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

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 1841.89 17.34 920 22574 131714 63333814
Status epilepticus 1140.59 17.34 359 23135 14874 63450654
Multiple-drug resistance 864.98 17.34 228 23266 4942 63460586
Generalised tonic-clonic seizure 558.39 17.34 253 23241 28763 63436765
Epilepsy 418.66 17.34 203 23291 26862 63438666
Partial seizures 360.43 17.34 119 23375 5723 63459805
Overdose 319.92 17.34 295 23199 114783 63350745
Drug ineffective 265.97 17.34 915 22579 1043850 62421678
Off label use 261.31 17.34 686 22808 673776 62791752
Focal dyscognitive seizures 261.25 17.34 79 23415 2842 63462686
Diplopia 208.10 17.34 122 23372 23606 63441922
Maternal exposure before pregnancy 207.66 17.34 85 23409 7518 63458010
Somnolence 156.08 17.34 255 23239 178430 63287098
Drug ineffective for unapproved indication 147.66 17.34 113 23381 33950 63431578
Pregnancy 137.73 17.34 112 23382 36724 63428804
Abortion spontaneous 132.85 17.34 122 23372 47073 63418455
Maternal exposure during pregnancy 129.84 17.34 265 23229 219797 63245731
Petit mal epilepsy 126.53 17.34 49 23445 3745 63461783
Pain 123.91 17.34 60 23434 740568 62724960
Drug resistance 121.78 17.34 86 23408 22847 63442681
Drug interaction 119.04 17.34 262 23232 228869 63236659
Aura 117.72 17.34 34 23460 1039 63464489
Myoclonus 116.95 17.34 73 23421 15795 63449733
Myoclonic epilepsy 116.80 17.34 35 23459 1219 63464309
Mitochondrial DNA mutation 112.30 17.34 27 23467 395 63465133
Propofol infusion syndrome 111.65 17.34 32 23462 951 63464577
Irritability 111.43 17.34 93 23401 31601 63433927
Electrocardiogram QRS complex prolonged 102.27 17.34 48 23446 5890 63459638
Arthralgia 101.67 17.34 42 23452 569668 62895860
Seizure cluster 98.65 17.34 22 23472 226 63465302
Abnormal behaviour 94.86 17.34 72 23422 21354 63444174
Premature delivery 90.53 17.34 81 23413 30200 63435328
Atrioventricular block complete 90.10 17.34 49 23445 8202 63457326
Bradycardia 88.85 17.34 122 23372 73105 63392423
Joint swelling 86.56 17.34 10 23484 327656 63137872
Diarrhoea 85.00 17.34 84 23410 715282 62750246
Drug reaction with eosinophilia and systemic symptoms 84.73 17.34 82 23412 33754 63431774
Balance disorder 81.15 17.34 126 23368 84296 63381232
Rheumatoid arthritis 80.77 17.34 3 23491 253816 63211712
Cognitive disorder 80.10 17.34 101 23393 55714 63409814
CSF oligoclonal band present 78.28 17.34 20 23474 380 63465148
Partial seizures with secondary generalisation 77.64 17.34 20 23474 393 63465135
Dyspnoea 76.99 17.34 79 23415 661234 62804294
Infusion related reaction 74.52 17.34 4 23490 245517 63220011
Sudden unexplained death in epilepsy 72.39 17.34 18 23476 305 63465223
Change in seizure presentation 72.34 17.34 19 23475 404 63465124
Encephalopathy 72.17 17.34 80 23414 38540 63426988
Electroencephalogram abnormal 70.47 17.34 32 23462 3640 63461888
Cardiac arrest 69.97 17.34 124 23370 92421 63373107
Product substitution issue 69.15 17.34 53 23441 15943 63449585
Atrioventricular block 68.81 17.34 40 23454 7607 63457921
Gene mutation 68.21 17.34 25 23469 1640 63463888
Swelling 66.59 17.34 11 23483 275367 63190161
Maternal exposure during breast feeding 66.07 17.34 32 23462 4209 63461319
Blood gases abnormal 64.64 17.34 20 23474 777 63464751
Neurotoxicity 64.19 17.34 52 23442 16938 63448590
Pleocytosis 63.49 17.34 20 23474 825 63464703
Ataxia 62.75 17.34 49 23445 15146 63450382
Aggression 62.72 17.34 59 23435 23439 63442089
Abdominal discomfort 59.85 17.34 22 23472 320863 63144665
No adverse event 59.51 17.34 75 23419 41330 63424198
Behaviour disorder 58.63 17.34 27 23467 3172 63462356
Sinusitis 57.20 17.34 8 23486 226645 63238883
Aphasia 55.95 17.34 65 23429 32935 63432593
Anticonvulsant drug level increased 55.63 17.34 21 23473 1496 63464032
Post stroke depression 54.08 17.34 9 23485 13 63465515
Simple partial seizures 53.40 17.34 16 23478 557 63464971
Disturbance in attention 53.03 17.34 68 23426 38121 63427407
Stillbirth 52.13 17.34 32 23462 6718 63458810
Hyperammonaemia 51.44 17.34 29 23465 5203 63460325
Tonic convulsion 51.38 17.34 19 23475 1278 63464250
Toxicity to various agents 51.34 17.34 204 23290 247046 63218482
Encephalitis 51.11 17.34 35 23459 8845 63456683
Psychotic disorder 51.06 17.34 55 23439 25657 63439871
Electrocardiogram PR prolongation 49.71 17.34 16 23478 708 63464820
Angiofibroma 49.59 17.34 11 23483 110 63465418
Nystagmus 49.35 17.34 30 23464 6190 63459338
Hallucination, visual 48.74 17.34 47 23447 19251 63446277
Tremor 48.07 17.34 132 23362 132107 63333421
Atonic seizures 47.49 17.34 15 23479 624 63464904
Discomfort 47.05 17.34 4 23490 167370 63298158
Systemic lupus erythematosus 46.95 17.34 10 23484 208908 63256620
Dizziness 46.65 17.34 295 23199 429630 63035898
Pain in extremity 46.51 17.34 33 23461 331453 63134075
