pramipexole 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | 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 µM/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

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
kinase-safety-class ACVR2B,BRAF,CAMK2D,CDK5,DYRK1B,EIF2AK3,GRK2,ITK,MAP3K21,MAPK10,MAPK7,PDK1,PDK2,PDK4,PRKDC 15
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pld-class Phospholipidosis risk class (1 = positive, 0 = negative) 0 High 1

Approvals:

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

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
Dyskinesia 517.38 12.45 268 37400 36266 90554513
Impulse-control disorder 348.03 12.45 81 37587 901 90589878
On and off phenomenon 333.53 12.45 95 37573 2448 90588331
Hallucination 266.07 12.45 220 37448 65739 90525040
Gambling disorder 239.74 12.45 63 37605 1189 90589590
Compulsive shopping 238.83 12.45 57 37611 712 90590067
Hallucination, visual 195.41 12.45 121 37547 22971 90567808
Freezing phenomenon 160.56 12.45 50 37618 1762 90589017
Tremor 154.72 12.45 249 37419 152924 90437855
Dystonia 147.06 12.45 90 37578 16729 90574050
Parkinsonism hyperpyrexia syndrome 146.77 12.45 31 37637 211 90590568
Restless legs syndrome 139.47 12.45 97 37571 22373 90568406
Stoma site discharge 135.72 12.45 45 37623 1944 90588835
Granuloma skin 133.11 12.45 72 37596 10608 90580171
Blood parathyroid hormone decreased 126.73 12.45 73 37595 12143 90578636
Bronchopulmonary aspergillosis allergic 124.80 12.45 50 37618 3716 90587063
Total lung capacity decreased 124.42 12.45 50 37618 3745 90587034
Breath sounds abnormal 123.56 12.45 78 37590 15308 90575471
Systemic lupus erythematosus 122.22 12.45 7 37661 361889 90228890
Fall 118.72 12.45 454 37214 481356 90109423
Panniculitis 117.87 12.45 74 37594 14384 90576395
Glossodynia 115.93 12.45 4 37664 321775 90269004
Muscle rigidity 113.55 12.45 72 37596 14237 90576542
Hypersexuality 112.70 12.45 30 37638 596 90590183
Bradykinesia 105.31 12.45 53 37615 6735 90584044
Skin necrosis 104.82 12.45 73 37595 16868 90573911
Lung opacity 104.63 12.45 51 37617 6051 90584728
Pleurothotonus 102.39 12.45 33 37635 1302 90589477
Hand deformity 99.23 12.45 6 37662 296356 90294423
Stoma site erythema 98.70 12.45 33 37635 1463 90589316
Pericarditis 98.58 12.45 3 37665 270148 90320631
Blood pressure inadequately controlled 97.74 12.45 49 37619 6175 90584604
Rheumatoid nodule 93.44 12.45 73 37595 20093 90570686
Suicidal ideation 92.84 12.45 133 37535 73722 90517057
Maternal exposure during pregnancy 89.63 12.45 20 37648 360043 90230736
Diabetes mellitus inadequate control 89.54 12.45 69 37599 18615 90572164
Exercise tolerance decreased 88.82 12.45 49 37619 7502 90583277
Aspiration 88.72 12.45 64 37604 15629 90575150
Stoma site pain 88.52 12.45 30 37638 1387 90589392
Stereotypy 87.57 12.45 23 37645 433 90590346
Blood calcium increased 81.80 12.45 55 37613 12003 90578776
Basal cell carcinoma 79.39 12.45 83 37585 33306 90557473
Camptocormia 77.08 12.45 19 37649 274 90590505
Hypercalcaemia 75.90 12.45 82 37586 34158 90556621
Binge eating 72.18 12.45 21 37647 584 90590195
Orthostatic hypotension 72.17 12.45 88 37580 41739 90549040
Blood test abnormal 70.42 12.45 63 37605 20889 90569890
Multiple drug therapy 70.35 12.45 41 37627 6968 90583811
Pulmonary fibrosis 69.33 12.45 144 37524 107359 90483420
Discomfort 68.73 12.45 15 37653 274320 90316459
Sputum discoloured 67.91 12.45 61 37607 20330 90570449
Cognitive disorder 67.51 12.45 111 37557 69296 90521483
Swelling 67.15 12.45 46 37622 419012 90171767
Hyperkinesia 65.40 12.45 26 37642 1893 90588886
Depressed mood 63.92 12.45 91 37577 50131 90540648
Drug eruption 63.54 12.45 76 37592 35331 90555448
Ulcer 63.02 12.45 73 37595 32809 90557970
Rales 62.12 12.45 52 37616 15775 90575004
Jealous delusion 59.79 12.45 12 37656 61 90590718
Stomatitis 59.45 12.45 20 37648 274678 90316101
Irritable bowel syndrome 59.28 12.45 8 37660 207440 90383339
Skin ulcer 58.31 12.45 87 37581 49988 90540791
Muscle injury 57.85 12.45 4 37664 176650 90414129
Blister 56.18 12.45 18 37650 254980 90335799
Delusion 55.41 12.45 46 37622 13794 90576985
Bronchiectasis 53.96 12.45 56 37612 22274 90568505
Liver injury 52.69 12.45 5 37663 170562 90420217
Drug tolerance decreased 51.26 12.45 65 37603 32065 90558714
Blood cholesterol increased 50.83 12.45 12 37656 208000 90382779
Ill-defined disorder 50.81 12.45 8 37660 184883 90405896
Neuroleptic malignant syndrome 49.95 12.45 45 37623 15051 90575728
Compulsive hoarding 49.80 12.45 10 37658 51 90590728
Somnolence 49.66 12.45 195 37473 208889 90381890
Medication error 49.51 12.45 109 37559 84543 90506236
Type 2 diabetes mellitus 49.13 12.45 12 37656 203232 90387547
Torticollis 48.78 12.45 23 37645 2535 90588244
Psychotic disorder 47.96 12.45 62 37606 31168 90559611
Akinesia 47.17 12.45 20 37648 1716 90589063
Drug dispensed to wrong patient 45.23 12.45 13 37655 346 90590433
Injury 45.14 12.45 13 37655 197336 90393443
Suicide attempt 45.13 12.45 98 37570 75301 90515478
Acute psychosis 44.74 12.45 23 37645 3055 90587724
Obsessive-compulsive disorder 44.29 12.45 26 37642 4478 90586301
Obstructive airways disorder 43.93 12.45 54 37614 25815 90564964
Stoma site infection 43.83 12.45 16 37652 922 90589857
Sudden onset of sleep 42.99 12.45 14 37654 571 90590208
Pleuritic pain 42.36 12.45 35 37633 10426 90580353
Wound 41.32 12.45 39 37629 302941 90287838
Exposure during pregnancy 41.13 12.45 24 37644 238386 90352393
Therapeutic response shortened 40.87 12.45 49 37619 22830 90567949
Drug interaction 40.60 12.45 224 37444 276229 90314550
Vestibular migraine 40.30 12.45 11 37657 241 90590538
Loss of personal independence in daily activities 39.95 12.45 136 37532 135969 90454810
Blood creatinine increased 39.69 12.45 112 37556 101274 90489505
Febrile neutropenia 38.95 12.45 9 37659 158340 90432439
Haemoptysis 38.95 12.45 58 37610 33262 90557517
Psychomotor hyperactivity 36.24 12.45 35 37633 12778 90578001
Red blood cell sedimentation rate increased 36.08 12.45 95 37573 82500 90508279
Pneumococcal infection 36.02 12.45 15 37653 1230 90589549
Impaired healing 35.78 12.45 27 37641 234172 90356607
Prescribed underdose 35.57 12.45 89 37579 74930 90515849
Joint range of motion decreased 34.81 12.45 7 37661 135636 90455143
Pituitary haemorrhage 34.70 12.45 8 37660 85 90590694
Rash pruritic 34.33 12.45 93 37575 82121 90508658
Dopamine dysregulation syndrome 33.89 12.45 9 37659 177 90590602
Malignant polyp 33.52 12.45 9 37659 185 90590594
Withdrawal syndrome 33.47 12.45 44 37624 22480 90568299
Insomnia 32.75 12.45 244 37424 333230 90257549
Arthritis 32.65 12.45 147 37521 167168 90423611
Abnormal dreams 32.31 12.45 31 37637 11226 90579553
Drug withdrawal syndrome 32.15 12.45 49 37619 28674 90562105
Pre-existing condition improved 31.66 12.45 28 37640 9141 90581638
Psoriatic arthropathy 31.58 12.45 29 37639 228306 90362473
Transaminases increased 31.56 12.45 56 37612 37136 90553643
Dependence 31.45 12.45 16 37652 2079 90588700
Peripheral swelling 30.79 12.45 284 37384 412822 90177957
Hallucination, tactile 30.16 12.45 10 37658 432 90590347
Gait disturbance 29.29 12.45 197 37471 260299 90330480
