | 79714254 |
| Dementia | 23.72 | 12.92 | 37 | 29697 | 24622 | 79690032 |
| Multiple sclerosis relapse | 23.56 | 12.92 | 53 | 29681 | 46480 | 79668174 |
| Systemic lupus erythematosus | 23.35 | 12.92 | 8 | 29726 | 121141 | 79593513 |
| Dizziness | 23.30 | 12.92 | 299 | 29435 | 526142 | 79188512 |
| Neutropenia | 23.25 | 12.92 | 45 | 29689 | 287665 | 79426989 |
| Multiple organ dysfunction syndrome | 23.07 | 12.92 | 8 | 29726 | 120238 | 79594416 |
| Compulsive sexual behaviour | 23.00 | 12.92 | 7 | 29727 | 255 | 79714399 |
| Malignant neoplasm progression | 22.92 | 12.92 | 11 | 29723 | 135979 | 79578675 |
| Exposure during pregnancy | 22.62 | 12.92 | 5 | 29729 | 101127 | 79613527 |
| Lower respiratory tract infection | 22.48 | 12.92 | 10 | 29724 | 129210 | 79585444 |
| Resting tremor | 22.19 | 12.92 | 11 | 29723 | 1510 | 79713144 |
| Pleurothotonus | 22.12 | 12.92 | 13 | 29721 | 2503 | 79712151 |
| Libido increased | 22.08 | 12.92 | 12 | 29722 | 1989 | 79712665 |
| Incorrect product dosage form administered | 21.91 | 12.92 | 7 | 29727 | 300 | 79714354 |
| Sexually inappropriate behaviour | 21.59 | 12.92 | 8 | 29726 | 537 | 79714117 |
| Posture abnormal | 21.58 | 12.92 | 15 | 29719 | 3851 | 79710803 |
| Nocturia | 21.45 | 12.92 | 26 | 29708 | 13655 | 79700999 |
| Medical device site dryness | 21.37 | 12.92 | 5 | 29729 | 64 | 79714590 |
| Fibroma | 20.99 | 12.92 | 9 | 29725 | 886 | 79713768 |
| Reduced facial expression | 20.98 | 12.92 | 13 | 29721 | 2752 | 79711902 |
| Apathy | 20.90 | 12.92 | 25 | 29709 | 12952 | 79701702 |
| Hypersensitivity | 20.34 | 12.92 | 42 | 29692 | 262197 | 79452457 |
| Suspiciousness | 20.25 | 12.92 | 8 | 29726 | 639 | 79714015 |
| Psychomotor hyperactivity | 20.14 | 12.92 | 28 | 29706 | 16821 | 79697833 |
| Agitation | 20.07 | 12.92 | 82 | 29652 | 99633 | 79615021 |
| Therapeutic response shortened | 19.92 | 12.92 | 27 | 29707 | 15836 | 79698818 |
| Nightmare | 19.77 | 12.92 | 35 | 29699 | 25826 | 79688828 |
| Off label use | 19.74 | 12.92 | 230 | 29504 | 906985 | 78807669 |
| Device dislocation | 19.67 | 12.92 | 35 | 29699 | 25935 | 79688719 |
| Glossodynia | 19.61 | 12.92 | 7 | 29727 | 103330 | 79611324 |
| Therapeutic response unexpected | 19.29 | 12.92 | 30 | 29704 | 19916 | 79694738 |
| Stoma site infection | 19.27 | 12.92 | 10 | 29724 | 1510 | 79713144 |
| Pancytopenia | 19.27 | 12.92 | 20 | 29714 | 165725 | 79548929 |
| Obsessive thoughts | 18.96 | 12.92 | 9 | 29725 | 1123 | 79713531 |
| Depression | 18.90 | 12.92 | 142 | 29592 | 216648 | 79498006 |
| Camptocormia | 18.73 | 12.92 | 7 | 29727 | 481 | 79714173 |
| Cognitive disorder | 18.68 | 12.92 | 63 | 29671 | 69863 | 79644791 |
| Hypersomnia | 18.64 | 12.92 | 32 | 29702 | 23054 | 79691600 |
| Inflammation | 18.40 | 12.92 | 6 | 29728 | 93747 | 79620907 |
| Stoma site irritation | 18.39 | 12.92 | 6 | 29728 | 275 | 79714379 |
| Persecutory delusion | 18.39 | 12.92 | 15 | 29719 | 4894 | 79709760 |
| Rash | 18.00 | 12.92 | 134 | 29600 | 578224 | 79136430 |
| Limbic encephalitis | 17.92 | 12.92 | 8 | 29726 | 867 | 79713787 |
