pramipexole ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
2233 104632-26-0

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • pramipexole hydrochloride
  • pramipexole hydrochloride hydrate
  • sifrol
  • oprymea
  • pramipexole
  • (S)-Pramipexole
  • mirapexin
  • pramipexole dihydrochloride
  • pramipexole dihydrochloride monohydrate
  • pramipexole HCl
  • pramipexol dihydrobromide
A dopamine agonist that binds with high selectivity and specificity to the D2 subfamily of dopamine receptors of which it has a preferential affinity to D3 receptors, and has full intrinsic activity. Pramipexole alleviates parkinsonian motor deficits by stimulation of dopamine receptors in the striatum. Animal studies have shown that pramipexole inhibits dopamine synthesis, release, and turnover.
  • Molecular weight: 211.33
  • Formula: C10H17N3S
  • CLOGP: 1.47
  • LIPINSKI: 0
  • HAC: 3
  • HDO: 2
  • TPSA: 50.94
  • ALOGS: -3.18
  • ROTB: 3

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
2.50 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 20 mg/mL Bocci G, Oprea TI, Benet LZ
EoM (Fraction excreted unchanged in urine) 90 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.30 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 93 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 7 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 7.20 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.85 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 12.40 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Sept. 12, 2008 EMA KRKA, D.D., NOVO MESTO
July 1, 1997 FDA BOEHRINGER INGELHEIM

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Gambling disorder 483.45 11.42 117 35180 1135 63452590
Dyskinesia 445.21 11.42 256 35041 31746 63421979
Impulse-control disorder 305.90 11.42 74 35223 716 63453009
Compulsive shopping 293.40 11.42 71 35226 688 63453037
On and off phenomenon 287.63 11.42 84 35213 1751 63451974
Hallucination 245.86 11.42 220 35077 54597 63399128
Hallucination, visual 183.07 11.42 121 35176 19177 63434548
Gambling 153.69 11.42 34 35263 212 63453513
Parkinsonism hyperpyrexia syndrome 146.07 11.42 30 35267 123 63453602
Dystonia 136.80 11.42 89 35208 13730 63439995
Restless legs syndrome 135.43 11.42 99 35198 18432 63435293
Tremor 133.65 11.42 253 35044 131986 63321739
Freezing phenomenon 126.19 11.42 41 35256 1231 63452494
Stoma site discharge 124.73 11.42 43 35254 1555 63452170
Hypersexuality 114.11 11.42 31 35266 491 63453234
Muscle rigidity 99.22 11.42 68 35229 11432 63442293
Systemic lupus erythematosus 98.85 11.42 4 35293 208914 63244811
Pleurothotonus 92.64 11.42 33 35264 1316 63452409
Fall 91.87 11.42 446 34851 391888 63061837
Stoma site erythema 91.33 11.42 32 35265 1215 63452510
Stoma site pain 89.92 11.42 30 35267 980 63452745
Bradykinesia 89.89 11.42 48 35249 5140 63448585
Sudden onset of sleep 89.69 11.42 26 35271 527 63453198
Obsessive-compulsive disorder 88.97 11.42 44 35253 4016 63449709
Stereotypy 81.65 11.42 23 35274 419 63453306
Glossodynia 76.72 11.42 6 35291 178870 63274855
Binge eating 70.86 11.42 21 35276 461 63453264
Camptocormia 70.59 11.42 19 35278 290 63453435
Maternal exposure during pregnancy 70.00 11.42 18 35279 220044 63233681
Total lung capacity decreased 67.45 11.42 30 35267 2153 63451572
Jealous delusion 63.51 11.42 12 35285 28 63453697
Bronchopulmonary aspergillosis allergic 63.32 11.42 29 35268 2229 63451496
Pericarditis 60.64 11.42 3 35294 131576 63322149
Orthostatic hypotension 60.62 11.42 87 35210 36073 63417652
Lung opacity 59.68 11.42 31 35266 3137 63450588
Hand deformity 59.15 11.42 9 35288 159448 63294277
Alopecia 58.34 11.42 61 35236 337475 63116250
Hyperkinesia 54.53 11.42 24 35273 1680 63452045
Pulmonary fibrosis 52.92 11.42 86 35211 39723 63414002
Compulsive hoarding 52.64 11.42 11 35286 50 63453675
Delusion 51.40 11.42 47 35250 11970 63441755
Acute psychosis 51.30 11.42 26 35271 2499 63451226
Therapeutic response shortened 47.95 11.42 45 35252 11843 63441882
Psychotic disorder 47.77 11.42 65 35232 25647 63428078
Neuroleptic malignant syndrome 47.41 11.42 45 35252 12011 63441714
Discomfort 45.56 11.42 18 35279 167356 63286369
Torticollis 45.33 11.42 22 35275 1927 63451798
Somnolence 45.22 11.42 208 35089 178477 63275248
Breath sounds abnormal 45.15 11.42 42 35255 10931 63442794
Granuloma skin 44.12 11.42 37 35260 8400 63445325
Diabetes mellitus inadequate control 44.04 11.42 48 35249 15078 63438647
Drug dispensed to wrong patient 42.89 11.42 13 35284 309 63453416
Abnormal dreams 42.79 11.42 40 35257 10476 63443249
Stoma site infection 41.54 11.42 16 35281 796 63452929
Febrile neutropenia 41.04 11.42 8 35289 118441 63335284
Swelling 40.91 11.42 56 35241 275322 63178403
Insomnia 40.77 11.42 231 35066 215021 63238704
Akinesia 40.14 11.42 19 35278 1574 63452151
Aspiration 39.84 11.42 39 35258 10812 63442913
Blood parathyroid hormone decreased 39.37 11.42 37 35260 9754 63443971
Blood calcium increased 38.88 11.42 36 35261 9314 63444411
Gait disturbance 38.33 11.42 202 35095 182976 63270749
Abnormal behaviour 38.05 11.42 53 35244 21373 63432352
Vestibular migraine 37.90 11.42 11 35286 224 63453501
Sleep attacks 37.68 11.42 9 35288 82 63453643
Panniculitis 36.45 11.42 38 35259 11347 63442378
Contraindicated product administered 35.72 11.42 41 35256 217607 63236118
Medication error 34.25 11.42 84 35213 52200 63401525
Psychomotor hyperactivity 33.09 11.42 35 35262 10628 63443097
Abdominal discomfort 32.79 11.42 82 35215 320803 63132922
Dependence 32.60 11.42 18 35279 2059 63451666
Pituitary haemorrhage 32.30 11.42 8 35289 86 63453639
Exposure during pregnancy 31.77 11.42 24 35273 155523 63298202
Dopamine dysregulation syndrome 31.59 11.42 9 35288 171 63453554
