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

Stem definitionDrug idCAS RN
4310 175481-36-4

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • ertosamide
  • SPM-927
  • lacosamide
  • erlosamide
  • harkoseride
  • vimpat
a functionalized amino acid, selectively enhances slow inactivation of voltage-gated sodium channels, resulting in stabilization of hyperexcitable neuronal membranes and inhibition of repetitive neuronal firing, indicated for partial-onset seizures
  • Molecular weight: 250.30
  • Formula: C13H18N2O3
  • CLOGP: 0.39
  • LIPINSKI: 0
  • HAC: 5
  • HDO: 2
  • TPSA: 67.43
  • ALOGS: -2.73
  • ROTB: 6
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.30 g O
0.30 g P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 2 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 40 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 22.83 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
Vd (Volume of distribution) 0.58 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 0.57 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) 12.30 hours Lombardo F, Berellini G, Obach RS
BA (Bioavailability) 100 %

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
kinase-safety-class ACVR2A,ACVR2B,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK5,CDK9,DDR1,DYRK1B,EGFR,EIF2AK3,EPHB4,ERBB2,FLT3,GRK2,ITK,JAK2,MAP3K21,MAP3K7,MAPK7,NTRK2,PDK1,PDK2,PDK4,PIK3CB,PRKCD,PRKDC,SIK2,SIK3,STK33,SYK,TEK,TTK 35
kinase-selectivity-class GRK2 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0

Approvals:

DateAgencyCompanyOrphan
July 4, 2016 PMDA UCB Japan Co., Ltd.
Aug. 29, 2008 EMA
Oct. 28, 2008 FDA UCB INC

