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

Stem definitionDrug idCAS RN
tricyclic compounds 2017 28721-07-5

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • oxcarbazepine
  • oxacarbazepine
  • oxecarb
  • oxetol
an antiepileptic drug, precise mechanism by which oxcarbazepine exerts its antiseizure effect is unknown, however, in vitro electrophysiological studies indicate that it produces blockade of voltage-sensitive sodium channels, resulting in stabilization of hyperexcited neural membranes, inhibition of repetitive neuronal firing, and diminution of propagation of synaptic impulses
  • Molecular weight: 252.27
  • Formula: C15H12N2O2
  • CLOGP: 1.21
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 1
  • TPSA: 63.40
  • ALOGS: -3.20
  • ROTB: 0
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
1 g O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.31 mg/mL Bocci G, Oprea TI, Benet LZ
MRTD (Maximum Recommended Therapeutic Daily Dose) 135.90 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 95 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
kinase-safety-class ACVR2A,ACVR2B,ALK,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK5,CDK9,DDR1,DYRK1B,EIF2AK3,EPHB4,ERBB2,FLT3,GRK2,GSK3B,ITK,JAK1,JAK2,MAP3K21,MAP3K7,MAPK10,MAPK12,MAPK7,MAPK9,MARK4,MET,MTOR,NTRK2,PAK4,PDK1,PDK2,PDK4,PDPK1,PIK3CB,PIK3CD,PIM2,PRKCD,PRKDC,SIK2,SIK3,STK33,SYK,TEK,TTK,ULK1 49
kinase-selectivity-class ACVR2A,ACVR2B,AXL,GRK2,MAP2K6,MAPK7,SIK2,STK33,TTK 9
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pld-class Phospholipidosis risk class (1 = positive, 0 = negative) 0 High 1

Approvals:

DateAgencyCompanyOrphan
Jan. 14, 2000 FDA NOVARTIS

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 1492.65 13.65 856 34573 151773 90441245
Hyponatraemia 791.39 13.65 546 34883 132992 90460026
Multiple-drug resistance 342.81 13.65 125 35304 7651 90585367
Abortion spontaneous 286.98 13.65 207 35222 53849 90539169
Status epilepticus 285.57 13.65 142 35287 18732 90574286
Generalised tonic-clonic seizure 247.84 13.65 160 35269 34743 90558275
Completed suicide 235.85 13.65 287 35142 144771 90448247
Drug interaction 209.46 13.65 382 35047 276071 90316947
Focal dyscognitive seizures 202.19 13.65 67 35362 3077 90589941
Petit mal epilepsy 186.67 13.65 71 35358 4887 90588131
Balance disorder 180.82 13.65 206 35223 96874 90496144
Somnolence 177.75 13.65 304 35125 208780 90384238
Product substitution issue 175.18 13.65 101 35328 17907 90575111
Sedation 172.08 13.65 146 35283 48025 90544993
Diplopia 168.63 13.65 117 35312 28597 90564421
Aggression 162.12 13.65 111 35318 26557 90566461
Cognitive disorder 151.29 13.65 160 35269 69247 90523771
Toxicity to various agents 145.90 13.65 337 35092 287509 90305509
Drug reaction with eosinophilia and systemic symptoms 145.40 13.65 126 35303 42632 90550386
Partial seizures 144.56 13.65 66 35363 7194 90585824
Inappropriate antidiuretic hormone secretion 134.96 13.65 88 35341 19417 90573601
Myoclonic epilepsy 126.31 13.65 40 35389 1587 90591431
Sedation complication 126.01 13.65 80 35349 16864 90576154
Psychogenic seizure 125.80 13.65 42 35387 1974 90591044
Creatinine renal clearance decreased 125.24 13.65 83 35346 18816 90574202
Infusion related reaction 117.38 13.65 13 35416 416767 90176251
Orthostatic hypotension 116.16 13.65 110 35319 41717 90551301
Epilepsy 111.89 13.65 149 35280 82057 90510961
