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

Stem definitionDrug idCAS RN
adamantane derivatives 144 768-94-5

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • amantadine
  • adamantamine
  • adamantanamine
  • adamantylamine
  • amantadine hydrochloride
  • amantidine
  • adamantamine fumarate
  • amantadine HCl
  • amantadine sulfate
An antiviral that is used in the prophylactic or symptomatic treatment of influenza A. It is also used as an antiparkinsonian agent, to treat extrapyramidal reactions, and for postherpetic neuralgia. The mechanisms of its effects in movement disorders are not well understood but probably reflect an increase in synthesis and release of dopamine, with perhaps some inhibition of dopamine uptake.
  • Molecular weight: 151.25
  • Formula: C10H17N
  • CLOGP: 2
  • LIPINSKI: 0
  • HAC: 1
  • HDO: 1
  • TPSA: 26.02
  • ALOGS: -3.25
  • ROTB: 0
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.20 g O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 50 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 85 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 37.78 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 90 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 6.60 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 4.80 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.33 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 16 hours Lombardo F, Berellini G, Obach RS

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 -0.648 High 1
caco2-efflux Caco-2 efflux ratio (BA/AB) 0.509 High 1
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 3.342 10^-6 cm/s High 1
dh-clint Dog hepatocyte intrinsic clearance 2.767 uL/min/10^6 cells High 1
dppb Dog plasma protein binding (% unbound) 75.080 % High 1
fcs-ppb Fetal calf serum protein binding (% unbound) 82.650 % High 1
herg hERG pIC50 4.405 pIC50 High 1
hh-clint Human hepatocyte intrinsic clearance 2.143 uL/min/10^6 cells High 1
hlm-clint Human liver microsomal intrinsic clearance 3.516 uL/min/mg protein High 1
hppb Human plasma protein binding (% unbound) 84.450 % High 1
kinase-safety-class ACVR2B,AKT3,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK4,CDK5,CDK9,DYRK1B,EIF2AK3,ERBB2,GRK2,IRAK4,ITK,MAP3K7,MAPK7,NTRK2,PDK2,PDK4,PIM2,PRKDC,TEK,TGFBR1 25
kinase-selectivity-class EIF2AK3 1
mdck-mdr1-bcrp-efflux MDCK-MDR1-BCRP efflux ratio 0.724 High 1
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 1.019 High 1
mh-clint Mouse hepatocyte intrinsic clearance 10.617 High 1
mppb Mouse plasma protein binding (% unbound) 68.830 High 1
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 0.993 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pld-class Phospholipidosis risk class (1 = positive, 0 = negative) 1 High 1
pppb Pig plasma protein binding (% unbound) 72.040 % High 1
rat-kpuu-brain Rat brain Kpuu 0.469 % High 1
rh-clint Rat hepatocyte intrinsic clearance 7.998 uL/min/10^6 cells High 1
rh-fuinc Rat hepatocyte fraction unbound in incubation 77.370 % High 1
rppb Rat plasma protein binding (% unbound) 87.470 % High 1
solubility-dd Solubility at pH 7.4 in DMSO 809.096 uM High 1

Approvals:

DateAgencyCompanyOrphan
Feb. 14, 1968 FDA ENDO PHARMS

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 627.69 14.22 258 21236 36276 90570677
Hallucination 459.78 14.22 250 21244 65709 90541244
Multiple sclerosis relapse 358.16 14.22 196 21298 52109 90554844
Parkinsonism hyperpyrexia syndrome 329.59 14.22 56 21438 186 90606767
Hallucination, visual 326.17 14.22 142 21352 22950 90584003
On and off phenomenon 306.88 14.22 79 21415 2464 90604489
Fall 294.90 14.22 458 21036 481352 90125601
Stoma site discharge 226.46 14.22 59 21435 1930 90605023
Freezing phenomenon 222.10 14.22 57 21437 1755 90605198
Tremor 199.02 14.22 212 21282 152961 90453992
Multiple sclerosis 178.58 14.22 100 21394 27740 90579213
Neuroleptic malignant syndrome 166.05 14.22 78 21416 15018 90591935
Bradykinesia 162.41 14.22 61 21433 6727 90600226
Dystonia 155.06 14.22 77 21417 16742 90590211
Gait disturbance 142.79 14.22 236 21258 260260 90346693
Balance disorder 141.52 14.22 143 21351 96937 90510016
Muscle rigidity 136.34 14.22 67 21427 14242 90592711
Corneal oedema 130.98 14.22 38 21456 1863 90605090
Stoma site erythema 130.69 14.22 36 21458 1460 90605493
Myoclonus 128.79 14.22 71 21423 19097 90587856
Hyperkinesia 117.47 14.22 35 21459 1884 90605069
Urinary tract infection 116.89 14.22 237 21257 305395 90301558
Psychotic disorder 115.52 14.22 79 21415 31151 90575802
Speech disorder 111.69 14.22 90 21404 45495 90561458
Dysphagia 92.06 14.22 123 21371 112155 90494798
Therapeutic response shortened 87.29 14.22 59 21435 22820 90584133
Akinesia 86.38 14.22 27 21467 1709 90605244
Seizure 84.46 14.22 139 21355 152490 90454463
Stoma site pain 83.08 14.22 25 21469 1392 90605561
Infusion related reaction 79.13 14.22 5 21489 416775 90190178
Delusion 78.77 14.22 46 21448 13794 90593159
Joint swelling 73.51 14.22 15 21479 503285 90103668
Abnormal dreams 68.28 14.22 39 21455 11218 90595735
Rheumatoid arthritis 64.17 14.22 6 21488 362608 90244345
Acute psychosis 64.08 14.22 25 21469 3053 90603900
Hypokinesia 63.53 14.22 42 21452 15655 90591298
Livedo reticularis 61.26 14.22 25 21469 3434 90603519
Dopamine dysregulation syndrome 60.97 14.22 13 21481 173 90606780
Stoma site hypergranulation 60.57 14.22 15 21479 398 90606555
Impulse-control disorder 60.50 14.22 18 21476 964 90605989
Rash 60.41 14.22 60 21434 796040 89810913
Hallucinations, mixed 60.38 14.22 29 21465 5860 90601093
Diarrhoea 59.27 14.22 82 21412 939108 89667845
Cognitive disorder 58.34 14.22 77 21417 69330 90537623
Glossodynia 57.81 14.22 5 21489 321774 90285179
Contraindicated product administered 57.44 14.22 5 21489 320134 90286819
Stoma site infection 56.95 14.22 17 21477 921 90606032
Gaze palsy 55.27 14.22 19 21475 1622 90605331
Stoma site reaction 53.74 14.22 13 21481 312 90606641
Spinal cord haematoma 52.73 14.22 12 21482 219 90606734
Systemic lupus erythematosus 52.36 14.22 11 21483 361885 90245068
Device issue 51.42 14.22 48 21446 29489 90577464
Arthropathy 51.24 14.22 12 21482 366230 90240723
Agitation 51.17 14.22 71 21423 67027 90539926
Wound 51.06 14.22 6 21488 302974 90303979
Choking 50.65 14.22 33 21461 12000 90594953
Abdominal discomfort 50.63 14.22 25 21469 477303 90129650
Orthostatic hypotension 49.17 14.22 55 21439 41772 90565181
Parkinsonism 48.29 14.22 34 21460 14031 90592922
Drug hypersensitivity 48.09 14.22 25 21469 463584 90143369
Dementia 45.88 14.22 41 21453 23820 90583133
Lower respiratory tract infection 44.72 14.22 4 21490 250655 90356298
Generalised tonic-clonic seizure 44.68 14.22 48 21446 34855 90572098
Dysstasia 44.17 14.22 41 21453 25011 90581942
Disorientation 41.88 14.22 52 21442 44062 90562891
Rapid eye movement sleep behaviour disorder 41.80 14.22 11 21483 374 90606579
Device dislocation 41.54 14.22 44 21450 31438 90575515
Therapeutic product effect variable 41.11 14.22 15 21479 1524 90605429
Treatment failure 40.49 14.22 11 21483 303917 90303036
Arthralgia 38.83 14.22 79 21415 778443 89828510
Somnolence 38.45 14.22 123 21371 208961 90397992
Stomatitis 38.41 14.22 9 21485 274689 90332264
Stoma site inflammation 38.35 14.22 12 21482 762 90606191
Relapsing-remitting multiple sclerosis 37.97 14.22 12 21482 787 90606166