Nasopharyngitis 46.44 17.34 18 23476 254239 63211289
Drug withdrawal convulsions 46.08 17.34 18 23476 1407 63464121
Memory impairment 46.06 17.34 112 23382 104146 63361382
Metabolic acidosis 45.72 17.34 69 23425 45000 63420528
Abdominal pain 45.57 17.34 26 23468 293430 63172098
Cough 45.37 17.34 26 23468 292717 63172811
Altered state of consciousness 44.97 17.34 51 23443 25179 63440349
Peripheral swelling 43.58 17.34 22 23472 265920 63199608
Musculoskeletal stiffness 43.24 17.34 8 23486 184610 63280918
Back pain 43.06 17.34 22 23472 264123 63201405
Wound 43.02 17.34 5 23489 163258 63302270
Drug level increased 42.30 17.34 47 23447 22689 63442839
Abortion induced 42.23 17.34 33 23461 10209 63455319
Encephalitis autoimmune 41.89 17.34 17 23477 1469 63464059
Wrong patient received product 41.62 17.34 19 23475 2188 63463340
Unmasking of previously unidentified disease 41.26 17.34 15 23479 961 63464567
Sinus arrest 40.64 17.34 18 23476 1931 63463597
Tachycardia 40.04 17.34 115 23379 118041 63347487
Lymphangioleiomyomatosis 39.54 17.34 10 23484 182 63465346
Depressed level of consciousness 39.17 17.34 77 23417 62001 63403527
Sinus node dysfunction 38.20 17.34 23 23471 4662 63460866
Therapeutic product effect decreased 38.15 17.34 12 23482 193175 63272353
Angiomyolipoma 38.10 17.34 10 23484 212 63465316
Sinus bradycardia 37.80 17.34 36 23458 14515 63451013
Suicidal ideation 37.67 17.34 76 23418 62345 63403183
Hypersensitivity 37.42 17.34 32 23462 292653 63172875
Coma 37.23 17.34 77 23417 64287 63401241
Injection site pain 36.76 17.34 3 23491 129797 63335731
Intentional overdose 36.37 17.34 83 23411 74069 63391459
Atrioventricular block first degree 35.67 17.34 26 23468 7247 63458281
Respiratory acidosis 35.21 17.34 25 23469 6690 63458838
Agitation 35.16 17.34 72 23422 59685 63405843
Ventricular tachycardia 34.95 17.34 40 23454 19939 63445589
Blood lactic acid increased 34.01 17.34 25 23469 7061 63458467
Hyperammonaemic encephalopathy 33.85 17.34 17 23477 2417 63463111
Suicide attempt 33.05 17.34 71 23423 60847 63404681
Laryngeal stenosis 32.69 17.34 13 23481 1065 63464463
Bronchitis 32.48 17.34 4 23490 124931 63340597
Head injury 32.23 17.34 45 23449 27351 63438177
Alopecia 31.13 17.34 48 23446 337488 63128040
Pneumonia aspiration 31.01 17.34 50 23444 34490 63431038
Lipids abnormal 30.88 17.34 9 23485 284 63465244
Anticonvulsant drug level decreased 30.81 17.34 13 23481 1239 63464289
Pericarditis 30.17 17.34 6 23488 131573 63333955
Cardiotoxicity 30.14 17.34 25 23469 8413 63457115
Nausea 29.76 17.34 190 23304 854281 62611247
Hospice care 29.38 17.34 24 23470 7908 63457620
Automatism epileptic 28.70 17.34 5 23489 11 63465517
Food interaction 28.57 17.34 11 23483 827 63464701
Intrusive thoughts 28.50 17.34 8 23486 220 63465308
Shock 28.29 17.34 39 23455 23424 63442104
Malaise 27.36 17.34 72 23422 415882 63049646
Arthritis 27.18 17.34 5 23489 115916 63349612
Electrocardiogram repolarisation abnormality 26.93 17.34 12 23482 1305 63464223
Macroglossia 26.73 17.34 10 23484 695 63464833
Hypertransaminasaemia 26.61 17.34 21 23473 6588 63458940
Exposure during pregnancy 26.55 17.34 121 23373 155426 63310102
Ventricular fibrillation 26.44 17.34 27 23467 11840 63453688
Electrocardiogram ST segment elevation 26.27 17.34 17 23477 3910 63461618
Postictal state 26.24 17.34 11 23483 1032 63464496
Arrhythmia 26.13 17.34 49 23445 38091 63427437
Severe myoclonic epilepsy of infancy 26.13 17.34 6 23488 71 63465457
Pruritus 25.77 17.34 60 23434 361393 63104135
Blister 25.73 17.34 8 23486 129806 63335722
Euthyroid sick syndrome 25.54 17.34 6 23488 79 63465449
Directional Doppler flow tests abnormal 25.37 17.34 4 23490 3 63465525
Intensive care unit acquired weakness 25.25 17.34 10 23484 811 63464717
Systolic dysfunction 24.71 17.34 12 23482 1587 63463941
Herpes oesophagitis 24.65 17.34 7 23487 201 63465327
Rhesus incompatibility 24.57 17.34 6 23488 94 63465434
Therapeutic product effective for unapproved indication 24.45 17.34 6 23488 96 63465432
Brain operation 24.41 17.34 9 23485 600 63464928
Therapeutic product ineffective for unapproved indication 24.08 17.34 7 23487 219 63465309
Cross sensitivity reaction 24.05 17.34 13 23481 2149 63463379
Febrile neutropenia 24.02 17.34 7 23487 118442 63347086
Acute kidney injury 23.76 17.34 38 23456 263377 63202151
Ventricular hypokinesia 23.68 17.34 17 23477 4627 63460901
Self-medication 23.66 17.34 14 23480 2749 63462779
Fatigue 23.55 17.34 213 23281 887815 62577713
Chest discomfort 23.23 17.34 6 23488 109963 63355565
Frontal lobe epilepsy 23.22 17.34 4 23490 8 63465520
Caesarean section 23.12 17.34 30 23464 17002 63448526
Sedation 23.11 17.34 47 23447 38762 63426766
White matter lesion 22.78 17.34 12 23482 1883 63463645
Amnesia 22.73 17.34 58 23436 55527 63410001
Intensive care unit delirium 22.45 17.34 5 23489 51 63465477