Fibroma 29.05 12.45 12 37656 964 90589815
Abnormal behaviour 28.78 12.45 41 37627 22587 90568192
Fibromyalgia 28.76 12.45 26 37642 206243 90384536
Nasopharyngitis 28.64 12.45 81 37587 407023 90183756
Rash 28.44 12.45 204 37464 795896 89794883
Hyperventilation 28.27 12.45 23 37645 6705 90584074
Pulmonary mass 27.95 12.45 46 37622 28726 90562053
Bursitis 27.75 12.45 10 37658 131644 90459135
Product prescribing error 27.68 12.45 47 37621 30098 90560681
Posture abnormal 27.58 12.45 16 37652 2695 90588084
Parkinsonian gait 27.30 12.45 10 37658 582 90590197
Alopecia 27 12.45 110 37558 494961 90095818
Night sweats 26.77 12.45 10 37658 128756 90462023
Malignant neoplasm progression 26.43 12.45 6 37662 106864 90483915
Dropped head syndrome 26.39 12.45 8 37660 257 90590522
Gambling 26.37 12.45 8 37660 258 90590521
Hypercholesterolaemia 26.32 12.45 5 37663 100887 90489892
Dermatillomania 26.16 12.45 8 37660 265 90590514
Condition aggravated 26.06 12.45 369 37299 595176 89995603
Deafness 26.04 12.45 39 37629 22475 90568304
Crime 25.51 12.45 5 37663 22 90590757
Orthostatic intolerance 25.28 12.45 12 37656 1342 90589437
Skin neoplasm excision 25.24 12.45 13 37655 1733 90589046
Stoma site reaction 24.79 12.45 8 37660 317 90590462
Stoma site inflammation 24.69 12.45 10 37658 764 90590015
Restlessness 24.37 12.45 49 37619 35671 90555108
Oedema peripheral 24.34 12.45 187 37481 257728 90333051
Infection 24.04 12.45 74 37594 362020 90228759
Sleep apnoea syndrome 23.42 12.45 45 37623 31702 90559077
Serum serotonin increased 23.40 12.45 7 37661 215 90590564
Parkinsonism 23.30 12.45 29 37639 14036 90576743
Abdominal pain 23.20 12.45 259 37409 395462 90195317
Vaccination site oedema 23.10 12.45 4 37664 7 90590772
Vaccination site bruising 23.10 12.45 4 37664 7 90590772
Treatment noncompliance 23.10 12.45 60 37608 51667 90539112
Chorea 22.93 12.45 13 37655 2097 90588682
Stoma site hypergranulation 22.91 12.45 8 37660 405 90590374
Sleep attacks 22.22 12.45 6 37662 126 90590653
Diarrhoea 22.15 12.45 267 37401 938923 89651856
Hallucination, auditory 21.89 12.45 30 37638 15945 90574834
Autoimmune disorder 21.82 12.45 3 37665 76741 90514038
Constipation 21.49 12.45 194 37474 280201 90310578
Abdominal discomfort 21.33 12.45 114 37554 477214 90113565
Neutropenia 21.31 12.45 38 37630 224866 90365913
Gastrointestinal disorder 21.21 12.45 47 37621 256640 90334139
Liver disorder 21.20 12.45 12 37656 121257 90469522
Balance disorder 21.00 12.45 88 37580 96992 90493787
Wound infection 20.91 12.45 9 37659 106393 90484386
Urticaria 20.70 12.45 64 37604 312670 90278109
Lower limb fracture 20.57 12.45 5 37663 85008 90505771
Speech disorder 20.48 12.45 53 37615 45532 90545247
Snoring 20.44 12.45 17 37651 5109 90585670
Heat stroke 19.96 12.45 9 37659 895 90589884
Deep brain stimulation 19.86 12.45 5 37663 79 90590700
Therapeutic response changed 19.60 12.45 10 37658 1307 90589472
Vaccination site pruritus 19.52 12.45 4 37664 23 90590756
Stoma site haemorrhage 19.45 12.45 10 37658 1328 90589451
Autonomic nervous system imbalance 19.34 12.45 14 37654 3436 90587343
Dyspepsia 19.21 12.45 33 37635 198127 90392652
Device connection issue 19.13 12.45 9 37659 987 90589792
Drug-induced liver injury 18.80 12.45 7 37661 90311 90500468
Conjunctival discolouration 18.61 12.45 5 37663 103 90590676
Product dose omission issue 18.51 12.45 194 37474 291493 90299286
Therapeutic response decreased 18.37 12.45 80 37588 89649 90501130
Device issue 18.37 12.45 39 37629 29498 90561281
Urinary tract infection 18.34 12.45 201 37467 305431 90285348
Peripheral venous disease 18.33 12.45 6 37662 83915 90506864
Neoplasm skin 18.18 12.45 13 37655 3129 90587650
Therapeutic product effect variable 18.14 12.45 10 37658 1529 90589250
Hypertension 17.83 12.45 278 37390 457254 90133525
C-reactive protein abnormal 17.83 12.45 16 37652 127413 90463366
Musculoskeletal stiffness 17.78 12.45 195 37473 296337 90294442
Product substitution issue 17.77 12.45 29 37639 17979 90572800
Osteoarthritis 17.72 12.45 34 37634 195696 90395083
Hypoaesthesia 17.62 12.45 69 37599 314141 90276638
Chronic obstructive pulmonary disease 17.62 12.45 69 37599 73760 90517019
Hypoxia 17.55 12.45 68 37600 72331 90518448
Wrong device used 17.31 12.45 4 37664 43 90590736
Stoma site extravasation 17.10 12.45 6 37662 308 90590471
Product residue present 16.63 12.45 14 37654 4277 90586502
Hypercapnia 16.59 12.45 17 37651 6660 90584119
Coronary artery dissection 16.43 12.45 8 37660 946 90589833
Stoma site irritation 16.40 12.45 6 37662 348 90590431
Sciatica 16.38 12.45 11 37657 101371 90489408
Nightmare 16.27 12.45 31 37637 21694 90569085
Patient elopement 16.20 12.45 5 37663 171 90590608
Disease progression 16.19 12.45 25 37643 156590 90434189
Deep vein thrombosis 16.11 12.45 9 37659 91611 90499168
Alanine aminotransferase increased 16.10 12.45 94 37574 118244 90472535
Neurotransmitter level altered 15.96 12.45 3 37665 10 90590769
Female orgasmic disorder 15.90 12.45 4 37664 63 90590716
Meningorrhagia 15.57 12.45 5 37663 195 90590584
Aspartate aminotransferase increased 15.48 12.45 84 37584 102853 90487926
Mucosal inflammation 14.72 12.45 3 37665 57622 90533157
Pancytopenia 14.67 12.45 17 37651 120246 90470533
Stoma site candida 14.53 12.45 3 37665 18 90590761
Endometrial cancer 14.45 12.45 12 37656 3600 90587179
Pregnancy 14.34 12.45 4 37664 62043 90528736
Pyrexia 14.33 12.45 191 37477 660294 89930485
Bulimia nervosa 14.23 12.45 6 37662 508 90590271
Surgery 14.18 12.45 46 37622 44841 90545938
Orgasm abnormal 14.12 12.45 4 37664 101 90590678
Hip arthroplasty 14.12 12.45 7 37661 76201 90514578
Resting tremor 14.01 12.45 7 37661 876 90589903
Erysipelas 13.94 12.45 18 37650 9034 90581745
Hypokinesia 13.79 12.45 24 37644 15673 90575106
Grip strength decreased 13.71 12.45 11 37657 92565 90498214
Inhibitory drug interaction 13.68 12.45 11 37657 3152 90587627
Anisomastia 13.67 12.45 3 37665 25 90590754
Hydronephrosis 13.66 12.45 21 37647 12381 90578398
Product quality issue 13.65 12.45 8 37660 79317 90511462
Product administration interrupted 13.54 12.45 21 37647 12471 90578308
Reduced facial expression 13.50 12.45 10 37658 2543 90588236
Kleptomania 13.46 12.45 3 37665 27 90590752
Hyperpyrexia 13.45 12.45 13 37655 4748 90586031
Nail disorder 13.30 12.45 4 37664 59063 90531716
Myelosuppression 13.27 12.45 3 37665 53588 90537191
Oedema 13.23 12.45 41 37627 200254 90390525
Hypersensitivity 13.21 12.45 123 37545 454554 90136225
Delusion of parasitosis 13.18 12.45 4 37664 129 90590650
Bone erosion 13.06 12.45 3 37665 53018 90537761
Drug intolerance 13.04 12.45 121 37547 447470 90143309
Hepatic cirrhosis 13.00 12.45 5 37663 63248 90527531
Vaccination site erythema 12.98 12.45 4 37664 136 90590643
Lipoedema 12.85 12.45 5 37663 344 90590435
Crying 12.76 12.45 31 37637 25614 90565165
Hyperphagia 12.62 12.45 10 37658 2808 90587971
Therapeutic response unexpected 12.59 12.45 28 37640 21852 90568927
Wrist fracture 12.58 12.45 23 37645 15601 90575178
Device dislocation 12.53 12.45 35 37633 31447 90559332
Major depression 12.49 12.45 18 37650 10017 90580762
Altered state of consciousness 12.49 12.45 35 37633 31497 90559282

