Stem definition | Drug id | CAS RN |
---|---|---|
4310 | 175481-36-4 |
Dose | Unit | Route |
---|---|---|
0.30 | g | O |
0.30 | g | P |
Property | Value | Reference |
---|---|---|
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 |
Date | Agency | Company | Orphan |
---|---|---|---|
July 4, 2016 | PMDA | UCB Japan Co., Ltd. | |
Aug. 29, 2008 | EMA | ||
Oct. 28, 2008 | FDA | UCB INC |
MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients 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 |
MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients 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 |
MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients 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 |
None
Source | Code | Description |
---|---|---|
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 |
Disease | Relation | SNOMED_ID | DOID |
---|---|---|---|
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 |
None
None
Dissociation level | Dissociation constant | Type (acidic/basic) |
---|---|---|
pKa1 | 12.83 | acidic |
Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent 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 |
Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
---|---|---|---|---|---|---|---|---|---|
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 |
Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA 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 |
ID | Source |
---|---|
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 |
Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
---|---|---|---|---|---|---|---|---|
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 |