| Hyperhidrosis | 17.88 | 12.92 | 107 | 29627 | 151385 | 79563269 |
| Anticholinergic syndrome | 17.83 | 12.92 | 13 | 29721 | 3598 | 79711056 |
| Interstitial lung disease | 17.66 | 12.92 | 10 | 29724 | 112590 | 79602064 |
| Hypokinesia | 17.51 | 12.92 | 28 | 29706 | 19032 | 79695622 |
| Labelled drug-disease interaction issue | 17.41 | 12.92 | 4 | 29730 | 47 | 79714607 |
| Dermatitis contact | 17.35 | 12.92 | 21 | 29713 | 11012 | 79703642 |
| Cerebral atrophy | 17.20 | 12.92 | 18 | 29716 | 8057 | 79706597 |
| Paranoia | 17.10 | 12.92 | 28 | 29706 | 19404 | 79695250 |
| Mania | 17.01 | 12.92 | 27 | 29707 | 18233 | 79696421 |
| Hypertonia | 17.00 | 12.92 | 17 | 29717 | 7215 | 79707439 |
| Stomatitis | 16.73 | 12.92 | 18 | 29716 | 146739 | 79567915 |
| Periodic limb movement disorder | 16.62 | 12.92 | 5 | 29729 | 175 | 79714479 |
| Diarrhoea | 16.62 | 12.92 | 230 | 29504 | 880259 | 78834395 |
| Extra dose administered | 16.59 | 12.92 | 18 | 29716 | 8397 | 79706257 |
| Poor quality sleep | 16.41 | 12.92 | 30 | 29704 | 22692 | 79691962 |
| Thrombocytopenia | 16.25 | 12.92 | 48 | 29686 | 265211 | 79449443 |
| Thunderclap headache | 16.25 | 12.92 | 6 | 29728 | 399 | 79714255 |
| Restlessness | 16.24 | 12.92 | 46 | 29688 | 46446 | 79668208 |
| Mental impairment | 16.18 | 12.92 | 27 | 29707 | 19009 | 79695645 |
| Device occlusion | 16.13 | 12.92 | 21 | 29713 | 11845 | 79702809 |
| Salivary gland cancer stage IV | 16.04 | 12.92 | 4 | 29730 | 68 | 79714586 |
| Patient elopement | 15.88 | 12.92 | 4 | 29730 | 71 | 79714583 |
| Neuroleptic malignant syndrome | 15.79 | 12.92 | 33 | 29701 | 27526 | 79687128 |
| Stress cardiomyopathy | 15.56 | 12.92 | 20 | 29714 | 11146 | 79703508 |
| Generalised onset non-motor seizure | 15.53 | 12.92 | 4 | 29730 | 78 | 79714576 |
| Prescribed underdose | 15.37 | 12.92 | 34 | 29700 | 29480 | 79685174 |
| Limb injury | 15.36 | 12.92 | 34 | 29700 | 29494 | 79685160 |
| Postural reflex impairment | 15.31 | 12.92 | 3 | 29731 | 15 | 79714639 |
| Occipital neuralgia | 15.30 | 12.92 | 6 | 29728 | 470 | 79714184 |
| Neutrophil count decreased | 15.23 | 12.92 | 8 | 29726 | 93951 | 79620703 |
| Renal impairment | 15.22 | 12.92 | 22 | 29712 | 157761 | 79556893 |
| Stoma site odour | 15.11 | 12.92 | 4 | 29730 | 87 | 79714567 |
| Teeth brittle | 15.02 | 12.92 | 6 | 29728 | 494 | 79714160 |
| Dependence | 14.95 | 12.92 | 10 | 29724 | 2412 | 79712242 |
| Anaemia | 14.86 | 12.92 | 101 | 29633 | 444914 | 79269740 |
| Alopecia | 14.80 | 12.92 | 41 | 29693 | 231314 | 79483340 |
| Wound | 14.69 | 12.92 | 13 | 29721 | 116166 | 79598488 |
| Hallucination, auditory | 14.54 | 12.92 | 27 | 29707 | 20666 | 79693988 |
| Dysstasia | 14.49 | 12.92 | 32 | 29702 | 27714 | 79686940 |
| Somnambulism | 14.48 | 12.92 | 14 | 29720 | 5707 | 79708947 |
| Increased appetite | 14.45 | 12.92 | 20 | 29714 | 11958 | 79702696 |
| Arthralgia | 14.41 | 12.92 | 140 | 29594 | 571663 | 79142991 |
| Hypertension | 14.35 | 12.92 | 69 | 29665 | 330923 | 79383731 |