Brain neoplasm 22.31 17.34 16 23478 4350 63461178
Lipoedema 22.17 17.34 7 23487 291 63465237
Affective disorder 21.52 17.34 18 23476 6128 63459400
Atrioventricular block second degree 21.52 17.34 15 23479 3899 63461629
Abdominal pain upper 21.36 17.34 27 23467 206417 63259111
Psoriatic arthropathy 21.34 17.34 4 23490 91516 63374012
Myalgia 21.30 17.34 14 23480 146515 63319013
Gastrointestinal disorder 21.26 17.34 11 23483 131228 63334300
Antinuclear antibody positive 21.18 17.34 20 23474 7979 63457549
Acquired macroglossia 20.81 17.34 6 23488 182 63465346
Blood creatine phosphokinase increased 20.73 17.34 39 23455 30391 63435137
Infection 20.72 17.34 33 23461 229140 63236388
Dyskinesia 20.55 17.34 40 23454 31962 63433566
Cellulitis 20.40 17.34 3 23491 81955 63383573
Electrocardiogram QT prolonged 20.21 17.34 58 23436 59472 63406056
Blood cholesterol increased 20.12 17.34 5 23489 94027 63371501
Violence-related symptom 20.01 17.34 7 23487 401 63465127
Fibromyalgia 19.89 17.34 3 23491 80417 63385111
Learning disorder 19.87 17.34 8 23486 677 63464851
Epilepsy surgery 19.84 17.34 4 23490 24 63465504
Focal segmental glomerulosclerosis 19.67 17.34 10 23484 1458 63464070
Bicytopenia 19.66 17.34 12 23482 2493 63463035
Depression 19.50 17.34 132 23362 196360 63269168
Loss of consciousness 19.49 17.34 91 23403 118030 63347498
Drug level decreased 19.45 17.34 19 23475 7900 63457628
Hypertension 19.39 17.34 47 23447 279256 63186272
Fall 19.34 17.34 226 23268 392108 63073420
QRS axis abnormal 19.23 17.34 9 23485 1096 63464432
Dysarthria 18.97 17.34 46 23448 42665 63422863
Wheezing 18.75 17.34 6 23488 95589 63369939
Osteoarthritis 18.67 17.34 6 23488 95337 63370191
Febrile infection-related epilepsy syndrome 18.63 17.34 3 23491 3 63465525
Anger 18.59 17.34 23 23471 12433 63453095
Resting tremor 18.45 17.34 8 23486 815 63464713
Intentional product misuse 18.44 17.34 57 23437 60860 63404668
Asthma 17.47 17.34 13 23481 127548 63337980

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 1424.46 16.77 814 18145 104043 34833929
Status epilepticus 858.58 16.77 304 18655 12310 34925662
Generalised tonic-clonic seizure 517.71 16.77 245 18714 20929 34917043
Multiple-drug resistance 496.53 16.77 162 18797 5077 34932895
Partial seizures 422.13 16.77 140 18819 4620 34933352
Drug ineffective 379.47 16.77 788 18171 455963 34482009
Epilepsy 281.87 16.77 164 18795 21331 34916641
Focal dyscognitive seizures 203.84 16.77 60 18899 1321 34936651
Aggression 195.78 16.77 165 18794 38799 34899173
Sudden unexplained death in epilepsy 182.21 16.77 44 18915 434 34937538
Off label use 174.87 16.77 560 18399 418964 34519008
Overdose 160.33 16.77 221 18738 90838 34847134
Petit mal epilepsy 132.01 16.77 53 18906 3025 34934947
Somnolence 109.27 16.77 207 18752 110909 34827063
Dyspnoea 93.46 16.77 44 18915 376738 34561234
Partial seizures with secondary generalisation 93.33 16.77 24 18935 312 34937660
Anticonvulsant drug level above therapeutic 84.96 16.77 26 18933 656 34937316
Drug resistance 83.94 16.77 86 18873 25841 34912131
Irritability 67.71 16.77 75 18884 24615 34913357
Aura 64.55 16.77 18 18941 324 34937648
Excessive eye blinking 64.10 16.77 20 18939 539 34937433
Drug withdrawal convulsions 63.70 16.77 24 18935 1153 34936819
Cognitive disorder 63.39 16.77 78 18881 28615 34909357
Necrosis ischaemic 62.66 16.77 17 18942 275 34937697
Ataxia 62.06 16.77 55 18904 13798 34924174
Drug ineffective for unapproved indication 59.85 16.77 69 18890 23646 34914326
Behaviour disorder 57.85 16.77 35 18924 4875 34933097
Atrioventricular block complete 56.31 16.77 44 18915 9275 34928697
Maternal exposure during pregnancy 55.23 16.77 34 18925 4884 34933088
Myoclonic epilepsy 53.36 16.77 21 18938 1136 34936836
Diarrhoea 50.35 16.77 84 18875 389828 34548144
Atrioventricular block second degree 49.85 16.77 29 18930 3759 34934213
Nystagmus 48.93 16.77 31 18928 4684 34933288
Gaze palsy 48.58 16.77 22 18937 1690 34936282
No adverse event 48.51 16.77 61 18898 22866 34915106
Seizure cluster 48.25 16.77 12 18947 135 34937837
Hyperammonaemia 47.24 16.77 34 18925 6333 34931639
Agitation 46.79 16.77 99 18860 57300 34880672
Congenital hypoplasia of depressor angularis oris muscle 46.62 16.77 8 18951 8 34937964
Atrioventricular block 46.41 16.77 37 18922 8026 34929946
Superinfection 46.16 16.77 24 18935 2495 34935477
Organic brain syndrome 45.19 16.77 13 18946 263 34937709
Postictal psychosis 44.29 16.77 12 18947 193 34937779
Haemoglobin decreased 42.94 16.77 7 18952 120765 34817207
Brain operation 42.51 16.77 13 18946 327 34937645
Mucosal ulceration 42.20 16.77 17 18942 978 34936994
Change in seizure presentation 42.09 16.77 11 18948 153 34937819
Arthralgia 40.28 16.77 21 18938 170020 34767952
Hyperammonaemic encephalopathy 39.35 16.77 21 18938 2303 34935669