Sputum discoloured 31.39 11.42 42 35255 16305 63437420
Malignant polyp 31.07 11.42 9 35288 182 63453543
Fibroma 30.76 11.42 13 35284 824 63452901
Blood pressure inadequately controlled 30.62 11.42 24 35273 4954 63448771
Skin necrosis 30.16 11.42 38 35259 13912 63439813
Multiple drug therapy 30.13 11.42 21 35276 3625 63450100
Drug interaction 29.95 11.42 224 35073 228907 63224818
Rash 29.43 11.42 187 35110 560684 62893041
Withdrawal syndrome 29.05 11.42 45 35252 19952 63433773
Anxiety 28.62 11.42 213 35084 217328 63236397
Drug intolerance 28.43 11.42 83 35214 308578 63145147
Economic problem 27.88 11.42 16 35281 1970 63451755
Depressed mood 27.86 11.42 66 35231 40125 63413600
Prescribed underdose 27.73 11.42 55 35242 29634 63424091
Malignant neoplasm progression 27.50 11.42 6 35291 82115 63371610
Diarrhoea 27.04 11.42 261 35036 715105 62738620
Dropped head syndrome 26.77 11.42 8 35289 181 63453544
Parkinsonism 26.75 11.42 31 35266 10408 63443317
Exercise tolerance decreased 26.48 11.42 23 35274 5474 63448251
Oedema peripheral 26.32 11.42 188 35109 189323 63264402
Orthostatic intolerance 26.31 11.42 13 35284 1184 63452541
Drug withdrawal syndrome 26.15 11.42 51 35246 27143 63426582
Parkinsonian gait 25.75 11.42 10 35287 509 63453216
Neutropenia 25.56 11.42 36 35261 174969 63278756
Crime 25.55 11.42 5 35292 15 63453710
Snoring 25.29 11.42 20 35277 4182 63449543
Stomatitis 25.15 11.42 24 35273 138701 63315024
Drug tolerance decreased 24.94 11.42 39 35258 17434 63436291
Product prescribing error 24.91 11.42 49 35248 26240 63427485
Delirium 24.82 11.42 73 35224 50468 63403257
Toxicity to various agents 24.61 11.42 64 35233 247186 63206539
Hyperventilation 24.37 11.42 23 35274 6093 63447632
Hyperphagia 24.09 11.42 14 35283 1765 63451960
Blood test abnormal 23.87 11.42 36 35261 15593 63438132
Ill-defined disorder 23.57 11.42 8 35289 81747 63371978
Muscle injury 23.52 11.42 4 35293 65341 63388384
Wound 23.43 11.42 34 35263 163229 63290496
Posture abnormal 23.03 11.42 15 35282 2317 63451408
Rheumatoid nodule 22.71 11.42 37 35260 17118 63436607
Chorea 22.58 11.42 13 35284 1611 63452114
Deep brain stimulation 21.98 11.42 5 35292 36 63453689
Vaccination site oedema 21.94 11.42 4 35293 7 63453718
Serum serotonin increased 21.94 11.42 7 35290 198 63453527
Rales 21.94 11.42 31 35266 12666 63441059
Blister 21.78 11.42 24 35273 129790 63323935
Basal cell carcinoma 21.64 11.42 48 35249 27943 63425782
Compulsions 21.61 11.42 7 35290 208 63453517
Vaccination site bruising 21.59 11.42 4 35293 8 63453717
Off label use 21.47 11.42 256 35041 674206 62779519
Hypersensitivity 21.33 11.42 87 35210 292598 63161127
Vaccination site pruritus 20.70 11.42 4 35293 11 63453714
Stoma site reaction 20.44 11.42 7 35290 248 63453477
Bronchiectasis 20.27 11.42 34 35263 16108 63437617
Movement disorder 20.07 11.42 40 35257 21621 63432104
Female orgasmic disorder 20.00 11.42 5 35292 56 63453669
Product residue present 19.88 11.42 17 35280 3962 63449763
Pancytopenia 19.73 11.42 15 35282 96918 63356807
Chronic obstructive pulmonary disease 19.72 11.42 78 35219 62608 63391117
Cognitive disorder 19.66 11.42 72 35225 55743 63397982
Stoma site inflammation 19.27 11.42 8 35289 485 63453240
Disease progression 19.19 11.42 24 35273 122734 63330991
Liver injury 19.13 11.42 5 35292 60515 63393210
Memory impairment 19.12 11.42 111 35186 104147 63349578
Therapeutic response changed 19.04 11.42 10 35287 1035 63452690
Restlessness 18.95 11.42 47 35250 29406 63424319
Obstructive airways disorder 18.91 11.42 38 35259 20661 63433064
Stoma site hypergranulation 18.84 11.42 7 35290 315 63453410
Stoma site haemorrhage 18.81 11.42 10 35287 1061 63452664
Delusion of parasitosis 18.51 11.42 4 35293 22 63453703
Nightmare 18.46 11.42 36 35261 19158 63434567
Joint swelling 18.31 11.42 107 35190 327559 63126166
Sleep apnoea syndrome 18.23 11.42 46 35251 29087 63424638
Orgasm abnormal 18.13 11.42 5 35292 84 63453641
Heat stroke 18.02 11.42 9 35288 839 63452886
Product substitution issue 17.88 11.42 32 35265 15964 63437761
Coronary artery dissection 17.88 11.42 9 35288 853 63452872
Irritable bowel syndrome 17.76 11.42 12 35285 82400 63371325
Suspiciousness 17.73 11.42 7 35290 372 63453353
Bipolar disorder 17.71 11.42 22 35275 7938 63445787
Parkinson's disease 17.60 11.42 10 35287 1209 63452516
Therapeutic product effect variable 17.57 11.42 10 35287 1213 63452512
Gastrointestinal disorder 17.23 11.42 29 35268 131210 63322515
Stoma site irritation 17.22 11.42 6 35291 224 63453501
Hypercapnia 17.16 11.42 18 35279 5413 63448312
Ulcer 17.15 11.42 42 35255 26065 63427660
Pre-existing condition improved 17.10 11.42 22 35275 8222 63445503
Conjunctival discolouration 17.08 11.42 5 35292 105 63453620
Wrong device used 16.89 11.42 4 35293 35 63453690
Device connection issue 16.85 11.42 8 35289 667 63453058
Infection 16.76 11.42 68 35229 229105 63224620
Synovitis 16.66 11.42 51 35246 186867 63266858
Feeling abnormal 16.59 11.42 140 35157 148252 63305473
Amnesia 16.55 11.42 68 35229 55517 63398208
Speech disorder 16.55 11.42 55 35242 40574 63413151
Narcolepsy 16.46 11.42 10 35287 1368 63452357
Blood cholesterol increased 16.20 11.42 17 35280 94015 63359710
Autonomic nervous system imbalance 16.08 11.42 13 35284 2805 63450920
Suicidal ideation 16.01 11.42 73 35224 62348 63391377
Hypercalcaemia 15.96 11.42 43 35254 28279 63425446
Inhibitory drug interaction 15.95 11.42 13 35284 2836 63450889
Depression 15.83 11.42 173 35124 196319 63257406
Blood creatinine increased 15.77 11.42 93 35204 87751 63365974
Nasopharyngitis 15.30 11.42 81 35216 254176 63199549
Stoma site extravasation 15.20 11.42 6 35291 319 63453406
Loss of personal independence in daily activities 14.96 11.42 99 35198 97191 63356534
Compulsive sexual behaviour 14.93 11.42 4 35293 60 63453665