Nasopharyngitis 37.89 14.22 25 21469 407079 90199874
Nightmare 37.23 14.22 35 21459 21690 90585263
Aspiration 36.35 14.22 30 21464 15663 90591290
Corneal decompensation 35.84 14.22 7 21487 58 90606895
Cerebral atrophy 35.42 14.22 20 21474 5626 90601327
Urinary incontinence 35.21 14.22 44 21450 37522 90569431
Peroneal nerve palsy 35.09 14.22 20 21474 5728 90601225
Head injury 34.94 14.22 40 21454 31148 90575805
Wheezing 34.91 14.22 7 21487 238073 90368880
Paratonia 34.85 14.22 6 21488 22 90606931
Drug intolerance 34.72 14.22 33 21461 447558 90159395
Blister 34.39 14.22 9 21485 254989 90351964
Parkinson's disease 34.31 14.22 12 21482 1078 90605875
Delirium 34.08 14.22 76 21418 104283 90502670
Hepatic enzyme increased 33.77 14.22 22 21472 360714 90246239
Irritable bowel syndrome 32.81 14.22 5 21489 207443 90399510
Withdrawal syndrome 32.45 14.22 33 21461 22491 90584462
Alopecia 32.37 14.22 42 21452 495029 90111924
Abnormal behaviour 32.32 14.22 33 21461 22595 90584358
Psychotic symptom 32.24 14.22 14 21480 2242 90604711
Tardive dyskinesia 32.02 14.22 24 21470 10906 90596047
Sinusitis 32.01 14.22 21 21473 343067 90263886
Hypophagia 31.95 14.22 41 21453 35896 90571057
Type 2 diabetes mellitus 31.92 14.22 5 21489 203239 90403714
Device occlusion 30.85 14.22 22 21472 9260 90597693
Pneumonia aspiration 30.72 14.22 43 21451 40897 90566056
Fibromyalgia 30.37 14.22 6 21488 206263 90400690
Lymphopenia 30.23 14.22 32 21462 22849 90584104
Swelling 30.11 14.22 33 21461 419025 90187928
Posture abnormal 29.78 14.22 14 21480 2697 90604256
Stoma site extravasation 29.49 14.22 8 21486 306 90606647
Device kink 29.24 14.22 13 21481 2202 90604751
Stoma site odour 28.87 14.22 6 21488 70 90606883
Mutism 28.67 14.22 12 21482 1757 90605196
Parkinsonian gait 28.59 14.22 9 21485 583 90606370
Stoma site irritation 28.54 14.22 8 21486 346 90606607
Injury 28.52 14.22 6 21488 197343 90409610
Death 27.58 14.22 194 21300 456357 90150596
Motor dysfunction 27.39 14.22 28 21466 19202 90587751
Dysarthria 26.64 14.22 47 21447 54435 90552518
Encephalopathy 26.60 14.22 43 21451 46401 90560552
Sleep talking 26.44 14.22 10 21484 1123 90605830
Progressive multifocal leukoencephalopathy 26.40 14.22 25 21469 15630 90591323
Muscle spasticity 26.36 14.22 37 21457 35285 90571668
Loss of consciousness 26.22 14.22 83 21411 140155 90466798
Urticaria 25.50 14.22 22 21472 312712 90294241
Hypersensitivity 25.40 14.22 43 21451 454634 90152319
Discomfort 25.30 14.22 17 21477 274318 90332635
Maternal exposure during pregnancy 25.15 14.22 29 21465 360034 90246919
Resting tremor 25.06 14.22 9 21485 874 90606079
Stoma site haemorrhage 24.82 14.22 10 21484 1328 90605625
Gastrointestinal complication associated with device 24.38 14.22 4 21490 10 90606943
Central nervous system lesion 24.37 14.22 21 21473 11625 90595328
Hypernatraemia 23.97 14.22 19 21475 9368 90597585
Hip fracture 23.72 14.22 34 21460 33043 90573910
Extrapyramidal disorder 23.69 14.22 24 21470 16279 90590674
Lymphocyte count decreased 23.64 14.22 35 21459 35015 90571938
Secondary progressive multiple sclerosis 23.23 14.22 10 21484 1569 90605384
Aggression 23.04 14.22 30 21464 26638 90580315
Liver injury 23.03 14.22 6 21488 170561 90436392
Device leakage 22.93 14.22 19 21475 9972 90596981
Vitamin B6 deficiency 22.80 14.22 6 21488 204 90606749
Stoma site candida 22.76 14.22 4 21490 17 90606936
Movement disorder 22.55 14.22 31 21463 28988 90577965
Nocturia 22.50 14.22 19 21475 10236 90596717
Compulsive shopping 22.43 14.22 8 21486 761 90606192
Impaired healing 22.29 14.22 14 21480 234185 90372768
Hallucination, auditory 22.28 14.22 23 21471 15952 90591001
Feeding disorder 22.26 14.22 24 21470 17488 90589465
Polyneuropathy 21.99 14.22 25 21469 19316 90587637
Pain 21.68 14.22 143 21351 996198 89610755
Exposure during pregnancy 21.68 14.22 15 21479 238395 90368558
Drug withdrawal syndrome 21.30 14.22 30 21464 28693 90578260
Sensory disturbance 21.15 14.22 22 21472 15391 90591562
Osteoarthritis 21.10 14.22 10 21484 195720 90411233
Autonomic nervous system imbalance 21.05 14.22 12 21482 3438 90603515
Camptocormia 20.82 14.22 6 21488 287 90606666
Fibroma 20.58 14.22 8 21486 968 90605985
Febrile neutropenia 20.57 14.22 6 21488 158343 90448610
Chorea 20.45 14.22 10 21484 2100 90604853
Wheelchair user 20.40 14.22 16 21478 7769 90599184
Tongue biting 20.35 14.22 10 21484 2123 90604830
Psoriasis 20.33 14.22 5 21489 147749 90459204
Unevaluable event 20.26 14.22 42 21452 54806 90552147
Stridor 19.82 14.22 13 21481 4780 90602173
Psychiatric symptom 19.46 14.22 15 21479 7103 90599850
Pruritus 19.26 14.22 65 21429 541460 90065493
Dehydration 19.11 14.22 94 21400 194353 90412600
Depression 18.87 14.22 129 21365 300472 90306481
Asthma 18.58 14.22 18 21476 242142 90364811
Compulsive hoarding 18.50 14.22 4 21490 57 90606896
Periorbital haematoma 18.35 14.22 7 21487 804 90606149
Intentional product use issue 17.99 14.22 15 21479 216877 90390076
Mental impairment 17.98 14.22 21 21473 16699 90590254
Dizziness 17.93 14.22 216 21278 589068 90017885
Infection 17.78 14.22 37 21457 362057 90244896
Tension 17.74 14.22 11 21483 3671 90603282
Memory impairment 17.74 14.22 93 21401 197151 90409802
Product use issue 17.68 14.22 32 21462 329887 90277066
Basal ganglia infarction 17.62 14.22 6 21488 498 90606455
Immune reconstitution inflammatory syndrome 17.48 14.22 14 21480 7005 90599948
Deep brain stimulation 17.23 14.22 4 21490 80 90606873
Influenza like illness 17.21 14.22 50 21444 80561 90526392
Nystagmus 17.12 14.22 14 21480 7213 90599740
Cornea verticillata 17.08 14.22 5 21489 253 90606700
Urosepsis 16.98 14.22 23 21471 21209 90585744
Device connection issue 16.96 14.22 7 21487 989 90605964
Constipation 16.81 14.22 119 21375 280276 90326677
Vomiting 16.69 14.22 114 21380 788179 89818774
Hyporesponsive to stimuli 16.69 14.22 8 21486 1609 90605344
Therapeutic product effect decreased 16.66 14.22 25 21469 277546 90329407
Nausea 16.60 14.22 176 21318 1110140 89496813
Hyperthermia 16.47 14.22 16 21478 10319 90596634
Serotonin syndrome 16.39 14.22 31 21463 37856 90569097
Abdominal wall wound 16.38 14.22 4 21490 100 90606853
Hypersexuality 16.34 14.22 6 21488 620 90606333
Muscular weakness 16.27 14.22 94 21400 206572 90400381
Malnutrition 16.22 14.22 21 21473 18537 90588416
Rib fracture 15.86 14.22 25 21469 26410 90580543
Depressed mood 15.74 14.22 36 21458 50186 90556767
Confusional state 15.66 14.22 150 21344 386055 90220898
Asthenia 15.52 14.22 194 21300 533557 90073396
Optic neuritis 15.46 14.22 15 21479 9663 90597290
Hospice care 15.42 14.22 15 21479 9689 90597264
Corneal endothelial cell loss 15.35 14.22 3 21491 25 90606928
Blood cholesterol increased 15.34 14.22 16 21478 207996 90398957
Neurotoxicity 15.30 14.22 22 21472 21445 90585508
Dysgraphia 15.25 14.22 10 21484 3673 90603280
Fractured coccyx 15.23 14.22 7 21487 1280 90605673
Progressive multiple sclerosis 15.20 14.22 7 21487 1287 90605666
Corneal endotheliitis 15.04 14.22 3 21491 28 90606925
Premature menopause 15.02 14.22 7 21487 1322 90605631
Pleurothotonus 14.99 14.22 7 21487 1328 90605625
Corneal disorder 14.92 14.22 8 21486 2034 90604919
Intentional underdose 14.90 14.22 8 21486 2041 90604912
Acute respiratory failure 14.84 14.22 32 21462 42886 90564067
Neutropenia 14.76 14.22 19 21475 224885 90382068