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
Seizure 2397.22 17.31 1133 30659 151496 90445159
Multiple-drug resistance 1486.08 17.31 377 31415 7399 90589256
Status epilepticus 1441.37 17.31 446 31346 18428 90578227
Generalised tonic-clonic seizure 718.41 17.31 314 31478 34589 90562066
Drug ineffective 605.58 17.31 1422 30370 1382876 89213779
Partial seizures 488.86 17.31 156 31636 7104 90589551
Off label use 375.46 17.31 1033 30759 1101219 89495436
Overdose 337.61 17.31 342 31450 157367 90439288
Epilepsy 334.82 17.31 257 31535 81949 90514706
Focal dyscognitive seizures 325.10 17.31 94 31698 3050 90593605
Abortion spontaneous 274.24 17.31 193 31599 53863 90542792
Petit mal epilepsy 259.16 17.31 88 31704 4870 90591785
Somnolence 249.80 17.31 336 31456 208748 90387907
Drug ineffective for unapproved indication 242.47 17.31 195 31597 66449 90530206
Maternal exposure before pregnancy 227.64 17.31 100 31692 11113 90585542
Diplopia 223.11 17.31 134 31658 28580 90568075
Drug interaction 220.90 17.31 368 31424 276085 90320570
Maternal exposure during pregnancy 218.40 17.31 425 31367 359638 90237017
Drug resistance 195.83 17.31 126 31666 30323 90566332
Cardiac arrest 170.67 17.31 197 31595 104738 90491917
Electrocardiogram QRS complex prolonged 170.40 17.31 72 31720 7276 90589379
Irritability 161.75 17.31 119 31673 35543 90561112
Propofol infusion syndrome 160.80 17.31 45 31747 1294 90595361
Cognitive disorder 160.24 17.31 157 31635 69250 90527405
Pain 151.23 17.31 81 31711 996260 89600395
Myoclonus 150.30 17.31 90 31702 19078 90577577
Premature delivery 146.43 17.31 116 31676 38646 90558009
Bradycardia 142.38 17.31 161 31631 83686 90512969
Atrioventricular block 139.16 17.31 66 31726 8749 90587906
Anticonvulsant drug level increased 136.45 17.31 42 31750 1694 90594961
Myoclonic epilepsy 134.85 17.31 41 31751 1586 90595069
Atrioventricular block complete 132.45 17.31 66 31726 9745 90586910
Change in seizure presentation 129.43 17.31 32 31760 560 90596095
Infusion related reaction 128.13 17.31 4 31788 416776 90179879
Drug reaction with eosinophilia and systemic symptoms 126.31 17.31 111 31681 42647 90554008
Arthralgia 125.97 17.31 58 31734 778464 89818191
Joint swelling 124.98 17.31 15 31777 503285 90093370
Aura 124.10 17.31 36 31756 1181 90595474
Mitochondrial DNA mutation 121.85 17.31 29 31763 429 90596226
Abnormal behaviour 117.50 17.31 82 31710 22546 90574109
Seizure cluster 115.91 17.31 27 31765 362 90596293
Behaviour disorder 112.77 17.31 47 31745 4588 90592067
Electrocardiogram PR prolongation 112.57 17.31 31 31761 839 90595816
Tonic convulsion 107.38 17.31 35 31757 1703 90594952
Ataxia 107.04 17.31 71 31721 17971 90578684
Rheumatoid arthritis 103.11 17.31 6 31786 362608 90234047
Maternal exposure during breast feeding 102.58 17.31 48 31744 6172 90590483
Toxicity to various agents 101.98 17.31 275 31517 287571 90309084
Arthropathy 101.34 17.31 7 31785 366235 90230420
Aggression 101.12 17.31 80 31712 26588 90570067
Swelling 100.36 17.31 14 31778 419044 90177611
Dyspnoea 100.35 17.31 97 31695 880858 89715797
Encephalopathy 99.67 17.31 101 31691 46343 90550312
Diarrhoea 99.56 17.31 110 31682 939080 89657575
Exposure during pregnancy 99.15 17.31 242 31550 238168 90358487
Contraindicated product administered 98.62 17.31 3 31789 320136 90276519
Suicide attempt 95.74 17.31 125 31667 75274 90521381
Balance disorder 94.99 17.31 142 31650 96938 90499717
Pregnancy 91.73 17.31 111 31681 61936 90534719
Partial seizures with secondary generalisation 89.84 17.31 23 31769 466 90596189
Sudden unexplained death in epilepsy 88.92 17.31 22 31770 386 90596269
Atonic seizures 87.04 17.31 25 31767 791 90595864
Systemic lupus erythematosus 86.85 17.31 12 31780 361884 90234771
Wound 86.16 17.31 5 31787 302975 90293680
Stillbirth 85.75 17.31 45 31747 7398 90589257
Sinusitis 85.67 17.31 10 31782 343078 90253577
Electroencephalogram abnormal 84.65 17.31 37 31755 4059 90592596
Abdominal discomfort 82.78 17.31 32 31760 477296 90119359
CSF oligoclonal band present 81.82 17.31 21 31771 430 90596225
Hallucination, visual 80.60 17.31 66 31726 23026 90573629
Myocardial depression 79.34 17.31 22 31770 611 90596044
Product substitution issue 79.18 17.31 59 31733 17949 90578706
Gene mutation 77.86 17.31 29 31763 2101 90594554
Nasopharyngitis 76.23 17.31 24 31768 407080 90189575
Intentional overdose 76.18 17.31 126 31666 93708 90502947
Altered state of consciousness 75.87 17.31 73 31719 31459 90565196
Depressed level of consciousness 73.40 17.31 108 31684 72676 90523979
Peripheral swelling 72.77 17.31 27 31765 413079 90183576
Psychotic disorder 72.70 17.31 71 31721 31159 90565496
Blood gases abnormal 71.19 17.31 22 31770 899 90595756
Abortion induced 71.04 17.31 47 31745 11841 90584814
Pericarditis 69.65 17.31 7 31785 270144 90326511
Pain in extremity 69.02 17.31 36 31756 450493 90146162
Encephalitis 68.92 17.31 45 31747 11089 90585566
Discomfort 68.46 17.31 8 31784 274327 90322328
Automatism epileptic 68.17 17.31 12 31780 31 90596624
Suicidal ideation 67.95 17.31 105 31687 73750 90522905
Tremor 67.41 17.31 159 31633 153014 90443641
Post stroke depression 67.06 17.31 11 31781 15 90596640
Sinus node dysfunction 66.02 17.31 34 31758 5378 90591277
Disturbance in attention 65.94 17.31 82 31710 47027 90549628
Pleocytosis 65.13 17.31 21 31771 987 90595668
Coma 65.06 17.31 102 31690 72530 90524125
Psoriatic arthropathy 64.20 17.31 4 31788 228331 90368324
Musculoskeletal stiffness 64.12 17.31 13 31779 296519 90300136
Pneumonia aspiration 63.39 17.31 75 31717 40865 90555790
Cerebral salt-wasting syndrome 63.33 17.31 15 31777 217 90596438
Alopecia 62.91 17.31 49 31743 495022 90101633
Ventricular tachycardia 62.87 17.31 59 31733 24649 90572006
Nystagmus 62.07 17.31 36 31756 7191 90589464
Atrioventricular block second degree 60.24 17.31 30 31762 4422 90592233
Neurotoxicity 59.95 17.31 54 31738 21413 90575242
Fibromyalgia 59.89 17.31 3 31789 206266 90390389
Folliculitis 59.24 17.31 3 31789 204350 90392305
Blister 57.64 17.31 10 31782 254988 90341667
Aphasia 55.92 17.31 72 31720 42740 90553915
Agitation 55.67 17.31 91 31701 67007 90529648
No adverse event 54.78 17.31 91 31701 67891 90528764
Wheezing 54.55 17.31 9 31783 238071 90358584
Dizziness 54.31 17.31 373 31419 588911 90007744
Drug level increased 53.49 17.31 57 31735 27705 90568950
Hyperammonaemia 52.31 17.31 31 31761 6444 90590211
Drug level decreased 52.24 17.31 36 31756 9694 90586961
Simple partial seizures 50.31 17.31 16 31776 719 90595936
Abdominal pain upper 50.31 17.31 27 31765 332647 90264008
Angiofibroma 50.18 17.31 11 31781 110 90596545
Unmasking of previously unidentified disease 49.97 17.31 19 31773 1457 90595198
Drug withdrawal convulsions 49.68 17.31 19 31773 1481 90595174
Hypersensitivity 49.40 17.31 52 31740 454625 90142030
Metabolic acidosis 48.21 17.31 77 31715 55599 90541056
Blood cholesterol increased 47.35 17.31 8 31784 208004 90388651
Encephalitis autoimmune 47.16 17.31 20 31772 2038 90594617
Malaise 46.62 17.31 84 31708 585902 90010753
Therapeutic product effect decreased 45.81 17.31 20 31772 277551 90319104
Osteoarthritis 45.74 17.31 7 31785 195723 90400932
Hypertension 45.71 17.31 56 31736 457476 90139179
Shock 45.01 17.31 53 31739 28725 90567930
Atrioventricular block first degree 44.54 17.31 31 31761 8480 90588175
Arrhythmia 44.39 17.31 64 31728 42268 90554387
Sinus bradycardia 44.13 17.31 41 31751 16911 90579744
Anticonvulsant drug level decreased 43.75 17.31 17 31775 1383 90595272
Pruritus 43.63 17.31 77 31715 541448 90055207
Respiratory acidosis 43.50 17.31 30 31762 8089 90588566
Infection 43.29 17.31 38 31754 362056 90234599
Head injury 43.18 17.31 54 31738 31134 90565521
Sinus arrest 43.10 17.31 19 31773 2127 90594528
Wrong patient received product 42.86 17.31 22 31770 3455 90593200
Hyponatraemia 42.67 17.31 123 31669 133415 90463240
Hyperammonaemic encephalopathy 41.96 17.31 20 31772 2679 90593976
Gastrointestinal disorder 41.56 17.31 19 31773 256668 90339987
Mobility decreased 41.48 17.31 18 31774 250716 90345939
Ventricular arrhythmia 41.07 17.31 23 31769 4298 90592357