Intestinal ischaemia 39.06 16.77 33 18926 7761 34930211
Bradycardia 38.86 16.77 109 18850 75309 34862663
Affective disorder 38.71 16.77 26 18933 4334 34933638
Foetal exposure during pregnancy 38.61 16.77 72 18887 38029 34899943
Glioblastoma 37.81 16.77 16 18943 1043 34936929
Posture abnormal 37.25 16.77 20 18939 2219 34935753
Exposure via breast milk 36.40 16.77 19 18940 1991 34935981
Urge incontinence 36.37 16.77 13 18946 537 34937435
Abdominal pain 36.17 16.77 22 18937 163596 34774376
Pneumonia aspiration 36.16 16.77 74 18885 41829 34896143
Electrocardiogram QRS complex prolonged 36.00 16.77 26 18933 4868 34933104
Coarctation of the aorta 34.36 16.77 12 18947 463 34937509
Myoclonus 34.09 16.77 41 18918 14684 34923288
Acoustic stimulation tests abnormal 33.98 16.77 8 18951 70 34937902
Bladder hypertrophy 33.78 16.77 13 18946 662 34937310
Psychogenic seizure 33.31 16.77 11 18948 357 34937615
Muscle twitching 33.02 16.77 34 18925 10264 34927708
Febrile neutropenia 32.25 16.77 17 18942 136832 34801140
Product availability issue 31.80 16.77 17 18942 1870 34936102
Hippocampal sclerosis 30.97 16.77 8 18951 106 34937866
Anomaly of external ear congenital 30.83 16.77 8 18951 108 34937864
Encephalopathy 30.03 16.77 62 18897 35257 34902715
Memory impairment 29.97 16.77 70 18889 43248 34894724
Drug interaction 29.78 16.77 217 18742 225729 34712243
Chest pain 29.50 16.77 16 18943 126746 34811226
Abnormal behaviour 28.89 16.77 50 18909 24919 34913053
Intellectual disability 28.17 16.77 14 18945 1324 34936648
Anger 27.36 16.77 33 18926 11851 34926121
Psychotic disorder 27.04 16.77 48 18911 24404 34913568
Prescribed overdose 26.89 16.77 31 18928 10616 34927356
Tonic convulsion 26.57 16.77 13 18946 1188 34936784
Encephalitis autoimmune 26.34 16.77 11 18948 694 34937278
Chills 26.04 16.77 6 18953 81037 34856935
Drug reaction with eosinophilia and systemic symptoms 25.80 16.77 56 18903 32956 34905016
Gastrointestinal haemorrhage 25.70 16.77 8 18951 88469 34849503
Pain 25.49 16.77 45 18914 204630 34733342
Congenital melanocytic naevus 25.44 16.77 5 18954 16 34937956
Pneumonia 25.37 16.77 106 18853 362521 34575451
Diplopia 25.33 16.77 38 18921 16805 34921167
Premature baby 24.95 16.77 41 18918 19592 34918380
Systemic inflammatory response syndrome 24.92 16.77 24 18935 6685 34931287
Dizziness 23.88 16.77 201 18758 218320 34719652
Language disorder 23.82 16.77 15 18944 2241 34935731
Hallucination 23.22 16.77 71 18888 51427 34886545
Atrial septal defect 22.97 16.77 24 18935 7368 34930604
Speech disorder 22.91 16.77 46 18913 25640 34912332
Temporal lobe epilepsy 22.86 16.77 7 18952 177 34937795
Interstitial lung disease 22.71 16.77 4 18955 65278 34872694
Haematuria traumatic 22.32 16.77 7 18952 192 34937780
Cardiac failure 21.99 16.77 11 18948 91237 34846735
Brain oedema 21.96 16.77 32 18927 13789 34924183
Hyperkinesia 21.85 16.77 13 18946 1755 34936217
Low birth weight baby 21.64 16.77 24 18935 7881 34930091
Initial insomnia 21.63 16.77 16 18943 3108 34934864
Product substitution issue 21.57 16.77 27 18932 10068 34927904
Drop attacks 21.46 16.77 9 18950 574 34937398
Sinus node dysfunction 21.31 16.77 18 18941 4231 34933741
Brain neoplasm 21.24 16.77 16 18943 3193 34934779
Idiopathic generalised epilepsy 21.01 16.77 5 18954 46 34937926
Acute kidney injury 20.79 16.77 90 18869 304898 34633074
Depressive symptom 20.60 16.77 15 18944 2844 34935128
Vitamin B6 decreased 20.54 16.77 4 18955 12 34937960
Anaemia 20.42 16.77 62 18897 233273 34704699
Joint swelling 20.13 16.77 4 18955 59886 34878086
Dissociation 20.00 16.77 12 18947 1646 34936326
Bradycardia neonatal 19.92 16.77 10 18949 966 34937006
Peroneal nerve palsy 19.90 16.77 15 18944 2996 34934976
Myocardial infarction 19.66 16.77 22 18937 121063 34816909
C-reactive protein increased 19.52 16.77 3 18956 54095 34883877
Blood lactic acid increased 19.41 16.77 21 18938 6707 34931265
Pyrexia 19.36 16.77 104 18855 332909 34605063
Acute myocardial infarction 19.33 16.77 3 18956 53716 34884256
Head injury 19.25 16.77 35 18924 18125 34919847
Myalgia 19.00 16.77 11 18948 84099 34853873
Product use issue 18.83 16.77 76 18883 63140 34874832
Dyskinesia 18.64 16.77 39 18920 22374 34915598
Bradykinesia 18.52 16.77 16 18943 3877 34934095
Amnesia 18.45 16.77 43 18916 26520 34911452
Periventricular haemorrhage neonatal 18.31 16.77 4 18955 24 34937948
Congenital aortic atresia 18.17 16.77 4 18955 25 34937947
Blood creatinine increased 18.04 16.77 15 18944 94961 34843011
Hypothermia neonatal 17.93 16.77 5 18954 90 34937882
Infantile spasms 17.90 16.77 6 18953 204 34937768
Renal failure 17.83 16.77 27 18932 130530 34807442
Electrocardiogram PR prolongation 17.77 16.77 9 18950 886 34937086
Unmasking of previously unidentified disease 17.59 16.77 9 18950 905 34937067
Abdominal compartment syndrome 17.23 16.77 9 18950 944 34937028