Depressed level of consciousness 110.11 13.65 139 35290 72645 90520373
Blood sodium decreased 109.63 13.65 89 35340 27524 90565494
Suicide attempt 109.35 13.65 141 35288 75258 90517760
Glossodynia 108.21 13.65 4 35425 321775 90271243
Abnormal behaviour 107.29 13.65 81 35348 22547 90570471
Ataxia 104.72 13.65 73 35356 17969 90575049
Mitochondrial DNA mutation 103.62 13.65 26 35403 432 90592586
Joint swelling 103.44 13.65 34 35395 503266 90089752
Renal function test abnormal 102.56 13.65 52 35377 7139 90585879
Creatinine renal clearance increased 102.36 13.65 41 35388 3240 90589778
Overdose 100.85 13.65 203 35226 157506 90435512
Irritability 99.43 13.65 94 35335 35568 90557450
Systemic lupus erythematosus 97.68 13.65 13 35416 361883 90231135
Arthropathy 96.86 13.65 14 35415 366228 90226790
Blood calcium decreased 96.70 13.65 86 35343 30096 90562922
Psychotic disorder 96.14 13.65 87 35342 31143 90561875
Suicidal ideation 93.12 13.65 129 35300 73726 90519292
Pericarditis 92.07 13.65 3 35426 270148 90322870
Peripheral swelling 82.94 13.65 29 35400 413077 90179941
Lower respiratory tract infection 81.32 13.65 4 35425 250655 90342363
Propofol infusion syndrome 80.00 13.65 27 35402 1312 90591706
Alopecia 78.91 13.65 48 35381 495023 90097995
Exposure during pregnancy 77.69 13.65 237 35192 238173 90354845
Mania 76.98 13.65 55 35374 14069 90578949
Contraindicated product administered 76.41 13.65 16 35413 320123 90272895
Nasopharyngitis 76.05 13.65 32 35397 407072 90185946
Infantile spasms 75.99 13.65 18 35411 232 90592786
Intentional overdose 75.13 13.65 133 35296 93701 90499317
Arthralgia 75.04 13.65 118 35311 778404 89814614
Drug resistance 75.01 13.65 75 35354 30374 90562644
Drug ineffective for unapproved indication 74.59 13.65 110 35319 66534 90526484
Drug ineffective 74.49 13.65 846 34583 1383452 89209566
Helicobacter infection 72.39 13.65 4 35425 226846 90366172
Impaired healing 72.12 13.65 5 35424 234194 90358824
Tremor 70.61 13.65 173 35256 153000 90440018
Swelling 70.52 13.65 38 35391 419020 90173998
Developmental delay 70.01 13.65 26 35403 1674 90591344
Infection 66.76 13.65 29 35400 362065 90230953
Speech disorder 65.68 13.65 85 35344 45500 90547518
Dizziness 65.57 13.65 424 35005 588860 90004158
Blood gases abnormal 64.75 13.65 21 35408 900 90592118
Nystagmus 63.61 13.65 38 35391 7189 90585829
General physical health deterioration 63.03 13.65 30 35399 355085 90237933
Stomatitis 62.98 13.65 15 35414 274683 90318335
Behaviour disorder 61.71 13.65 32 35397 4603 90588415
Hyperammonaemic encephalopathy 61.60 13.65 27 35402 2672 90590346
Gene mutation 60.89 13.65 25 35404 2105 90590913
CSF oligoclonal band present 60.85 13.65 17 35412 434 90592584
Psoriatic arthropathy 59.70 13.65 9 35420 228326 90364692
Agitation 58.80 13.65 99 35330 66999 90526019
Sopor 57.59 13.65 59 35370 24585 90568433
Fall 56.85 13.65 352 35077 481458 90111560
Drug abuse 56.22 13.65 109 35320 82238 90510780
Hypochloraemia 55.89 13.65 25 35404 2597 90590421
Respiratory arrest 55.81 13.65 67 35362 33244 90559774
Tonic convulsion 55.19 13.65 22 35407 1716 90591302
Irritable bowel syndrome 54.64 13.65 8 35421 207440 90385578
Multiple drug therapy 54.38 13.65 34 35395 6975 90586043
Discomfort 53.77 13.65 20 35409 274315 90318703
Bipolar disorder 53.65 13.65 37 35392 8948 90584070
Sudden unexplained death in epilepsy 53.32 13.65 15 35414 393 90592625
Pleocytosis 51.19 13.65 18 35411 990 90592028