Red blood cell sedimentation rate increased 14.87 11.42 56 35241 43926 63409799
Mucosal inflammation 14.60 11.42 4 35293 46924 63406801
Pyrexia 14.39 11.42 180 35117 470298 62983427
Stoma site candida 14.29 11.42 3 35294 14 63453711
Balance disorder 14.27 11.42 88 35209 84334 63369391
Meningorrhagia 14.24 11.42 5 35292 191 63453534
Vaccination site erythema 13.94 11.42 4 35293 78 63453647
Confusional state 13.83 11.42 196 35101 236184 63217541
Drug eruption 13.66 11.42 41 35256 28653 63425072
Haemoptysis 13.64 11.42 41 35256 28685 63425040
Urticaria 13.55 11.42 47 35250 165755 63287970
Arthritis 13.29 11.42 110 35187 115811 63337914
Hyperpyrexia 13.23 11.42 13 35284 3619 63450106
Peripheral swelling 13.04 11.42 214 35083 265728 63187997
Bulimia nervosa 13.02 11.42 6 35291 468 63453257
Hydronephrosis 12.78 11.42 22 35275 10640 63443085
Condition aggravated 12.76 11.42 303 34994 401914 63051811
Kleptomania 12.70 11.42 3 35294 26 63453699
Vitamin B6 deficiency 12.68 11.42 4 35293 109 63453616
Endometrial cancer 12.61 11.42 12 35285 3213 63450512
Middle insomnia 12.51 11.42 24 35273 12619 63441106
Anisomastia 12.50 11.42 3 35294 28 63453697
Skin ulcer 12.30 11.42 52 35245 42993 63410732
Therapeutic response decreased 12.27 11.42 67 35230 61458 63392267
Initial insomnia 12.10 11.42 16 35281 6141 63447584
Muscle atrophy 11.90 11.42 17 35280 7016 63446709
Patient elopement 11.89 11.42 3 35294 35 63453690
Agitation 11.86 11.42 65 35232 59692 63394033
Hepatotoxicity 11.82 11.42 3 35294 37038 63416687
Microcephaly 11.69 11.42 7 35290 933 63452792
Type 2 diabetes mellitus 11.63 11.42 11 35286 63857 63389868
Product administration error 11.62 11.42 33 35264 22364 63431361

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Impulse-control disorder 787.58 13.47 178 21081 1123 34934549
Gambling disorder 616.76 13.47 153 21106 1507 34934165
Hypersexuality 592.02 13.47 145 21114 1348 34934324
Hallucination 487.66 13.47 333 20926 51165 34884507
Dyskinesia 387.10 13.47 213 21046 22200 34913472
On and off phenomenon 320.49 13.47 100 21159 2397 34933275
Dopamine dysregulation syndrome 231.01 13.47 54 21205 402 34935270
Hallucination, visual 211.87 13.47 133 21126 17658 34918014
Gambling 202.39 13.47 42 21217 164 34935508
Compulsive shopping 184.56 13.47 44 21215 360 34935312
Freezing phenomenon 138.14 13.47 47 21212 1489 34934183
Needle fatigue 120.26 13.47 37 21222 844 34934828
Relapsing-remitting multiple sclerosis 117.94 13.47 38 21221 1012 34934660
Stereotypy 117.03 13.47 35 21224 723 34934949
Gait spastic 112.31 13.47 37 21222 1059 34934613
Jealous delusion 111.96 13.47 28 21231 285 34935387
Bradykinesia 111.07 13.47 52 21207 3841 34931831
Delusion 110.57 13.47 78 21181 12557 34923115
Gait disturbance 109.24 13.47 190 21069 84950 34850722
Obsessive-compulsive disorder 107.42 13.47 57 21202 5507 34930165
Muscle rigidity 106.39 13.47 71 21188 10447 34925225
Restless legs syndrome 103.31 13.47 64 21195 8290 34927382
Paraphilia 99.94 13.47 20 21239 62 34935610
Nocturia 98.67 13.47 67 21192 10143 34925529
Hypertonic bladder 93.13 13.47 37 21222 1827 34933845
Monoparesis 91.48 13.47 39 21220 2307 34933365
Sudden onset of sleep 91.07 13.47 25 21234 375 34935297
Fall 88.88 13.47 298 20961 202587 34733085
Stoma site erythema 88.22 13.47 29 21230 824 34934848
Libido increased 84.28 13.47 28 21231 823 34934849
Parkinsonism hyperpyrexia syndrome 80.81 13.47 17 21242 72 34935600
Micturition urgency 80.70 13.47 50 21209 6475 34929197
Movement disorder 79.03 13.47 63 21196 12185 34923487
Insomnia 78.35 13.47 186 21073 103721 34831951
Memory impairment 76.61 13.47 112 21147 43206 34892466
Binge eating 74.78 13.47 17 21242 110 34935562
Abnormal behaviour 73.27 13.47 83 21176 24886 34910786
Muscle spasticity 72.52 13.47 45 21214 5843 34929829
Central nervous system lesion 68.68 13.47 45 21214 6418 34929254
Psychomotor hyperactivity 67.50 13.47 52 21207 9570 34926102
Balance disorder 67.42 13.47 102 21157 40552 34895120
Dysarthria 61.59 13.47 90 21169 34692 34900980
Stoma site discharge 60.33 13.47 24 21235 1189 34934483
Toxicity to various agents 59.08 13.47 24 21235 200338 34735334
Hyperkinesia 57.92 13.47 26 21233 1742 34933930
Confusional state 55.43 13.47 203 21056 143957 34791715
Agitation 53.62 13.47 112 21147 57287 34878385
Psychotic disorder 53.38 13.47 70 21189 24382 34911290
Ataxia 52.95 13.47 53 21206 13800 34921872
Impulsive behaviour 52.92 13.47 26 21233 2136 34933536
Somnolence 52.82 13.47 168 21091 110948 34824724
Delirium 52.25 13.47 95 21164 43896 34891776
Encephalitis toxic 51.93 13.47 15 21244 273 34935399
Tremor 51.89 13.47 138 21121 82449 34853223
Anxiety 50.64 13.47 154 21105 99274 34836398
Febrile neutropenia 50.09 13.47 11 21248 136838 34798834
Aggression 49.94 13.47 87 21172 38877 34896795
Neuroleptic malignant syndrome 49.88 13.47 58 21201 17876 34917796
Multiple sclerosis relapse 49.74 13.47 50 21209 13083 34922589
Compulsive hoarding 48.84 13.47 9 21250 15 34935657
Neutropenia 47.48 13.47 18 21241 156760 34778912
Stoma site pain 46.50 13.47 17 21242 667 34935005
Voyeurism 44.84 13.47 7 21252 0 34935672
Device dislocation 44.33 13.47 34 21225 6215 34929457
Dystonia 44.24 13.47 43 21216 10802 34924870
Mania 43.16 13.47 40 21219 9471 34926201
Diarrhoea 43.02 13.47 110 21149 389802 34545870
Pyrexia 42.33 13.47 87 21172 332926 34602746
Sleep attacks 41.67 13.47 11 21248 141 34935531
Embedded device 41.39 13.47 13 21246 318 34935354
Dependence 41.17 13.47 18 21241 1132 34934540
Compulsive sexual behaviour 40.53 13.47 12 21247 239 34935433
Pleurothotonus 40.36 13.47 18 21241 1187 34934485
Dizziness 39.93 13.47 248 21011 218273 34717399
Pollakiuria 39.39 13.47 54 21205 19620 34916052
Acute kidney injury 39.32 13.47 79 21180 304909 34630763