Impulsive behaviour 17.08 16.77 12 18947 2150 34935822
Hyperhidrosis 16.96 16.77 10 18949 75682 34862290
Tremor 16.95 16.77 89 18870 82498 34855474
Therapeutic product effect incomplete 16.87 16.77 63 18896 50478 34887494

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 2227.90 15.48 1226 32332 187608 79523222
Status epilepticus 1675.94 15.48 559 32999 24482 79686348
Multiple-drug resistance 1210.87 15.48 342 33216 8466 79702364
Generalised tonic-clonic seizure 807.65 15.48 386 33172 43524 79667306
Drug ineffective 660.94 15.48 1416 32142 1079497 78631333
Partial seizures 650.26 15.48 213 33345 8765 79702065
Epilepsy 576.15 15.48 300 33258 40560 79670270
Focal dyscognitive seizures 335.77 15.48 103 33455 3409 79707421
Off label use 313.95 15.48 962 32596 906253 78804577
Overdose 263.84 15.48 355 33203 183851 79526979
Petit mal epilepsy 220.37 15.48 85 33473 5642 79705188
Somnolence 218.91 15.48 374 33184 238607 79472223
Aggression 209.98 15.48 173 33385 50785 79660045
Sudden unexplained death in epilepsy 199.05 15.48 48 33510 620 79710210
Drug ineffective for unapproved indication 194.69 15.48 166 33392 51072 79659758
Drug resistance 181.66 15.48 147 33411 42066 79668764
Diplopia 168.78 15.48 128 33430 33338 79677492
Partial seizures with secondary generalisation 155.27 15.48 39 33519 602 79710228
Dyspnoea 145.43 15.48 91 33467 856934 78853896
Drug interaction 144.03 15.48 442 33116 414741 79296089
Atrioventricular block complete 134.43 15.48 85 33473 16525 79694305
Electrocardiogram QRS complex prolonged 134.09 15.48 73 33485 10760 79700070
Seizure cluster 130.72 15.48 31 33527 371 79710459
Pain 125.97 15.48 70 33488 703732 79007098
Aura 122.24 15.48 35 33523 907 79709923
Behaviour disorder 120.46 15.48 57 33501 6256 79704574
Myoclonus 120.42 15.48 97 33461 27563 79683267
Irritability 118.31 15.48 114 33444 41030 79669800
Arthralgia 114.20 15.48 49 33509 571754 79139076
Mitochondrial DNA mutation 113.17 15.48 28 33530 405 79710425
Myoclonic epilepsy 112.04 15.48 39 33519 1931 79708899
Maternal exposure before pregnancy 110.42 15.48 48 33510 4325 79706505
Cognitive disorder 109.54 15.48 141 33417 69785 79641045
Drug reaction with eosinophilia and systemic symptoms 109.31 15.48 135 33423 64109 79646721
Bradycardia 106.99 15.48 199 33359 135358 79575472
Diarrhoea 103.14 15.48 132 33426 880357 78830473
Hyperammonaemia 103.07 15.48 62 33496 11031 79699799
Propofol infusion syndrome 96.62 15.48 35 33523 1948 79708882
Change in seizure presentation 93.59 15.48 25 33533 497 79710333
Ataxia 92.78 15.48 80 33478 24959 79685871
Product substitution issue 90.22 15.48 72 33486 20184 79690646
Drug withdrawal convulsions 89.16 15.48 34 33524 2186 79708644
Anticonvulsant drug level above therapeutic 85.62 15.48 28 33530 1143 79709687
Electroencephalogram abnormal 85.48 15.48 43 33515 5391 79705439
Atrioventricular block 85.03 15.48 60 33498 13981 79696849
Joint swelling 84.23 15.48 11 33547 288635 79422195
Encephalopathy 80.14 15.48 119 33439 67278 79643552
Abdominal pain 79.92 15.48 32 33526 389537 79321293
No adverse event 77.96 15.48 87 33471 37105 79673725
Nystagmus 75.96 15.48 49 33509 9855 79700975
Cardiac arrest 74.81 15.48 199 33359 171897 79538933
CSF oligoclonal band present 74.71 15.48 20 33538 401 79710429
Agitation 73.22 15.48 142 33416 99573 79611257
Infusion related reaction 71.62 15.48 7 33551 230230 79480600
Pneumonia aspiration 69.45 15.48 111 33447 66856 79643974
Balance disorder 69.22 15.48 138 33420 98719 79612111
Hyperammonaemic encephalopathy 66.99 15.48 35 33523 4747 79706083
Abnormal behaviour 65.94 15.48 79 33479 36342 79674488
Tonic convulsion 64.77 15.48 27 33531 2193 79708637
Sinus node dysfunction 58.81 15.48 38 33520 7663 79703167
Metabolic acidosis 58.72 15.48 116 33442 82413 79628417
Excessive eye blinking 57.53 15.48 23 33535 1678 79709152
Pregnancy 56.60 15.48 63 33495 26788 79684042
Blood lactic acid increased 56.11 15.48 45 33513 12699 79698131
Altered state of consciousness 55.89 15.48 80 33478 43742 79667088
Memory impairment 55.58 15.48 136 33422 111598 79599232
Swelling 54.95 15.48 12 33546 216699 79494131
Atonic seizures 54.48 15.48 18 33540 759 79710071
Blood gases abnormal 54.42 15.48 20 33538 1160 79709670
Encephalitis autoimmune 54.09 15.48 24 33534 2270 79708560
Gene mutation 53.55 15.48 25 33533 2661 79708169
Sinusitis 53.44 15.48 9 33549 195492 79515338
Unmasking of previously unidentified disease 53.31 15.48 23 33535 2034 79708796
Toxicity to various agents 53.21 15.48 331 33227 421209 79289621
Atrioventricular block second degree 53.19 15.48 35 33523 7277 79703553
Hallucination, visual 52.81 15.48 67 33491 32662 79678168
Coma 52.74 15.48 125 33433 100524 79610306
Abdominal discomfort 52.36 15.48 20 33538 250707 79460123
Angiofibroma 52.21 15.48 12 33546 124 79710706