Decubitus ulcer 14.68 14.22 16 21478 11797 90595156
Eye movement disorder 14.67 14.22 12 21482 6186 90600767
Dementia with Lewy bodies 14.55 14.22 5 21489 426 90606527
Product dosage form issue 14.51 14.22 3 21491 34 90606919
Vision blurred 14.37 14.22 58 21436 110235 90496718
Urine analysis abnormal 14.27 14.22 11 21483 5210 90601743
Dyspnoea 14.24 14.22 137 21357 880818 89726135
Progressive supranuclear palsy 14.23 14.22 4 21490 175 90606778

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
Hallucination 557.18 16.37 327 17259 57180 42546569
Dyskinesia 545.67 16.37 247 17339 25143 42578606
On and off phenomenon 489.94 16.37 137 17449 3330 42600419
Hallucination, visual 281.10 16.37 148 17438 20872 42582877
Freezing phenomenon 245.76 16.37 70 17516 1819 42601930
Dopamine dysregulation syndrome 186.25 16.37 44 17542 529 42603220
Fall 185.73 16.37 340 17246 234180 42369569
Gait disturbance 173.91 16.37 208 17378 97792 42505957
Bradykinesia 166.36 16.37 68 17518 5368 42598381
Muscle rigidity 161.40 16.37 85 17501 11974 42591775
Speech disorder 139.24 16.37 107 17479 29014 42574735
Cerebral hypoperfusion 137.23 16.37 39 17547 1004 42602745
Tremor 126.80 16.37 177 17409 96752 42506997
Hyperkinesia 125.85 16.37 43 17543 2055 42601694
Delusion 122.18 16.37 76 17510 14658 42589091
Stoma site discharge 119.72 16.37 38 17548 1438 42602311
Hypersexuality 118.41 16.37 39 17547 1663 42602086
Neuroleptic malignant syndrome 113.96 16.37 84 17502 21388 42582361
Stoma site erythema 103.03 16.37 31 17555 979 42602770
Balance disorder 97.58 16.37 109 17477 47536 42556213
Gambling disorder 97.23 16.37 34 17552 1742 42602007
Dystonia 96.12 16.37 62 17524 12728 42591021
Impulse-control disorder 93.37 16.37 32 17554 1543 42602206
Device dislocation 93.00 16.37 51 17535 7780 42595969
Agitation 90.91 16.37 122 17464 64192 42539557
Parkinsonism hyperpyrexia syndrome 88.18 16.37 22 17564 337 42603412
Confusional state 83.12 16.37 201 17385 167396 42436353
Stoma site pain 74.87 16.37 23 17563 780 42602969
Delirium 73.24 16.37 99 17487 52420 42551329
Aggression 72.12 16.37 90 17496 44073 42559676
Illusion 69.26 16.37 23 17563 1006 42602743
Multiple sclerosis 67.58 16.37 41 17545 7557 42596192
Corneal oedema 63.69 16.37 24 17562 1524 42602225
Myoclonus 63.11 16.37 54 17532 17011 42586738
Multiple sclerosis relapse 62.92 16.37 50 17536 14214 42589535
Psychotic disorder 61.80 16.37 68 17518 29140 42574609
Binocular eye movement disorder 61.71 16.37 16 17570 288 42603461
Febrile neutropenia 60.96 16.37 4 17582 185699 42418050
Diarrhoea 60.28 16.37 61 17525 460788 42142961
Mobility decreased 56.11 16.37 71 17515 35235 42568514
Embedded device 55.78 16.37 16 17570 426 42603323
Stoma site infection 55.08 16.37 19 17567 934 42602815
Abnormal dreams 54.63 16.37 37 17549 8234 42595515
Nocturia 54.59 16.37 43 17543 12069 42591680
Hypersomnia 53.53 16.37 46 17540 14572 42589177
Somnolence 53.30 16.37 153 17433 140952 42462797
Serotonin syndrome 52.66 16.37 59 17527 25786 42577963
Akinesia 49.70 16.37 23 17563 2449 42601300
Stoma site inflammation 48.54 16.37 15 17571 519 42603230
Abnormal behaviour 48.20 16.37 57 17529 26394 42577355
Feeling cold 47.86 16.37 41 17545 12932 42590817
Therapeutic product effect variable 47.59 16.37 24 17562 3085 42600664
Neutropenia 47.32 16.37 12 17574 199419 42404330
Stoma site reaction 46.76 16.37 13 17573 308 42603441
Parkinsonism 46.34 16.37 37 17549 10586 42593163
Reduced facial expression 46.29 16.37 19 17567 1514 42602235
Posture abnormal 46.19 16.37 22 17564 2499 42601250
Cerebellar stroke 45.93 16.37 15 17571 622 42603127
Cognitive disorder 43.99 16.37 62 17524 34110 42569639
Pneumonia aspiration 42.43 16.37 75 17511 50003 42553746
Memory impairment 42.28 16.37 75 17511 50147 42553602
Paranoia 41.23 16.37 39 17547 13987 42589762
Dementia 39.50 16.37 41 17545 16439 42587310
Anaemia 37.81 16.37 36 17550 280242 42323507
Gambling 37.48 16.37 10 17576 202 42603547
Constipation 37.33 16.37 149 17437 162142 42441607
Pancytopenia 37.29 16.37 3 17583 117740 42486009
Deep brain stimulation 36.71 16.37 7 17579 26 42603723
Device connection issue 36.06 16.37 12 17574 528 42603221
Parkinson's disease 35.26 16.37 15 17571 1307 42602442
Fibroma 34.96 16.37 11 17575 404 42603345
Compulsive shopping 33.83 16.37 11 17575 450 42603299
Middle insomnia 33.56 16.37 27 17559 7806 42595943
Device issue 33.08 16.37 34 17552 13475 42590274
Dysphagia 32.56 16.37 84 17502 72635 42531114
Rash 32.44 16.37 40 17546 276914 42326835
Tension 31.91 16.37 17 17569 2447 42601302
Platelet count decreased 31.61 16.37 9 17577 138572 42465177
Male sexual dysfunction 31.41 16.37 10 17576 382 42603367
Thrombocytopenia 31.26 16.37 20 17566 190259 42413490
Drug withdrawal syndrome 30.59 16.37 41 17545 21508 42582241
Motor dysfunction 30.57 16.37 26 17560 8120 42595629
Dysarthria 30.40 16.37 57 17529 39750 42563999
Choking 29.76 16.37 23 17563 6275 42597474
Anticholinergic syndrome 29.52 16.37 14 17572 1575 42602174
Rapid eye movements sleep abnormal 29.51 16.37 8 17578 172 42603577
Disturbance in attention 28.28 16.37 47 17539 29819 42573930
Bedridden 27.97 16.37 19 17567 4246 42599503
Sensory disturbance 27.56 16.37 23 17563 7000 42596749
Movement disorder 27.31 16.37 32 17554 14666 42589083
Dysphonia 27.24 16.37 45 17541 28405 42575344
Hyporesponsive to stimuli 26.83 16.37 13 17573 1533 42602216
Urinary tract infection 26.81 16.37 96 17490 99188 42504561
Malignant neoplasm progression 26.72 16.37 6 17580 108394 42495355
Intentional medical device removal by patient 26.40 16.37 9 17577 427 42603322
Restlessness 26.32 16.37 45 17541 29204 42574545
Saccadic eye movement 25.42 16.37 7 17579 160 42603589
Acute kidney injury 25.41 16.37 73 17513 367264 42236485
Depression 25.38 16.37 102 17484 111261 42492488
Musculoskeletal stiffness 25.11 16.37 66 17520 57699 42546050
Device kink 25.02 16.37 9 17577 501 42603248
Somatic delusion 24.04 16.37 6 17580 92 42603657
Psychomotor hyperactivity 24.02 16.37 26 17560 10932 42592817
Micturition urgency 23.95 16.37 27 17559 11871 42591878
Withdrawal syndrome 23.92 16.37 30 17556 14745 42589004
Parkinsonian gait 23.86 16.37 9 17577 573 42603176
Hallucination, tactile 23.77 16.37 9 17577 579 42603170
Feeling abnormal 23.76 16.37 73 17513 69713 42534036
Persecutory delusion 23.67 16.37 16 17570 3548 42600201
Insomnia 23.59 16.37 104 17482 118149 42485600
Autonomic nervous system imbalance 23.14 16.37 15 17571 3101 42600648
Sleep talking 23.07 16.37 9 17577 628 42603121
Hyperkalaemia 23.01 16.37 3 17583 80455 42523294
Disorientation 22.83 16.37 48 17538 36341 42567408
Therapeutic response shortened 22.71 16.37 28 17558 13526 42590223
Unevaluable event 22.42 16.37 46 17540 34242 42569507
Stoma site hypergranulation 22.38 16.37 7 17579 252 42603497
Progressive supranuclear palsy 22.00 16.37 5 17581 50 42603699
Anxiety 21.95 16.37 102 17484 118458 42485291
Hallucinations, mixed 21.81 16.37 15 17571 3420 42600329
General symptom 21.64 16.37 10 17576 1061 42602688
Parkinsonian rest tremor 20.70 16.37 7 17579 324 42603425
White blood cell count decreased 20.42 16.37 10 17576 110386 42493363
Dysstasia 20.29 16.37 27 17559 14059 42589690
Mental status changes 20.25 16.37 50 17536 42065 42561684
Stoma site oedema 20.02 16.37 4 17582 20 42603729
Depressed mood 19.77 16.37 35 17551 23349 42580400