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 794.40 14.66 180 21716 1395 42598044
Hypersexuality 526.50 14.66 131 21765 1571 42597868
Hallucination 461.93 14.66 315 21581 57192 42542247
Dyskinesia 444.17 14.66 230 21666 25160 42574279
On and off phenomenon 442.82 14.66 133 21763 3334 42596105
Gambling disorder 408.75 14.66 108 21788 1668 42597771
Dopamine dysregulation syndrome 254.10 14.66 59 21837 514 42598925
Hallucination, visual 202.09 14.66 129 21767 20891 42578548
Freezing phenomenon 188.51 14.66 60 21836 1829 42597610
Compulsive shopping 160.33 14.66 39 21857 422 42599017
Nocturia 159.51 14.66 91 21805 12021 42587418
Relapsing-remitting multiple sclerosis 151.31 14.66 48 21848 1447 42597992
Gait disturbance 151.02 14.66 217 21679 97783 42501656
Needle fatigue 131.31 14.66 41 21855 1172 42598267
Bradykinesia 129.99 14.66 61 21835 5375 42594064
Jealous delusion 128.75 14.66 32 21864 381 42599058
Gait spastic 125.27 14.66 41 21855 1368 42598071
Muscle rigidity 118.33 14.66 75 21821 11984 42587455
Gambling 116.48 14.66 26 21870 186 42599253
Micturition urgency 114.27 14.66 73 21823 11825 42587614
Stereotypy 110.50 14.66 33 21863 809 42598630
Restless legs syndrome 110.13 14.66 66 21830 9548 42589891
Delusion 106.98 14.66 76 21820 14658 42584781
Balance disorder 106.82 14.66 127 21769 47518 42551921
Hypertonic bladder 104.26 14.66 41 21855 2340 42597099
Cerebral hypoperfusion 103.54 14.66 33 21863 1010 42598429
Monoparesis 102.27 14.66 43 21853 2917 42596522
Muscle spasticity 97.25 14.66 54 21842 6768 42592671
Fall 95.83 14.66 301 21595 234219 42365220
Memory impairment 95.12 14.66 123 21773 50099 42549340
Paraphilia 93.41 14.66 19 21877 81 42599358
Stoma site erythema 92.26 14.66 30 21866 980 42598459
Dysarthria 89.04 14.66 106 21790 39701 42559738
Movement disorder 86.90 14.66 67 21829 14631 42584808
Central nervous system lesion 74.85 14.66 48 21848 7822 42591617
Binge eating 74.16 14.66 17 21879 139 42599300
Parkinsonism hyperpyrexia syndrome 73.92 14.66 20 21876 339 42599100
Troponin increased 71.71 14.66 67 21829 18995 42580444
Hyperkinesia 70.89 14.66 30 21866 2068 42597371
Insomnia 68.04 14.66 172 21724 118081 42481358
Psychomotor hyperactivity 67.07 14.66 51 21845 10907 42588532
Tremor 66.54 14.66 151 21745 96778 42502661
Embedded device 65.35 14.66 19 21877 423 42599016
Febrile neutropenia 65.33 14.66 9 21887 185694 42413745
Ataxia 61.28 14.66 57 21839 16068 42583371
Neutropenia 60.77 14.66 14 21882 199417 42400022
Stoma site discharge 59.69 14.66 24 21872 1452 42597987
Multiple sclerosis relapse 57.27 14.66 52 21844 14212 42585227
Agitation 56.69 14.66 111 21785 64203 42535236
Hyperthyroidism 55.08 14.66 51 21845 14290 42585149
Encephalitis toxic 55.02 14.66 15 21881 262 42599177
Anxiety 54.70 14.66 159 21737 118401 42481038
Neuroleptic malignant syndrome 54.41 14.66 61 21835 21411 42578028
Device dislocation 53.64 14.66 39 21857 7792 42591647
Abnormal behaviour 53.55 14.66 67 21829 26384 42573055
Reduced facial expression 52.06 14.66 22 21874 1511 42597928
Delirium 51.67 14.66 95 21801 52424 42547015
Toxicity to various agents 51.15 14.66 27 21869 229109 42370330
Stoma site pain 50.38 14.66 18 21878 785 42598654
Compulsive hoarding 50.35 14.66 9 21887 15 42599424
Dystonia 50.12 14.66 46 21850 12744 42586695
Aggression 50.05 14.66 85 21811 44078 42555361
Sudden onset of sleep 49.42 14.66 15 21881 389 42599050
Drug withdrawal syndrome 49.18 14.66 58 21838 21491 42577948
Binocular eye movement disorder 49.10 14.66 14 21882 290 42599149
Impulsive behaviour 48.26 14.66 24 21872 2401 42597038
Somnolence 47.61 14.66 170 21726 140935 42458504
Confusional state 47.53 14.66 191 21705 167406 42432033
Pollakiuria 47.15 14.66 58 21838 22447 42576992
Adrenal insufficiency 46.65 14.66 53 21843 18871 42580568
Pleurothotonus 46.59 14.66 19 21877 1192 42598247
Therapeutic product effect variable 45.38 14.66 25 21871 3084 42596355
Posture abnormal 44.47 14.66 23 21873 2498 42596941
Suspiciousness 44.34 14.66 14 21882 415 42599024
Parkinsonian gait 44.04 14.66 15 21881 567 42598872
Sleep attacks 43.73 14.66 11 21885 138 42599301
Mania 43.42 14.66 39 21857 10508 42588931
Cerebellar stroke 42.71 14.66 15 21881 622 42598817
Psychotic disorder 42.45 14.66 63 21833 29145 42570294
Akinesia 42.03 14.66 22 21874 2450 42596989
Pyrexia 40.59 14.66 89 21807 393953 42205486
Acute kidney injury 40.33 14.66 80 21816 367257 42232182
Voyeurism 39.45 14.66 6 21890 0 42599439
Delusional disorder, jealous type 39.45 14.66 6 21890 0 42599439
Dizziness 39.11 14.66 240 21656 249014 42350425
Diarrhoea 38.33 14.66 116 21780 460733 42138706
Platelet count decreased 37.91 14.66 12 21884 138569 42460870
Libido increased 36.45 14.66 15 21881 963 42598476
Hypomania 36.14 14.66 20 21876 2488 42596951
Speech disorder 35.60 14.66 58 21838 29063 42570376
Restlessness 35.41 14.66 58 21838 29191 42570248
Erectile dysfunction 35.15 14.66 53 21843 24860 42574579
Pancytopenia 34.40 14.66 9 21887 117734 42481705
Paranoia 34.09 14.66 39 21857 13987 42585452
Obsessive-compulsive disorder 31.92 14.66 27 21869 6716 42592723