Hepatic enzyme increased 50.76 13.65 40 35389 360696 90232322
Diarrhoea 49.82 13.65 194 35235 938996 89654022
Anticonvulsant drug level decreased 48.95 13.65 19 35410 1381 90591637
Rheumatoid arthritis 48.81 13.65 42 35387 362572 90230446
Cardiac arrest 47.78 13.65 118 35311 104817 90488201
Cardio-respiratory arrest 47.34 13.65 87 35342 63053 90529965
Abdominal discomfort 47.18 13.65 71 35358 477257 90115761
Atonic seizures 46.97 13.65 16 35413 800 90592218
Mental disorder 46.14 13.65 60 35369 32258 90560760
Wound 46.00 13.65 31 35398 302949 90290069
Dysphoria 45.61 13.65 29 35400 6125 90586893
Sinusitis 44.65 13.65 41 35388 343047 90249971
Fibromyalgia 43.98 13.65 13 35416 206256 90386762
Change in seizure presentation 43.67 13.65 14 35415 578 90592440
Hallucination 43.43 13.65 86 35343 65873 90527145
Electroencephalogram abnormal 42.58 13.65 24 35405 4072 90588946
Febrile neutropenia 41.94 13.65 6 35423 158343 90434675
Pneumonia 41.87 13.65 120 35309 637939 89955079
Aura 40.73 13.65 16 35413 1201 90591817
Simple partial seizures 40.70 13.65 14 35415 721 90592297
Gastrointestinal disorder 40.68 13.65 25 35404 256662 90336356
Encephalitis 40.26 13.65 34 35395 11100 90581918
Gastric lavage 40.14 13.65 8 35421 42 90592976
Therapeutic product effect decreased 40.03 13.65 30 35399 277541 90315477
Drug level decreased 39.97 13.65 32 35397 9698 90583320
Dyskinesia 39.00 13.65 59 35370 36475 90556543
Abortion induced 38.32 13.65 34 35395 11854 90581164
Stevens-Johnson syndrome 38.04 13.65 52 35377 29324 90563694
Paradoxical drug reaction 37.42 13.65 25 35404 5741 90587277
Bursitis 37.28 13.65 4 35425 131650 90461368
Parkinsonism 37.16 13.65 36 35393 14029 90578989
Type 2 diabetes mellitus 36.30 13.65 17 35412 203227 90389791
Loss of consciousness 36.29 13.65 129 35300 140109 90452909
Seizure cluster 36.25 13.65 11 35418 378 90592640
Musculoskeletal pain 36.13 13.65 11 35418 171240 90421778
Cross sensitivity reaction 35.97 13.65 19 35410 2838 90590180
Hypothermia 35.87 13.65 37 35392 15538 90577480
Mood swings 35.27 13.65 42 35387 20660 90572358
Postictal paralysis 34.95 13.65 10 35419 279 90592739
Maternal exposure during pregnancy 34.53 13.65 250 35179 359813 90233205
Psychomotor hyperactivity 34.23 13.65 33 35396 12780 90580238
Partial seizures with secondary generalisation 33.77 13.65 11 35418 478 90592540
Depression 33.14 13.65 216 35213 300385 90292633
Constipation 33.08 13.65 205 35224 280190 90312828
Tardive dyskinesia 32.75 13.65 30 35399 10900 90582118
Rash maculo-papular 32.72 13.65 58 35371 40875 90552143
Intentional self-injury 32.21 13.65 48 35381 29286 90563732
Therapeutic product effective for unapproved indication 32.05 13.65 8 35421 130 90592888
Trigeminal neuralgia 31.95 13.65 20 35409 4111 90588907
Inflammation 31.79 13.65 15 35414 178577 90414441
Psychomotor retardation 31.64 13.65 21 35408 4768 90588250
Asthma 31.42 13.65 29 35400 242131 90350887
Cough 30.84 13.65 61 35368 368901 90224117
Therapeutic product ineffective for unapproved indication 30.15 13.65 9 35420 292 90592726
Drug withdrawal syndrome 30.11 13.65 46 35383 28677 90564341
Blood osmolarity decreased 29.97 13.65 12 35417 947 90592071
Drug level increased 29.87 13.65 45 35384 27717 90565301
Electrocardiogram QRS complex prolonged 29.83 13.65 24 35405 7324 90585694
Multiple sclerosis 29.77 13.65 45 35384 27795 90565223