| Neutrophil count increased | 14.34 | 12.92 | 33 | 29701 | 29363 | 79685291 |
| Aphasia | 14.19 | 12.92 | 44 | 29690 | 46688 | 79667966 |
| Wrong product administered | 13.92 | 12.92 | 17 | 29717 | 8995 | 79705659 |
| Device issue | 13.86 | 12.92 | 31 | 29703 | 27077 | 79687577 |
| Underdose | 13.80 | 12.92 | 35 | 29699 | 33116 | 79681538 |
| Blood pressure systolic increased | 13.66 | 12.92 | 4 | 29730 | 66982 | 79647672 |
| Dysphagia | 13.61 | 12.92 | 85 | 29649 | 122051 | 79592603 |
| Device connection issue | 13.59 | 12.92 | 7 | 29727 | 1041 | 79713613 |
| Obsessive-compulsive personality disorder | 13.55 | 12.92 | 4 | 29730 | 131 | 79714523 |
| Female orgasmic disorder | 13.41 | 12.92 | 3 | 29731 | 31 | 79714623 |
| Sleep talking | 13.30 | 12.92 | 7 | 29727 | 1089 | 79713565 |
| Suicidal ideation | 13.22 | 12.92 | 60 | 29674 | 76280 | 79638374 |
| Salivary hypersecretion | 13.21 | 12.92 | 21 | 29713 | 14203 | 79700451 |
| Stoma site extravasation | 13.16 | 12.92 | 5 | 29729 | 360 | 79714294 |
| Gait inability | 13.10 | 12.92 | 50 | 29684 | 58867 | 79655787 |
| Tic | 13.07 | 12.92 | 10 | 29724 | 2976 | 79711678 |
| Surgery | 13.02 | 12.92 | 34 | 29700 | 32732 | 79681922 |
| Living in residential institution | 12.99 | 12.92 | 6 | 29728 | 704 | 79713950 |
| Swelling of eyelid | 12.93 | 12.92 | 11 | 29723 | 3800 | 79710854 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | N04BC04 | NERVOUS SYSTEM ANTI-PARKINSON DRUGS DOPAMINERGIC AGENTS Dopamine agonists |
| FDA MoA | N0000000117 | Dopamine Agonists |
| MeSH PA | D018726 | Anti-Dyskinesia Agents |
| MeSH PA | D000978 | Antiparkinson Agents |
| MeSH PA | D002491 | Central Nervous System Agents |
| MeSH PA | D015259 | Dopamine Agents |
| MeSH PA | D018491 | Dopamine Agonists |
| MeSH PA | D018377 | Neurotransmitter Agents |
| CHEBI has role | CHEBI:35470 | central nervous system agents |
| CHEBI has role | CHEBI:48407 | antiparkinson agent |
| CHEBI has role | CHEBI:51065 | Dopamine receptor agonist |
| CHEBI has role | CHEBI:66956 | antidyskinetic agent |
| FDA EPC | N0000175768 | Nonergot Dopamine Agonist |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Restless legs | indication | 32914008 | DOID:0050425 |
| Parkinson's disease | indication | 49049000 | DOID:14330 |
| Hallucinations | contraindication | 7011001 | |
| Dyskinesia | contraindication | 9748009 | |
| Orthostatic hypotension | contraindication | 28651003 | |
| Low blood pressure | contraindication | 45007003 | |
| Bradycardia | contraindication | 48867003 | |
| Acute nephropathy | contraindication | 58574008 | |
| Hepatic failure | contraindication | 59927004 | |
| Psychotic disorder | contraindication | 69322001 | |
| Syncope | contraindication | 271594007 | |
| Drowsy | contraindication | 271782001 | |
| Central nervous system depression | contraindication | 418072004 | |
| Smokes tobacco daily | contraindication | 449868002 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
| Product | Applicant | Ingredients |
|---|---|---|
| CLEVOR | Orion Corp. | 1 |