Dyspnoea 19.69 16.37 105 17481 442516 42161233
Device use issue 19.30 16.37 9 17577 974 42602775
Jealous delusion 19.18 16.37 7 17579 406 42603343
Soft tissue mass 19.06 16.37 9 17577 1003 42602746
Tic 19.01 16.37 12 17574 2371 42601378
Band neutrophil percentage increased 18.69 16.37 5 17581 102 42603647
Prescribed underdose 18.46 16.37 22 17564 10260 42593489
Nasal discomfort 17.95 16.37 10 17576 1572 42602177
Facial paresis 17.88 16.37 13 17573 3237 42600512
Frustration tolerance decreased 17.75 16.37 13 17573 3273 42600476
Catatonia 17.67 16.37 17 17569 6222 42597527
Stoma site odour 17.51 16.37 4 17582 41 42603708
Hyperammonaemic encephalopathy 17.41 16.37 12 17574 2746 42601003
Stoma site induration 17.17 16.37 4 17582 45 42603704
Underdose 16.82 16.37 27 17559 16639 42587110
Cogwheel rigidity 16.74 16.37 10 17576 1791 42601958
Drooling 16.70 16.37 14 17572 4285 42599464
Pruritus 16.61 16.37 33 17553 188738 42415011
Injection site necrosis 16.60 16.37 7 17579 597 42603152
Sepsis 16.57 16.37 36 17550 199298 42404451
Gait inability 16.57 16.37 32 17554 22801 42580948
Gastrointestinal haemorrhage 16.41 16.37 10 17576 97716 42506033
Sexually inappropriate behaviour 16.39 16.37 7 17579 616 42603133
Impulsive behaviour 16.37 16.37 11 17575 2414 42601335

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
Dyskinesia 982.35 13.46 414 31408 51032 110506445
Hallucination 796.52 13.46 444 31378 100988 110456489
On and off phenomenon 610.24 13.46 159 31663 4265 110553212
Hallucination, visual 540.54 13.46 252 31570 39353 110518124
Parkinsonism hyperpyrexia syndrome 396.80 13.46 78 31744 540 110556937
Fall 382.54 13.46 648 31174 602834 109954643
Freezing phenomenon 356.08 13.46 93 31729 2516 110554961
Multiple sclerosis relapse 291.34 13.46 181 31641 50059 110507418
Neuroleptic malignant syndrome 272.08 13.46 151 31671 33908 110523569
Tremor 259.41 13.46 305 31517 201927 110355550
Stoma site discharge 248.00 13.46 71 31751 2724 110554753
Bradykinesia 229.82 13.46 94 31728 10694 110546783
Dystonia 218.75 13.46 119 31703 25686 110531791
Muscle rigidity 218.21 13.46 116 31706 23915 110533562
Dopamine dysregulation syndrome 214.66 13.46 47 31775 580 110556897
Hyperkinesia 208.75 13.46 64 31758 3120 110554357
Corneal oedema 200.50 13.46 62 31760 3111 110554366
Gait disturbance 193.32 13.46 312 31510 277896 110279581
Myoclonus 191.56 13.46 119 31703 32879 110524598
Psychotic disorder 177.41 13.46 134 31688 50803 110506674
Balance disorder 158.01 13.46 181 31641 116379 110441098
Impulse-control disorder 156.24 13.46 47 31775 2147 110555330
Multiple sclerosis 155.06 13.46 95 31727 25603 110531874
Stoma site erythema 149.25 13.46 45 31777 2072 110555405
Agitation 145.61 13.46 171 31651 112880 110444597
Delusion 143.80 13.46 88 31734 23667 110533810
Speech disorder 129.36 13.46 121 31701 61448 110496029
Serotonin syndrome 127.66 13.46 118 31704 59035 110498442
Hypersexuality 118.75 13.46 37 31785 1903 110555574
Stoma site pain 114.15 13.46 36 31786 1927 110555550
Akinesia 110.14 13.46 41 31781 3626 110553851
Urinary tract infection 106.42 13.46 267 31555 326015 110231462
Gambling disorder 102.23 13.46 34 31788 2157 110555320
Delirium 101.32 13.46 157 31665 134868 110422609
Abnormal dreams 97.50 13.46 55 31767 12725 110544752
Stoma site infection 96.47 13.46 31 31791 1764 110555713
Dysphagia 92.84 13.46 162 31660 153438 110404039
Therapeutic response shortened 92.45 13.46 73 31749 29510 110527967
Aggression 88.85 13.46 97 31725 59113 110498364
Device dislocation 88.00 13.46 73 31749 31631 110525846
Seizure 85.02 13.46 193 31629 220992 110336485
Infusion related reaction 83.58 13.46 7 31815 381155 110176322
Diarrhoea 82.03 13.46 126 31696 1139379 109418098
Parkinsonism 76.41 13.46 58 31764 22129 110535348
Somnolence 75.47 13.46 222 31600 297227 110260250
Abnormal behaviour 74.92 13.46 73 31749 38966 110518511
Joint swelling 74.39 13.46 18 31804 442827 110114650
Rheumatoid arthritis 73.25 13.46 3 31819 299610 110257867
Pneumonia aspiration 70.28 13.46 101 31721 81132 110476345
Cognitive disorder 70.21 13.46 105 31717 87406 110470071
Dementia 69.90 13.46 64 31758 31609 110525868
Therapeutic product effect variable 69.42 13.46 27 31795 2691 110554786
Hallucinations, mixed 67.91 13.46 38 31784 8655 110548822
Rash 67.84 13.46 82 31740 820882 109736595
Drug withdrawal syndrome 67.18 13.46 68 31754 37986 110519491
Confusional state 64.98 13.46 287 31535 468393 110089084
Acute psychosis 62.65 13.46 30 31792 4957 110552520
Illusion 62.33 13.46 23 31799 1984 110555493
Febrile neutropenia 61.42 13.46 9 31813 316758 110240719
Drug hypersensitivity 61.26 13.46 27 31795 454063 110103414
Stoma site hypergranulation 56.54 13.46 16 31806 588 110556889
Stoma site reaction 55.96 13.46 15 31807 449 110557028
Hypokinesia 55.93 13.46 48 31774 21778 110535699
Device issue 54.29 13.46 58 31764 34477 110523000
Disorientation 54.13 13.46 83 31739 70588 110486889
Contraindicated product administered 53.21 13.46 5 31817 248262 110309215
Withdrawal syndrome 51.64 13.46 54 31768 31326 110526151
Pericarditis 50.97 13.46 3 31819 219111 110338366
Neutropenia 50.95 13.46 22 31800 374598 110182879
Compulsive shopping 50.81 13.46 16 31806 852 110556625
Arthropathy 49.62 13.46 11 31811 287511 110269966
Stomatitis 49.43 13.46 9 31813 270233 110287244
Parkinson's disease 49.14 13.46 18 31804 1521 110555956
Glossodynia 48.86 13.46 4 31818 222000 110335477
Livedo reticularis 48.34 13.46 26 31796 5480 110551997
Dysstasia 45.96 13.46 52 31770 32934 110524543
Stoma site odour 45.92 13.46 10 31812 120 110557357
Generalised tonic-clonic seizure 45.85 13.46 67 31755 54613 110502864
Hypersomnia 45.66 13.46 48 31774 28013 110529464
Swelling 45.58 13.46 22 31800 351019 110206458
Death 45.40 13.46 350 31472 698519 109858958
Systemic lupus erythematosus 45.39 13.46 9 31813 254329 110303148
Paranoia 45.12 13.46 43 31779 22331 110535146
Device connection issue 44.79 13.46 16 31806 1258 110556219
Arthralgia 44.60 13.46 99 31723 779533 109777944
Stoma site inflammation 44.09 13.46 15 31807 1020 110556457
Wheezing 43.57 13.46 10 31812 255220 110302257
Rapid eye movement sleep behaviour disorder 42.55 13.46 13 31809 626 110556851
Posture abnormal 41.91 13.46 22 31800 4416 110553061
Autonomic nervous system imbalance 41.74 13.46 24 31798 5756 110551721
Orthostatic hypotension 41.47 13.46 71 31751 66178 110491299
Sleep talking 41.11 13.46 15 31807 1253 110556224
Nasopharyngitis 41.07 13.46 32 31790 394329 110163148
Cerebral atrophy 41.02 13.46 28 31794 9057 110548420
Choking 40.29 13.46 34 31788 15076 110542401
Resting tremor 40.09 13.46 16 31806 1707 110555770
Mental status changes 39.26 13.46 75 31747 76047 110481430
Abdominal discomfort 38.50 13.46 34 31788 393824 110163653
Urticaria 38.41 13.46 22 31800 318835 110238642
Rapid eye movements sleep abnormal 38.29 13.46 10 31812 270 110557207
Deep brain stimulation 38.16 13.46 8 31814 79 110557398
Drug intolerance 37.49 13.46 37 31785 406475 110151002
Encephalopathy 37.14 13.46 76 31746 80979 110476498
Urinary incontinence 37.12 13.46 57 31765 48530 110508947
Male sexual dysfunction 36.94 13.46 10 31812 311 110557166
Motor dysfunction 36.63 13.46 40 31782 24366 110533111
Unevaluable event 36.44 13.46 63 31759 59164 110498313
Alopecia 36.24 13.46 31 31791 364722 110192755