Arterial intramural haematoma 40.94 17.31 10 31782 166 90596489
Stomatitis 40.50 17.31 23 31769 274675 90321980
Inflammation 40.36 17.31 7 31785 178585 90418070
Cough 40.28 17.31 42 31750 368920 90227735
Fall 40.28 17.31 298 31494 481512 90115143
Abdominal pain 39.97 17.31 48 31744 395673 90200982
Macroglossia 39.73 17.31 14 31778 865 90595790
Lipids abnormal 39.55 17.31 11 31781 309 90596346
Blood creatine phosphokinase increased 39.48 17.31 54 31738 33969 90562686
Caesarean section 39.12 17.31 40 31752 18537 90578118
C-reactive protein increased 39.09 17.31 8 31784 181381 90415274
Asthma 39.09 17.31 18 31774 242142 90354513
Injection site pain 38.83 17.31 7 31785 173692 90422963
Urticaria 38.38 17.31 32 31760 312702 90283953
Hepatic enzyme increased 38.33 17.31 42 31750 360694 90235961
Dyspepsia 38.29 17.31 11 31781 198149 90398506
Back pain 38.25 17.31 33 31759 317142 90279513
Injury 38.05 17.31 11 31781 197338 90399317
Type 2 diabetes mellitus 37.97 17.31 12 31780 203232 90393423
Human T-cell lymphotropic virus infection 37.58 17.31 6 31786 6 90596649
Angiomyolipoma 37.22 17.31 10 31782 246 90596409
Postictal state 36.85 17.31 15 31777 1378 90595277
Arthritis 36.85 17.31 7 31785 167308 90429347
Gastrooesophageal reflux disease 36.55 17.31 7 31785 166330 90430325
Lymphangioleiomyomatosis 36.19 17.31 10 31782 274 90596381
Brain operation 35.63 17.31 12 31780 647 90596008
Nausea 35.13 17.31 237 31555 1110079 89486576
Toxic encephalopathy 34.93 17.31 27 31765 8672 90587983
Electrocardiogram QT prolonged 33.80 17.31 77 31715 72379 90524276
Anticonvulsant drug level above therapeutic 33.30 17.31 11 31781 558 90596097
Defect conduction intraventricular 33.28 17.31 9 31783 227 90596428
Therapeutic product effective for unapproved indication 32.91 17.31 8 31784 130 90596525
Cardiotoxicity 32.49 17.31 29 31763 11360 90585295
Mood swings 32.16 17.31 38 31754 20664 90575991
Night sweats 31.50 17.31 4 31788 128762 90467893
Postictal paralysis 31.48 17.31 9 31783 280 90596375
Therapeutic product ineffective for unapproved indication 31.12 17.31 9 31783 292 90596363
Hypernatraemia 31.03 17.31 26 31766 9361 90587294
Laryngeal stenosis 30.64 17.31 13 31779 1326 90595329
Oedema 30.63 17.31 16 31776 200279 90396376
Bronchitis 30.46 17.31 8 31784 152919 90443736
Blood lactic acid increased 30.44 17.31 25 31767 8753 90587902
Hospice care 30.27 17.31 26 31766 9678 90586977
Self-medication 30.23 17.31 17 31775 3203 90593452
Febrile neutropenia 30.20 17.31 9 31783 158340 90438315
Treatment noncompliance 29.93 17.31 60 31732 51667 90544988
Hypertransaminasaemia 29.62 17.31 32 31760 15793 90580862
Herpes oesophagitis 29.32 17.31 8 31784 209 90596446
Sedation 29.23 17.31 57 31735 48114 90548541
Gait inability 28.53 17.31 8 31784 146448 90450207
Disease recurrence 28.47 17.31 49 31743 37604 90559051
Lichenoid keratosis 28.28 17.31 15 31777 2519 90594136
Electrocardiogram repolarisation abnormality 27.04 17.31 12 31780 1364 90595291
Rebound effect 26.98 17.31 24 31768 9360 90587295
Contusion 26.95 17.31 29 31763 251187 90345468
Hypoaesthesia 26.82 17.31 43 31749 314167 90282488
Electrocardiogram ST segment elevation 26.75 17.31 17 31775 3999 90592656
Affective disorder 26.62 17.31 22 31770 7771 90588884
Obesity 26.49 17.31 3 31789 105504 90491151
Severe myoclonic epilepsy of infancy 26.45 17.31 6 31786 71 90596584
Drug effective for unapproved indication 26.31 17.31 22 31770 7896 90588759
Drug intolerance 25.97 17.31 76 31716 447515 90149140
Euthyroid sick syndrome 25.65 17.31 6 31786 82 90596573
Directional Doppler flow tests abnormal 25.59 17.31 4 31788 3 90596652
Tachycardia 25.28 17.31 116 31676 157557 90439098
Drug hypersensitivity 25.28 17.31 81 31711 463528 90133127
Cardio-respiratory arrest 25.03 17.31 63 31729 63077 90533578
Food interaction 24.77 17.31 11 31781 1253 90595402
Thrombotic microangiopathy 24.63 17.31 29 31763 15714 90580941
Acquired macroglossia 24.51 17.31 7 31785 217 90596438
Chest discomfort 24.40 17.31 9 31783 138356 90458299
Dyskinesia 24.35 17.31 45 31747 36489 90560166
Intrusive thoughts 24.03 17.31 8 31784 416 90596239
Postictal psychosis 23.90 17.31 6 31786 112 90596543
Rhesus incompatibility 23.90 17.31 6 31786 112 90596543
Ventricular fibrillation 23.87 17.31 27 31765 14017 90582638
Intensive care unit acquired weakness 23.75 17.31 10 31782 1001 90595654
Systolic dysfunction 23.33 17.31 12 31780 1892 90594763
Upper respiratory tract infection 23.22 17.31 8 31784 128310 90468345
Anger 22.68 17.31 26 31766 13694 90582961
Fatigue 22.60 17.31 278 31514 1153745 89442910
Ventricular hypokinesia 22.37 17.31 17 31775 5324 90591331
Oedema peripheral 22.28 17.31 35 31757 257880 90338775
Cholestasis 22.08 17.31 43 31749 36256 90560399
Intensive care unit delirium 22.05 17.31 5 31787 59 90596596
Hallucination, olfactory 21.96 17.31 7 31785 317 90596338
Product confusion 21.91 17.31 6 31786 159 90596496
Speech disorder 21.88 17.31 49 31743 45536 90551119
Brain death 21.88 17.31 15 31777 4006 90592649
Rash morbilliform 21.85 17.31 15 31777 4014 90592641
Frontal lobe epilepsy 21.81 17.31 4 31788 14 90596641
Intentional product misuse 21.69 17.31 75 31717 89529 90507126
Brain neoplasm 21.52 17.31 16 31776 4848 90591807
Antinuclear antibody positive 21.48 17.31 21 31771 9220 90587435
Lipoedema 21.45 17.31 7 31785 342 90596313
Lung disorder 21.44 17.31 13 31779 149870 90446785
Cross sensitivity reaction 21.32 17.31 13 31779 2844 90593811
Soliloquy 21.25 17.31 7 31785 352 90596303
Dry mouth 21.16 17.31 20 31772 184039 90412616
Febrile infection-related epilepsy syndrome 20.66 17.31 4 31788 20 90596635
Memory impairment 20.61 17.31 129 31663 197115 90399540
Hypoventilation 20.31 17.31 16 31776 5280 90591375
Liver injury 20.24 17.31 18 31774 170549 90426106
Amnestic disorder 20.24 17.31 7 31785 409 90596246
Chest pain 20.23 17.31 52 31740 319593 90277062
Depression 20.20 17.31 177 31615 300424 90296231
White matter lesion 20.18 17.31 12 31780 2509 90594146
Epilepsy surgery 20.05 17.31 4 31788 24 90596631
Erysipelas 19.99 17.31 20 31772 9032 90587623
Drug clearance increased 19.73 17.31 6 31786 232 90596423
Cellulitis 19.73 17.31 4 31788 91333 90505322
Hepatocellular injury 19.72 17.31 36 31756 28922 90567733
Pregnancy on oral contraceptive 19.62 17.31 9 31783 1106 90595549
Hippocampal sclerosis 19.59 17.31 5 31787 100 90596555
Gamma-glutamyltransferase increased 19.58 17.31 42 31750 37910 90558745
Hemianopia 19.57 17.31 11 31781 2071 90594584
Psoriasis 19.53 17.31 14 31778 147740 90448915
Loss of consciousness 19.47 17.31 99 31693 140139 90456516
Product availability issue 19.45 17.31 18 31774 7386 90589269
Rectal haemorrhage 19.23 17.31 3 31789 82741 90513914
Dysarthria 19.18 17.31 52 31740 54430 90542225
Dropped head syndrome 19.10 17.31 6 31786 259 90596396
Myalgia 19.02 17.31 20 31772 175105 90421550
Hypersomnia 18.94 17.31 30 31762 21501 90575154
Hypercholesterolaemia 18.76 17.31 6 31786 100886 90495769
QRS axis abnormal 18.72 17.31 9 31783 1229 90595426
Wrong patient 18.55 17.31 8 31784 849 90595806
Vagal nerve stimulator implantation 18.53 17.31 4 31788 37 90596618
Urine output increased 18.46 17.31 10 31782 1752 90594903
Therapy partial responder 18.41 17.31 30 31762 22013 90574642
Learning disorder 18.37 17.31 8 31784 870 90595785
Pregnancy on contraceptive 18.33 17.31 9 31783 1286 90595369
Resting tremor 18.32 17.31 8 31784 875 90595780
Anticoagulation drug level abnormal 18.31 17.31 5 31787 131 90596524
Erythema multiforme 18.24 17.31 22 31770 12224 90584431
Foetal exposure during pregnancy 18.22 17.31 44 31748 42931 90553724
Cortical dysplasia 18.16 17.31 4 31788 41 90596614
Agoraphobia 18.11 17.31 7 31785 561 90596094
Psychiatric symptom 18.11 17.31 17 31775 7101 90589554
Bicytopenia 18.03 17.31 13 31779 3758 90592897
Focal segmental glomerulosclerosis 18.00 17.31 10 31782 1841 90594814
Pneumonia 17.78 17.31 141 31651 637918 89958737
Systolic hypertension 17.78 17.31 7 31785 590 90596065
Violence-related symptom 17.62 17.31 7 31785 604 90596051
Gastrointestinal haemorrhage 17.44 17.31 5 31787 90243 90506412
Vertigo 17.39 17.31 59 31733 69752 90526903