Disturbance in attention 30.60 14.66 55 21841 29811 42569628
Bradycardia 30.53 14.66 105 21791 85379 42514060
Dependence 30.50 14.66 15 21881 1465 42597974
Excessive masturbation 30.35 14.66 8 21888 122 42599317
Anticholinergic syndrome 29.49 14.66 15 21881 1574 42597865
Dropped head syndrome 29.17 14.66 9 21887 247 42599192
Sleep apnoea syndrome 29.11 14.66 45 21851 21563 42577876
Abnormal dreams 29.06 14.66 28 21868 8243 42591196
Cognitive disorder 28.91 14.66 58 21838 34114 42565325
Hypervigilance 28.76 14.66 8 21888 151 42599288
Obsessive-compulsive personality disorder 28.51 14.66 8 21888 156 42599283
Compulsive sexual behaviour 28.40 14.66 9 21887 270 42599169
Sexually inappropriate behaviour 28.23 14.66 11 21885 612 42598827
Bipolar I disorder 28.09 14.66 12 21884 846 42598593
Feeling cold 28.09 14.66 34 21862 12939 42586500
Acute psychosis 27.89 14.66 16 21880 2133 42597306
Depression 27.70 14.66 122 21774 111241 42488198
Withdrawal syndrome 27.65 14.66 36 21860 14739 42584700
Sopor 27.61 14.66 34 21862 13168 42586271
Device issue 26.99 14.66 34 21862 13475 42585964
Hyporesponsive to stimuli 26.97 14.66 14 21882 1532 42597907
Dementia 26.05 14.66 37 21859 16443 42582996
Hyperphagia 25.95 14.66 14 21882 1656 42597783
VACTERL syndrome 25.76 14.66 6 21890 53 42599386
Irritability 25.31 14.66 49 21847 28079 42571360
Gait inability 24.61 14.66 43 21853 22790 42576649
Intentional medical device removal by patient 24.47 14.66 9 21887 427 42599012
Malignant neoplasm progression 23.82 14.66 13 21883 108387 42491052
Contraindicated product prescribed 23.63 14.66 10 21886 689 42598750
Rapid eye movements sleep abnormal 23.38 14.66 7 21889 173 42599266
Tension 23.36 14.66 15 21881 2449 42596990
White blood cell count decreased 23.17 14.66 14 21882 110382 42489057
Upper motor neurone lesion 23.12 14.66 7 21889 180 42599259
Food interaction 22.99 14.66 11 21885 1011 42598428
Disease progression 22.90 14.66 24 21872 143632 42455807
Hyperadrenocorticism 22.86 14.66 7 21889 187 42599252
Stoma site inflammation 22.69 14.66 9 21887 525 42598914
Neutrophil count decreased 22.44 14.66 3 21893 63412 42536027
Condition aggravated 22.28 14.66 218 21678 260536 42338903
Sleep-related eating disorder 22.07 14.66 8 21888 364 42599075
Stoma site haemorrhage 22.04 14.66 11 21885 1108 42598331
Rash 22.04 14.66 71 21825 276883 42322556
Hallucination, tactile 21.85 14.66 9 21887 579 42598860
Frustration tolerance decreased 21.68 14.66 16 21880 3270 42596169
Sleep disorder 21.66 14.66 64 21832 48031 42551408
Inappropriate antidiuretic hormone secretion 21.66 14.66 34 21862 16507 42582932
Device occlusion 21.39 14.66 24 21872 8426 42591013
Personality change 21.30 14.66 20 21876 5699 42593740
Verbal abuse 21.26 14.66 7 21889 238 42599201
Stoma site infection 20.66 14.66 10 21886 943 42598496
Motor dysfunction 20.39 14.66 23 21873 8123 42591316
Hypotension 20.38 14.66 212 21684 257419 42342020
Hemivertebra 20.33 14.66 6 21890 141 42599298
Alanine aminotransferase increased 20.31 14.66 10 21886 88396 42511043
Marital problem 20.31 14.66 5 21891 57 42599382
Haemoglobin decreased 20.15 14.66 23 21873 132448 42466991
Hypokinesia 19.96 14.66 25 21871 9846 42589593
Dysstasia 19.91 14.66 30 21866 14056 42585383
Mobility decreased 19.89 14.66 51 21845 35255 42564184
Medical device site dryness 19.87 14.66 4 21892 16 42599423
Human ehrlichiosis 19.64 14.66 8 21888 500 42598939
Off label use 19.58 14.66 222 21674 638113 41961326
Interstitial lung disease 19.40 14.66 8 21888 78454 42520985
Therapeutic response shortened 19.35 14.66 29 21867 13525 42585914
Device alarm issue 19.29 14.66 9 21887 782 42598657
Lung hyperinflation 19.04 14.66 10 21886 1121 42598318
Sexual activity increased 18.82 14.66 4 21892 22 42599417
Stoma site discomfort 18.25 14.66 4 21892 26 42599413
Road traffic accident 18.09 14.66 34 21862 19059 42580380
Cardiac arrest 17.71 14.66 18 21878 109302 42490137
Oedema peripheral 17.62 14.66 125 21771 135951 42463488
Device placement issue 17.21 14.66 5 21891 111 42599328
Excessive exercise 17.18 14.66 3 21893 4 42599435
Expanded disability status scale score increased 17.05 14.66 7 21889 447 42598992
Parkinsonism 17.01 14.66 24 21872 10599 42588840
Stoma site hypergranulation 16.99 14.66 6 21890 253 42599186
Cardiac dysfunction 16.89 14.66 14 21882 3385 42596054
Somnambulism 16.84 14.66 14 21882 3401 42596038
Chorea 16.76 14.66 10 21886 1434 42598005
Sepsis 16.62 14.66 50 21846 199284 42400155
Electric shock sensation 16.56 14.66 7 21889 481 42598958
Thrombocytopenia 16.39 14.66 47 21849 190232 42409207
Renal aplasia 16.32 14.66 8 21888 775 42598664
Vomiting 16.32 14.66 85 21811 289638 42309801
Eosinophilic fasciitis 16.28 14.66 5 21891 135 42599304
Device kink 16.26 14.66 7 21889 503 42598936
Faecaloma 16.20 14.66 18 21878 6252 42593187
Mucosal inflammation 15.97 14.66 3 21893 49371 42550068
Dysphonia 15.92 14.66 41 21855 28409 42571030
Anaemia 15.91 14.66 82 21814 280196 42319243
Mental impairment 15.68 14.66 25 21871 12292 42587147
Device loosening 15.41 14.66 5 21891 162 42599277
IVth nerve paresis 14.90 14.66 3 21893 12 42599427