Parkinsonian gait 35.95 13.46 13 31809 1059 110556418
Hyperthermia 35.71 13.46 37 31785 21235 110536242
Progressive supranuclear palsy 35.52 13.46 9 31813 215 110557262
Stoma site extravasation 35.11 13.46 10 31812 376 110557101
Tardive dyskinesia 35.07 13.46 30 31792 13549 110543928
Nightmare 34.60 13.46 49 31773 38814 110518663
Irritable bowel syndrome 33.41 13.46 4 31818 164211 110393266
Pruritus 33.10 13.46 74 31748 581486 109975991
Fibromyalgia 32.78 13.46 5 31817 170904 110386573
Pancytopenia 32.39 13.46 10 31812 209603 110347874
Sensory disturbance 32.33 13.46 32 31790 17397 110540080
Hip fracture 32.30 13.46 45 31777 35106 110522371
Type 2 diabetes mellitus 32.19 13.46 6 31816 177226 110380251
Treatment failure 32.16 13.46 20 31802 277214 110280263
Lower respiratory tract infection 31.90 13.46 15 31807 243091 110314386
Wound 31.49 13.46 14 31808 234423 110323054
Middle insomnia 31.46 13.46 34 31788 20468 110537009
Blister 31.46 13.46 13 31809 227363 110330114
Reduced facial expression 31.38 13.46 17 31805 3634 110553843
Nocturia 31.16 13.46 31 31791 16959 110540518
Dyspnoea 31.13 13.46 189 31633 1106683 109450794
Gambling 30.99 13.46 9 31813 363 110557114
Paratonia 30.98 13.46 6 31816 38 110557439
Hallucination, auditory 30.79 13.46 38 31784 26359 110531118
Dysarthria 30.73 13.46 72 31750 84049 110473428
Hypersensitivity 30.57 13.46 43 31779 403955 110153522
Psychotic symptom 30.47 13.46 17 31805 3850 110553627
Persecutory delusion 29.86 13.46 20 31802 6271 110551206
Movement disorder 29.64 13.46 44 31778 36360 110521117
Depressed mood 29.03 13.46 58 31764 60751 110496726
Nausea 28.81 13.46 223 31599 1235467 109322010
Neurotoxicity 28.77 13.46 47 31775 42160 110515317
Hypophagia 28.56 13.46 53 31769 52573 110504904
Pain 28.46 13.46 160 31662 954795 109602682
Mutism 28.17 13.46 15 31807 3098 110554379
Vomiting 28.00 13.46 151 31671 910524 109646953
Osteoarthritis 27.70 13.46 9 31813 182614 110374863
Relapsing-remitting multiple sclerosis 27.61 13.46 13 31809 2069 110555408
Platelet count decreased 27.60 13.46 16 31806 230427 110327050
Malignant neoplasm progression 27.56 13.46 8 31814 174559 110382918
Embedded device 27.14 13.46 16 31806 4017 110553460
Psychomotor hyperactivity 26.62 13.46 31 31791 20246 110537231
Device occlusion 26.55 13.46 27 31795 15158 110542319
Postural reflex impairment 26.50 13.46 5 31817 27 110557450
Saccadic eye movement 26.33 13.46 7 31815 203 110557274
Mania 25.99 13.46 31 31791 20765 110536712
Stereotypy 25.61 13.46 10 31812 1007 110556470
Head injury 25.48 13.46 45 31777 42972 110514505
Stoma site oedema 25.34 13.46 6 31816 107 110557370
Constipation 25.32 13.46 183 31639 357603 110199874
Feeding disorder 25.32 13.46 31 31791 21331 110536146
Anxiety 25.29 13.46 178 31644 344900 110212577
Catatonia 25.25 13.46 23 31799 11277 110546200
Restlessness 24.89 13.46 52 31770 56207 110501270
Disturbance in attention 24.79 13.46 55 31767 61940 110495537
Intentional product use issue 24.70 13.46 21 31801 247885 110309592
Headache 24.60 13.46 151 31671 882226 109675251
Secondary progressive multiple sclerosis 24.58 13.46 11 31811 1558 110555919
Camptocormia 24.48 13.46 8 31814 480 110556997
Hepatic enzyme increased 24.42 13.46 34 31788 320858 110236619
Discomfort 24.20 13.46 16 31806 214691 110342786
Blood creatine phosphokinase increased 23.96 13.46 60 31762 73017 110484460
Inflammation 23.74 13.46 13 31809 193225 110364252
Anticholinergic syndrome 23.73 13.46 15 31807 4265 110553212
Stoma site induration 23.70 13.46 5 31817 51 110557426
Extrapyramidal disorder 23.66 13.46 35 31787 28832 110528645
Night sweats 23.36 13.46 5 31817 133978 110423499
Psychiatric symptom 23.07 13.46 20 31802 9193 110548284
Asthma 22.81 13.46 23 31799 250268 110307209
Maternal exposure during pregnancy 22.57 13.46 24 31798 254859 110302618
Peroneal nerve palsy 22.53 13.46 18 31804 7396 110550081
Decubitus ulcer 22.48 13.46 27 31795 18209 110539268
Joint range of motion decreased 22.39 13.46 4 31818 121828 110435649
Behaviour disorder 22.28 13.46 20 31802 9627 110547850
Impulsive behaviour 21.91 13.46 13 31809 3302 110554175
Parkinsonian rest tremor 21.87 13.46 7 31815 393 110557084
Device kink 21.78 13.46 11 31811 2038 110555439
Stoma site candida 21.62 13.46 4 31818 19 110557458
Hospice care 21.48 13.46 22 31800 12451 110545026
Somatic delusion 21.43 13.46 8 31814 713 110556764
Corneal decompensation 21.34 13.46 5 31817 85 110557392
Psoriasis 21.05 13.46 7 31815 139986 110417491
Sinusitis 21.05 13.46 33 31789 296655 110260822
Insomnia 20.84 13.46 176 31646 360414 110197063
Delusion of grandeur 20.76 13.46 11 31811 2249 110555228
Jealous delusion 20.72 13.46 7 31815 466 110557011
Neuropathy peripheral 20.69 13.46 13 31809 179264 110378213
Leukocytosis 20.68 13.46 47 31775 53781 110503696
Impaired healing 20.42 13.46 16 31806 196701 110360776
Injury 20.26 13.46 13 31809 177252 110380225
Thrombocytopenia 20.15 13.46 44 31778 348841 110208636
Bedridden 20.14 13.46 22 31800 13403 110544074
Neuroprosthesis implantation 19.95 13.46 4 31818 31 110557446
Hypernatraemia 19.73 13.46 25 31797 17808 110539669
Exposure during pregnancy 19.52 13.46 12 31810 167412 110390065
Mental impairment 19.35 13.46 28 31794 22611 110534866
Corneal disorder 19.33 13.46 11 31811 2586 110554891
Loss of consciousness 19.18 13.46 109 31713 196197 110361280
Toxicity to various agents 19.16 13.46 217 31605 480338 110077139
Gastrointestinal disorder 19.05 13.46 25 31797 241927 110315550
Memory impairment 19.01 13.46 109 31713 196835 110360642
Anaemia 18.91 13.46 87 31735 546999 110010478
Soft tissue mass 18.58 13.46 9 31813 1524 110555953
Oedema 18.33 13.46 20 31802 209956 110347521
Sexually inappropriate behaviour 18.33 13.46 7 31815 664 110556813
Drug interaction 18.23 13.46 222 31600 499961 110057516
Stoma site irritation 18.22 13.46 6 31816 369 110557108
Urinary hesitation 17.88 13.46 13 31809 4645 110552832
Myelosuppression 17.55 13.46 3 31819 94337 110463140
Unresponsive to stimuli 17.48 13.46 49 31773 63741 110493736
Chest pain 17.48 13.46 53 31769 376322 110181155
Cough 17.42 13.46 71 31751 461570 110095907
Injection site necrosis 17.38 13.46 9 31813 1757 110555720
Screaming 17.34 13.46 13 31809 4868 110552609
Liver injury 17.23 13.46 11 31811 150402 110407075
Device placement issue 17.14 13.46 9 31813 1808 110555669
Compulsive hoarding 17.07 13.46 4 31818 68 110557409
Aspiration 16.88 13.46 31 31791 30502 110526975
Tension 16.88 13.46 13 31809 5065 110552412
Intentional underdose 16.85 13.46 10 31812 2542 110554935
Faecaloma 16.65 13.46 21 31801 14887 110542590
Drug ineffective for unapproved indication 16.56 13.46 66 31756 102772 110454705
Obesity 16.47 13.46 6 31816 113345 110444132
Intentional medical device removal by patient 16.44 13.46 6 31816 502 110556975
Abdominal pain upper 16.32 13.46 49 31773 349062 110208415
Nervous system cyst 16.09 13.46 3 31819 15 110557462
Wound infection 16.02 13.46 4 31818 96461 110461016
Progressive multifocal leukoencephalopathy 15.95 13.46 27 31795 24929 110532548
Corneal endothelial cell loss 15.93 13.46 3 31819 16 110557461
Saliva altered 15.89 13.46 6 31816 552 110556925
Gastrooesophageal reflux disease 15.87 13.46 17 31805 179959 110377518
Depression 15.82 13.46 150 31672 317185 110240292
Cogwheel rigidity 15.76 13.46 11 31811 3687 110553790