Economic problem 38.96 13.47 18 21241 1289 34934383
Delusional disorder, jealous type 38.44 13.47 6 21253 0 34935672
Posture abnormal 37.82 13.47 21 21238 2218 34933454
Hyperphagia 37.50 13.47 18 21241 1405 34934267
Hypomania 36.80 13.47 21 21238 2338 34933334
Akinesia 35.58 13.47 20 21239 2164 34933508
Restlessness 35.42 13.47 59 21200 25423 34910249
Excessive masturbation 34.79 13.47 9 21250 106 34935566
Somnambulism 34.13 13.47 22 21237 3050 34932622
Paranoia 33.51 13.47 39 21220 12029 34923643
Therapeutic product effect variable 33.39 13.47 20 21239 2436 34933236
Erectile dysfunction 33.09 13.47 51 21208 20586 34915086
Suspiciousness 32.96 13.47 11 21248 328 34935344
Personality change 32.22 13.47 26 21233 5113 34930559
Troponin increased 31.95 13.47 37 21222 11352 34924320
Parkinsonian gait 31.82 13.47 12 21247 514 34935158
Drug withdrawal syndrome 31.78 13.47 49 21210 19785 34915887
Platelet count decreased 31.15 13.47 17 21242 119700 34815972
Dementia 31.00 13.47 40 21219 13708 34921964
Bipolar I disorder 30.41 13.47 13 21246 774 34934898
Reduced facial expression 29.36 13.47 14 21245 1077 34934595
Road traffic accident 29.22 13.47 44 21215 17406 34918266
Depression 28.65 13.47 126 21133 96972 34838700
Sexually inappropriate behaviour 28.53 13.47 11 21248 501 34935171
Cognitive disorder 27.96 13.47 57 21202 28636 34907036
Hypervigilance 27.94 13.47 8 21251 141 34935531
Dropped head syndrome 27.73 13.47 8 21251 145 34935527
Acute psychosis 27.66 13.47 16 21243 1827 34933845
Obsessive-compulsive personality disorder 27.47 13.47 8 21251 150 34935522
Pancytopenia 27.04 13.47 12 21247 95145 34840527
Disturbance in attention 27.03 13.47 53 21206 25892 34909780
Contraindicated product prescribed 27.00 13.47 10 21249 407 34935265
Malignant neoplasm progression 26.81 13.47 10 21249 88036 34847636
Intentional medical device removal by patient 25.90 13.47 9 21250 304 34935368
Stoma site hypergranulation 25.89 13.47 8 21251 185 34935487
Parkinson's disease 25.83 13.47 14 21245 1410 34934262
Hallucination, tactile 25.54 13.47 9 21250 317 34935355
Bradycardia 25.47 13.47 102 21157 75316 34860356
Sleep disorder 25.21 13.47 58 21201 31630 34904042
VACTERL syndrome 25.06 13.47 6 21253 50 34935622
Spontaneous penile erection 24.69 13.47 8 21251 217 34935455
Withdrawal syndrome 24.64 13.47 34 21225 12421 34923251
Anticholinergic syndrome 24.49 13.47 13 21246 1256 34934416
Hyperthyroidism 24.22 13.47 31 21228 10535 34925137
Compulsions 24.11 13.47 8 21251 234 34935438
Condition aggravated 23.94 13.47 199 21060 191997 34743675
Parkinsonism 23.77 13.47 27 21232 8111 34927561
Dysstasia 23.70 13.47 33 21226 12162 34923510
Medical device site dryness 22.92 13.47 5 21254 26 34935646
Device issue 22.91 13.47 29 21230 9748 34925924
Device effect decreased 22.85 13.47 4 21255 4 34935668
Stoma site haemorrhage 22.67 13.47 11 21248 879 34934793
Sleep-related eating disorder 22.62 13.47 8 21251 285 34935387
Inappropriate antidiuretic hormone secretion 22.56 13.47 33 21226 12720 34922952
Gait inability 22.35 13.47 43 21216 20715 34914957
Food interaction 21.96 13.47 11 21248 942 34934730
Rapid eye movements sleep abnormal 21.92 13.47 7 21252 181 34935491
Abnormal dreams 21.89 13.47 25 21234 7553 34928119
Motor dysfunction 21.85 13.47 24 21235 6950 34928722
Oedema peripheral 21.83 13.47 136 21123 119676 34815996
Stoma site inflammation 21.78 13.47 9 21250 492 34935180
Sleep apnoea syndrome 21.76 13.47 42 21217 20279 34915393
Sepsis 21.53 13.47 43 21216 166518 34769154
Device occlusion 21.33 13.47 23 21236 6522 34929150
Verbal abuse 21.22 13.47 7 21252 201 34935471
Human ehrlichiosis 20.75 13.47 8 21251 364 34935308
Disease progression 19.69 13.47 22 21237 108055 34827617
Device alarm issue 19.61 13.47 9 21250 635 34935037
Cardiac dysfunction 19.45 13.47 14 21245 2324 34933348
Hyperkalaemia 19.32 13.47 9 21250 69380 34866292
Cardiac arrest 19.31 13.47 18 21241 96141 34839531
Depressive symptom 19.07 13.47 15 21244 2844 34932828
White blood cell count decreased 19.01 13.47 18 21241 95427 34840245
Marital problem 18.95 13.47 5 21254 64 34935608
Hemivertebra 18.87 13.47 6 21253 153 34935519
Mobility decreased 18.54 13.47 50 21209 30078 34905594
Sexual activity increased 18.15 13.47 4 21255 22 34935650
Cerebral hypoperfusion 18.10 13.47 8 21251 516 34935156
Rash 18.05 13.47 72 21187 222680 34712992
Tension 18.03 13.47 13 21246 2162 34933510
Off label use 17.98 13.47 166 21093 419358 34516314
Anaemia 17.93 13.47 77 21182 233258 34702414
Stoma site infection 17.64 13.47 9 21250 801 34934871
Stoma site discomfort 17.58 13.47 4 21255 26 34935646
Adrenal insufficiency 17.51 13.47 31 21228 14016 34921656
Interstitial lung disease 17.37 13.47 9 21250 65273 34870399
Suicidal ideation 17.29 13.47 59 21200 40329 34895343
Torticollis 17.27 13.47 10 21249 1144 34934528
Eosinophilic fasciitis 17.11 13.47 5 21254 95 34935577
Neutrophil count decreased 16.96 13.47 5 21254 51099 34884573
Visual impairment 16.85 13.47 54 21205 35748 34899924
Lung hyperinflation 16.75 13.47 9 21250 891 34934781
Sopor 16.73 13.47 28 21231 12108 34923564
Device kink 16.27 13.47 7 21252 423 34935249
Nightmare 15.72 13.47 30 21229 14361 34921311
Therapeutic response unexpected 15.48 13.47 24 21235 9733 34925939
Excessive exercise 15.32 13.47 3 21256 8 34935664
Paedophilia 15.32 13.47 3 21256 8 34935664
Device loosening 15.21 13.47 5 21254 142 34935530
Rapid eye movement sleep behaviour disorder 14.80 13.47 5 21254 155 34935517
Chorea 14.79 13.47 9 21250 1128 34934544
Mental impairment 14.47 13.47 24 21235 10298 34925374
Vomiting 14.35 13.47 90 21169 247531 34688141
Therapeutic response shortened 14.33 13.47 20 21239 7384 34928288
Mucosal inflammation 14.32 13.47 3 21256 38619 34897053
Hypokinesia 14.31 13.47 22 21237 8858 34926814