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 839.83 12.15 196 50225 1998 110536880
Dyskinesia 745.22 12.15 395 50026 51051 110487827
On and off phenomenon 542.03 12.15 160 50261 4264 110534614
Hallucination 516.99 12.15 403 50018 101029 110437849
Gambling disorder 494.35 12.15 128 50293 2063 110536815
Hypersexuality 407.12 12.15 107 50314 1833 110537045
Hallucination, visual 328.60 12.15 212 50209 39393 110499485
Compulsive shopping 261.93 12.15 64 50357 804 110538074
Dopamine dysregulation syndrome 255.78 12.15 59 50362 568 110538310
Freezing phenomenon 245.36 12.15 77 50344 2532 110536346
Parkinsonism hyperpyrexia syndrome 214.43 12.15 51 50370 567 110538311
Fall 172.51 12.15 635 49786 602847 109936031
Dystonia 170.56 12.15 120 50301 25685 110513193
Tremor 169.66 12.15 319 50102 201913 110336965
Bradykinesia 167.93 12.15 87 50334 10701 110528177
Restless legs syndrome 159.25 12.15 113 50308 24513 110514365
Jealous delusion 158.75 12.15 38 50383 435 110538443
Muscle rigidity 157.09 12.15 111 50310 23920 110514958
Stereotypy 138.78 12.15 40 50381 977 110537901
Relapsing-remitting multiple sclerosis 137.38 12.15 47 50374 2035 110536843
Stoma site discharge 134.78 12.15 50 50371 2745 110536133
Gambling 130.64 12.15 31 50390 341 110538537
Needle fatigue 130.19 12.15 40 50381 1224 110537654
Pleurothotonus 125.29 12.15 46 50375 2452 110536426
Gait spastic 122.19 12.15 40 50381 1509 110537369
Granuloma skin 120.55 12.15 71 50350 11212 110527666
Hyperkinesia 117.91 12.15 47 50374 3137 110535741
Stoma site erythema 117.45 12.15 42 50379 2075 110536803
Delusion 115.72 12.15 92 50329 23663 110515215
Binge eating 114.42 12.15 31 50390 599 110538279
Blood parathyroid hormone decreased 113.31 12.15 72 50349 13017 110525861
Panniculitis 108.91 12.15 75 50346 15507 110523371
Bronchopulmonary aspergillosis allergic 108.78 12.15 60 50361 8366 110530512
Nocturia 107.63 12.15 77 50344 16913 110521965
Neuroleptic malignant syndrome 107.49 12.15 103 50318 33956 110504922
Total lung capacity decreased 101.14 12.15 54 50367 7060 110531818
Stoma site pain 94.23 12.15 35 50386 1928 110536950
Breath sounds abnormal 94.07 12.15 84 50337 25320 110513558
Systemic lupus erythematosus 92.31 12.15 6 50415 254332 110284546
Blood pressure inadequately controlled 89.43 12.15 51 50370 7582 110531296
Compulsive hoarding 89.28 12.15 17 50404 55 110538823
Febrile neutropenia 89.10 12.15 18 50403 316749 110222129
Psychotic disorder 89.09 12.15 113 50308 50824 110488054
Akinesia 88.68 12.15 40 50381 3627 110535251
Suicidal ideation 87.32 12.15 155 50266 93782 110445096
Pericarditis 86.48 12.15 3 50418 219111 110319767
Monoparesis 86.40 12.15 42 50379 4511 110534367
Drug withdrawal syndrome 85.64 12.15 96 50325 37958 110500920
Skin necrosis 85.39 12.15 74 50347 21438 110517440
Rheumatoid nodule 85.01 12.15 72 50349 20224 110518654
Glossodynia 84.39 12.15 4 50417 222000 110316878
Cognitive disorder 82.11 12.15 145 50276 87366 110451512
Gait disturbance 81.96 12.15 296 50125 277912 110260966
Insomnia 81.50 12.15 353 50068 360237 110178641
Hypertonic bladder 80.34 12.15 42 50379 5260 110533618
Hand deformity 79.75 12.15 5 50416 218501 110320377
Blood calcium increased 77.63 12.15 65 50356 17975 110520903
Pulmonary fibrosis 76.97 12.15 154 50267 101888 110436990
Balance disorder 75.21 12.15 165 50256 116395 110422483
Stomatitis 74.67 12.15 16 50405 270226 110268652
Lung opacity 74.25 12.15 53 50368 11599 110527279
Aspiration 73.86 12.15 80 50341 30453 110508425
Movement disorder 72.12 12.15 86 50335 36318 110502560
Troponin increased 72.02 12.15 78 50343 29688 110509190
Micturition urgency 71.76 12.15 64 50357 19256 110519622
Acute psychosis 71.30 12.15 38 50383 4949 110533929
Neutropenia 68.65 12.15 43 50378 374577 110164301
Somnolence 68.57 12.15 293 50128 297156 110241722
Duodenal ulcer perforation 68.19 12.15 3 50418 177697 110361181
Obsessive-compulsive disorder 68.14 12.15 42 50379 7199 110531679
Orthostatic hypotension 66.36 12.15 113 50308 66136 110472742
Blood test abnormal 65.91 12.15 73 50348 28481 110510397
Camptocormia 65.73 12.15 19 50402 469 110538409
Maternal exposure during pregnancy 64.73 12.15 18 50403 254865 110284013
Sudden onset of sleep 62.86 12.15 20 50401 688 110538190
Parkinsonian gait 62.25 12.15 22 50399 1050 110537828
Torticollis 61.98 12.15 30 50391 3191 110535687
Multiple drug therapy 61.80 12.15 41 50380 7973 110530905
Exercise tolerance decreased 61.49 12.15 48 50373 12019 110526859
Depressed mood 61.28 12.15 104 50317 60705 110478173
Abnormal behaviour 61.10 12.15 82 50339 38957 110499921
Therapeutic product effect variable 60.54 12.15 28 50393 2690 110536188
Sputum discoloured 60.33 12.15 69 50352 27876 110511002
Paraphilia 56.73 12.15 12 50409 74 110538804
Psychomotor hyperactivity 55.95 12.15 57 50364 20220 110518658
Posture abnormal 55.64 12.15 31 50390 4407 110534471
Therapeutic response shortened 55.52 12.15 68 50353 29515 110509363
Drug tolerance decreased 54.45 12.15 65 50356 27475 110511403
Blister 54.23 12.15 18 50403 227358 110311520
Diabetes mellitus inadequate control 53.57 12.15 67 50354 29708 110509170
Central nervous system lesion 52.83 12.15 49 50372 15504 110523374
Impulsive behaviour 52.35 12.15 27 50394 3288 110535590
Ulcer 51.98 12.15 80 50341 43036 110495842
Basal cell carcinoma 51.80 12.15 82 50339 45188 110493690
Hypercalcaemia 51.31 12.15 83 50338 46574 110492304
Restlessness 51.20 12.15 92 50329 56167 110482711
Discomfort 51.20 12.15 17 50404 214690 110324188
Encephalitis toxic 51.03 12.15 14 50407 284 110538594
Liver injury 50.53 12.15 5 50416 150408 110388470
Muscle injury 49.13 12.15 4 50417 140803 110398075
Prescribed underdose 48.71 12.15 98 50323 65076 110473802
Hallucination, tactile 48.36 12.15 18 50403 997 110537881
Ill-defined disorder 48.29 12.15 7 50414 156846 110382032
Oedema peripheral 48.25 12.15 285 50136 328375 110210503
Withdrawal syndrome 47.72 12.15 65 50356 31315 110507563
Delirium 47.03 12.15 152 50269 134873 110404005