Pain in extremity 52.17 15.48 46 33512 364492 79346338
Neurotoxicity 51.57 15.48 66 33492 32452 79678378
Gaze palsy 50.88 15.48 25 33533 2980 79707850
Anticonvulsant drug level increased 50.75 15.48 24 33534 2629 79708201
Pleocytosis 50.56 15.48 20 33538 1419 79709411
Nausea 49.64 15.48 221 33337 956975 78753855
Sinus bradycardia 49.41 15.48 57 33501 25190 79685640
Cough 49.30 15.48 49 33509 366740 79344090
Sinus arrest 49.29 15.48 26 33532 3596 79707234
Electrocardiogram PR prolongation 48.71 15.48 20 33538 1563 79709267
Atrioventricular block first degree 48.49 15.48 41 33517 12450 79698380
Affective disorder 46.81 15.48 34 33524 8285 79702545
Temporal lobe epilepsy 46.56 15.48 14 33544 432 79710398
Encephalitis 46.43 15.48 43 33515 14717 79696113
Head injury 45.88 15.48 67 33491 37302 79673528
Tremor 45.36 15.48 166 33392 169917 79540913
Aphasia 45.11 15.48 75 33483 46657 79664173
Necrosis ischaemic 44.88 15.48 17 33541 1073 79709757
Premature delivery 44.28 15.48 52 33506 23415 79687415
Injection site pain 42.97 15.48 3 33555 129835 79580995
Malaise 42.60 15.48 89 33469 489780 79221050
Disturbance in attention 41.82 15.48 76 33482 50725 79660105
Intensive care unit acquired weakness 41.69 15.48 19 33539 1914 79708916
Anticonvulsant drug level decreased 41.68 15.48 19 33539 1915 79708915
Dizziness 41.13 15.48 369 33189 526072 79184758
Maternal exposure during breast feeding 40.78 15.48 21 33537 2764 79708066
Simple partial seizures 40.28 15.48 14 33544 690 79710140
Haemoglobin decreased 39.72 15.48 22 33536 222097 79488733
Febrile neutropenia 39.72 15.48 24 33534 230975 79479855
Drug level decreased 39.69 15.48 39 33519 14363 79696467
Back pain 39.31 15.48 42 33516 304138 79406692
Lymphangioleiomyomatosis 39.30 15.48 10 33548 163 79710667
Nasopharyngitis 38.82 15.48 30 33528 253851 79456979
Cardiac failure congestive 37.94 15.48 7 33551 142395 79568435
Angiomyolipoma 37.76 15.48 10 33548 192 79710638
Hypersensitivity 37.61 15.48 33 33525 262206 79448624
Superinfection 36.97 15.48 24 33534 4878 79705952
Myalgia 36.81 15.48 16 33542 185625 79525205
Psychotic disorder 36.73 15.48 64 33494 41338 79669492
Peripheral swelling 36.22 15.48 36 33522 269581 79441249
Discomfort 36.11 15.48 5 33553 125612 79585218
Drug level increased 36.10 15.48 62 33496 39589 79671241
Mucosal ulceration 36.00 15.48 17 33541 1856 79708974
Contraindicated product administered 35.58 15.48 11 33547 157527 79553303
Hippocampal sclerosis 35.07 15.48 9 33549 152 79710678
Depressed level of consciousness 34.37 15.48 104 33454 96548 79614282
Therapeutic product effect decreased 34.31 15.48 13 33545 163850 79546980
Brain oedema 33.51 15.48 47 33511 25216 79685614
Chest pain 33.22 15.48 42 33516 282262 79428568
Therapeutic product ineffective for unapproved indication 33.09 15.48 9 33549 192 79710638
Intentional overdose 33.08 15.48 109 33449 105851 79604979
C-reactive protein increased 32.99 15.48 7 33551 129020 79581810
Pericarditis 32.84 15.48 3 33555 104233 79606597
Therapeutic product effect incomplete 32.63 15.48 132 33426 141513 79569317
Abdominal pain upper 32.29 15.48 28 33530 223791 79487039
Abortion spontaneous 32.09 15.48 50 33508 29457 79681373
Suicidal ideation 31.85 15.48 87 33471 76253 79634577
Posture abnormal 31.81 15.48 20 33538 3846 79706984
Intellectual disability 31.74 15.48 14 33544 1306 79709524
Intestinal ischaemia 31.22 15.48 33 33525 13237 79697593
Suicide attempt 31.16 15.48 91 33467 82841 79627989
Laryngeal stenosis 30.96 15.48 13 33545 1075 79709755
Wrong patient received product 30.93 15.48 21 33537 4597 79706233
Chest discomfort 30.53 15.48 10 33548 138034 79572796
Mobility decreased 30.49 15.48 7 33551 122168 79588662
Gastrointestinal haemorrhage 30.46 15.48 12 33546 147707 79563123
Wound 30.33 15.48 6 33552 116173 79594657
Chills 29.93 15.48 15 33543 160219 79550611
Postictal state 29.86 15.48 15 33543 1874 79708956
Arthritis 29.85 15.48 6 33552 114874 79595956
Postictal psychosis 29.67 15.48 8 33550 165 79710665
Brain operation 29.67 15.48 11 33547 654 79710176
Musculoskeletal pain 29.59 15.48 4 33554 102350 79608480
Post stroke depression 29.10 15.48 5 33553 8 79710822
Automatism epileptic 29.10 15.48 5 33553 8 79710822
Product availability issue 28.97 15.48 19 33539 3928 79706902
Glioblastoma 28.67 15.48 14 33544 1646 79709184
Intrusive thoughts 28.37 15.48 10 33548 514 79710316
Systemic lupus erythematosus 28.19 15.48 8 33550 121141 79589689
Cholestasis 27.59 15.48 65 33493 52044 79658786
Ventricular tachycardia 27.50 15.48 57 33501 41878 79668952
Hallucination 27.48 15.48 89 33469 85656 79625174
Pruritus 27.03 15.48 81 33477 394567 79316263
Cortical dysplasia 26.94 15.48 5 33553 15 79710815
Speech disorder 26.77 15.48 66 33492 54379 79656451
Acute kidney injury 26.76 15.48 120 33438 519284 79191546