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
Seizure 1746.69 16.86 1024 25443 119537 42475331
Status epilepticus 1060.44 16.86 389 26078 15189 42579679
Multiple-drug resistance 850.86 16.86 273 26194 7049 42587819
Drug ineffective 665.60 16.86 1298 25169 628899 41965969
Generalised tonic-clonic seizure 616.61 16.86 309 26158 26070 42568798
Partial seizures 522.58 16.86 179 26288 5680 42589188
Epilepsy 407.26 16.86 234 26233 25937 42568931
Focal dyscognitive seizures 230.59 16.86 69 26398 1398 42593470
Aggression 227.36 16.86 201 26266 43962 42550906
Off label use 209.02 16.86 863 25604 637472 41957396
Sudden unexplained death in epilepsy 206.68 16.86 51 26416 478 42594390
Electrocardiogram QRS complex prolonged 153.09 16.86 74 26393 5749 42589119
Overdose 148.69 16.86 248 26219 105016 42489852
Petit mal epilepsy 142.18 16.86 61 26406 3589 42591279
Dyspnoea 130.68 16.86 56 26411 442565 42152303
Partial seizures with secondary generalisation 121.81 16.86 32 26435 393 42594475
Somnolence 120.98 16.86 269 26198 140836 42454032
Drug ineffective for unapproved indication 115.73 16.86 143 26324 46020 42548848
Ataxia 115.57 16.86 89 26378 16036 42578832
Drug resistance 107.36 16.86 119 26348 34129 42560739
Vanishing bile duct syndrome 106.30 16.86 41 26426 1830 42593038
Atrioventricular block complete 104.70 16.86 73 26394 11291 42583577
Behaviour disorder 101.47 16.86 60 26407 6994 42587874
Drug withdrawal convulsions 89.35 16.86 33 26434 1305 42593563
Aura 89.05 16.86 25 26442 400 42594468
Seizure cluster 87.66 16.86 23 26444 281 42594587
Myoclonic epilepsy 85.64 16.86 34 26433 1640 42593228
Cognitive disorder 84.25 16.86 105 26362 34067 42560801
Cholestatic liver injury 82.27 16.86 42 26425 3667 42591201
Anticonvulsant drug level above therapeutic 80.35 16.86 26 26441 687 42594181
Electroencephalogram abnormal 75.56 16.86 37 26430 2955 42591913
Irritability 71.86 16.86 88 26379 28040 42566828
Drug interaction 69.11 16.86 338 26129 266661 42328207
Maternal exposure during pregnancy 67.03 16.86 46 26421 6932 42587936
Diarrhoea 66.89 16.86 115 26352 460734 42134134
Hyperammonaemia 66.61 16.86 48 26419 7818 42587050
Change in seizure presentation 63.26 16.86 18 26449 303 42594565
Agitation 60.00 16.86 127 26340 64187 42530681
Necrosis ischaemic 59.76 16.86 18 26449 373 42594495
Arthralgia 58.74 16.86 27 26440 205211 42389657
Excessive eye blinking 58.68 16.86 20 26447 623 42594245
Glioblastoma 55.94 16.86 24 26443 1411 42593457
Sinus bradycardia 54.27 16.86 56 26411 14797 42580071
Organic brain syndrome 53.28 16.86 16 26451 328 42594540
Febrile neutropenia 52.25 16.86 25 26442 185678 42409190
Atrioventricular block second degree 50.94 16.86 32 26435 4155 42590713
Product availability issue 50.41 16.86 30 26437 3537 42591331
Abdominal pain 50.09 16.86 28 26439 190443 42404425
Atrioventricular block 49.88 16.86 44 26423 9571 42585297
Hyperammonaemic encephalopathy 49.19 16.86 27 26440 2731 42592137
Pneumonia aspiration 49.17 16.86 101 26366 49977 42544891
Prescribed overdose 47.70 16.86 49 26418 12878 42581990
Tonic convulsion 46.39 16.86 22 26445 1637 42593231
Postictal psychosis 46.30 16.86 13 26454 208 42594660
Diplopia 46.22 16.86 60 26407 20256 42574612
Nystagmus 45.85 16.86 33 26434 5363 42589505
Congenital hypoplasia of depressor angularis oris muscle 45.54 16.86 8 26459 8 42594860
Superinfection 44.81 16.86 26 26441 2925 42591943
Atrioventricular block first degree 44.70 16.86 35 26432 6456 42588412
Haemoglobin decreased 43.56 16.86 14 26453 132457 42462411
Gaze palsy 43.50 16.86 22 26445 1883 42592985
Cardiac failure congestive 41.58 16.86 3 26464 85599 42509269
Urge incontinence 41.43 16.86 15 26452 560 42594308
Mucosal ulceration 41.09 16.86 19 26448 1335 42593533
Hippocampal sclerosis 40.61 16.86 11 26456 153 42594715
Chest pain 40.45 16.86 18 26449 139512 42455356
Posture abnormal 40.38 16.86 23 26444 2498 42592370
Intellectual disability 40.37 16.86 21 26446 1906 42592962
Cataract congenital 39.49 16.86 10 26457 105 42594763
Sedation 39.23 16.86 69 26398 30406 42564462
Foetal exposure during pregnancy 39.09 16.86 89 26378 47222 42547646
Brain operation 39.02 16.86 14 26453 509 42594359
Bradycardia 38.74 16.86 129 26338 85355 42509513
Affective disorder 38.60 16.86 31 26436 5929 42588939
Pneumonia 38.54 16.86 134 26333 422015 42172853
Intentional overdose 38.38 16.86 93 26374 51363 42543505
Acute kidney injury 37.42 16.86 111 26356 367226 42227642
Myoclonus 36.66 16.86 49 26418 17016 42577852
Pain 36.42 16.86 60 26407 244788 42350080
No adverse event 36.31 16.86 77 26390 38944 42555924
Hyperkinesia 35.93 16.86 20 26447 2078 42592790
Postictal paralysis 35.48 16.86 12 26455 365 42594503
Atonic seizures 34.32 16.86 12 26455 404 42594464
Cardiac failure 33.89 16.86 12 26455 106844 42488024
Bladder hypertrophy 33.71 16.86 14 26453 759 42594109
Anger 33.68 16.86 41 26426 12977 42581891
Memory impairment 33.50 16.86 87 26380 50135 42544733
Drug reaction with eosinophilia and systemic symptoms 33.49 16.86 78 26389 41997 42552871
Sinus node dysfunction 33.25 16.86 26 26441 4786 42590082
Acoustic stimulation tests abnormal 33.11 16.86 8 26459 68 42594800
Exposure via breast milk 32.85 16.86 20 26447 2457 42592411
Coarctation of the aorta 32.77 16.86 12 26455 463 42594405
Psychogenic seizure 32.77 16.86 12 26455 463 42594405
Chills 32.63 16.86 9 26458 94057 42500811
Bradykinesia 32.53 16.86 27 26440 5409 42589459
Intestinal ischaemia 31.80 16.86 34 26433 9354 42585514
Abnormal behaviour 31.63 16.86 58 26409 26393 42568475
Metabolic encephalopathy 31.19 16.86 26 26441 5239 42589629
Dysarthria 30.81 16.86 73 26394 39734 42555134
Muscle twitching 30.31 16.86 37 26430 11743 42583125
Hypernatraemia 29.94 16.86 34 26433 9998 42584870
Anomaly of external ear congenital 29.42 16.86 8 26459 113 42594755
Gastrointestinal haemorrhage 29.28 16.86 12 26455 97714 42497154
Blood creatinine increased 29.14 16.86 16 26451 109987 42484881
Abdominal compartment syndrome 28.91 16.86 14 26453 1091 42593777
Joint swelling 28.84 16.86 4 26463 68018 42526850
Haematuria traumatic 28.65 16.86 10 26457 335 42594533
Wrong patient received product 28.37 16.86 21 26446 3562 42591306
Product substitution issue 28.30 16.86 35 26432 11255 42583613
Interstitial lung disease 28.18 16.86 7 26460 78455 42516413
Cough 28.02 16.86 42 26425 178061 42416807
Pleural effusion 27.43 16.86 13 26454 97153 42497715
Intensive care unit acquired weakness 26.98 16.86 14 26453 1264 42593604
Postictal state 26.92 16.86 13 26454 1007 42593861
Infantile spasms 26.76 16.86 9 26458 269 42594599
Premature baby 26.72 16.86 50 26417 23103 42571765
Platelet count decreased 26.68 16.86 28 26439 138553 42456315
Brain oedema 26.44 16.86 41 26426 16286 42578582
Vagal nerve stimulator implantation 26.35 16.86 7 26460 90 42594778
Myocardial infarction 26.27 16.86 23 26444 123986 42470882
Cholestasis 26.21 16.86 61 26406 32818 42562050
Encephalitis autoimmune 26.00 16.86 14 26453 1363 42593505
Treatment noncompliance 25.88 16.86 66 26401 37606 42557262
Pyrexia 25.62 16.86 142 26325 393900 42200968
Psychotic disorder 25.30 16.86 56 26411 29152 42565716
Pain in extremity 25.19 16.86 34 26433 150570 42444298
Vitamin B6 deficiency 25.06 16.86 9 26458 328 42594540
Idiopathic generalised epilepsy 25.05 16.86 6 26461 49 42594819
Congenital melanocytic naevus 24.76 16.86 5 26462 16 42594852
Tremor 24.46 16.86 122 26345 96807 42498061
Speech disorder 24.29 16.86 55 26412 29066 42565802
Temporal lobe epilepsy 24.25 16.86 8 26459 225 42594643
Initial insomnia 24.08 16.86 20 26447 4010 42590858
Automatism 24.01 16.86 7 26460 129 42594739
Myalgia 23.99 16.86 15 26452 96065 42498803
Epistaxis 23.92 16.86 6 26461 66820 42528048
Quadriparesis 23.78 16.86 16 26451 2334 42592534
Anticonvulsant drug level increased 23.69 16.86 14 26453 1629 42593239
Hallucination 23.61 16.86 84 26383 57423 42537445
Drop attacks 23.42 16.86 10 26457 581 42594287
Acute myocardial infarction 23.34 16.86 4 26463 58161 42536707
Hypertension 22.99 16.86 43 26424 167161 42427707
Encephalopathy 22.99 16.86 67 26400 41266 42553602
Hyperhidrosis 22.78 16.86 14 26453 90498 42504370
Circulating anticoagulant 22.77 16.86 4 26463 4 42594864
Muscle contracture 22.74 16.86 13 26454 1422 42593446
Simple partial seizures 22.73 16.86 9 26458 431 42594437
Acute psychosis 22.63 16.86 15 26452 2134 42592734
Low birth weight baby 22.02 16.86 29 26438 9926 42584942
Systemic inflammatory response syndrome 21.98 16.86 25 26442 7365 42587503
Head injury 21.97 16.86 43 26424 20539 42574329
Cardiotoxicity 21.83 16.86 25 26442 7420 42587448
Personality change 21.68 16.86 22 26445 5697 42589171
COVID-19 21.68 16.86 24 26443 115924 42478944
Asthma 21.53 16.86 6 26461 62308 42532560
Neuropathy peripheral 21.44 16.86 19 26448 101834 42493034
Haematochezia 21.40 16.86 5 26462 58431 42536437
Skin warm 21.14 16.86 16 26451 2807 42592061
Injection site pain 21.05 16.86 5 26462 57793 42537075
Impulsive behaviour 20.99 16.86 15 26452 2410 42592458
Rectal haemorrhage 20.83 16.86 3 26464 49603 42545265
Infusion related reaction 20.74 16.86 6 26461 60800 42534068
Depressive symptom 20.72 16.86 18 26449 3835 42591033
Language disorder 20.71 16.86 15 26452 2460 42592408
Mucosal inflammation 20.70 16.86 3 26464 49371 42545497
Dizziness 20.63 16.86 241 26226 249013 42345855
Blood glucose increased 20.58 16.86 10 26457 73689 42521179
Electrocardiogram QT prolonged 20.51 16.86 71 26396 47874 42546994
Depressed level of consciousness 20.49 16.86 71 26396 47899 42546969
Sepsis 20.41 16.86 60 26407 199274 42395594
C-reactive protein increased 20.38 16.86 7 26460 63553 42531315
Suicide attempt 20.36 16.86 69 26398 46031 42548837
Peroneal nerve palsy 20.14 16.86 17 26450 3485 42591383
Bundle branch block right 20.11 16.86 25 26442 8081 42586787
Pulmonary embolism 20.00 16.86 27 26440 119585 42475283
Cardiac arrest 19.88 16.86 126 26341 109194 42485674
Brain neoplasm 19.86 16.86 17 26450 3551 42591317
Abdominal discomfort 19.84 16.86 11 26456 75244 42519624
Malignant neoplasm progression 19.65 16.86 23 26444 108377 42486491
Treatment failure 19.62 16.86 84 26383 62540 42532328
Thrombosis 19.59 16.86 9 26458 68502 42526366
Wheezing 19.45 16.86 5 26462 54776 42540092
Toxicity to various agents 19.16 16.86 222 26245 228914 42365954
Corpus callosotomy 19.16 16.86 3 26464 0 42594868
Inability to crawl 19.16 16.86 3 26464 0 42594868
Abdominal pain upper 19.14 16.86 14 26453 82595 42512273
Keloid scar 19.06 16.86 5 26462 61 42594807
Atrial septal defect 18.97 16.86 24 26443 7895 42586973
Drug level decreased 18.95 16.86 27 26440 9950 42584918
Nausea 18.79 16.86 157 26310 396642 42198226
Blood lactic acid increased 18.68 16.86 24 26443 8015 42586853
Ascites 18.60 16.86 6 26461 56672 42538196
Anticonvulsant drug level below therapeutic 18.50 16.86 9 26458 708 42594160
Chronic obstructive pulmonary disease 18.50 16.86 8 26459 63106 42531762
Thrombotic microangiopathy 18.42 16.86 33 26434 14749 42580119
Vitamin B6 decreased 18.39 16.86 4 26463 20 42594848
Leukocytosis 18.32 16.86 50 26417 29658 42565210
Conduction disorder 18.26 16.86 14 26453 2504 42592364
Accidental death 17.80 16.86 15 26452 3068 42591800
Periventricular haemorrhage neonatal 17.77 16.86 4 26463 24 42594844
Productive cough 17.75 16.86 5 26462 51562 42543306
Bundle branch block left 17.74 16.86 21 26446 6455 42588413
Amnesia 17.68 16.86 48 26419 28389 42566479
Anaemia 17.64 16.86 102 26365 280176 42314692
Plasma cell myeloma 17.56 16.86 4 26463 47574 42547294
Malaise 17.55 16.86 70 26397 212086 42382782
Sinusitis 17.41 16.86 4 26463 47288 42547580
Pancreatitis acute 17.33 16.86 53 26414 33511 42561357
Congenital aortic atresia 17.24 16.86 4 26463 28 42594840
Hyperbilirubinaemia 17.24 16.86 39 26428 20596 42574272
Hypothermia neonatal 17.21 16.86 5 26462 91 42594777
Disturbance in attention 17.17 16.86 49 26418 29817 42565051
Hypoglycaemia 16.90 16.86 8 26459 59846 42535022