Faecaloma 14.30 13.47 17 21242 5360 34930312
Alanine aminotransferase increased 14.12 13.47 17 21242 80798 34854874
Drug hypersensitivity 14.01 13.47 17 21242 80512 34855160
IVth nerve paresis 13.85 13.47 3 21256 15 34935657
Thrombocytopenia 13.62 13.47 49 21210 156198 34779474

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Impulse-control disorder 768.24 11.57 182 44340 1592 79698274
Gambling disorder 663.57 11.57 166 44356 1860 79698006
Dyskinesia 631.86 11.57 362 44160 44411 79655455
Hallucination 487.82 11.57 395 44127 85350 79614516
On and off phenomenon 432 11.57 131 44391 3109 79696757
Hypersexuality 405.65 11.57 108 44414 1572 79698294
Hallucination, visual 316.56 11.57 208 44314 32521 79667345
Compulsive shopping 282.94 11.57 70 44452 746 79699120
Dopamine dysregulation syndrome 249.90 11.57 58 44464 459 79699407
Parkinsonism hyperpyrexia syndrome 227.05 11.57 47 44475 201 79699665
Gambling 190.22 11.57 42 44480 258 79699608
Freezing phenomenon 178.77 11.57 59 44463 1855 79698011
Dystonia 159.75 11.57 116 44406 21283 79678583
Bradykinesia 146.37 11.57 77 44445 7966 79691900
Jealous delusion 143.61 11.57 34 44488 296 79699570
Restless legs syndrome 143.39 11.57 106 44416 19986 79679880
Fall 142.84 11.57 594 43928 487035 79212831
Stereotypy 142.38 11.57 42 44480 903 79698963
Muscle rigidity 131.01 11.57 100 44422 19782 79680084
Stoma site discharge 129.01 11.57 48 44474 2161 79697705
Tremor 121.39 11.57 283 44239 169800 79530066
Binge eating 114.75 11.57 31 44491 478 79699388
Needle fatigue 113.96 11.57 35 44487 867 79698999
Delusion 113.66 11.57 93 44429 20330 79679536
Pleurothotonus 112.43 11.57 45 44477 2471 79697395
Stoma site erythema 109.41 11.57 40 44482 1713 79698153
Gait spastic 104.23 11.57 35 44487 1162 79698704
Obsessive-compulsive disorder 102.93 11.57 55 44467 5872 79693994
Neuroleptic malignant syndrome 100.77 11.57 99 44423 27460 79672406
Relapsing-remitting multiple sclerosis 99.80 11.57 36 44486 1483 79698383
Hyperkinesia 98.84 11.57 42 44480 2687 79697179
Psychotic disorder 97.58 11.57 118 44404 41284 79658582
Stoma site pain 97.47 11.57 35 44487 1423 79698443
Sudden onset of sleep 94.31 11.57 28 44494 616 79699250
Compulsive hoarding 91.67 11.57 18 44504 55 79699811
Gait disturbance 89.54 11.57 287 44235 207219 79492647
Insomnia 88.16 11.57 319 44203 244851 79455015
Febrile neutropenia 79.72 11.57 16 44506 230983 79468883
Abnormal behaviour 76.52 11.57 98 44424 36323 79663543
Monoparesis 73.68 11.57 37 44485 3474 79696392
Nocturia 73.41 11.57 61 44461 13620 79686246
Acute psychosis 73.18 11.57 39 44483 4141 79695725
Akinesia 72.74 11.57 36 44486 3276 79696590
Movement disorder 69.69 11.57 81 44441 27178 79672688
Toxicity to various agents 68.22 11.57 81 44441 421459 79278407
Hypertonic bladder 67.42 11.57 37 44485 4164 79695702
Torticollis 64.76 11.57 30 44492 2357 79697509
Drug withdrawal syndrome 64.57 11.57 88 44434 34630 79665236
Therapeutic response shortened 63.68 11.57 60 44462 15803 79684063
Paraphilia 63.10 11.57 13 44509 54 79699812
Delirium 62.71 11.57 143 44379 84484 79615382
Camptocormia 61.93 11.57 19 44503 469 79699397
Neutropenia 59.81 11.57 44 44478 287666 79412200
Sleep attacks 59.78 11.57 15 44507 170 79699696
Total lung capacity decreased 59.16 11.57 30 44492 2875 79696991
Orthostatic hypotension 58.23 11.57 109 44413 56055 79643811
Somnolence 56.09 11.57 273 44249 238708 79461158
Micturition urgency 54.97 11.57 50 44472 12591 79687275
Anxiety 54.87 11.57 279 44243 248233 79451633
Bronchopulmonary aspergillosis allergic 54.83 11.57 29 44493 3032 79696834
Pulmonary fibrosis 53.93 11.57 92 44430 44020 79655846
Impulsive behaviour 53.44 11.57 28 44494 2872 79696994
Psychomotor hyperactivity 53.33 11.57 56 44466 16793 79683073
Therapeutic product effect variable 50.65 11.57 24 44498 1985 79697881
Parkinsonian gait 49.57 11.57 19 44503 929 79698937
Balance disorder 49.38 11.57 144 44378 98713 79601153
Central nervous system lesion 48.82 11.57 48 44474 13320 79686546
Posture abnormal 48.51 11.57 29 44493 3837 79696029
Encephalitis toxic 48.46 11.57 14 44508 279 79699587
Diarrhoea 46.90 11.57 294 44228 880195 78819671
Dropped head syndrome 46.32 11.57 14 44508 328 79699538
Suspiciousness 45.02 11.57 16 44506 631 79699235
Malignant neoplasm progression 43.72 11.57 11 44511 135979 79563887
Pericarditis 43.52 11.57 4 44518 104232 79595634
Lung opacity 43.11 11.57 30 44492 5144 79694722
Withdrawal syndrome 42.46 11.57 63 44459 26791 79673075
Pancytopenia 41.96 11.57 20 44502 165725 79534141
Parkinsonism 41.92 11.57 49 44473 16535 79683331
Multiple sclerosis relapse 41.77 11.57 85 44437 46448 79653418
Libido increased 41.73 11.57 21 44501 1980 79697886
Memory impairment 41.46 11.57 147 44375 111587 79588279
Stoma site infection 40.92 11.57 19 44503 1501 79698365
Hand deformity 40.79 11.57 5 44517 103914 79595952
Oedema peripheral 40.38 11.57 260 44262 252028 79447838
Pyrexia 39.60 11.57 220 44302 678489 79021377
Agitation 39.44 11.57 134 44388 99581 79600285
Delusional disorder, jealous type 38.95 11.57 6 44516 0 79699866
Voyeurism 38.95 11.57 6 44516 0 79699866
Restlessness 38.32 11.57 82 44440 46410 79653456
Erectile dysfunction 38.19 11.57 44 44478 14620 79685246
Prescribed underdose 37.99 11.57 63 44459 29451 79670415
Cognitive disorder 37.97 11.57 105 44417 69821 79630045
Aggression 37.62 11.57 86 44436 50872 79648994
Granuloma skin 37.40 11.57 35 44487 9139 79690727
Rash 36.78 11.57 182 44340 578176 79121690
Economic problem 36.45 11.57 20 44502 2250 79697616
Abnormal dreams 36.24 11.57 38 44484 11374 79688492
Glossodynia 35.96 11.57 7 44515 103330 79596536
Acute kidney injury 35.63 11.57 159 44363 519245 79180621
Blood calcium increased 35.50 11.57 36 44486 10364 79689502
Maternal exposure during pregnancy 35.29 11.57 16 44506 136522 79563344