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 10.82 | acidic |
| pKa2 | 9.18 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| D(2) dopamine receptor | GPCR | AGONIST | Ki | 8.14 | IUPHAR | IUPHAR | |||
| Alpha-2A adrenergic receptor | GPCR | Ki | 5.73 | PDSP | |||||
| 5-hydroxytryptamine receptor 1A | GPCR | Ki | 6.54 | WOMBAT-PK | |||||
| 5-hydroxytryptamine receptor 2A | GPCR | EC50 | 6.85 | CHEMBL | |||||
| 5-hydroxytryptamine receptor 2B | GPCR | Ki | 5.42 | PDSP | |||||
| 5-hydroxytryptamine receptor 7 | GPCR | Ki | 5.82 | PDSP | |||||
| Alpha-2B adrenergic receptor | GPCR | Ki | 6.12 | WOMBAT-PK | |||||
| D(3) dopamine receptor | GPCR | AGONIST | Ki | 7.43 | WOMBAT-PK | ||||
| D(1B) dopamine receptor | GPCR | Ki | 4.38 | CHEMBL | |||||
| 5-hydroxytryptamine receptor 1D | GPCR | Ki | 5.86 | PDSP | |||||
| Alpha-2C adrenergic receptor | GPCR | Ki | 5.92 | PDSP | |||||
| D(4) dopamine receptor | GPCR | AGONIST | Ki | 6.07 | WOMBAT-PK | ||||
| D(1A) dopamine receptor | GPCR | Ki | 4.49 | CHEMBL | |||||
| D(2) dopamine receptor | GPCR | Ki | 5.57 | CHEMBL | |||||
| D(2) dopamine receptor | GPCR | IC50 | 5.17 | CHEMBL | |||||
| D(3) dopamine receptor | GPCR | Ki | 7.53 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| 4024081 | VUID |
| N0000022086 | NUI |
| D00784 | KEGG_DRUG |
| 91374-20-8 | SECONDARY_CAS_RN |
| 4021058 | VANDF |
| 4024081 | VANDF |
| C0244821 | UMLSCUI |
| CHEBI:8888 | CHEBI |
| CHEMBL589 | ChEMBL_ID |
| CHEMBL1200411 | ChEMBL_ID |
| DB00268 | DRUGBANK_ID |
| C046649 | MESH_SUPPLEMENTAL_RECORD_UI |
| 5095 | PUBCHEM_CID |
| 7295 | IUPHAR_LIGAND_ID |
| 6436 | INN_ID |
| 030PYR8953 | UNII |
| 152951 | RXNORM |
| 11369 | MMSL |
| 136707 | MMSL |
| 25995 | MMSL |
| 5434 | MMSL |
| d04215 | MMSL |
| 006273 | NDDF |
| 006274 | NDDF |
| 108473005 | SNOMEDCT_US |
| 108474004 | SNOMEDCT_US |
| 372499000 | SNOMEDCT_US |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Ropinirole | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0228-3640 | TABLET, FILM COATED, EXTENDED RELEASE | 6 mg | ORAL | ANDA | 18 sections |
| Ropinirole | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0228-3640 | TABLET, FILM COATED, EXTENDED RELEASE | 6 mg | ORAL | ANDA | 18 sections |
| Ropinirole | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0228-3658 | TABLET, FILM COATED, EXTENDED RELEASE | 2 mg | ORAL | ANDA | 18 sections |
| Ropinirole | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0228-3658 | TABLET, FILM COATED, EXTENDED RELEASE | 2 mg | ORAL | ANDA | 18 sections |
| Ropinirole | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0228-3659 | TABLET, FILM COATED, EXTENDED RELEASE | 4 mg | ORAL | ANDA | 18 sections |
| Ropinirole | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0228-3659 | TABLET, FILM COATED, EXTENDED RELEASE | 4 mg | ORAL | ANDA | 18 sections |
| Ropinirole | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0228-3660 | TABLET, FILM COATED, EXTENDED RELEASE | 8 mg | ORAL | ANDA | 18 sections |