Rhesus incompatibility 26.70 15.48 5 33553 16 79710814
Impaired healing 26.38 15.48 3 33555 87652 79623178
Anger 25.91 15.48 34 33524 17128 79693702
Blister 25.82 15.48 9 33549 119467 79591363
Organic brain syndrome 25.30 15.48 9 33549 475 79710355
Pleural effusion 25.09 15.48 15 33543 145247 79565583
Language disorder 24.89 15.48 16 33542 3198 79707632
Hypertension 24.83 15.48 65 33493 330927 79379903
Asthma 24.70 15.48 13 33545 135082 79575748
Cardiotoxicity 24.57 15.48 28 33530 12211 79698619
Pneumonia 24.50 15.48 170 33388 660076 79050754
Automatism 24.35 15.48 7 33551 184 79710646
Systemic inflammatory response syndrome 24.33 15.48 27 33531 11438 79699392
Productive cough 24.27 15.48 4 33554 88327 79622503
Haematuria traumatic 24.14 15.48 7 33551 190 79710640
Euthyroid sick syndrome 24.05 15.48 6 33552 90 79710740
Sedation 23.52 15.48 61 33497 51834 79658996
Bronchitis 23.26 15.48 13 33545 130631 79580199
Wheezing 23.21 15.48 10 33548 116654 79594176
Lipids abnormal 23.12 15.48 9 33549 612 79710218
Low birth weight baby 23.09 15.48 9 33549 614 79710216
Maternal exposure during pregnancy 23.00 15.48 116 33442 136422 79574408
Therapeutic product effective for unapproved indication 22.92 15.48 6 33552 110 79710720
Brain neoplasm 22.88 15.48 19 33539 5627 79705203
Cross sensitivity reaction 22.79 15.48 16 33542 3696 79707134
Dyskinesia 22.78 15.48 55 33503 44718 79666112
Amnesia 22.55 15.48 68 33490 62989 79647841
Inflammation 22.17 15.48 6 33552 93747 79617083
Hyperkinesia 22.16 15.48 14 33544 2715 79708115
Gastrointestinal disorder 21.99 15.48 12 33546 122193 79588637
Haematochezia 21.91 15.48 5 33553 87640 79623190
Alopecia 21.83 15.48 40 33518 231315 79479515
Febrile infection-related epilepsy syndrome 21.81 15.48 5 33553 51 79710779
Ascites 21.73 15.48 3 33555 75559 79635271
Agranulocytosis 21.52 15.48 54 33504 44976 79665854
Respiratory acidosis 21.43 15.48 25 33533 11175 79699655
Intensive care unit delirium 21.39 15.48 5 33553 56 79710774
Vitamin B6 decreased 21.31 15.48 4 33554 13 79710817
Urticaria 21.31 15.48 28 33530 185173 79525657
Idiopathic generalised epilepsy 21.23 15.48 5 33553 58 79710772
Epileptic psychosis 21.23 15.48 5 33553 58 79710772
Dysarthria 20.60 15.48 69 33489 67553 79643277
Fatigue 20.58 15.48 272 33286 929455 78781375
Macroglossia 20.52 15.48 10 33548 1171 79709659
Self-medication 20.24 15.48 17 33541 5115 79705715
Learning disorder 20.18 15.48 8 33550 571 79710259
Staring 20.07 15.48 13 33545 2632 79708198
Acute myocardial infarction 20.06 15.48 4 33554 77032 79633798
Vagal nerve stimulator implantation 19.94 15.48 4 33554 20 79710810
Nasal congestion 19.88 15.48 4 33554 76548 79634282
Rectal haemorrhage 19.79 15.48 4 33554 76296 79634534
Prescribed overdose 19.77 15.48 47 33511 37836 79672994
Food interaction 19.77 15.48 11 33547 1691 79709139
Leukocytosis 19.61 15.48 51 33507 43404 79667426
Hepatocellular injury 19.61 15.48 54 33504 47539 79663291
Shock 19.54 15.48 51 33507 43497 79667333
Depression 19.52 15.48 157 33401 216633 79494197
Loss of consciousness 19.35 15.48 129 33429 167814 79543016
Electrocardiogram repolarisation abnormality 19.34 15.48 12 33546 2255 79708575
Herpes oesophagitis 19.28 15.48 7 33551 392 79710438
Creutzfeldt-Jakob disease 19.26 15.48 6 33552 209 79710621
Antinuclear antibody positive 19.24 15.48 20 33538 7870 79702960
Bladder hypertrophy 19.17 15.48 8 33550 651 79710179
Abortion induced 19.12 15.48 19 33539 7090 79703740
Exposure via breast milk 19.02 15.48 9 33549 987 79709843
Acquired macroglossia 18.99 15.48 6 33552 219 79710611
Anaemia 18.83 15.48 110 33448 444905 79265925
Oedema peripheral 18.57 15.48 50 33508 252238 79458592
Psychogenic seizure 18.47 15.48 11 33547 1920 79708910
Myocardial infarction 18.12 15.48 31 33527 184098 79526732
Tachycardia 17.82 15.48 132 33426 177636 79533194
General physical health deterioration 17.76 15.48 58 33500 275180 79435650
Neuropathy peripheral 17.69 15.48 20 33538 141285 79569545
Mucosal inflammation 17.57 15.48 5 33553 75575 79635255
Cerebellar syndrome 17.30 15.48 16 33542 5464 79705366
Dissociation 17.28 15.48 14 33544 4007 79706823
Sexually inappropriate behaviour 17.16 15.48 7 33551 538 79710292
Blood glucose increased 17.04 15.48 14 33544 114961 79595869
Herpes zoster 16.95 15.48 9 33549 93074 79617756
Musculoskeletal stiffness 16.73 15.48 30 33528 174978 79535852
Cellulitis 16.51 15.48 13 33545 109047 79601783
Electrocardiogram ST segment elevation 16.50 15.48 19 33539 8378 79702452
Arrhythmia 16.48 15.48 60 33498 61212 79649618
Calcinosis 16.43 15.48 11 33547 2354 79708476
Leukopenia 16.24 15.48 94 33464 116419 79594411
Blood pressure increased 16.23 15.48 41 33517 211319 79499511
Product administration error 16.07 15.48 39 33519 31807 79679023
Drug effective for unapproved indication 16.07 15.48 16 33542 5985 79704845