Blood parathyroid hormone decreased 35.11 11.57 36 44486 10500 79689366
Confusional state 35.09 11.57 300 44222 317697 79382169
Troponin increased 34.59 11.57 48 44474 19207 79680659
Hyperphagia 34.26 11.57 20 44502 2532 79697334
Drug tolerance decreased 33.90 11.57 39 44483 12939 79686927
Depressed mood 33.80 11.57 80 44442 48400 79651466
Stomatitis 33.78 11.57 20 44502 146737 79553129
Panniculitis 33.71 11.57 38 44484 12333 79687533
Dysarthria 33.28 11.57 98 44424 67524 79632342
Ataxia 32.97 11.57 54 44468 24985 79674881
Drug dispensed to wrong patient 32.84 11.57 13 44509 693 79699173
Dementia 32.23 11.57 53 44469 24606 79675260
Mania 32.02 11.57 45 44477 18215 79681651
Compulsions 31.88 11.57 11 44511 397 79699469
Excessive masturbation 31.39 11.57 8 44514 97 79699769
Product residue present 30.63 11.57 21 44501 3515 79696351
Discomfort 30.52 11.57 16 44506 125601 79574265
Reduced facial expression 30.24 11.57 19 44503 2746 79697120
Chorea 29.99 11.57 18 44504 2399 79697467
Blood pressure inadequately controlled 29.98 11.57 26 44496 6151 79693715
Dizziness 29.68 11.57 435 44087 526006 79173860
Depressive symptom 29.10 11.57 26 44496 6397 79693469
Condition aggravated 29.01 11.57 416 44106 500708 79199158
Breath sounds abnormal 28.94 11.57 40 44482 15944 79683922
Platelet count decreased 28.75 11.57 40 44482 194624 79505242
Medication error 28.70 11.57 94 44428 68548 79631318
Muscle spasticity 27.85 11.57 46 44476 21429 79678437
Nightmare 27.81 11.57 51 44471 25810 79674056
Device dislocation 27.66 11.57 51 44471 25919 79673947
Pollakiuria 27.57 11.57 63 44459 37254 79662612
Sputum discoloured 27.43 11.57 46 44476 21697 79678169
Alopecia 27.27 11.57 55 44467 231300 79468566
Malignant polyp 27.21 11.57 8 44514 170 79699696
Duodenal ulcer perforation 26.45 11.57 3 44519 66208 79633658
Inappropriate antidiuretic hormone secretion 25.95 11.57 50 44472 26263 79673603
Aspiration 25.91 11.57 43 44479 20115 79679751
Multiple drug therapy 25.74 11.57 20 44502 4058 79695808
Marital problem 25.39 11.57 8 44514 216 79699650
Stoma site extravasation 25.30 11.57 9 44513 356 79699510
Dysstasia 25.28 11.57 51 44471 27695 79672171
Sexually inappropriate behaviour 25.23 11.57 10 44512 535 79699331
Dependence 24.89 11.57 16 44506 2406 79697460
Obsessive-compulsive personality disorder 24.80 11.57 7 44515 128 79699738
Mucosal inflammation 24.51 11.57 6 44516 75574 79624292
Disease progression 24.23 11.57 41 44481 184321 79515545
Snoring 24.17 11.57 22 44500 5544 79694322
Compulsive sexual behaviour 24.16 11.57 8 44514 254 79699612
Personality change 23.97 11.57 29 44493 10141 79689725
Kleptomania 23.68 11.57 5 44517 24 79699842
Stoma site hypergranulation 23.56 11.57 9 44513 436 79699430
Cardiac arrest 22.87 11.57 38 44484 172058 79527808
Stoma site inflammation 22.87 11.57 10 44512 686 79699180
Pituitary haemorrhage 22.82 11.57 8 44514 303 79699563
Urticaria 22.71 11.57 43 44479 185158 79514708
Off label use 22.48 11.57 364 44158 906851 78793015
Irritable bowel syndrome 22.11 11.57 4 44518 62237 79637629
Sleep apnoea syndrome 22.05 11.57 57 44465 36421 79663445
Vaccination site bruising 21.92 11.57 4 44518 7 79699859
Device connection issue 21.86 11.57 11 44511 1037 79698829
Bipolar I disorder 21.72 11.57 14 44508 2115 79697751
Vaccination site oedema 21.58 11.57 4 44518 8 79699858
Autonomic nervous system imbalance 21.49 11.57 19 44503 4611 79695255
Diabetes mellitus inadequate control 21.39 11.57 44 44478 24220 79675646
Skin necrosis 21.15 11.57 37 44485 18050 79681816
White blood cell count decreased 21.14 11.57 46 44476 188242 79511624
Intentional medical device removal by patient 21.11 11.57 8 44514 379 79699487
Hallucination, tactile 20.83 11.57 9 44513 600 79699266
Vaccination site pruritus 20.68 11.57 4 44518 11 79699855
Stoma site haemorrhage 20.54 11.57 13 44509 1903 79697963
Paranoia 20.49 11.57 38 44484 19394 79680472
Orthostatic intolerance 20.49 11.57 13 44509 1911 79697955
Spontaneous penile erection 20.43 11.57 6 44516 127 79699739
Blister 20.32 11.57 22 44500 119454 79580412
Musculoskeletal stiffness 20.28 11.57 167 44355 174841 79525025
Rapid eye movements sleep abnormal 19.79 11.57 7 44515 272 79699594
Therapeutic response unexpected 19.79 11.57 38 44484 19908 79679958
Verbal abuse 19.62 11.57 7 44515 279 79699587
Depression 19.58 11.57 196 44326 216594 79483272
Rheumatoid nodule 19.53 11.57 35 44487 17403 79682463
Paedophilia 19.47 11.57 3 44519 0 79699866
Hyperventilation 19.40 11.57 23 44499 7876 79691990
Food interaction 19.38 11.57 12 44510 1690 79698176
Vestibular migraine 19.33 11.57 6 44516 154 79699712
Product prescribing error 19.30 11.57 62 44460 44751 79655115
Device issue 19.18 11.57 45 44477 27063 79672803
Suicidal ideation 19.18 11.57 89 44433 76251 79623615
Hypervigilance 19.14 11.57 8 44514 491 79699375
Blood test abnormal 19.14 11.57 35 44487 17675 79682191
Device occlusion 18.99 11.57 28 44494 11838 79688028
Delusion of parasitosis 18.98 11.57 4 44518 19 79699847
Swelling 18.95 11.57 60 44462 216651 79483215
Bone marrow failure 18.78 11.57 3 44519 51104 79648762
Serum serotonin increased 18.65 11.57 7 44515 323 79699543
Drug intolerance 18.59 11.57 80 44442 264039 79435827
Human ehrlichiosis 18.29 11.57 8 44514 549 79699317
Obsessive thoughts 18.25 11.57 10 44512 1122 79698744
Device kink 18.20 11.57 12 44510 1883 79697983
Ill-defined disorder 18.18 11.57 7 44515 65868 79633998
Disturbance in attention 18.12 11.57 66 44456 50735 79649131
Drug interaction 18.12 11.57 329 44193 414854 79285012
Loss of personal independence in daily activities 17.81 11.57 108 44414 102472 79597394
Nasopharyngitis 17.80 11.57 77 44445 253804 79446062
Fibroma 17.52 11.57 9 44513 886 79698980