Dropped head syndrome 46.68 12.15 15 50406 533 110538345
Condition aggravated 46.66 12.15 526 49895 734310 109804568
Mania 46.00 12.15 52 50369 20744 110518134
Diarrhoea 45.84 12.15 318 50103 1139187 109399691
Erectile dysfunction 45.54 12.15 49 50372 18507 110520371
Suspiciousness 45.52 12.15 16 50405 751 110538127
Blood cholesterol increased 45.17 12.15 14 50407 184771 110354107
Rales 45.03 12.15 56 50365 24683 110514195
Sleep attacks 44.94 12.15 12 50409 219 110538659
Malignant neoplasm progression 44.93 12.15 12 50409 174555 110364323
Abnormal dreams 44.83 12.15 41 50380 12739 110526139
Stoma site infection 44.75 12.15 20 50401 1775 110537103
Pancytopenia 42.80 12.15 21 50400 209592 110329286
Ataxia 42.25 12.15 60 50361 30048 110508830
Pleuritic pain 42.06 12.15 44 50377 16096 110522782
Agitation 41.87 12.15 130 50291 112921 110425957
Reduced facial expression 41.71 12.15 24 50397 3627 110535251
Toxicity to various agents 41.60 12.15 99 50322 480456 110058422
Suicide attempt 41.21 12.15 122 50299 103272 110435606
Delusional disorder, jealous type 40.16 12.15 6 50415 0 110538878
Voyeurism 40.16 12.15 6 50415 0 110538878
Aggression 39.52 12.15 85 50336 59125 110479753
Loss of personal independence in daily activities 39.46 12.15 154 50267 149866 110389012
Swelling 39.35 12.15 62 50359 350979 110187899
Pyrexia 38.94 12.15 245 50176 898020 109640858
Anxiety 38.88 12.15 280 50141 344798 110194080
Dysarthria 38.14 12.15 104 50317 84017 110454861
Hyperthyroidism 37.69 12.15 56 50365 29205 110509673
Injury 37.36 12.15 17 50404 177248 110361630
Musculoskeletal stiffness 36.24 12.15 235 50186 279587 110259291
Medication error 36.13 12.15 118 50303 105248 110433630
Impaired healing 35.43 12.15 23 50398 196694 110342184
Drug dispensed to wrong patient 34.66 12.15 13 50408 736 110538142
Rash 34.50 12.15 226 50195 820738 109718140
Skin ulcer 34.33 12.15 84 50337 63561 110475317
Parkinsonism 33.80 12.15 46 50375 22141 110516737
Pollakiuria 33.67 12.15 67 50354 44128 110494750
Chorea 33.62 12.15 20 50401 3215 110535663
Bronchiectasis 33.62 12.15 60 50361 36433 110502445
Drug eruption 33.51 12.15 75 50346 53584 110485294
Multiple sclerosis relapse 33.39 12.15 72 50349 50168 110488710
Platelet count decreased 32.76 12.15 34 50387 230409 110308469
Nasopharyngitis 32.73 12.15 83 50338 394278 110144600
Product residue present 32.43 12.15 21 50400 3920 110534958
Fibromyalgia 32.14 12.15 19 50402 170890 110367988
Myelosuppression 32.04 12.15 3 50418 94337 110444541
Red blood cell sedimentation rate increased 31.78 12.15 93 50328 78209 110460669
Muscle spasticity 31.75 12.15 58 50363 35857 110503021
Device dislocation 31.64 12.15 54 50367 31650 110507228
Excessive masturbation 31.36 12.15 8 50413 121 110538757
Night sweats 31.25 12.15 11 50410 133972 110404906
Device connection issue 31.14 12.15 14 50407 1260 110537618
Exposure during pregnancy 30.94 12.15 19 50402 167405 110371473
Sleep apnoea syndrome 30.43 12.15 61 50360 40386 110498492
Inappropriate antidiuretic hormone secretion 30.34 12.15 55 50366 33796 110505082
Type 2 diabetes mellitus 30.22 12.15 22 50399 177210 110361668
Bursitis 29.74 12.15 11 50410 129907 110408971
Device issue 29.55 12.15 55 50366 34480 110504398
Hyperphagia 29.51 12.15 19 50402 3512 110535366
Obstructive airways disorder 29.38 12.15 65 50356 46084 110492794
Pneumococcal infection 29.26 12.15 15 50406 1804 110537074
Dementia 29.08 12.15 52 50369 31621 110507257
Malignant polyp 28.81 12.15 8 50413 170 110538708
Constipation 28.79 12.15 269 50152 357517 110181361
Acute kidney injury 28.70 12.15 171 50250 635259 109903619
Transaminases increased 28.37 12.15 78 50343 63312 110475566
Mucosal inflammation 27.99 12.15 5 50416 96136 110442742
Wound 27.62 12.15 40 50381 234397 110304481
Disease progression 27.43 12.15 43 50378 243991 110294887
Marital problem 27.39 12.15 8 50413 205 110538673
Urticaria 27.32 12.15 66 50355 318791 110220087
Stoma site inflammation 27.30 12.15 12 50409 1023 110537855
Resting tremor 27.11 12.15 14 50407 1709 110537169
Joint range of motion decreased 26.75 12.15 11 50410 121821 110417057
Stoma site extravasation 26.59 12.15 9 50412 377 110538501
Infection 26.51 12.15 81 50340 362119 110176759
Snoring 26.24 12.15 23 50398 6761 110532117
Hyperventilation 26.24 12.15 26 50395 8921 110529957
Depressive symptom 25.70 12.15 25 50396 8389 110530489
Irritability 25.68 12.15 63 50358 47746 110491132
Bradycardia 25.52 12.15 139 50282 155378 110383500
Sexually inappropriate behaviour 25.18 12.15 10 50411 661 110538217
C-reactive protein abnormal 24.98 12.15 14 50407 129681 110409197
Compulsive sexual behaviour 24.87 12.15 8 50413 285 110538593
Paranoia 24.87 12.15 40 50381 22334 110516544
Drug-induced liver injury 24.55 12.15 12 50409 120055 110418823
Kleptomania 24.52 12.15 5 50416 25 110538853
Dyspepsia 24.09 12.15 31 50390 190934 110347944
Pituitary haemorrhage 24.04 12.15 8 50413 318 110538560
Nightmare 23.91 12.15 54 50367 38809 110500069
Psoriatic arthropathy 23.74 12.15 33 50388 196728 110342150
Dermatillomania 23.73 12.15 8 50413 331 110538547
Peripheral swelling 23.69 12.15 285 50136 403749 110135129
White blood cell count decreased 23.41 12.15 43 50378 229347 110309531
Neutrophil count decreased 23.37 12.15 13 50408 120928 110417950
Peripheral venous disease 23.18 12.15 5 50416 84112 110454766
Drug interaction 22.77 12.15 337 50084 499846 110039032
Vaccination site bruising 22.73 12.15 4 50417 7 110538871
Sopor 22.73 12.15 51 50370 36495 110502383
Stoma site hypergranulation 22.66 12.15 9 50412 595 110538283
Liver disorder 22.55 12.15 19 50402 142224 110396654
Hallucination, auditory 22.54 12.15 42 50379 26355 110512523
Vaccination site oedema 22.38 12.15 4 50417 8 110538870
Memory impairment 22.27 12.15 160 50261 196784 110342094
Skin neoplasm excision 22.11 12.15 13 50408 2045 110536833
Adrenal insufficiency 21.86 12.15 55 50366 42335 110496543
Arthritis 21.84 12.15 141 50280 167445 110371433