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
Seizure 3005.93 15.24 1598 46706 219587 110321408
Multiple-drug resistance 2204.19 15.24 602 47702 12633 110528362
Status epilepticus 2178.62 15.24 728 47576 30843 110510152
Drug ineffective 1285.45 15.24 2328 45976 1518212 109022783
Generalised tonic-clonic seizure 1046.95 15.24 500 47804 54180 110486815
Partial seizures 863.34 15.24 282 48022 11067 110529928
Epilepsy 593.22 15.24 428 47876 99781 110441214
Off label use 452.64 15.24 1555 46749 1498630 109042365
Focal dyscognitive seizures 432.75 15.24 129 48175 3720 110537275
Petit mal epilepsy 377.10 15.24 137 48167 7410 110533585
Drug ineffective for unapproved indication 369.87 15.24 328 47976 102510 110438485
Somnolence 341.10 15.24 526 47778 296923 110244072
Electrocardiogram QRS complex prolonged 333.71 15.24 146 48158 12875 110528120
Aggression 314.35 15.24 237 48067 58973 110482022
Drug interaction 289.07 15.24 659 47645 499524 110041471
Drug resistance 289 15.24 221 48083 56153 110484842
Overdose 279.95 15.24 422 47882 233372 110307623
Sudden unexplained death in epilepsy 247.44 15.24 60 48244 763 110540232
Atrioventricular block complete 240.26 15.24 134 48170 19948 110521047
Behaviour disorder 240.18 15.24 106 48198 9541 110531454
Partial seizures with secondary generalisation 219.73 15.24 55 48249 804 110540191
Diplopia 207.62 15.24 161 48143 41733 110499262
Dyspnoea 197.63 15.24 120 48184 1106752 109434243
Cognitive disorder 194.89 15.24 215 48089 87296 110453699
Seizure cluster 186.73 15.24 48 48256 785 110540210
Ataxia 183.43 15.24 131 48173 29977 110511018
Myoclonic epilepsy 177.18 15.24 60 48244 2631 110538364
Irritability 172.77 15.24 153 48151 47656 110493339
Pain 168.29 15.24 105 48199 954850 109586145
Arthralgia 162.15 15.24 69 48235 779563 109761432
Cardiac arrest 160.21 15.24 299 48005 196454 110344541
Atrioventricular block 157.86 15.24 96 48208 16781 110524214
Myoclonus 157.40 15.24 124 48180 32874 110508121
Drug reaction with eosinophilia and systemic symptoms 154.63 15.24 185 48119 81910 110459085
Bradycardia 154.61 15.24 258 48046 155259 110385736
Aura 154.32 15.24 44 48260 1080 110539915
Change in seizure presentation 148.33 15.24 40 48264 794 110540201
Propofol infusion syndrome 144.41 15.24 51 48253 2538 110538457
Joint swelling 137.88 15.24 16 48288 442829 110098166
Tonic convulsion 135.86 15.24 51 48253 3023 110537972
Atonic seizures 135.48 15.24 40 48264 1114 110539881
Infusion related reaction 134.46 15.24 8 48296 381154 110159841
Agitation 125.19 15.24 197 48107 112854 110428141
Drug withdrawal convulsions 124.36 15.24 45 48259 2404 110538591
Diarrhoea 123.81 15.24 192 48112 1139313 109401682
Pneumonia aspiration 122.71 15.24 164 48140 81069 110459926
Hyperammonaemia 120.50 15.24 75 48229 13657 110527338
Mitochondrial DNA mutation 119.37 15.24 30 48274 446 110540549
Rheumatoid arthritis 116.71 15.24 3 48301 299610 110241385
Anticonvulsant drug level increased 114.01 15.24 44 48260 2814 110538181
Maternal exposure before pregnancy 110.84 15.24 57 48247 7208 110533787
Electroencephalogram abnormal 110.57 15.24 54 48250 6119 110534876
Suicide attempt 106.03 15.24 174 48130 103220 110437775
Toxicity to various agents 105.22 15.24 452 47852 480103 110060892
Product substitution issue 104.29 15.24 84 48220 22977 110518018
Sinus bradycardia 101.84 15.24 92 48212 29391 110511604
Intentional overdose 99.94 15.24 195 48109 132306 110408689
Swelling 99.13 15.24 17 48287 351024 110189971
Sinus node dysfunction 99.11 15.24 57 48247 8990 110532005
Anticonvulsant drug level above therapeutic 98.53 15.24 32 48272 1230 110539765
Arthropathy 98.52 15.24 7 48297 287515 110253480
Encephalopathy 94.97 15.24 145 48159 80910 110460085
Electrocardiogram PR prolongation 94.09 15.24 34 48270 1809 110539186
No adverse event 93.52 15.24 137 48167 73702 110467293
Lower respiratory tract infection 92.60 15.24 3 48301 243103 110297892
Abnormal behaviour 92.25 15.24 99 48205 38940 110502055
Sinusitis 91.60 15.24 11 48293 296677 110244318
Atrioventricular block first degree 91.51 15.24 64 48240 14161 110526834
Hyperammonaemic encephalopathy 89.80 15.24 45 48259 5389 110535606
Nystagmus 88.59 15.24 58 48246 11519 110529476
Abdominal pain 85.29 15.24 60 48244 512929 110028066
Abdominal discomfort 83.11 15.24 34 48270 393824 110147171
Depressed level of consciousness 80.75 15.24 162 48142 112116 110428879
Drug level decreased 80.58 15.24 66 48238 18482 110522513
Premature delivery 80.09 15.24 82 48222 30550 110510445
Coma 79.96 15.24 166 48138 117703 110423292
Wound 79.47 15.24 6 48298 234431 110306564
Pericarditis 79.09 15.24 4 48300 219110 110321885
Balance disorder 78.89 15.24 164 48140 116396 110424599
Pain in extremity 78.34 15.24 59 48245 487059 110053936
Systemic lupus erythematosus 77.12 15.24 10 48294 254328 110286667
CSF oligoclonal band present 76.31 15.24 21 48283 451 110540544
Peripheral swelling 75.82 15.24 41 48263 403993 110137002
Altered state of consciousness 73.09 15.24 107 48197 57519 110483476
Wrong patient received product 72.98 15.24 42 48262 6632 110534363
Nasopharyngitis 71.15 15.24 42 48262 394319 110146676
Malaise 71.05 15.24 115 48189 671704 109869291
Abdominal pain upper 70.68 15.24 32 48272 349079 110191916
Contraindicated product administered 70.12 15.24 12 48292 248255 110292740
Atrioventricular block second degree 70.06 15.24 44 48260 8137 110532858
Impaired healing 69.72 15.24 4 48300 196713 110344282
Nausea 68.99 15.24 292 48012 1235398 109305597
Vagal nerve stimulator implantation 68.93 15.24 17 48287 233 110540762
Wheezing 68.53 15.24 14 48290 255216 110285779
Myocardial depression 67.21 15.24 21 48283 711 110540284
Blister 66.44 15.24 10 48294 227366 110313629
Automatism epileptic 66.40 15.24 12 48292 28 110540967
Hypernatraemia 66.26 15.24 58 48246 17775 110523220
Maternal exposure during breast feeding 63.93 15.24 33 48271 4205 110536790
Tremor 63.86 15.24 214 48090 202018 110338977
Hypertension 63.15 15.24 78 48226 510006 110030989
Gaze palsy 61.61 15.24 30 48274 3377 110537618
Anticonvulsant drug level decreased 61.45 15.24 26 48278 2110 110538885
Musculoskeletal pain 61.14 15.24 5 48299 183018 110357977
Vanishing bile duct syndrome 60.62 15.24 29 48275 3139 110537856
Disturbance in attention 60.41 15.24 102 48202 61893 110479102
Metabolic acidosis 60.21 15.24 134 48170 99610 110441385
Hallucination, visual 59.85 15.24 80 48224 39525 110501470
Encephalitis 59.65 15.24 56 48248 18783 110522212
Head injury 59.13 15.24 83 48221 42934 110498061
Alopecia 58.84 15.24 44 48260 364709 110176286
Electrocardiogram QT prolonged 58.74 15.24 140 48164 108820 110432175
Pruritus 58.28 15.24 103 48201 581457 109959538
Febrile neutropenia 58.17 15.24 33 48271 316734 110224261
Blood gases abnormal 58.09 15.24 22 48282 1336 110539659
Excessive eye blinking 57.95 15.24 24 48280 1846 110539149
Postictal paralysis 57.79 15.24 18 48286 603 110540392
Hypersensitivity 57.50 15.24 55 48249 403943 110137052
Affective disorder 57.42 15.24 44 48260 11197 110529798
Unmasking of previously unidentified disease 57.16 15.24 27 48277 2841 110538154
Sedation 56.76 15.24 106 48198 69577 110471418
Intellectual disability 56.64 15.24 24 48280 1955 110539040
C-reactive protein increased 56.37 15.24 13 48291 217906 110323089
Cerebral salt-wasting syndrome 56.29 15.24 15 48289 284 110540711
Simple partial seizures 56.23 15.24 20 48284 1016 110539979
Mobility decreased 56.04 15.24 17 48287 237405 110303590
Intensive care unit acquired weakness 55.76 15.24 25 48279 2334 110538661
Treatment noncompliance 55.71 15.24 108 48196 72882 110468113
Asthma 55.44 15.24 20 48284 250271 110290724
Discomfort 55.16 15.24 13 48291 214694 110326301
Ventricular tachycardia 55.12 15.24 87 48217 49922 110491073
Chest pain 55.02 15.24 50 48254 376325 110164670
Postictal state 54.89 15.24 25 48279 2421 110538574
Encephalitis autoimmune 54.74 15.24 28 48276 3500 110537495
Cough 53.63 15.24 74 48230 461567 110079428
Ill-defined disorder 53.19 15.24 4 48300 156849 110384146
Pleocytosis 53.00 15.24 22 48282 1702 110539293
Sinus arrest 52.63 15.24 29 48275 4213 110536782
Gene mutation 52.59 15.24 27 48277 3402 110537593
Folliculitis 52.27 15.24 6 48298 167647 110373348
Aphasia 52.17 15.24 93 48211 58904 110482091
Blood lactic acid increased 51.96 15.24 48 48256 15773 110525222
Cholestatic liver injury 51.72 15.24 35 48269 7341 110533654
Angiofibroma 51.67 15.24 12 48292 125 110540870
Injection site pain 51.58 15.24 8 48296 177914 110363081
Cardiotoxicity 51.19 15.24 49 48255 16832 110524163
Cholestasis 51.13 15.24 97 48207 64421 110476574
Hippocampal sclerosis 50.95 15.24 13 48291 206 110540789
Therapeutic product effect decreased 50.05 15.24 22 48282 244294 110296701
Glioblastoma 49.44 15.24 22 48282 2018 110538977
Metabolic encephalopathy 49.40 15.24 40 48264 11020 110529975
Hypoaesthesia 49.28 15.24 39 48265 314184 110226811
Thrombotic microangiopathy 48.90 15.24 62 48242 29087 110511908
Temporal lobe epilepsy 48.72 15.24 15 48289 483 110540512
Drug level increased 48.48 15.24 80 48224 47639 110493356
Blood cholesterol increased 47.84 15.24 11 48293 184774 110356221
Product availability issue 47.28 15.24 34 48270 7856 110533139
Psychotic disorder 47.25 15.24 82 48222 50855 110490140
Urticaria 47.02 15.24 42 48262 318815 110222180
Suicidal ideation 46.69 15.24 117 48187 93820 110447175
Ventricular arrhythmia 46.15 15.24 37 48267 10050 110530945
Arthritis 45.38 15.24 9 48295 167577 110373418
Drug hypersensitivity 44.05 15.24 82 48222 454008 110086987
Necrosis ischaemic 44.01 15.24 18 48286 1341 110539654
Muscle injury 43.99 15.24 5 48299 140802 110400193
Inflammation 43.54 15.24 15 48289 193223 110347772
Postictal psychosis 43.29 15.24 12 48292 265 110540730
Neurotoxicity 43.20 15.24 71 48233 42136 110498859
Dizziness 43.01 15.24 480 47824 697713 109843282
Mood swings 40.63 15.24 50 48254 22762 110518233
Back pain 40.58 15.24 62 48242 370934 110170061
Stomatitis 40.56 15.24 35 48269 270207 110270788
Hyperkinesia 40.14 15.24 22 48282 3162 110537833
Pneumonia 39.63 15.24 223 48081 876491 109664504
Anger 39.37 15.24 45 48259 18962 110522033
Gastrointestinal disorder 39.24 15.24 29 48275 241923 110299072
Night sweats 38.89 15.24 6 48298 133977 110407018
Brain oedema 38.35 15.24 57 48247 31041 110509954
Posture abnormal 38.33 15.24 24 48280 4414 110536581
Chest discomfort 38.30 15.24 14 48290 173834 110367161
Abortion spontaneous 38.28 15.24 60 48244 34222 110506773
Osteoarthritis 38.11 15.24 16 48288 182607 110358388
Rectal haemorrhage 38.08 15.24 4 48300 119829 110421166
Dysarthria 37.91 15.24 101 48203 84020 110456975
Type 2 diabetes mellitus 37.84 15.24 15 48289 177217 110363778
Musculoskeletal stiffness 37.61 15.24 40 48264 279782 110261213
Speech disorder 37.47 15.24 83 48221 61486 110479509
Therapeutic product ineffective for unapproved indication 37.37 15.24 11 48293 303 110540692
Mucosal ulceration 37.26 15.24 19 48285 2360 110538635