Drug reaction with eosinophilia and systemic symptoms 17.44 11.57 7 44515 64237 79635629
Female orgasmic disorder 17.42 11.57 4 44518 30 79699836
Liver injury 17.40 11.57 5 44517 56609 79643257
Contraindicated product administered 17.27 11.57 39 44483 157499 79542367
Speech disorder 17.16 11.57 68 44454 54377 79645489
Hepatocellular injury 17.03 11.57 3 44519 47590 79652276
Abdominal discomfort 17.00 11.57 77 44445 250650 79449216
Product substitution issue 17.00 11.57 36 44486 20220 79679646
Hypomania 16.95 11.57 21 44501 7523 79692343
Neutrophil count decreased 16.32 11.57 17 44505 93942 79605924
Conjunctival discolouration 16.12 11.57 5 44517 128 79699738
Stoma site irritation 16.02 11.57 6 44516 275 79699591
Interstitial lung disease 15.77 11.57 24 44498 112576 79587290
Wrong device used 15.73 11.57 4 44518 48 79699818
Exposure during pregnancy 15.72 11.57 20 44502 101112 79598754
Constipation 15.56 11.57 233 44289 282817 79417049
Muscle injury 15.46 11.57 4 44518 48557 79651309
Thrombocytopenia 15.40 11.57 86 44436 265173 79434693
Feeling abnormal 15.38 11.57 146 44376 159053 79540813
Delusion of replacement 14.95 11.57 5 44517 164 79699702
Obstructive airways disorder 14.91 11.57 45 44477 31414 79668452
Infection 14.78 11.57 77 44445 241635 79458231
Hypersensitivity 14.69 11.57 86 44436 262153 79437713
Parkinson's disease 14.65 11.57 10 44512 1661 79698205
Somnambulism 14.62 11.57 17 44505 5704 79694162
Orgasm abnormal 14.50 11.57 5 44517 180 79699686
Choking 14.47 11.57 25 44497 12076 79687790
Stoma site candida 14.46 11.57 3 44519 13 79699853
Drug resistance 14.39 11.57 3 44519 42210 79657656
Contraindicated product prescribed 14.39 11.57 10 44512 1711 79698155
Vaccination site pain 14.02 11.57 5 44517 199 79699667
Deep vein thrombosis 14.02 11.57 29 44493 120890 79578976
Exercise tolerance decreased 13.94 11.57 21 44501 9050 79690816
Rales 13.93 11.57 33 44489 19968 79679898
Ascites 13.89 11.57 13 44509 75549 79624317
Stoma site reaction 13.86 11.57 6 44516 402 79699464
Agranulocytosis 13.79 11.57 4 44518 45026 79654840
Hyperthyroidism 13.72 11.57 35 44487 22174 79677692
Lung hyperinflation 13.69 11.57 10 44512 1849 79698017
Blood cholesterol increased 13.60 11.57 16 44506 83704 79616162
Bronchiectasis 13.55 11.57 35 44487 22351 79677515
Euphoric mood 13.49 11.57 19 44503 7707 79692159
Sleep-related eating disorder 13.46 11.57 7 44515 707 79699159
Bradycardia 13.43 11.57 125 44397 135432 79564434
Vaccination site erythema 13.39 11.57 4 44518 90 79699776
Anticholinergic syndrome 13.25 11.57 13 44509 3598 79696268
Apathy 13.21 11.57 25 44497 12952 79686914
Impaired healing 12.95 11.57 18 44504 87637 79612229
Angioedema 12.93 11.57 14 44508 76021 79623845
Anisomastia 12.90 11.57 3 44519 24 79699842
Coronary artery dissection 12.86 11.57 8 44514 1136 79698730
Hypersomnia 12.86 11.57 35 44487 23051 79676815
Middle insomnia 12.84 11.57 28 44494 16041 79683825
Sexual activity increased 12.79 11.57 3 44519 25 79699841
Sopor 12.73 11.57 44 44478 32966 79666900
Coma 12.66 11.57 23 44499 100626 79599240
Multiple sclerosis 12.63 11.57 34 44488 22248 79677618
Peripheral swelling 12.58 11.57 216 44306 269401 79430465
Eosinophilic fasciitis 12.40 11.57 5 44517 280 79699586
Blood creatine phosphokinase increased 12.38 11.57 71 44451 66019 79633847
Hiccups 12.36 11.57 21 44501 10010 79689856
Excessive exercise 12.30 11.57 3 44519 30 79699836
Poor quality sleep 12.21 11.57 34 44488 22688 79677178
Multiple organ dysfunction syndrome 12.20 11.57 31 44491 120215 79579651
Heat stroke 12.18 11.57 9 44513 1694 79698172
Hallucination, auditory 12.16 11.57 32 44490 20661 79679205
Cholestasis 12.13 11.57 7 44515 52102 79647764
Micturition disorder 12.06 11.57 13 44509 4015 79695851
Bladder sphincter atony 12.02 11.57 4 44518 129 79699737
Neoplasm progression 11.95 11.57 7 44515 51675 79648191
Hepatotoxicity 11.81 11.57 7 44515 51345 79648521
Cardiac dysfunction 11.81 11.57 13 44509 4111 79695755
Hypokinesia 11.74 11.57 30 44492 19030 79680836
Meningorrhagia 11.73 11.57 5 44517 322 79699544
Myelosuppression 11.59 11.57 4 44518 40292 79659574

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC N04BC05 NERVOUS SYSTEM
ANTI-PARKINSON DRUGS
DOPAMINERGIC AGENTS
Dopamine agonists
FDA MoA N0000000117 Dopamine Agonists
MeSH PA D018726 Anti-Dyskinesia Agents
MeSH PA D000975 Antioxidants
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
MeSH PA D020011 Protective Agents
CHEBI has role CHEBI:48407 antiparkinson agent
CHEBI has role CHEBI:48578 free radical scavengers
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|

DiseaseRelationSNOMED_IDDOID
Restless legs indication 32914008 DOID:0050425
Parkinson's disease indication 49049000 DOID:14330
Fibromyalgia off-label use 203082005 DOID:631
Hallucinations contraindication 7011001
Dyskinesia contraindication 9748009
Orthostatic hypotension contraindication 28651003
Narcolepsy contraindication 60380001 DOID:8986
Psychotic disorder contraindication 69322001
Sleep apnea contraindication 73430006 DOID:0050847
Kidney disease contraindication 90708001 DOID:557
Drowsy contraindication 271782001
Malignant melanoma contraindication 372244006
Breastfeeding (mother) contraindication 413712001




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 9.57 Basic
pKa2 5.18 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
0.375MG MIRAPEX ER BOEHRINGER INGELHEIM N022421 Feb. 19, 2010 RX TABLET, EXTENDED RELEASE ORAL 8679533 Sept. 8, 2029 TREATMENT OF PARKINSONS DISEASE
0.75MG MIRAPEX ER BOEHRINGER INGELHEIM N022421 Feb. 19, 2010 RX TABLET, EXTENDED RELEASE ORAL 8679533 Sept. 8, 2029 TREATMENT OF PARKINSONS DISEASE
1.5MG MIRAPEX ER BOEHRINGER INGELHEIM N022421 Feb. 19, 2010 RX TABLET, EXTENDED RELEASE ORAL 8679533 Sept. 8, 2029 TREATMENT OF PARKINSONS DISEASE