Disturbance in attention 21.76 12.15 70 50351 61925 110476953
Orthostatic intolerance 21.64 12.15 13 50408 2128 110536750
Dysstasia 21.61 12.15 47 50374 32939 110505939
Obsessive-compulsive personality disorder 21.45 12.15 6 50415 131 110538747
Product substitution issue 21.35 12.15 38 50383 23023 110515855
Stoma site reaction 21.27 12.15 8 50413 456 110538422
Autonomic nervous system imbalance 21.17 12.15 19 50402 5761 110533117
Rapid eye movements sleep abnormal 21.16 12.15 7 50414 273 110538605
Pulmonary mass 20.94 12.15 50 50371 37251 110501627
Treatment noncompliance 20.89 12.15 77 50344 72913 110465965
Cardiac arrest 20.87 12.15 36 50385 196717 110342161
Product prescribing error 20.86 12.15 61 50360 51270 110487608
Wound infection 20.72 12.15 9 50412 96456 110442422
Poor quality sleep 20.71 12.15 42 50379 28035 110510843
Deep vein thrombosis 20.60 12.15 20 50401 139867 110399011
Intentional medical device removal by patient 20.57 12.15 8 50413 500 110538378
Stoma site haemorrhage 20.28 12.15 13 50408 2385 110536493
Hypokinesia 20.25 12.15 36 50385 21790 110517088
Verbal abuse 19.95 12.15 7 50414 327 110538551
Vestibular migraine 19.87 12.15 6 50415 173 110538705
Musculoskeletal pain 19.86 12.15 33 50388 182990 110355888
Upper motor neurone lesion 19.75 12.15 7 50414 337 110538541
Thrombocytopenia 19.62 12.15 87 50334 348798 110190080
Libido increased 19.60 12.15 13 50408 2526 110536352
Device kink 19.57 12.15 12 50409 2037 110536841
Speech disorder 19.37 12.15 67 50354 61502 110477376
Vaccination site pruritus 19.15 12.15 4 50417 23 110538855
Neoplasm skin 19.10 12.15 14 50407 3190 110535688
Serum serotonin increased 19.03 12.15 7 50414 375 110538503
Food interaction 19.03 12.15 12 50409 2140 110536738
Obsessive thoughts 18.80 12.15 10 50411 1297 110537581
Dependence 18.75 12.15 13 50408 2716 110536162
Hypervigilance 18.58 12.15 8 50413 649 110538229
Bipolar I disorder 18.38 12.15 12 50409 2271 110536607
Female orgasmic disorder 18.11 12.15 4 50417 31 110538847
Device occlusion 18.05 12.15 28 50393 15157 110523721
Human ehrlichiosis 17.93 12.15 8 50413 707 110538171
Sciatica 17.76 12.15 10 50411 92389 110446489
Dizziness 17.76 12.15 430 49991 697763 109841115
Rash pruritic 17.69 12.15 90 50331 97979 110440899
Epilepsy 17.66 12.15 12 50409 100197 110438681
Anticholinergic syndrome 17.55 12.15 15 50406 4265 110534613
Confusional state 17.29 12.15 305 50116 468375 110070503
Conjunctival discolouration 17.27 12.15 5 50416 124 110538754
Anaphylactic reaction 17.23 12.15 16 50405 114284 110424594
Bone marrow failure 16.86 12.15 3 50418 57845 110481033
Apathy 16.65 12.15 28 50393 16211 110522667
Pulpless tooth 16.47 12.15 3 50418 7 110538871
Behaviour disorder 16.23 12.15 21 50400 9626 110529252
Lower limb fracture 16.23 12.15 7 50414 75341 110463537
Lung hyperinflation 16.22 12.15 11 50410 2218 110536660
Interstitial lung disease 16.18 12.15 24 50397 139310 110399568
Feeling abnormal 16.12 12.15 139 50282 180572 110358306
Hyperadrenocorticism 15.94 12.15 7 50414 596 110538282
Rhinorrhoea 15.92 12.15 14 50407 102652 110436226
Angioedema 15.80 12.15 13 50408 98487 110440391
Therapeutic response unexpected 15.65 12.15 34 50387 23809 110515069
Personality change 15.54 12.15 22 50399 10980 110527898
Stoma site irritation 15.52 12.15 6 50415 369 110538509
Wrong device used 15.36 12.15 4 50417 66 110538812
Hypomania 15.30 12.15 21 50400 10189 110528689
Decreased appetite 15.25 12.15 141 50280 475705 110063173
Deafness 15.21 12.15 36 50385 26673 110512205
Ascites 15.20 12.15 12 50409 92796 110446082
Parkinsonian rest tremor 15.14 12.15 6 50415 394 110538484
Fibroma 15.14 12.15 8 50413 1024 110537854
Nail disorder 14.87 12.15 4 50417 57931 110480947
Fracture 14.76 12.15 34 50387 24754 110514124
Euthanasia 14.51 12.15 5 50416 221 110538657
Blood creatinine increased 14.44 12.15 137 50284 182752 110356126
Product dose omission issue 14.31 12.15 216 50205 321566 110217312
Hiccups 14.29 12.15 23 50398 12846 110526032
Abdominal discomfort 14.28 12.15 113 50308 393745 110145133
Anisomastia 14.25 12.15 3 50418 18 110538860
Rash erythematous 14.15 12.15 10 50411 81822 110457056
Alopecia 14.00 12.15 103 50318 364650 110174228
Stoma site candida 13.98 12.15 3 50418 20 110538858
Hepatocellular injury 13.97 12.15 3 50418 50639 110488239
Osteoarthritis 13.96 12.15 40 50381 182583 110356295
Haemoptysis 13.95 12.15 67 50354 71287 110467591
Neoplasm progression 13.91 12.15 6 50415 64589 110474289
Cholestasis 13.88 12.15 6 50415 64512 110474366
Neurotransmitter level altered 13.85 12.15 3 50418 21 110538857
Coronary artery dissection 13.72 12.15 8 50413 1240 110537638
Contraindicated product prescribed 13.63 12.15 10 50411 2283 110536595
Excessive exercise 13.61 12.15 3 50418 23 110538855
Delusion of replacement 13.54 12.15 5 50416 271 110538607
Blood bilirubin increased 13.52 12.15 9 50412 75963 110462915
Sexual activity increased 13.39 12.15 3 50418 25 110538853
Hypercholesterolaemia 13.36 12.15 13 50408 90824 110448054
Frequent bowel movements 13.33 12.15 8 50413 71382 110467496
Ear infection 13.24 12.15 6 50415 62726 110476152
Middle insomnia 13.19 12.15 29 50392 20473 110518405
Expanded disability status scale score increased 13.14 12.15 7 50414 911 110537967
Sleep-related eating disorder 13.09 12.15 7 50414 918 110537960
Therapeutic response decreased 13.07 12.15 82 50339 96417 110442461
Drug ineffective 13.05 12.15 831 49590 1519709 109019169
Off label use 12.96 12.15 556 49865 1499629 109039249
Cytokine release syndrome 12.96 12.15 8 50413 70298 110468580
Cardiac dysfunction 12.82 12.15 15 50406 6208 110532670
Heat stroke 12.79 12.15 9 50412 1926 110536952
Colitis ulcerative 12.67 12.15 10 50411 77353 110461525
Lung disorder 12.64 12.15 41 50380 180006 110358872
Micturition disorder 12.59 12.15 13 50408 4685 110534193
Colitis 12.50 12.15 17 50404 102306 110436572
Illusion 12.49 12.15 9 50412 1998 110536880
Patient elopement 12.36 12.15 5 50416 347 110538531
Bone erosion 12.29 12.15 3 50418 46368 110492510