Neuroleptic malignant syndrome 29.72 13.65 33 35396 15063 90577955
Aphasia 29.61 13.65 57 35372 42755 90550263
Bipolar I disorder 29.53 13.65 15 35414 2067 90590951
Immune thrombocytopenia 29.51 13.65 31 35398 13295 90579723
Hallucination, olfactory 29.50 13.65 9 35420 315 90592703
Hypersensitivity 29.43 13.65 86 35343 454591 90138427
Liver injury 29.34 13.65 15 35414 170552 90422466
Neurotoxicity 29.32 13.65 39 35390 21428 90571590
Intentional product use issue 29.31 13.65 25 35404 216867 90376151
Hypercholesterolaemia 28.73 13.65 3 35426 100889 90492129
Herpes oesophagitis 28.46 13.65 8 35421 209 90592809
Arthritis 28.36 13.65 15 35414 167300 90425718
Blood lactic acid increased 28.09 13.65 25 35404 8753 90584265
Unmasking of previously unidentified disease 28.07 13.65 13 35416 1463 90591555
Drug intolerance 28.00 13.65 86 35343 447505 90145513
Drug withdrawal convulsions 27.87 13.65 13 35416 1487 90591531
Poisoning 27.80 13.65 32 35397 15185 90577833
Musculoskeletal stiffness 27.47 13.65 46 35383 296486 90296532
Brown tumour 27.39 13.65 6 35423 53 90592965
Appetite disorder 27.23 13.65 25 35404 9108 90583910
Paranoia 26.77 13.65 29 35400 12879 90580139
Ill-defined disorder 26.62 13.65 20 35409 184871 90408147
Dysmorphism 26.57 13.65 15 35414 2553 90590465
Low set ears 26.42 13.65 8 35421 273 90592745
Coma blister 26.40 13.65 7 35422 146 90592872
Electrocardiogram QT prolonged 26.39 13.65 75 35354 72381 90520637
Night sweats 25.87 13.65 9 35420 128757 90464261
Electrocardiogram repolarisation abnormality 25.80 13.65 12 35417 1364 90591654
Lennox-Gastaut syndrome 25.77 13.65 8 35421 297 90592721
Caesarean section 25.76 13.65 34 35395 18543 90574475
Blood cholesterol increased 25.71 13.65 26 35403 207986 90385032
Pain 25.47 13.65 258 35171 996083 89596935
Stillbirth 25.42 13.65 22 35407 7421 90585597
Ventricular hypokinesia 25.05 13.65 19 35410 5322 90587696
Head injury 24.68 13.65 44 35385 31144 90561874
Reversible cerebral vasoconstriction syndrome 24.64 13.65 17 35412 4113 90588905
Hypertension 24.49 13.65 94 35335 457438 90135580
Blister 24.14 13.65 39 35390 254959 90338059
Injury 24.02 13.65 25 35404 197324 90395694
Wheezing 23.89 13.65 35 35394 238045 90354973
Phobia 23.88 13.65 8 35421 380 90592638
Gaze palsy 23.79 13.65 12 35417 1629 90591389
Thinking abnormal 23.70 13.65 26 35403 11706 90581312
Anger 23.64 13.65 28 35401 13692 90579326
Coma 23.42 13.65 72 35357 72560 90520458
Anaemia 23.35 13.65 66 35363 352736 90240282
Brain operation 23.24 13.65 9 35420 650 90592368
Mood altered 23.19 13.65 31 35398 17113 90575905
Unresponsive to stimuli 23.06 13.65 48 35381 38073 90554945
Arrhythmia 22.97 13.65 51 35378 42281 90550737
Catatonia 22.94 13.65 19 35410 6037 90586981
Atrioventricular block first degree 22.89 13.65 22 35407 8489 90584529
Electrocardiogram ST segment elevation 22.72 13.65 16 35413 4000 90589018
Crying 22.67 13.65 38 35391 25607 90567411
Pain in extremity 22.57 13.65 95 35334 450434 90142584
Haemorrhagic diathesis 22.33 13.65 18 35411 5506 90587512
Sciatica 22.32 13.65 6 35423 101376 90491642
Systolic dysfunction 22.11 13.65 12 35417 1892 90591126
C-reactive protein increased 22.05 13.65 23 35406 181366 90411652
Renal impairment 21.82 13.65 7 35422 105414 90487604
Chronic papillomatous dermatitis 21.75 13.65 5 35424 56 90592962
Decreased appetite 21.70 13.65 75 35354 376465 90216553
Intestinal obstruction 21.59 13.65 46 35383 37085 90555933