Ill-defined disorder 15.99 15.48 4 33554 65871 79644959
Systolic dysfunction 15.86 15.48 13 33545 3782 79707048
Exposure during pregnancy 15.70 15.48 84 33474 101048 79609782
Fall 15.62 15.48 290 33268 487339 79223491
Ureaplasma infection 15.61 15.48 8 33550 1042 79709788

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 D002491 Central Nervous System Agents
MeSH PA D049990 Membrane Transport Modulators
MeSH PA D026941 Sodium Channel Blockers
MeSH PA D061567 Voltage-Gated Sodium Channel Blockers

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




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 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 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 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 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 Nov. 16, 2023 ADDITION OF A NEW INDICATION FOR ADJUNCTIVE THERAPY IN THE TREATMENT OF PRIMARY GENERALIZED TONIC-CLONIC SEIZURES IN PATIENTS 4 YEARS OF AGE AND OLDER
150MG VIMPAT UCB INC N022253 Oct. 28, 2008 RX TABLET ORAL Nov. 16, 2023 ADDITION OF A NEW INDICATION FOR ADJUNCTIVE THERAPY IN THE TREATMENT OF PRIMARY GENERALIZED TONIC-CLONIC SEIZURES IN PATIENTS 4 YEARS OF AGE AND OLDER
200MG VIMPAT UCB INC N022253 Oct. 28, 2008 RX TABLET ORAL Nov. 16, 2023 ADDITION OF A NEW INDICATION FOR ADJUNCTIVE THERAPY IN THE TREATMENT OF PRIMARY GENERALIZED TONIC-CLONIC SEIZURES IN PATIENTS 4 YEARS OF AGE AND OLDER
50MG VIMPAT UCB INC N022253 Oct. 28, 2008 RX TABLET ORAL Nov. 16, 2023 ADDITION OF A NEW INDICATION FOR ADJUNCTIVE THERAPY IN THE TREATMENT OF PRIMARY GENERALIZED TONIC-CLONIC SEIZURES IN PATIENTS 4 YEARS OF AGE AND OLDER
200MG/20ML (10MG/ML) VIMPAT UCB INC N022254 Oct. 28, 2008 RX SOLUTION INTRAVENOUS Nov. 16, 2023 ADDITION OF A NEW INDICATION FOR ADJUNCTIVE THERAPY IN THE TREATMENT OF PRIMARY GENERALIZED TONIC-CLONIC SEIZURES IN PATIENTS 4 YEARS OF AGE AND OLDER
200MG/20ML (10MG/ML) VIMPAT UCB INC N022254 Oct. 28, 2008 RX SOLUTION INTRAVENOUS Nov. 16, 2023 NEW PATIENT POPULATION
10MG/ML VIMPAT UCB INC N022255 April 20, 2010 RX SOLUTION ORAL Nov. 16, 2023 ADDITION OF A NEW INDICATION FOR ADJUNCTIVE THERAPY IN THE TREATMENT OF PRIMARY GENERALIZED TONIC-CLONIC SEIZURES IN PATIENTS 4 YEARS OF AGE AND OLDER
100MG VIMPAT UCB INC N022253 Oct. 28, 2008 RX TABLET ORAL Oct. 14, 2024 NEW PATIENT POPULATION
150MG VIMPAT UCB INC N022253 Oct. 28, 2008 RX TABLET ORAL Oct. 14, 2024 NEW PATIENT POPULATION
200MG VIMPAT UCB INC N022253 Oct. 28, 2008 RX TABLET ORAL Oct. 14, 2024 NEW PATIENT POPULATION
50MG VIMPAT UCB INC N022253 Oct. 28, 2008 RX TABLET ORAL Oct. 14, 2024 NEW PATIENT POPULATION
200MG/20ML (10MG/ML) VIMPAT UCB INC N022254 Oct. 28, 2008 RX SOLUTION INTRAVENOUS Oct. 14, 2024 NEW PATIENT POPULATION
10MG/ML VIMPAT UCB INC N022255 April 20, 2010 RX SOLUTION ORAL Oct. 14, 2024 NEW PATIENT POPULATION

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 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
Carbonic anhydrase 2 Enzyme Ki 6.48 CHEMBL
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

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 36 sections
Vimpat HUMAN PRESCRIPTION DRUG LABEL 1 0131-1810 INJECTION 10 mg INTRAVENOUS NDA 36 sections
Vimpat HUMAN PRESCRIPTION DRUG LABEL 1 0131-1810 INJECTION 10 mg INTRAVENOUS NDA 36 sections
Vimpat HUMAN PRESCRIPTION DRUG LABEL 1 0131-2477 TABLET, FILM COATED 50 mg ORAL NDA 36 sections
Vimpat HUMAN PRESCRIPTION DRUG LABEL 1 0131-2477 TABLET, FILM COATED 50 mg ORAL NDA 36 sections
Vimpat HUMAN PRESCRIPTION DRUG LABEL 1 0131-2477 TABLET, FILM COATED 50 mg ORAL NDA 36 sections
Vimpat HUMAN PRESCRIPTION DRUG LABEL 1 0131-2478 TABLET, FILM COATED 100 mg ORAL NDA 36 sections
Vimpat HUMAN PRESCRIPTION DRUG LABEL 1 0131-2478 TABLET, FILM COATED 100 mg ORAL NDA 36 sections
Vimpat HUMAN PRESCRIPTION DRUG LABEL 1 0131-2478 TABLET, FILM COATED 100 mg ORAL NDA 36 sections
Vimpat HUMAN PRESCRIPTION DRUG LABEL 1 0131-2479 TABLET, FILM COATED 150 mg ORAL NDA 36 sections
Vimpat HUMAN PRESCRIPTION DRUG LABEL 1 0131-2479 TABLET, FILM COATED 150 mg ORAL NDA 36 sections
Vimpat HUMAN PRESCRIPTION DRUG LABEL 1 0131-2479 TABLET, FILM COATED 150 mg ORAL NDA 36 sections
Vimpat HUMAN PRESCRIPTION DRUG LABEL 1 0131-2480 TABLET, FILM COATED 200 mg ORAL NDA 36 sections
Vimpat HUMAN PRESCRIPTION DRUG LABEL 1 0131-2480 TABLET, FILM COATED 200 mg ORAL NDA 36 sections
Vimpat HUMAN PRESCRIPTION DRUG LABEL 1 0131-2480 TABLET, FILM COATED 200 mg ORAL NDA 36 sections
Vimpat HUMAN PRESCRIPTION DRUG LABEL 1 0131-5410 SOLUTION 10 mg ORAL NDA 36 sections
Vimpat HUMAN PRESCRIPTION DRUG LABEL 1 0131-5410 SOLUTION 10 mg ORAL NDA 36 sections
Vimpat HUMAN PRESCRIPTION DRUG LABEL 1 0131-5410 SOLUTION 10 mg ORAL NDA 36 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