2.25MG MIRAPEX ER BOEHRINGER INGELHEIM N022421 June 17, 2011 RX TABLET, EXTENDED RELEASE ORAL 8679533 Sept. 8, 2029 TREATMENT OF PARKINSONS DISEASE
3.75MG MIRAPEX ER BOEHRINGER INGELHEIM N022421 June 17, 2011 RX TABLET, EXTENDED RELEASE ORAL 8679533 Sept. 8, 2029 TREATMENT OF PARKINSONS DISEASE
3MG MIRAPEX ER BOEHRINGER INGELHEIM N022421 Feb. 19, 2010 RX TABLET, EXTENDED RELEASE ORAL 8679533 Sept. 8, 2029 TREATMENT OF PARKINSONS DISEASE
4.5MG MIRAPEX ER BOEHRINGER INGELHEIM N022421 Feb. 19, 2010 RX TABLET, EXTENDED RELEASE ORAL 8679533 Sept. 8, 2029 TREATMENT OF PARKINSONS DISEASE

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
D(2) dopamine receptor GPCR AGONIST EC50 6.60 WOMBAT-PK CHEMBL
Alpha-2A adrenergic receptor GPCR Ki 7.12 PDSP
5-hydroxytryptamine receptor 1A GPCR Ki 6.16 WOMBAT-PK
5-hydroxytryptamine receptor 2A GPCR EC50 5.93 CHEMBL
5-hydroxytryptamine receptor 7 GPCR Ki 5.93 PDSP
Alpha-2B adrenergic receptor GPCR Ki 6.20 WOMBAT-PK
D(3) dopamine receptor GPCR AGONIST EC50 8.67 WOMBAT-PK
Histamine H1 receptor GPCR Kd 8.35 CHEMBL
Histamine H2 receptor GPCR Ki 5.57 PDSP
Histamine H4 receptor GPCR Kd 7.80 CHEMBL
5-hydroxytryptamine receptor 1B GPCR Ki 5.46 PDSP
5-hydroxytryptamine receptor 1D GPCR Ki 5.78 PDSP
Alpha-2C adrenergic receptor GPCR Ki 7.28 PDSP
D(4) dopamine receptor GPCR AGONIST Ki 9.31 CHEMBL
Beta-2 adrenergic receptor GPCR Ki 4 CHEMBL
D(2) dopamine receptor GPCR Ki 8.51 CHEMBL
D(2) dopamine receptor GPCR Kd 8.80 CHEMBL
D(3) dopamine receptor GPCR Ki 9.35 CHEMBL

External reference:

IDSource
4024071 VUID
N0000022076 NUI
D00559 KEGG_DRUG
191217-81-9 SECONDARY_CAS_RN
4021042 VANDF
4024071 VANDF
C0074710 UMLSCUI
CHEBI:8356 CHEBI
G6L PDB_CHEM_ID
CHEMBL301265 ChEMBL_ID
DB00413 DRUGBANK_ID
CHEMBL3182733 ChEMBL_ID
CHEMBL542257 ChEMBL_ID
D000077487 MESH_DESCRIPTOR_UI
119570 PUBCHEM_CID
953 IUPHAR_LIGAND_ID
6227 INN_ID
83619PEU5T UNII
236747 RXNORM
169631 MMSL
23370 MMSL
5340 MMSL
d04145 MMSL
006721 NDDF
006722 NDDF
108471007 SNOMEDCT_US
386852009 SNOMEDCT_US
412282004 SNOMEDCT_US
725650009 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Mirapex ER HUMAN PRESCRIPTION DRUG LABEL 1 0597-0109 TABLET, EXTENDED RELEASE 0.38 mg ORAL NDA 32 sections
Mirapex ER HUMAN PRESCRIPTION DRUG LABEL 1 0597-0109 TABLET, EXTENDED RELEASE 0.38 mg ORAL NDA 32 sections
Mirapex ER HUMAN PRESCRIPTION DRUG LABEL 1 0597-0113 TABLET, EXTENDED RELEASE 1.50 mg ORAL NDA 32 sections
Mirapex ER HUMAN PRESCRIPTION DRUG LABEL 1 0597-0113 TABLET, EXTENDED RELEASE 1.50 mg ORAL NDA 32 sections
Mirapex ER HUMAN PRESCRIPTION DRUG LABEL 1 0597-0115 TABLET, EXTENDED RELEASE 3 mg ORAL NDA 32 sections
Mirapex ER HUMAN PRESCRIPTION DRUG LABEL 1 0597-0115 TABLET, EXTENDED RELEASE 3 mg ORAL NDA 32 sections
Mirapex ER HUMAN PRESCRIPTION DRUG LABEL 1 0597-0116 TABLET, EXTENDED RELEASE 4.50 mg ORAL NDA 32 sections
Mirapex ER HUMAN PRESCRIPTION DRUG LABEL 1 0597-0116 TABLET, EXTENDED RELEASE 4.50 mg ORAL NDA 32 sections
Mirapex ER HUMAN PRESCRIPTION DRUG LABEL 1 0597-0285 TABLET, EXTENDED RELEASE 0.75 mg ORAL NDA 32 sections
Mirapex ER HUMAN PRESCRIPTION DRUG LABEL 1 0597-0285 TABLET, EXTENDED RELEASE 0.75 mg ORAL NDA 32 sections
Mirapex ER HUMAN PRESCRIPTION DRUG LABEL 1 0597-0286 TABLET, EXTENDED RELEASE 2.25 mg ORAL NDA 32 sections
Mirapex ER HUMAN PRESCRIPTION DRUG LABEL 1 0597-0286 TABLET, EXTENDED RELEASE 2.25 mg ORAL NDA 32 sections
Mirapex ER HUMAN PRESCRIPTION DRUG LABEL 1 0597-0287 TABLET, EXTENDED RELEASE 3.75 mg ORAL NDA 32 sections
Mirapex ER HUMAN PRESCRIPTION DRUG LABEL 1 0597-0287 TABLET, EXTENDED RELEASE 3.75 mg ORAL NDA 32 sections
Pramipexole Dihydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-7597 TABLET 1 mg ORAL ANDA 28 sections
Pramipexole Dihydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-6704 TABLET 0.25 mg ORAL ANDA 20 sections
Pramipexole Dihydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-6704 TABLET 0.25 mg ORAL ANDA 20 sections
Pramipexole DihydrochlorideExtended-Release HUMAN PRESCRIPTION DRUG LABEL 1 10370-251 TABLET, EXTENDED RELEASE 0.38 mg ORAL ANDA 28 sections
Pramipexole DihydrochlorideExtended-Release HUMAN PRESCRIPTION DRUG LABEL 1 10370-251 TABLET, EXTENDED RELEASE 0.38 mg ORAL ANDA 28 sections
Pramipexole DihydrochlorideExtended-Release HUMAN PRESCRIPTION DRUG LABEL 1 10370-252 TABLET, EXTENDED RELEASE 0.75 mg ORAL ANDA 28 sections
Pramipexole DihydrochlorideExtended-Release HUMAN PRESCRIPTION DRUG LABEL 1 10370-252 TABLET, EXTENDED RELEASE 0.75 mg ORAL ANDA 28 sections
Pramipexole DihydrochlorideExtended-Release HUMAN PRESCRIPTION DRUG LABEL 1 10370-253 TABLET, EXTENDED RELEASE 1.50 mg ORAL ANDA 28 sections
Pramipexole DihydrochlorideExtended-Release HUMAN PRESCRIPTION DRUG LABEL 1 10370-253 TABLET, EXTENDED RELEASE 1.50 mg ORAL ANDA 28 sections
Pramipexole DihydrochlorideExtended-Release HUMAN PRESCRIPTION DRUG LABEL 1 10370-254 TABLET, EXTENDED RELEASE 3 mg ORAL ANDA 28 sections
Pramipexole DihydrochlorideExtended-Release HUMAN PRESCRIPTION DRUG LABEL 1 10370-254 TABLET, EXTENDED RELEASE 3 mg ORAL ANDA 28 sections
Pramipexole DihydrochlorideExtended-Release HUMAN PRESCRIPTION DRUG LABEL 1 10370-255 TABLET, EXTENDED RELEASE 4.50 mg ORAL ANDA 28 sections
Pramipexole DihydrochlorideExtended-Release HUMAN PRESCRIPTION DRUG LABEL 1 10370-255 TABLET, EXTENDED RELEASE 4.50 mg ORAL ANDA 28 sections
Pramipexole DihydrochlorideExtended-Release HUMAN PRESCRIPTION DRUG LABEL 1 10370-305 TABLET, EXTENDED RELEASE 2.25 mg ORAL ANDA 28 sections
Pramipexole DihydrochlorideExtended-Release HUMAN PRESCRIPTION DRUG LABEL 1 10370-305 TABLET, EXTENDED RELEASE 2.25 mg ORAL ANDA 28 sections
Pramipexole DihydrochlorideExtended-Release HUMAN PRESCRIPTION DRUG LABEL 1 10370-306 TABLET, EXTENDED RELEASE 3.75 mg ORAL ANDA 28 sections