Gastrooesophageal reflux disease 21.47 13.65 20 35409 166317 90426701
Disturbance in attention 21.46 13.65 53 35376 47056 90545962
Screaming 21.35 13.65 15 35414 3735 90589283
Grip strength decreased 21.31 13.65 5 35424 92571 90500447
Dyspepsia 21.01 13.65 28 35401 198132 90394886
Hypotonia 20.83 13.65 24 35405 11402 90581616
Abdominal pain upper 20.73 13.65 64 35365 332610 90260408
Hypoxic-ischaemic encephalopathy 20.57 13.65 16 35413 4652 90588366
Follicular mucinosis 20.54 13.65 3 35426 0 90593018
Congenital epiglottal anomaly 20.54 13.65 3 35426 0 90593018
Restlessness 20.48 13.65 44 35385 35676 90557342
Ventricular fibrillation 19.93 13.65 26 35403 14018 90579000
Anal incontinence 19.92 13.65 28 35401 16202 90576816
Postictal state 19.65 13.65 10 35419 1383 90591635
Hypotension 19.64 13.65 204 35225 325193 90267825
Ammonia increased 19.64 13.65 16 35413 4970 90588048
Epilepsy surgery 19.62 13.65 4 35425 24 90592994
Antinuclear antibody positive 19.58 13.65 21 35408 9220 90583798
Muscle rigidity 19.55 13.65 26 35403 14283 90578735
Dry mouth 19.52 13.65 26 35403 184033 90408985
Shock 19.51 13.65 38 35391 28740 90564278
Photophobia 19.45 13.65 32 35397 21237 90571781
Lung disorder 19.37 13.65 18 35411 149865 90443153
Temporal lobe epilepsy 19.35 13.65 7 35422 418 90592600
Strabismus 19.22 13.65 12 35417 2456 90590562
Myoclonus 19.12 13.65 30 35399 19138 90573880
Muscle spasms 19.07 13.65 44 35385 251839 90341179
Mental status changes 19.03 13.65 49 35380 44630 90548388
Malignant neoplasm progression 18.98 13.65 9 35420 106861 90486157
Live birth 18.75 13.65 4 35425 79103 90513915
Liver function test increased 18.72 13.65 5 35424 84850 90508168
Delusion 18.68 13.65 25 35404 13815 90579203
Arthritis infective 18.43 13.65 19 35410 7973 90585045
Visual impairment 18.33 13.65 101 35328 132264 90460754
Logorrhoea 18.12 13.65 12 35417 2715 90590303
Gun shot wound 18.11 13.65 5 35424 122 90592896
Lethargy 18.00 13.65 60 35369 63079 90529939
Thyroxine free decreased 17.80 13.65 8 35421 840 90592178
Hip arthroplasty 17.77 13.65 4 35425 76204 90516814
Cardiopulmonary failure 17.68 13.65 14 35415 4174 90588844
Therapeutic response unexpected 17.48 13.65 31 35398 21849 90571169
Disorientation 17.38 13.65 47 35382 44067 90548951
Anticonvulsant drug level above therapeutic 17.37 13.65 7 35422 562 90592456
Sleep paralysis 17.36 13.65 8 35421 890 90592128
Hallucination, auditory 17.34 13.65 26 35403 15949 90577069
Rasmussen encephalitis 17.25 13.65 3 35426 6 90593012
Skin warm 17.23 13.65 18 35411 7669 90585349
Pregnancy 16.84 13.65 58 35371 61989 90531029
Neonatal seizure 16.82 13.65 7 35422 610 90592408
Oedema peripheral 16.51 13.65 49 35380 257866 90335152
Muscle twitching 16.46 13.65 32 35397 24170 90568848
Dysphagia 16.44 13.65 87 35342 112191 90480827
Knee arthroplasty 16.39 13.65 6 35423 83176 90509842
Liver disorder 16.35 13.65 14 35415 121255 90471763
Vertigo 16.18 13.65 62 35367 69749 90523269
Product complaint 16.14 13.65 23 35406 13477 90579541
Granulocytopenia 16.11 13.65 16 35413 6425 90586593
Dyspnoea 16.10 13.65 245 35184 880710 89712308
Autoimmune disorder 16.05 13.65 5 35424 76739 90516279
Off label use 15.83 13.65 552 34877 1101700 89491318
Amnestic disorder 15.81 13.65 6 35423 410 90592608
Product administration error 15.67 13.65 33 35396 26390 90566628
Central nervous system lesion 15.66 13.65 21 35408 11625 90581393