| Ropinirole | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0228-3660 | TABLET, FILM COATED, EXTENDED RELEASE | 8 mg | ORAL | ANDA | 18 sections |
| Ropinirole | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0228-3661 | TABLET, FILM COATED, EXTENDED RELEASE | 12 mg | ORAL | ANDA | 18 sections |
| Ropinirole | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0228-3661 | TABLET, FILM COATED, EXTENDED RELEASE | 12 mg | ORAL | ANDA | 18 sections |
| Ropinirole | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0378-5501 | TABLET | 1 mg | ORAL | ANDA | 28 sections |
| Ropinirole | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0378-5501 | TABLET | 1 mg | ORAL | ANDA | 28 sections |
| Ropinirole | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0378-5502 | TABLET | 2 mg | ORAL | ANDA | 28 sections |
| Ropinirole | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0378-5502 | TABLET | 2 mg | ORAL | ANDA | 28 sections |
| Ropinirole | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0378-5503 | TABLET | 3 mg | ORAL | ANDA | 28 sections |
| Ropinirole | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0378-5503 | TABLET | 3 mg | ORAL | ANDA | 28 sections |
| Ropinirole | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0378-5504 | TABLET | 4 mg | ORAL | ANDA | 28 sections |
| Ropinirole | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0378-5504 | TABLET | 4 mg | ORAL | ANDA | 28 sections |
| Ropinirole | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0378-5505 | TABLET | 5 mg | ORAL | ANDA | 28 sections |
| Ropinirole | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0378-5505 | TABLET | 5 mg | ORAL | ANDA | 28 sections |
| Ropinirole | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0378-5525 | TABLET | 0.25 mg | ORAL | ANDA | 28 sections |
| Ropinirole | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0378-5525 | TABLET | 0.25 mg | ORAL | ANDA | 28 sections |
| Ropinirole | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0378-5550 | TABLET | 0.50 mg | ORAL | ANDA | 28 sections |
| Ropinirole | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0378-5550 | TABLET | 0.50 mg | ORAL | ANDA | 28 sections |
| ROPINIROLE HYDROCHLORIDE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0615-8188 | TABLET, FILM COATED | 0.25 mg | ORAL | ANDA | 26 sections |
| ROPINIROLE HYDROCHLORIDE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0615-8189 | TABLET, FILM COATED | 0.50 mg | ORAL | ANDA | 26 sections |
| ROPINIROLE HYDROCHLORIDE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0615-8190 | TABLET, FILM COATED | 1 mg | ORAL | ANDA | 26 sections |
| ROPINIROLE HYDROCHLORIDE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0615-8191 | TABLET, FILM COATED | 2 mg | ORAL | ANDA | 26 sections |
| ropinirole | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0781-5780 | TABLET, FILM COATED, EXTENDED RELEASE | 2 mg | ORAL | ANDA | 24 sections |
| ropinirole | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0781-5780 | TABLET, FILM COATED, EXTENDED RELEASE | 2 mg | ORAL | ANDA | 24 sections |