Fall 37.19 15.24 415 47889 603067 109937928
Gastrooesophageal reflux disease 37.18 15.24 16 48288 179960 110361035
Human T-cell lymphotropic virus infection 36.26 15.24 6 48298 6 110540989
Automatism 36.24 15.24 10 48294 217 110540778
Bundle branch block right 36.00 15.24 35 48269 12256 110528739
Lymphangioleiomyomatosis 35.89 15.24 10 48294 225 110540770
Myalgia 35.62 15.24 27 48277 222354 110318641
Haematuria traumatic 35.44 15.24 11 48293 364 110540631
Cardiac failure congestive 35.28 15.24 11 48293 150989 110390006
Haemoglobin decreased 35.20 15.24 34 48270 248693 110292302
Arterial intramural haematoma 34.97 15.24 10 48294 248 110540747
Superinfection 34.92 15.24 25 48279 5738 110535257
Therapeutic product effective for unapproved indication 34.63 15.24 9 48295 154 110540841
Organic brain syndrome 34.41 15.24 12 48292 575 110540420
Oedema 34.27 15.24 25 48279 209951 110331044
Lung disorder 34.14 15.24 18 48286 180029 110360966
Febrile infection-related epilepsy syndrome 33.57 15.24 8 48296 94 110540901
Toxic encephalopathy 33.18 15.24 37 48267 15177 110525818
Macroglossia 33.00 15.24 15 48289 1446 110539549
Anticoagulation drug level abnormal 32.84 15.24 10 48294 310 110540685
Angiomyolipoma 32.78 15.24 10 48294 312 110540683
Memory impairment 32.58 15.24 171 48133 196773 110344222
Gastrointestinal haemorrhage 32.20 15.24 16 48288 165502 110375493
Chills 32.01 15.24 22 48282 190558 110350437
Pleural effusion 31.92 15.24 19 48285 177690 110363305
Drug effective for unapproved indication 31.84 15.24 35 48269 14132 110526863
Haematochezia 31.70 15.24 6 48298 115518 110425477
Thrombocytopenia 31.41 15.24 260 48044 348625 110192370
Paraesthesia 31.41 15.24 45 48259 276476 110264519
Blood creatine phosphokinase increased 31.19 15.24 86 48218 72991 110468004
Hallucination 30.81 15.24 106 48198 101326 110439669
Contusion 30.65 15.24 34 48270 233327 110307668
Injury 30.39 15.24 20 48284 177245 110363750
Circulating anticoagulant 30.22 15.24 5 48299 5 110540990
Arrhythmia 29.81 15.24 82 48222 69493 110471502
Abortion induced 29.63 15.24 26 48278 7993 110533002
Oedema peripheral 29.57 15.24 62 48242 328598 110212397
Cortical dysplasia 29.20 15.24 6 48298 33 110540962
Brain operation 29.16 15.24 12 48292 908 110540087
Lipids abnormal 28.95 15.24 11 48293 674 110540321
Lennox-Gastaut syndrome 28.88 15.24 9 48295 302 110540693
Maternal exposure during pregnancy 28.58 15.24 200 48104 254683 110286312
Post stroke depression 28.54 15.24 5 48299 9 110540986
Intrusive thoughts 28.40 15.24 11 48293 710 110540285
Gait inability 28.36 15.24 12 48292 136364 110404631
Dyspepsia 28.32 15.24 25 48279 190940 110350055
Fatigue 27.64 15.24 370 47934 1215588 109325407
Loss of consciousness 27.52 15.24 163 48141 196143 110344852
Laryngeal stenosis 27.37 15.24 13 48291 1385 110539610
Infection 27.30 15.24 75 48229 362125 110178870
Productive cough 27.30 15.24 8 48296 114297 110426698
Ascites 27.29 15.24 4 48300 92804 110448191
Obesity 26.95 15.24 8 48296 113343 110427652
Bronchitis 26.54 15.24 18 48286 157014 110383981
Dyskinesia 26.53 15.24 65 48239 51381 110489614
Intestinal ischaemia 26.49 15.24 34 48270 16145 110524850
Muscle spasms 26.28 15.24 51 48253 278106 110262889
Abdominal compartment syndrome 26.20 15.24 14 48290 1913 110539082
Neuropathy peripheral 25.96 15.24 24 48280 179253 110361742
Rhesus incompatibility 25.85 15.24 5 48299 19 110540976
Idiopathic generalised epilepsy 25.79 15.24 6 48298 63 110540932
Respiratory acidosis 25.75 15.24 31 48273 13795 110527200
Quadriparesis 25.31 15.24 19 48285 4688 110536307
Hepatocellular injury 25.08 15.24 63 48241 50579 110490416
Cerebral atrophy 24.99 15.24 25 48279 9060 110531935
Acute kidney injury 24.83 15.24 169 48135 635261 109905734
Shock 24.81 15.24 65 48239 53523 110487472
Therapeutic product effect incomplete 24.72 15.24 175 48129 223630 110317365
Leukocytosis 24.63 15.24 65 48239 53763 110487232
Personality change 24.41 15.24 27 48277 10975 110530020
Acute psychosis 24.33 15.24 19 48285 4968 110536027
Mucosal inflammation 24.33 15.24 6 48298 96135 110444860
Drooling 24.11 15.24 22 48282 7117 110533878
Language disorder 24.06 15.24 17 48287 3821 110537174
Headache 24.03 15.24 258 48046 882119 109658876
Drug eruption 23.75 15.24 64 48240 53595 110487400
Pregnancy 23.71 15.24 62 48242 51005 110489990
Hepatic cytolysis 23.70 15.24 65 48239 54988 110486007
Exposure during pregnancy 23.45 15.24 139 48165 167285 110373710
Euthyroid sick syndrome 23.40 15.24 6 48298 97 110540898
Hypersomnia 23.24 15.24 43 48261 28018 110512977
Conduction disorder 23.22 15.24 17 48287 4038 110536957
Vitamin B6 deficiency 23.15 15.24 9 48295 587 110540408
Psychiatric symptom 22.89 15.24 24 48280 9189 110531806
Product confusion 22.52 15.24 7 48297 233 110540762
Psoriasis 22.41 15.24 17 48287 139976 110401019
Herpes oesophagitis 22.41 15.24 8 48296 411 110540584
Hypercholesterolaemia 22.35 15.24 6 48298 90831 110450164
Rhabdomyolysis 22.34 15.24 108 48196 120293 110420702
Systemic inflammatory response syndrome 22.29 15.24 28 48276 13015 110527980
Upper respiratory tract infection 22.26 15.24 15 48289 131313 110409682
Gait disturbance 22.24 15.24 202 48102 278006 110262989
Sexually inappropriate behaviour 22.12 15.24 9 48295 662 110540333
Gelastic seizure 21.94 15.24 4 48300 10 110540985
Acquired macroglossia 21.75 15.24 7 48297 261 110540734
Brain death 21.70 15.24 20 48284 6553 110534442
Acute myocardial infarction 21.65 15.24 5 48299 83772 110457223
Hyponatraemia 21.65 15.24 166 48138 217487 110323508
Red blood cell sedimentation rate increased 21.63 15.24 4 48300 78298 110462697
Tricuspid valve incompetence 21.58 15.24 38 48266 23835 110517160
Nasal congestion 21.50 15.24 8 48296 98274 110442721
Defect conduction intraventricular 21.49 15.24 9 48295 712 110540283
Exposure via breast milk 21.48 15.24 10 48294 1018 110539977
Blood pressure systolic increased 21.36 15.24 5 48299 82986 110458009
Muscle contracture 21.32 15.24 14 48290 2794 110538201
Hypertransaminasaemia 21.14 15.24 38 48266 24217 110516778
Psychogenic seizure 20.96 15.24 13 48291 2351 110538644
Stevens-Johnson syndrome 20.81 15.24 56 48248 46845 110494150
Drop attacks 20.60 15.24 10 48294 1118 110539877
Cellulitis 20.56 15.24 15 48289 126001 110414994
Intensive care unit delirium 20.38 15.24 5 48299 67 110540928
Brain neoplasm 20.37 15.24 19 48285 6318 110534677
Anticonvulsant drug level below therapeutic 20.32 15.24 10 48294 1152 110539843
Educational problem 20.31 15.24 8 48296 540 110540455
Ventriculo-peritoneal shunt 20.31 15.24 5 48299 68 110540927
Inability to crawl 20.21 15.24 3 48301 0 110540995
Epileptic psychosis 20.17 15.24 5 48299 70 110540925
Blood glucose increased 20.06 15.24 17 48287 132479 110408516
Low birth weight baby 20.01 15.24 9 48295 846 110540149
Unresponsive to stimuli 19.67 15.24 67 48237 63723 110477272
Loss of personal independence in daily activities 19.54 15.24 22 48282 149998 110390997
Caesarean section 19.49 15.24 27 48277 13790 110527205
Dry mouth 19.46 15.24 36 48268 199912 110341083
Depressive symptom 19.28 15.24 21 48283 8393 110532602
Malignant neoplasm progression 19.24 15.24 29 48275 174538 110366457
Blood pressure increased 19.09 15.24 54 48250 258319 110282676
Flushing 19.08 15.24 11 48293 104725 110436270
Disease recurrence 18.88 15.24 64 48240 60720 110480275
Autoimmune disorder 18.84 15.24 3 48301 65480 110475515
Self-medication 18.73 15.24 18 48286 6214 110534781
Electrocardiogram repolarisation abnormality 18.60 15.24 12 48292 2323 110538672
Liver injury 18.58 15.24 23 48281 150390 110390605
Staring 18.57 15.24 13 48291 2879 110538116
Urge incontinence 18.46 15.24 10 48294 1405 110539590
Screaming 18.38 15.24 16 48288 4865 110536130
Constipation 18.37 15.24 87 48217 357699 110183296
Creutzfeldt-Jakob disease 18.36 15.24 6 48298 235 110540760
Myocardial infarction 18.33 15.24 35 48269 192048 110348947
Colitis 18.28 15.24 11 48293 102312 110438683
Hyperbilirubinaemia 18.27 15.24 41 48263 30630 110510365
Therapy partial responder 18.24 15.24 46 48258 37015 110503980
Epistaxis 18.23 15.24 18 48286 130354 110410641
Restlessness 18.15 15.24 60 48244 56199 110484796
Anaphylactic reaction 18.14 15.24 14 48290 114286 110426709
Epilepsy surgery 18.13 15.24 3 48301 3 110540992
Cardio-respiratory arrest 18.07 15.24 99 48205 115737 110425258
Rebound effect 18.06 15.24 27 48277 14779 110526216
Astrocytoma 17.92 15.24 6 48298 254 110540741
Learning disorder 17.87 15.24 8 48296 744 110540251
Antinuclear antibody positive 17.81 15.24 21 48283 9147 110531848
Mental status changes 17.68 15.24 73 48231 76049 110464946
Corpus callosotomy 17.67 15.24 3 48301 4 110540991
Bladder hypertrophy 17.67 15.24 9 48295 1115 110539880
Craniocerebral injury 17.57 15.24 17 48287 5917 110535078
Hepatic enzyme increased 17.08 15.24 77 48227 320815 110220180
Food interaction 17.00 15.24 11 48293 2141 110538854
Impulsive behaviour 16.98 15.24 13 48291 3302 110537693
Delusion 16.74 15.24 34 48270 23721 110517274
Lichenoid keratosis 16.71 15.24 17 48287 6285 110534710
Cerebellar syndrome 16.71 15.24 17 48287 6285 110534710
General physical health deterioration 16.65 15.24 113 48191 425182 110115813
Disorientation 16.59 15.24 68 48236 70603 110470392
Cross sensitivity reaction 16.58 15.24 16 48288 5551 110535444
COVID-19 immunisation 16.53 15.24 9 48295 1277 110539718
Transaminases increased 16.50 15.24 63 48241 63327 110477668
Vitamin B6 decreased 16.48 15.24 4 48300 51 110540944
Cardiac failure 16.36 15.24 36 48268 187590 110353405
Hyperhidrosis 16.28 15.24 36 48268 187262 110353733
Drug metabolite level high 16.27 15.24 4 48300 54 110540941
Bradyarrhythmia 16.26 15.24 15 48289 4919 110536076
Ammonia increased 16.19 15.24 19 48285 8231 110532764
Accidental death 16.07 15.24 15 48289 4994 110536001
Skin ulcer 16.05 15.24 4 48300 63641 110477354
Respiratory depression 16.04 15.24 40 48264 31961 110509034
Blood creatinine increased 16.02 15.24 35 48269 182854 110358141
Violence-related symptom 16.02 15.24 8 48296 951 110540044
Feeling hot 15.99 15.24 10 48294 91096 110449899
Homicidal ideation 15.95 15.24 13 48291 3614 110537381
Prescribed overdose 15.84 15.24 78 48226 87503 110453492
Pancreatitis acute 15.76 15.24 60 48244 60214 110480781
Agranulocytosis 15.76 15.24 61 48243 61699 110479296
Pulmonary embolism 15.71 15.24 45 48259 214429 110326566
Myelosuppression 15.69 15.24 11 48293 94329 110446666
Febrile infection 15.59 15.24 14 48290 4434 110536561
Angina pectoris 15.55 15.24 4 48300 62291 110478704
Infantile spasms 15.53 15.24 6 48298 385 110540610
Joint stiffness 15.52 15.24 5 48299 67238 110473757
Autoimmune encephalopathy 15.50 15.24 5 48299 188 110540807
Interstitial lung disease 15.49 15.24 23 48281 139311 110401684
COVID-19 15.45 15.24 55 48249 245005 110295990
Rasmussen encephalitis 15.39 15.24 3 48301 12 110540983
Oropharyngeal pain 15.37 15.24 22 48282 135254 110405741
Drug clearance increased 15.36 15.24 6 48298 396 110540599