Arthritis 15.72 13.46 15 31807 167571 110389906
Blood cholesterol increased 15.69 13.46 18 31804 184767 110372710
Wheelchair user 15.67 13.46 15 31807 7827 110549650
Device use issue 15.53 13.46 11 31811 3773 110553704
Hallucination, tactile 15.53 13.46 7 31815 1008 110556469
Vitamin B6 deficiency 15.50 13.46 6 31816 590 110556887
Device leakage 15.43 13.46 21 31801 16027 110541450
Irritability 15.41 13.46 39 31783 47770 110509707
Stridor 15.34 13.46 14 31808 6881 110550596
Dementia with Lewy bodies 15.20 13.46 7 31815 1059 110556418
Cornea verticillata 15.07 13.46 5 31817 315 110557162
Prescribed underdose 14.95 13.46 47 31775 65127 110492350
Dysphemia 14.89 13.46 11 31811 4026 110553451
Incoherent 14.87 13.46 15 31807 8343 110549134
Incontinence 14.84 13.46 21 31801 16614 110540863
Rectal haemorrhage 14.81 13.46 8 31814 119825 110437652
Toxic encephalopathy 14.77 13.46 20 31802 15194 110542283
Ataxia 14.71 13.46 29 31793 30079 110527398
Chorea 14.67 13.46 10 31812 3225 110554252
Muscle spasticity 14.51 13.46 32 31790 35883 110521594
Pleurothotonus 14.47 13.46 9 31813 2489 110554988
Central nervous system lesion 14.42 13.46 20 31802 15533 110541944
Oromandibular dystonia 14.31 13.46 7 31815 1212 110556265
Radioisotope scan abnormal 14.27 13.46 6 31816 731 110556746
Lymphopenia 14.25 13.46 34 31788 40136 110517341
Basal ganglia infarction 14.25 13.46 6 31816 734 110556743
Liver disorder 14.22 13.46 12 31810 142231 110415246
Therapeutic response unexpected 14.19 13.46 25 31797 23818 110533659
Subdural haematoma 14.19 13.46 32 31790 36422 110521055
Hyperammonaemic encephalopathy 14.02 13.46 12 31810 5422 110552055
Band neutrophil percentage increased 13.92 13.46 5 31817 399 110557078
Volvulus 13.92 13.46 10 31812 3508 110553969
Lymphocyte count decreased 13.80 13.46 42 31780 57201 110500276
Progressive multiple sclerosis 13.76 13.46 7 31815 1317 110556160
Weight increased 13.75 13.46 68 31754 419576 110137901
Formication 13.62 13.46 12 31810 5636 110551841

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC N04BB01 NERVOUS SYSTEM
ANTI-PARKINSON DRUGS
DOPAMINERGIC AGENTS
Adamantane derivatives
FDA MoA N0000175542 M2 Protein Inhibitors
FDA EPC N0000175543 Influenza A M2 Protein Inhibitor
CHEBI has role CHEBI:22587 antiviral agent
CHEBI has role CHEBI:35441 antiinfective agent
CHEBI has role CHEBI:35476 antipsychotic agent
CHEBI has role CHEBI:35480 analgesic
CHEBI has role CHEBI:35481 non-narcotic analgesic
CHEBI has role CHEBI:35526 hypoglycemic agent
CHEBI has role CHEBI:35705 immunosuppressive agent
CHEBI has role CHEBI:36044 antiviral drug
CHEBI has role CHEBI:48407 antiparkinson drug
CHEBI has role CHEBI:48560 dopaminergic agent
CHEBI has role CHEBI:60643 NMDA receptor antagonist
CHEBI has role CHEBI:63726 neuroprotective agent
CHEBI has role CHEBI:51065 dopamine agonist
MeSH PA D000700 Analgesics
MeSH PA D000890 Anti-Infective Agents
MeSH PA D000978 Antiparkinson Agents
MeSH PA D000998 Antiviral Agents
MeSH PA D015259 Dopamine Agents
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D018689 Sensory System Agents
MeSH PA D018712 Analgesics, Non-Narcotic
MeSH PA D018726 Anti-Dyskinesia Agents

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Postencephalitic parkinsonism indication 19972008 DOID:14332
Parkinsonism indication 32798002
Parkinson's disease indication 49049000 DOID:14330
Extrapyramidal disease indication 76349003
Influenza due to Influenza A virus indication 442438000
Arteriosclerotic Parkinsonism indication
Influenza A Prevention indication
Jakob-Creutzfeldt disease off-label use 792004 DOID:11949
Cognitive impairment following traumatic brain injury off-label use 127295002
Arousal post traumatic brain injury off-label use 127295002
Cognitive Impairment following Traumatic Brain Injury off-label use
Fatigue due to Multiple Sclerosis off-label use
Suicidal thoughts contraindication 6471006
Orthostatic hypotension contraindication 28651003
Eczema contraindication 43116000
Chronic heart failure contraindication 48447003
Substance abuse contraindication 66214007
Psychotic disorder contraindication 69322001
Epilepsy contraindication 84757009 DOID:1826
Kidney disease contraindication 90708001 DOID:557
Edema contraindication 267038008
Malignant melanoma contraindication 372244006
Angle-closure glaucoma contraindication 392291006 DOID:13550
Psychiatric Disturbance contraindication




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 10.4 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 137MG BASE GOCOVRI SUPERNUS PHARMS N208944 Aug. 24, 2017 RX CAPSULE, EXTENDED RELEASE ORAL 8389578 Jan. 22, 2028 TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING IMMEDIATE RELEASE LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
EQ 68.5MG BASE GOCOVRI SUPERNUS PHARMS N208944 Aug. 24, 2017 RX CAPSULE, EXTENDED RELEASE ORAL 8389578 Jan. 22, 2028 TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING IMMEDIATE RELEASE LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
EQ 129MG BASE OSMOLEX ER SUPERNUS PHARMS N209410 Feb. 16, 2018 DISCN TABLET, EXTENDED RELEASE ORAL 8389578 Jan. 22, 2028 TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTIONS IN ADULT PATIENTS WITH PARKINSONS DISEASE
EQ 129MG BASE OSMOLEX ER SUPERNUS PHARMS N209410 Feb. 16, 2018 DISCN TABLET, EXTENDED RELEASE ORAL 8389578 Jan. 22, 2028 TREATMENT OF PARKINSONS DISEASE
EQ 161MG BASE OSMOLEX ER SUPERNUS PHARMS N209410 April 22, 2020 DISCN TABLET, EXTENDED RELEASE ORAL 8389578 Jan. 22, 2028 TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTIONS IN ADULT PATIENTS WITH PARKINSONS DISEASE
EQ 161MG BASE OSMOLEX ER SUPERNUS PHARMS N209410 April 22, 2020 DISCN TABLET, EXTENDED RELEASE ORAL 8389578 Jan. 22, 2028 TREATMENT OF PARKINSONS DISEASE
EQ 193MG BASE OSMOLEX ER SUPERNUS PHARMS N209410 Feb. 16, 2018 DISCN TABLET, EXTENDED RELEASE ORAL 8389578 Jan. 22, 2028 TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTIONS IN ADULT PATIENTS WITH PARKINSONS DISEASE
EQ 193MG BASE OSMOLEX ER SUPERNUS PHARMS N209410 Feb. 16, 2018 DISCN TABLET, EXTENDED RELEASE ORAL 8389578 Jan. 22, 2028 TREATMENT OF PARKINSONS DISEASE
EQ 258MG BASE OSMOLEX ER SUPERNUS PHARMS N209410 Feb. 16, 2018 DISCN TABLET, EXTENDED RELEASE ORAL 8389578 Jan. 22, 2028 TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTIONS IN ADULT PATIENTS WITH PARKINSONS DISEASE
EQ 258MG BASE OSMOLEX ER SUPERNUS PHARMS N209410 Feb. 16, 2018 DISCN TABLET, EXTENDED RELEASE ORAL 8389578 Jan. 22, 2028 TREATMENT OF PARKINSONS DISEASE
EQ 137MG BASE GOCOVRI SUPERNUS PHARMS N208944 Aug. 24, 2017 RX CAPSULE, EXTENDED RELEASE ORAL 11197835 Dec. 2, 2030 TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
EQ 137MG BASE GOCOVRI SUPERNUS PHARMS N208944 Aug. 24, 2017 RX CAPSULE, EXTENDED RELEASE ORAL 8741343 Dec. 2, 2030 TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
EQ 137MG BASE GOCOVRI SUPERNUS PHARMS N208944 Aug. 24, 2017 RX CAPSULE, EXTENDED RELEASE ORAL 9867791 Dec. 2, 2030 TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
EQ 137MG BASE GOCOVRI SUPERNUS PHARMS N208944 Aug. 24, 2017 RX CAPSULE, EXTENDED RELEASE ORAL 9867792 Dec. 2, 2030 TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
EQ 137MG BASE GOCOVRI SUPERNUS PHARMS N208944 Aug. 24, 2017 RX CAPSULE, EXTENDED RELEASE ORAL 9867793 Dec. 2, 2030 TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