FDA Adverse Event Reporting System (Pediatric)

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
Microcephaly 24.12 18.01 6 6 508 113433

Pharmacologic Action:

SourceCodeDescription
ATC N04BC05 NERVOUS SYSTEM
ANTI-PARKINSON DRUGS
DOPAMINERGIC AGENTS
Dopamine agonists
FDA MoA N0000000117 Dopamine Agonists
MeSH PA D000975 Antioxidants
MeSH PA D000978 Antiparkinson Agents
MeSH PA D015259 Dopamine Agents
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D018491 Dopamine Agonists
MeSH PA D018726 Anti-Dyskinesia Agents
MeSH PA D020011 Protective Agents
FDA EPC N0000175768 Nonergot Dopamine Agonist
CHEBI has role CHEBI:35469 antidepressant
CHEBI has role CHEBI:35476 antipsychotic agent
CHEBI has role CHEBI:35480 analgesic
CHEBI has role CHEBI:48407 antiparkinson drug
CHEBI has role CHEBI:48578 radical scavenger
CHEBI has role CHEBI:51065 dopamine agonist
CHEBI has role CHEBI:66956 antidyskinesia agent

Related Drugs by ATC class:

N04BC Dopamine agonists 8 drugs
apomorphinebromocriptinecabergolinedihydroergocryptinepergolidepiribedilropinirolerotigotine

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




🐶 Veterinary Drug Use

None

🐶 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 DISCN TABLET, EXTENDED RELEASE ORAL 8679533 Sept. 8, 2029 TREATMENT OF PARKINSONS DISEASE
0.75MG MIRAPEX ER BOEHRINGER INGELHEIM N022421 Feb. 19, 2010 DISCN TABLET, EXTENDED RELEASE ORAL 8679533 Sept. 8, 2029 TREATMENT OF PARKINSONS DISEASE
1.5MG MIRAPEX ER BOEHRINGER INGELHEIM N022421 Feb. 19, 2010 DISCN TABLET, EXTENDED RELEASE ORAL 8679533 Sept. 8, 2029 TREATMENT OF PARKINSONS DISEASE
2.25MG MIRAPEX ER BOEHRINGER INGELHEIM N022421 June 17, 2011 DISCN TABLET, EXTENDED RELEASE ORAL 8679533 Sept. 8, 2029 TREATMENT OF PARKINSONS DISEASE
3.75MG MIRAPEX ER BOEHRINGER INGELHEIM N022421 June 17, 2011 DISCN TABLET, EXTENDED RELEASE ORAL 8679533 Sept. 8, 2029 TREATMENT OF PARKINSONS DISEASE
3MG MIRAPEX ER BOEHRINGER INGELHEIM N022421 Feb. 19, 2010 DISCN TABLET, EXTENDED RELEASE ORAL 8679533 Sept. 8, 2029 TREATMENT OF PARKINSONS DISEASE
4.5MG MIRAPEX ER BOEHRINGER INGELHEIM N022421 Feb. 19, 2010 DISCN 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
5-hydroxytryptamine receptor 1D GPCR Ki 5.78 PDSP
Beta-2 adrenergic receptor GPCR Ki 4 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
Alpha-2C adrenergic receptor GPCR Ki 7.28 PDSP
D(4) dopamine receptor GPCR AGONIST Ki 9.31 CHEMBL
5-hydroxytryptamine receptor 1B GPCR Ki 5.46 PDSP
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
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
83619PEU5T INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Pramipexole dihydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-8551 TABLET 0.25 mg ORAL ANDA 28 sections
Pramipexole dihydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-8552 TABLET 0.50 mg ORAL ANDA 28 sections
Pramipexole Dihydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-6704 TABLET 0.25 mg ORAL ANDA 21 sections
Pramipexole Dihydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 13668-091 TABLET 0.13 mg ORAL ANDA 21 sections
Pramipexole Dihydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 13668-091 TABLET 0.13 mg ORAL ANDA 21 sections
Pramipexole Dihydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 13668-092 TABLET 0.25 mg ORAL ANDA 21 sections
Pramipexole Dihydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 13668-092 TABLET 0.25 mg ORAL ANDA 21 sections
Pramipexole Dihydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 13668-093 TABLET 0.50 mg ORAL ANDA 21 sections
Pramipexole Dihydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 13668-093 TABLET 0.50 mg ORAL ANDA 21 sections
Pramipexole Dihydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 13668-094 TABLET 1 mg ORAL ANDA 21 sections
Pramipexole Dihydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 13668-094 TABLET 1 mg ORAL ANDA 21 sections
Pramipexole Dihydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 13668-095 TABLET 1.50 mg ORAL ANDA 21 sections
Pramipexole Dihydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 13668-095 TABLET 1.50 mg ORAL ANDA 21 sections
Pramipexole Dihydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 13668-184 TABLET 0.75 mg ORAL ANDA 21 sections
Pramipexole Dihydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 13668-184 TABLET 0.75 mg ORAL ANDA 21 sections
PRAMIPEXOLE DIHYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 16590-409 TABLET 0.50 mg ORAL ANDA 28 sections
Pramipexole Dihydrochloride Human Prescription Drug Label 1 16714-916 TABLET, EXTENDED RELEASE 0.38 mg ORAL ANDA 26 sections
Pramipexole Dihydrochloride Human Prescription Drug Label 1 16714-917 TABLET, EXTENDED RELEASE 0.75 mg ORAL ANDA 26 sections
Pramipexole Dihydrochloride Human Prescription Drug Label 1 16714-918 TABLET, EXTENDED RELEASE 1.50 mg ORAL ANDA 26 sections
Pramipexole Dihydrochloride Human Prescription Drug Label 1 16714-919 TABLET, EXTENDED RELEASE 2.25 mg ORAL ANDA 26 sections
Pramipexole Dihydrochloride Human Prescription Drug Label 1 16714-920 TABLET, EXTENDED RELEASE 3 mg ORAL ANDA 26 sections
Pramipexole Dihydrochloride Human Prescription Drug Label 1 16714-922 TABLET, EXTENDED RELEASE 4.50 mg ORAL ANDA 26 sections
Mirapex HUMAN PRESCRIPTION DRUG LABEL 1 21695-867 TABLET 0.50 mg ORAL NDA 25 sections
pramipexole dihydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 29300-207 TABLET 0.13 mg ORAL ANDA 20 sections
pramipexole dihydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 29300-207 TABLET 0.13 mg ORAL ANDA 20 sections
pramipexole dihydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 29300-208 TABLET 0.25 mg ORAL ANDA 20 sections
pramipexole dihydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 29300-208 TABLET 0.25 mg ORAL ANDA 20 sections
pramipexole dihydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 29300-209 TABLET 0.50 mg ORAL ANDA 20 sections
pramipexole dihydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 29300-209 TABLET 0.50 mg ORAL ANDA 20 sections
pramipexole dihydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 29300-210 TABLET 1 mg ORAL ANDA 20 sections