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC N03AX18 NERVOUS SYSTEM
ANTIEPILEPTICS
ANTIEPILEPTICS
Other antiepileptics
FDA PE N0000008486 Decreased Central Nervous System Disorganized Electrical Activity
MeSH PA D000927 Anticonvulsants
MeSH PA D002317 Cardiovascular Agents
MeSH PA D026941 Sodium Channel Blockers
MeSH PA D049990 Membrane Transport Modulators
MeSH PA D061567 Voltage-Gated Sodium Channel Blockers
CHEBI has role CHEBI:35469 antidepressant
CHEBI has role CHEBI:35474 anxiolytic drug
CHEBI has role CHEBI:35476 antipsychotic agent
CHEBI has role CHEBI:35480 analgesic
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:35623 anticonvulsant
CHEBI has role CHEBI:231911 renoprotective agent

Related Drugs by ATC class:

N03AX Other antiepileptics 18 drugs
beclamidebrivaracetamcannabidiolcarisbamatecenobamatefelbamatefenfluramineganaxolonelamotriginelevetiracetamperampanelphenacemide show all 18 →

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

DiseaseRelationSNOMED_IDDOID
Idiopathic generalized epilepsy indication 36803009
Tonic-clonic seizure in patients with epilepsy indication 352818000 DOID:7725
Partial Epilepsy Treatment Adjunct indication
Atrial flutter contraindication 5370000
Suicidal thoughts contraindication 6471006
Complete atrioventricular block contraindication 27885002
Orthostatic hypotension contraindication 28651003
Sick sinus syndrome contraindication 36083008 DOID:13884
Chronic heart failure contraindication 48447003
Atrial fibrillation contraindication 49436004 DOID:0060224
Acute nephropathy contraindication 58574008
Second degree atrioventricular block contraindication 195042002
Disease of liver contraindication 235856003 DOID:409
Suicidal contraindication 267073005
Disorder of coronary artery contraindication 414024009
Myocardial ischemia contraindication 414795007 DOID:3393
Severe Cardiac Disease contraindication
First Degree Atrioventricular Heart Block contraindication




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 12.83 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
100MG MOTPOLY XR AUCTA N216185 May 4, 2023 RX CAPSULE, EXTENDED RELEASE ORAL 11337943 June 5, 2040 ADJUNCTIVE THERAPY IN THE TREATMENT OF PRIMARY GENERALIZED TONIC-CLONIC SEIZURES IN ADULTS AND IN PEDIATRIC PATIENTS WEIGHING AT LEAST 50 KG
100MG MOTPOLY XR AUCTA N216185 May 4, 2023 RX CAPSULE, EXTENDED RELEASE ORAL 11337943 June 5, 2040 TREATMENT OF PARTIAL-ONSET SEIZURES IN ADULTS AND IN PEDIATRIC PATIENTS WEIGHING AT LEAST 50 KG
100MG MOTPOLY XR AUCTA N216185 May 4, 2023 RX CAPSULE, EXTENDED RELEASE ORAL 11883374 June 5, 2040 ADJUNCTIVE THERAPY IN THE TREATMENT OF PRIMARY GENERALIZED TONIC-CLONIC SEIZURES IN ADULTS AND IN PEDIATRIC PATIENTS WEIGHING AT LEAST 50 KG
100MG MOTPOLY XR AUCTA N216185 May 4, 2023 RX CAPSULE, EXTENDED RELEASE ORAL 11883374 June 5, 2040 TREATMENT OF PARTIAL-ONSET SEIZURES IN ADULTS AND IN PEDIATRIC PATIENTS WEIGHING AT LEAST 50 KG
100MG MOTPOLY XR AUCTA N216185 May 4, 2023 RX CAPSULE, EXTENDED RELEASE ORAL 12042474 June 5, 2040 ADJUNCTIVE THERAPY IN THE TREATMENT OF PRIMARY GENERALIZED TONIC-CLONIC SEIZURES IN ADULTS AND IN PEDIATRIC PATIENTS WEIGHING AT LEAST 50 KG
100MG MOTPOLY XR AUCTA N216185 May 4, 2023 RX CAPSULE, EXTENDED RELEASE ORAL 12042474 June 5, 2040 TREATMENT OF PARTIAL-ONSET SEIZURES IN ADULTS AND IN PEDIATRIC PATIENTS WEIGHING AT LEAST 50 KG
150MG MOTPOLY XR AUCTA N216185 May 4, 2023 RX CAPSULE, EXTENDED RELEASE ORAL 11337943 June 5, 2040 ADJUNCTIVE THERAPY IN THE TREATMENT OF PRIMARY GENERALIZED TONIC-CLONIC SEIZURES IN ADULTS AND IN PEDIATRIC PATIENTS WEIGHING AT LEAST 50 KG
150MG MOTPOLY XR AUCTA N216185 May 4, 2023 RX CAPSULE, EXTENDED RELEASE ORAL 11337943 June 5, 2040 TREATMENT OF PARTIAL-ONSET SEIZURES IN ADULTS AND IN PEDIATRIC PATIENTS WEIGHING AT LEAST 50 KG
150MG MOTPOLY XR AUCTA N216185 May 4, 2023 RX CAPSULE, EXTENDED RELEASE ORAL 11883374 June 5, 2040 ADJUNCTIVE THERAPY IN THE TREATMENT OF PRIMARY GENERALIZED TONIC-CLONIC SEIZURES IN ADULTS AND IN PEDIATRIC PATIENTS WEIGHING AT LEAST 50 KG
150MG MOTPOLY XR AUCTA N216185 May 4, 2023 RX CAPSULE, EXTENDED RELEASE ORAL 11883374 June 5, 2040 TREATMENT OF PARTIAL-ONSET SEIZURES IN ADULTS AND IN PEDIATRIC PATIENTS WEIGHING AT LEAST 50 KG
150MG MOTPOLY XR AUCTA N216185 May 4, 2023 RX CAPSULE, EXTENDED RELEASE ORAL 12042474 June 5, 2040 ADJUNCTIVE THERAPY IN THE TREATMENT OF PRIMARY GENERALIZED TONIC-CLONIC SEIZURES IN ADULTS AND IN PEDIATRIC PATIENTS WEIGHING AT LEAST 50 KG
150MG MOTPOLY XR AUCTA N216185 May 4, 2023 RX CAPSULE, EXTENDED RELEASE ORAL 12042474 June 5, 2040 TREATMENT OF PARTIAL-ONSET SEIZURES IN ADULTS AND IN PEDIATRIC PATIENTS WEIGHING AT LEAST 50 KG
200MG MOTPOLY XR AUCTA N216185 May 4, 2023 RX CAPSULE, EXTENDED RELEASE ORAL 11337943 June 5, 2040 ADJUNCTIVE THERAPY IN THE TREATMENT OF PRIMARY GENERALIZED TONIC-CLONIC SEIZURES IN ADULTS AND IN PEDIATRIC PATIENTS WEIGHING AT LEAST 50 KG
200MG MOTPOLY XR AUCTA N216185 May 4, 2023 RX CAPSULE, EXTENDED RELEASE ORAL 11337943 June 5, 2040 TREATMENT OF PARTIAL-ONSET SEIZURES IN ADULTS AND IN PEDIATRIC PATIENTS WEIGHING AT LEAST 50 KG
200MG MOTPOLY XR AUCTA N216185 May 4, 2023 RX CAPSULE, EXTENDED RELEASE ORAL 11883374 June 5, 2040 ADJUNCTIVE THERAPY IN THE TREATMENT OF PRIMARY GENERALIZED TONIC-CLONIC SEIZURES IN ADULTS AND IN PEDIATRIC PATIENTS WEIGHING AT LEAST 50 KG
200MG MOTPOLY XR AUCTA N216185 May 4, 2023 RX CAPSULE, EXTENDED RELEASE ORAL 11883374 June 5, 2040 TREATMENT OF PARTIAL-ONSET SEIZURES IN ADULTS AND IN PEDIATRIC PATIENTS WEIGHING AT LEAST 50 KG
200MG MOTPOLY XR AUCTA N216185 May 4, 2023 RX CAPSULE, EXTENDED RELEASE ORAL 12042474 June 5, 2040 ADJUNCTIVE THERAPY IN THE TREATMENT OF PRIMARY GENERALIZED TONIC-CLONIC SEIZURES IN ADULTS AND IN PEDIATRIC PATIENTS WEIGHING AT LEAST 50 KG
200MG MOTPOLY XR AUCTA N216185 May 4, 2023 RX CAPSULE, EXTENDED RELEASE ORAL 12042474 June 5, 2040 TREATMENT OF PARTIAL-ONSET SEIZURES IN ADULTS AND IN PEDIATRIC PATIENTS WEIGHING AT LEAST 50 KG