EQ 137MG BASE GOCOVRI SUPERNUS PHARMS N208944 Aug. 24, 2017 RX CAPSULE, EXTENDED RELEASE ORAL 9877933 Dec. 2, 2030 TREATMENT OF DYSKINESIA AND INCREASING ON TIME WITHOUT TROUBLESOME DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
EQ 68.5MG BASE GOCOVRI SUPERNUS PHARMS N208944 Aug. 24, 2017 RX CAPSULE, EXTENDED RELEASE ORAL 11197835 Dec. 2, 2030 TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
EQ 68.5MG BASE GOCOVRI SUPERNUS PHARMS N208944 Aug. 24, 2017 RX CAPSULE, EXTENDED RELEASE ORAL 8741343 Dec. 2, 2030 TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
EQ 68.5MG BASE GOCOVRI SUPERNUS PHARMS N208944 Aug. 24, 2017 RX CAPSULE, EXTENDED RELEASE ORAL 9867791 Dec. 2, 2030 TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
EQ 68.5MG BASE GOCOVRI SUPERNUS PHARMS N208944 Aug. 24, 2017 RX CAPSULE, EXTENDED RELEASE ORAL 9867792 Dec. 2, 2030 TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
EQ 68.5MG BASE GOCOVRI SUPERNUS PHARMS N208944 Aug. 24, 2017 RX CAPSULE, EXTENDED RELEASE ORAL 9867793 Dec. 2, 2030 TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
EQ 68.5MG BASE GOCOVRI SUPERNUS PHARMS N208944 Aug. 24, 2017 RX CAPSULE, EXTENDED RELEASE ORAL 9877933 Dec. 2, 2030 TREATMENT OF DYSKINESIA AND INCREASING ON TIME WITHOUT TROUBLESOME DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
EQ 137MG BASE GOCOVRI SUPERNUS PHARMS N208944 Aug. 24, 2017 RX CAPSULE, EXTENDED RELEASE ORAL 10646456 June 17, 2034 TREATMENT OF DYSKINESIA, DECREASING OFF TIME, AND INCREASING ON TIME WITHOUT TROUBLESOME DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
EQ 137MG BASE GOCOVRI SUPERNUS PHARMS N208944 Aug. 24, 2017 RX CAPSULE, EXTENDED RELEASE ORAL 11903908 June 17, 2034 AS ADJUNCTIVE TREATMENT TO LEVODOPA/CARBIDOPA IN PATIENTS WITH PARKINSONS DISEASE EXPERIENCING OFF EPISODES
EQ 68.5MG BASE GOCOVRI SUPERNUS PHARMS N208944 Aug. 24, 2017 RX CAPSULE, EXTENDED RELEASE ORAL 10646456 June 17, 2034 TREATMENT OF DYSKINESIA, DECREASING OFF TIME, AND INCREASING ON TIME WITHOUT TROUBLESOME DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
EQ 68.5MG BASE GOCOVRI SUPERNUS PHARMS N208944 Aug. 24, 2017 RX CAPSULE, EXTENDED RELEASE ORAL 11903908 June 17, 2034 AS ADJUNCTIVE TREATMENT TO LEVODOPA/CARBIDOPA IN PATIENTS WITH PARKINSONS DISEASE EXPERIENCING OFF EPISODES
EQ 137MG BASE GOCOVRI SUPERNUS PHARMS N208944 Aug. 24, 2017 RX CAPSULE, EXTENDED RELEASE ORAL 10154971 Dec. 4, 2034 TREATMENT OF DYSKINESIA AND DECREASING OFF TIME IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
EQ 68.5MG BASE GOCOVRI SUPERNUS PHARMS N208944 Aug. 24, 2017 RX CAPSULE, EXTENDED RELEASE ORAL 10154971 Dec. 4, 2034 TREATMENT OF DYSKINESIA AND DECREASING OFF TIME IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
EQ 129MG BASE OSMOLEX ER SUPERNUS PHARMS N209410 Feb. 16, 2018 DISCN TABLET, EXTENDED RELEASE ORAL 10213393 Feb. 15, 2038 A PROCESS FOR TREATING A PATIENT SUFFERING FROM PARKINSONS SYNDROME AND IN NEED OF TREATMENT
EQ 129MG BASE OSMOLEX ER SUPERNUS PHARMS N209410 Feb. 16, 2018 DISCN TABLET, EXTENDED RELEASE ORAL 10213394 Feb. 15, 2038 TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS
EQ 129MG BASE OSMOLEX ER SUPERNUS PHARMS N209410 Feb. 16, 2018 DISCN TABLET, EXTENDED RELEASE ORAL 10500170 Feb. 15, 2038 A PROCESS FOR TREATING A PATIENT SUFFERING FROM PARKINSONS SYNDROME AND IN NEED OF TREATMENT
EQ 129MG BASE OSMOLEX ER SUPERNUS PHARMS N209410 Feb. 16, 2018 DISCN TABLET, EXTENDED RELEASE ORAL 10500171 Feb. 15, 2038 TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS
EQ 129MG BASE OSMOLEX ER SUPERNUS PHARMS N209410 Feb. 16, 2018 DISCN TABLET, EXTENDED RELEASE ORAL 10500172 Feb. 15, 2038 TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS
EQ 129MG BASE OSMOLEX ER SUPERNUS PHARMS N209410 Feb. 16, 2018 DISCN TABLET, EXTENDED RELEASE ORAL 10512617 Feb. 15, 2038 TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS
EQ 129MG BASE OSMOLEX ER SUPERNUS PHARMS N209410 Feb. 16, 2018 DISCN TABLET, EXTENDED RELEASE ORAL 11890261 Feb. 15, 2038 TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS
EQ 161MG BASE OSMOLEX ER SUPERNUS PHARMS N209410 April 22, 2020 DISCN TABLET, EXTENDED RELEASE ORAL 10213393 Feb. 15, 2038 A PROCESS FOR TREATING A PATIENT SUFFERING FROM PARKINSONS SYNDROME AND IN NEED OF TREATMENT
EQ 161MG BASE OSMOLEX ER SUPERNUS PHARMS N209410 April 22, 2020 DISCN TABLET, EXTENDED RELEASE ORAL 10213394 Feb. 15, 2038 TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS
EQ 161MG BASE OSMOLEX ER SUPERNUS PHARMS N209410 April 22, 2020 DISCN TABLET, EXTENDED RELEASE ORAL 10500170 Feb. 15, 2038 A PROCESS FOR TREATING A PATIENT SUFFERING FROM PARKINSONS SYNDROME AND IN NEED OF TREATMENT
EQ 161MG BASE OSMOLEX ER SUPERNUS PHARMS N209410 April 22, 2020 DISCN TABLET, EXTENDED RELEASE ORAL 10500171 Feb. 15, 2038 TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS
EQ 161MG BASE OSMOLEX ER SUPERNUS PHARMS N209410 April 22, 2020 DISCN TABLET, EXTENDED RELEASE ORAL 10500172 Feb. 15, 2038 TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS
EQ 161MG BASE OSMOLEX ER SUPERNUS PHARMS N209410 April 22, 2020 DISCN TABLET, EXTENDED RELEASE ORAL 10512617 Feb. 15, 2038 TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS
EQ 193MG BASE OSMOLEX ER SUPERNUS PHARMS N209410 Feb. 16, 2018 DISCN TABLET, EXTENDED RELEASE ORAL 10213393 Feb. 15, 2038 A PROCESS FOR TREATING A PATIENT SUFFERING FROM PARKINSONS SYNDROME AND IN NEED OF TREATMENT
EQ 193MG BASE OSMOLEX ER SUPERNUS PHARMS N209410 Feb. 16, 2018 DISCN TABLET, EXTENDED RELEASE ORAL 10213394 Feb. 15, 2038 TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS
EQ 193MG BASE OSMOLEX ER SUPERNUS PHARMS N209410 Feb. 16, 2018 DISCN TABLET, EXTENDED RELEASE ORAL 10500170 Feb. 15, 2038 A PROCESS FOR TREATING A PATIENT SUFFERING FROM PARKINSONS SYNDROME AND IN NEED OF TREATMENT
EQ 193MG BASE OSMOLEX ER SUPERNUS PHARMS N209410 Feb. 16, 2018 DISCN TABLET, EXTENDED RELEASE ORAL 10500171 Feb. 15, 2038 TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS
EQ 193MG BASE OSMOLEX ER SUPERNUS PHARMS N209410 Feb. 16, 2018 DISCN TABLET, EXTENDED RELEASE ORAL 10500172 Feb. 15, 2038 TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS
EQ 193MG BASE OSMOLEX ER SUPERNUS PHARMS N209410 Feb. 16, 2018 DISCN TABLET, EXTENDED RELEASE ORAL 10512617 Feb. 15, 2038 TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS
EQ 193MG BASE OSMOLEX ER SUPERNUS PHARMS N209410 Feb. 16, 2018 DISCN TABLET, EXTENDED RELEASE ORAL 11890261 Feb. 15, 2038 TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS
EQ 258MG BASE OSMOLEX ER SUPERNUS PHARMS N209410 Feb. 16, 2018 DISCN TABLET, EXTENDED RELEASE ORAL 10213393 Feb. 15, 2038 A PROCESS FOR TREATING A PATIENT SUFFERING FROM PARKINSONS SYNDROME AND IN NEED OF TREATMENT
EQ 258MG BASE OSMOLEX ER SUPERNUS PHARMS N209410 Feb. 16, 2018 DISCN TABLET, EXTENDED RELEASE ORAL 10213394 Feb. 15, 2038 TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS
EQ 258MG BASE OSMOLEX ER SUPERNUS PHARMS N209410 Feb. 16, 2018 DISCN TABLET, EXTENDED RELEASE ORAL 10500170 Feb. 15, 2038 A PROCESS FOR TREATING A PATIENT SUFFERING FROM PARKINSONS SYNDROME AND IN NEED OF TREATMENT
EQ 258MG BASE OSMOLEX ER SUPERNUS PHARMS N209410 Feb. 16, 2018 DISCN TABLET, EXTENDED RELEASE ORAL 10500171 Feb. 15, 2038 TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS