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
100MG VIMPAT UCB INC N022253 Oct. 28, 2008 RX TABLET ORAL April 28, 2026 USE OF ALTERNATE INITIAL DOSING REGIMEN FOR INITIATION OF LACOSAMIDE TREATMENT IN PARTIAL ONSET SEIZURE PATIENTS ≥1 MONTH TO <17 YEARS OF AGE AND IN PRIMARY GENERALIZED TONIC-CLONIC SEIZURE PATIENTS ≥4 TO <17 YEARS
150MG VIMPAT UCB INC N022253 Oct. 28, 2008 RX TABLET ORAL April 28, 2026 USE OF ALTERNATE INITIAL DOSING REGIMEN FOR INITIATION OF LACOSAMIDE TREATMENT IN PARTIAL ONSET SEIZURE PATIENTS ≥1 MONTH TO <17 YEARS OF AGE AND IN PRIMARY GENERALIZED TONIC-CLONIC SEIZURE PATIENTS ≥4 TO <17 YEARS
200MG VIMPAT UCB INC N022253 Oct. 28, 2008 RX TABLET ORAL April 28, 2026 USE OF ALTERNATE INITIAL DOSING REGIMEN FOR INITIATION OF LACOSAMIDE TREATMENT IN PARTIAL ONSET SEIZURE PATIENTS ≥1 MONTH TO <17 YEARS OF AGE AND IN PRIMARY GENERALIZED TONIC-CLONIC SEIZURE PATIENTS ≥4 TO <17 YEARS
50MG VIMPAT UCB INC N022253 Oct. 28, 2008 RX TABLET ORAL April 28, 2026 USE OF ALTERNATE INITIAL DOSING REGIMEN FOR INITIATION OF LACOSAMIDE TREATMENT IN PARTIAL ONSET SEIZURE PATIENTS ≥1 MONTH TO <17 YEARS OF AGE AND IN PRIMARY GENERALIZED TONIC-CLONIC SEIZURE PATIENTS ≥4 TO <17 YEARS
200MG/20ML (10MG/ML) VIMPAT UCB INC N022254 Oct. 28, 2008 RX SOLUTION INTRAVENOUS April 28, 2026 USE OF ALTERNATE INITIAL DOSING REGIMEN FOR INITIATION OF LACOSAMIDE TREATMENT IN PARTIAL ONSET SEIZURE PATIENTS ≥1 MONTH TO <17 YEARS OF AGE AND IN PRIMARY GENERALIZED TONIC-CLONIC SEIZURE PATIENTS ≥4 TO <17 YEARS
10MG/ML VIMPAT UCB INC N022255 April 20, 2010 RX SOLUTION ORAL April 28, 2026 USE OF ALTERNATE INITIAL DOSING REGIMEN FOR INITIATION OF LACOSAMIDE TREATMENT IN PARTIAL ONSET SEIZURE PATIENTS ≥1 MONTH TO <17 YEARS OF AGE AND IN PRIMARY GENERALIZED TONIC-CLONIC SEIZURE PATIENTS ≥4 TO <17 YEARS

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Sodium channel protein type 9 subunit alpha Ion channel BLOCKER IC50 6.74 CHEMBL CHEMBL
Carbonic anhydrase 2 Enzyme Ki 6.48 CHEMBL
Carbonic anhydrase 1 Enzyme Ki 6.44 CHEMBL
Carbonic anhydrase 4 Enzyme Ki 6.28 CHEMBL
Carbonic anhydrase 9 Enzyme Ki 6.45 CHEMBL
Carbonic anhydrase 12 Enzyme Ki 5.43 CHEMBL
Carbonic anhydrase 5A, mitochondrial Enzyme Ki 5.34 CHEMBL
Carbonic anhydrase 5B, mitochondrial Enzyme Ki 6.47 CHEMBL
Carbonic anhydrase 7 Enzyme Ki 5.35 CHEMBL
Carbonic anhydrase 3 Enzyme Ki 6.43 CHEMBL
Carbonic anhydrase 6 Enzyme Ki 6.39 CHEMBL
Carbonic anhydrase 14 Enzyme Ki 6.33 CHEMBL
Carbonic anhydrase 13 Enzyme Ki 5.92 CHEMBL
Dihydropyrimidinase-related protein 2 Enzyme WOMBAT-PK
Sodium channel protein type 2 subunit alpha Ion channel BLOCKER IC50 4.52 IUPHAR
Carbonic anhydrase 15 Enzyme Ki 6.34 CHEMBL
Sodium channel protein type 3 subunit alpha Ion channel IC50 6.38 CHEMBL
Sodium channel protein type X alpha subunit Ion channel IC50 4.80 CHEMBL

External reference:

IDSource
4028103 VUID
N0000179735 NUI
D07299 KEGG_DRUG
4028103 VANDF
C0893761 UMLSCUI
CHEBI:135939 CHEBI
LQO PDB_CHEM_ID
CHEMBL58323 ChEMBL_ID
D000078334 MESH_DESCRIPTOR_UI
DB06218 DRUGBANK_ID
C476828 MESH_SUPPLEMENTAL_RECORD_UI
7472 IUPHAR_LIGAND_ID
8094 INN_ID
563KS2PQY5 UNII
219078 PUBCHEM_CID
623400 RXNORM
158490 MMSL
25914 MMSL
350800 MMSL
d07349 MMSL
012839 NDDF
441532003 SNOMEDCT_US
441647003 SNOMEDCT_US
563KS2PQY5 INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Lacosamide HUMAN PRESCRIPTION DRUG LABEL 1 0121-0992 SOLUTION 50 mg ORAL ANDA 31 sections
Lacosamide HUMAN PRESCRIPTION DRUG LABEL 1 0121-1012 SOLUTION 50 mg ORAL ANDA 31 sections
Lacosamide HUMAN PRESCRIPTION DRUG LABEL 1 0121-1984 SOLUTION 100 mg ORAL ANDA 31 sections
Lacosamide HUMAN PRESCRIPTION DRUG LABEL 1 0121-2024 SOLUTION 100 mg ORAL ANDA 31 sections
Lacosamide HUMAN PRESCRIPTION DRUG LABEL 1 0121-2976 SOLUTION 150 mg ORAL ANDA 31 sections
Lacosamide HUMAN PRESCRIPTION DRUG LABEL 1 0121-3036 SOLUTION 150 mg ORAL ANDA 31 sections
Lacosamide HUMAN PRESCRIPTION DRUG LABEL 1 0121-3968 SOLUTION 200 mg ORAL ANDA 31 sections
Lacosamide HUMAN PRESCRIPTION DRUG LABEL 1 0121-4048 SOLUTION 200 mg ORAL ANDA 31 sections
Vimpat HUMAN PRESCRIPTION DRUG LABEL 1 0131-1810 INJECTION 10 mg INTRAVENOUS NDA 35 sections
Vimpat HUMAN PRESCRIPTION DRUG LABEL 1 0131-2477 TABLET, FILM COATED 50 mg ORAL NDA 35 sections
Vimpat HUMAN PRESCRIPTION DRUG LABEL 1 0131-2478 TABLET, FILM COATED 100 mg ORAL NDA 35 sections
Vimpat HUMAN PRESCRIPTION DRUG LABEL 1 0131-2479 TABLET, FILM COATED 150 mg ORAL NDA 35 sections
Vimpat HUMAN PRESCRIPTION DRUG LABEL 1 0131-2480 TABLET, FILM COATED 200 mg ORAL NDA 35 sections
Vimpat HUMAN PRESCRIPTION DRUG LABEL 1 0131-5410 SOLUTION 10 mg ORAL NDA 35 sections
Lacosamide HUMAN PRESCRIPTION DRUG LABEL 1 0904-7244 TABLET, FILM COATED 50 mg ORAL ANDA 30 sections
Lacosamide HUMAN PRESCRIPTION DRUG LABEL 1 0904-7245 TABLET, FILM COATED 100 mg ORAL ANDA 30 sections
Lacosamide HUMAN PRESCRIPTION DRUG LABEL 1 0904-7246 TABLET, FILM COATED 150 mg ORAL ANDA 30 sections
Lacosamide HUMAN PRESCRIPTION DRUG LABEL 1 0904-7247 TABLET, FILM COATED 200 mg ORAL ANDA 30 sections
Lacosamide HUMAN PRESCRIPTION DRUG LABEL 1 0904-7463 SOLUTION 50 mg ORAL ANDA 29 sections
Lacosamide HUMAN PRESCRIPTION DRUG LABEL 1 0904-7464 SOLUTION 100 mg ORAL ANDA 29 sections
Lacosamide Human Prescription Drug Label 1 10135-799 TABLET, FILM COATED 50 mg ORAL ANDA 35 sections
Lacosamide Human Prescription Drug Label 1 10135-800 TABLET, FILM COATED 100 mg ORAL ANDA 35 sections
Lacosamide Human Prescription Drug Label 1 10135-801 TABLET, FILM COATED 150 mg ORAL ANDA 35 sections
Lacosamide Human Prescription Drug Label 1 10135-802 TABLET, FILM COATED 200 mg ORAL ANDA 35 sections
Lacosamide HUMAN PRESCRIPTION DRUG LABEL 1 13811-207 INJECTION 10 mg INTRAVENOUS ANDA 36 sections
Lacosamide HUMAN PRESCRIPTION DRUG LABEL 1 14335-330 INJECTION 10 mg INTRAVENOUS ANDA 36 sections
Lacosamide Human Prescription Drug Label 1 14445-129 TABLET 50 mg ORAL ANDA 30 sections
Lacosamide Human Prescription Drug Label 1 14445-130 TABLET 100 mg ORAL ANDA 30 sections
Lacosamide Human Prescription Drug Label 1 14445-131 TABLET 150 mg ORAL ANDA 30 sections
Lacosamide Human Prescription Drug Label 1 14445-132 TABLET 200 mg ORAL ANDA 30 sections