EQ 258MG BASE OSMOLEX ER SUPERNUS PHARMS N209410 Feb. 16, 2018 DISCN TABLET, EXTENDED RELEASE ORAL 10500172 Feb. 15, 2038 TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS
EQ 258MG BASE OSMOLEX ER SUPERNUS PHARMS N209410 Feb. 16, 2018 DISCN TABLET, EXTENDED RELEASE ORAL 10512617 Feb. 15, 2038 TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS
EQ 137MG BASE GOCOVRI SUPERNUS PHARMS N208944 Aug. 24, 2017 RX CAPSULE, EXTENDED RELEASE ORAL 11077073 Aug. 23, 2038 DECREASING OFF TIME IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
EQ 137MG BASE GOCOVRI SUPERNUS PHARMS N208944 Aug. 24, 2017 RX CAPSULE, EXTENDED RELEASE ORAL 11077073 Aug. 23, 2038 TREATMENT OF DYSKINESIA AND INCREASING ON TIME WITHOUT TROUBLESOME DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
EQ 137MG BASE GOCOVRI SUPERNUS PHARMS N208944 Aug. 24, 2017 RX CAPSULE, EXTENDED RELEASE ORAL 11077073 Aug. 23, 2038 TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
EQ 137MG BASE GOCOVRI SUPERNUS PHARMS N208944 Aug. 24, 2017 RX CAPSULE, EXTENDED RELEASE ORAL 12233033 Aug. 23, 2038 DECREASING OFF TIME IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
EQ 137MG BASE GOCOVRI SUPERNUS PHARMS N208944 Aug. 24, 2017 RX CAPSULE, EXTENDED RELEASE ORAL 12233033 Aug. 23, 2038 TREATMENT OF DYSKINESIA AND INCREASING ON TIME WITHOUT TROUBLESOME DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
EQ 137MG BASE GOCOVRI SUPERNUS PHARMS N208944 Aug. 24, 2017 RX CAPSULE, EXTENDED RELEASE ORAL 12233033 Aug. 23, 2038 TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
EQ 68.5MG BASE GOCOVRI SUPERNUS PHARMS N208944 Aug. 24, 2017 RX CAPSULE, EXTENDED RELEASE ORAL 11077073 Aug. 23, 2038 DECREASING OFF TIME IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
EQ 68.5MG BASE GOCOVRI SUPERNUS PHARMS N208944 Aug. 24, 2017 RX CAPSULE, EXTENDED RELEASE ORAL 11077073 Aug. 23, 2038 TREATMENT OF DYSKINESIA AND INCREASING ON TIME WITHOUT TROUBLESOME DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
EQ 68.5MG BASE GOCOVRI SUPERNUS PHARMS N208944 Aug. 24, 2017 RX CAPSULE, EXTENDED RELEASE ORAL 11077073 Aug. 23, 2038 TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
EQ 68.5MG BASE GOCOVRI SUPERNUS PHARMS N208944 Aug. 24, 2017 RX CAPSULE, EXTENDED RELEASE ORAL 12233033 Aug. 23, 2038 DECREASING OFF TIME IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
EQ 68.5MG BASE GOCOVRI SUPERNUS PHARMS N208944 Aug. 24, 2017 RX CAPSULE, EXTENDED RELEASE ORAL 12233033 Aug. 23, 2038 TREATMENT OF DYSKINESIA AND INCREASING ON TIME WITHOUT TROUBLESOME DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
EQ 68.5MG BASE GOCOVRI SUPERNUS PHARMS N208944 Aug. 24, 2017 RX CAPSULE, EXTENDED RELEASE ORAL 12233033 Aug. 23, 2038 TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSONS DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Glutamate [NMDA] receptor Ion channel BLOCKER Ki 4.98 CHEMBL CHEMBL
Solute carrier family 22 member 2 Transporter IC50 4.34 CHEMBL
Multidrug and toxin extrusion protein 1 Transporter IC50 4.42 CHEMBL
Sigma non-opioid intracellular receptor 1 Membrane receptor Ki 7.69 CHEMBL
Solute carrier family 22 member 1 Transporter IC50 4.40 CHEMBL
Matrix protein 2 Ion channel INHIBITOR IC50 4.80 CHEMBL CHEMBL
Matrix protein 2 Ion channel IC50 4.80 CHEMBL
Matrix protein 2 Ion channel Kd 6.50 CHEMBL
Matrix protein 2 Ion channel EC50 6.18 CHEMBL
Matrix protein 2 Ion channel Kd 6.50 CHEMBL

External reference:

IDSource
4019601 VUID
N0000147697 NUI
D00777 KEGG_DRUG
665-66-7 SECONDARY_CAS_RN
282415 RXNORM
C0002403 UMLSCUI
CHEBI:2618 CHEBI
308 PDB_CHEM_ID
CHEMBL660 ChEMBL_ID
DB00915 DRUGBANK_ID
CHEMBL1569 ChEMBL_ID
D000547 MESH_DESCRIPTOR_UI
2130 PUBCHEM_CID
1816 INN_ID
4128 IUPHAR_LIGAND_ID
BF4C9Z1J53 UNII
2543 MMSL
33122 MMSL
34880 MMSL
4161 MMSL
d00086 MMSL
CHEMBL465617 ChEMBL_ID
31377-23-8 SECONDARY_CAS_RN
4018546 VANDF
4019601 VANDF
001640 NDDF
004663 NDDF
006089 NDDF
372763006 SNOMEDCT_US
51361008 SNOMEDCT_US
64507008 SNOMEDCT_US
703084004 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Amantadine HUMAN PRESCRIPTION DRUG LABEL 1 0116-4010 SOLUTION 50 mg ORAL ANDA 13 sections
AMANTADINE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0121-0646 SOLUTION 50 mg ORAL ANDA 24 sections
Amantadine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-8263 CAPSULE 100 mg ORAL ANDA 13 sections
Amantadine HUMAN PRESCRIPTION DRUG LABEL 1 0615-8605 TABLET 100 mg ORAL ANDA 11 sections
Amantadine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0832-0111 TABLET 100 mg ORAL ANDA 24 sections
Amantadine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0832-1015 CAPSULE, GELATIN COATED 100 mg ORAL ANDA 23 sections
Amantadine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-7042 CAPSULE 100 mg ORAL ANDA 13 sections
Amantadine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 10135-692 TABLET 100 mg ORAL ANDA 22 sections
Amantadine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 10135-693 CAPSULE, GELATIN COATED 100 mg ORAL ANDA 22 sections
Amantadine HCl Human Prescription Drug Label 1 10888-5006 CAPSULE, LIQUID FILLED 100 mg ORAL ANDA 19 sections
Amantadine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 16571-834 CAPSULE 100 mg ORAL ANDA 11 sections
AMANTADINE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 16590-008 CAPSULE 100 mg ORAL ANDA 24 sections
GOCOVRI HUMAN PRESCRIPTION DRUG LABEL 1 17772-085 CAPSULE, COATED PELLETS 68.50 mg ORAL NDA 29 sections
GOCOVRI HUMAN PRESCRIPTION DRUG LABEL 1 17772-085 CAPSULE, COATED PELLETS 68.50 mg ORAL NDA 29 sections
GOCOVRI HUMAN PRESCRIPTION DRUG LABEL 1 17772-170 CAPSULE, COATED PELLETS 137 mg ORAL NDA 29 sections
GOCOVRI HUMAN PRESCRIPTION DRUG LABEL 1 17772-170 CAPSULE, COATED PELLETS 137 mg ORAL NDA 29 sections
Amantadine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 17856-0093 SOLUTION 50 mg ORAL ANDA 25 sections
AMANTADINE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 17856-0646 SOLUTION 50 mg ORAL ANDA 24 sections
Amantadine HCl HUMAN PRESCRIPTION DRUG LABEL 1 21695-564 CAPSULE 100 mg ORAL ANDA 20 sections
Amantadine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 23155-362 CAPSULE 100 mg ORAL ANDA 13 sections
AMANTADINE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 24689-105 CAPSULE 100 mg ORAL ANDA 12 sections
AMANTADINE HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 24689-112 TABLET 100 mg ORAL ANDA 12 sections
Amantadine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 33261-773 CAPSULE 100 mg ORAL ANDA 24 sections
Amantadine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 39328-530 SOLUTION 50 mg ORAL ANDA 22 sections
Amantadine HCl HUMAN PRESCRIPTION DRUG LABEL 1 42291-125 CAPSULE, LIQUID FILLED 100 mg ORAL ANDA 19 sections
Amantadine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 42543-493 CAPSULE 100 mg ORAL ANDA 17 sections
Amantadine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 42543-497 TABLET 100 mg ORAL ANDA 12 sections
amantadine hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 42806-716 CAPSULE 100 mg ORAL ANDA 22 sections
Amantadine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 43353-947 CAPSULE 100 mg ORAL ANDA 24 sections
amantadine Human Prescription Drug Label 1 46708-246 CAPSULE 100 mg ORAL ANDA 19 sections