Product use issue 15.64 13.65 71 35358 329848 90263170
Conversion disorder 15.62 13.65 10 35419 2136 90590882
Hepatic cirrhosis 15.41 13.65 3 35426 63250 90529768
Psychomotor skills impaired 15.23 13.65 11 35418 2861 90590157
Blood creatine phosphokinase increased 15.20 13.65 38 35391 33985 90559033
Nervousness 15.18 13.65 38 35391 34018 90559000
Atrial fibrillation 15.07 13.65 18 35411 133593 90459425
Hallucination, visual 15.06 13.65 30 35399 23062 90569956
Impulsive behaviour 14.97 13.65 9 35420 1721 90591297
Automatism 14.88 13.65 4 35425 88 90592930
Red blood cell sedimentation rate increased 14.60 13.65 7 35422 82588 90510430
Gastrostomy 14.50 13.65 7 35422 864 90592154
Learning disorder 14.45 13.65 7 35422 871 90592147
Fever neonatal 14.44 13.65 3 35426 20 90592998
Dermatitis allergic 14.42 13.65 25 35404 17302 90575716
Feeling abnormal 14.25 13.65 113 35316 167122 90425896
Amenorrhoea 14.06 13.65 20 35409 11702 90581316
Treatment failure 14.05 13.65 66 35363 303862 90289156
Retrognathia 14.04 13.65 6 35423 558 90592460
Potentiating drug interaction 14.04 13.65 14 35415 5648 90587370
Memory impairment 14.02 13.65 128 35301 197116 90395902
Hyperkalaemia 14.01 13.65 4 35425 64960 90528058
Amniocentesis abnormal 14.00 13.65 4 35425 111 90592907
Dysarthria 13.98 13.65 50 35379 54432 90538586
Hypogammaglobulinaemia 13.98 13.65 19 35410 10655 90582363
Educational problem 13.95 13.65 6 35423 567 90592451
Extensor plantar response 13.86 13.65 8 35421 1419 90591599
Bladder disorder 13.84 13.65 19 35410 10753 90582265
Mental impairment 13.76 13.65 24 35405 16696 90576322
Drug level below therapeutic 13.73 13.65 14 35415 5800 90587218
Gait disturbance 13.72 13.65 159 35270 260337 90332681
Anxiety 13.71 13.65 183 35246 309589 90283429
Dystonia 13.65 13.65 24 35405 16795 90576223

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 1267.03 14.42 804 23055 119757 42477719
Hyponatraemia 418.60 14.42 389 23470 101073 42496403
Multiple-drug resistance 272.80 14.42 115 23744 7207 42590269
Epilepsy 225.70 14.42 155 23704 26016 42571460
Generalised tonic-clonic seizure 205.95 14.42 147 23712 26232 42571244
Aggression 198.60 14.42 178 23681 43985 42553491
Product substitution issue 196.60 14.42 105 23754 11185 42586291
Drug ineffective 181.18 14.42 762 23097 629435 41968041
Status epilepticus 150.41 14.42 99 23760 15479 42581997
Ataxia 140.15 14.42 96 23763 16029 42581447
Partial seizures 123.59 14.42 62 23797 5797 42591679
Stevens-Johnson syndrome 123.30 14.42 101 23758 22077 42575399
Somnolence 114.18 14.42 247 23612 140858 42456618
Sudden unexplained death in epilepsy 113.50 14.42 31 23828 498 42596978
Petit mal epilepsy 111.97 14.42 50 23809 3600 42593876
Electroencephalogram abnormal 108.11 14.42 46 23813 2946 42594530
Inappropriate antidiuretic hormone secretion 106.22 14.42 82 23777 16459 42581017
Nystagmus 85.06 14.42 47 23812 5349 42592127
Febrile neutropenia 78.27 14.42 7 23852 185696 42411780
Drug interaction 76.00 14.42 323 23536 266676 42330800
Completed suicide 73.56 14.42 165 23694 96300 42501176
Abnormal behaviour 73.26 14.42 82 23777 26369 42571107
Hypochloraemia 72.25 14.42 25 23834 908 42596568
Death 70.32 14.42 97 23762 471088 42126388
Focal dyscognitive seizures 68.14 14.42 27 23832 1440 42596036
Acute kidney injury 66.19 14.42 65 23794 367272 42230204
Dyspnoea 59.35 14.42 98 23761 442523 42154953
Anaemia 57.22 14.42 44 23815 280234 42317242
Pneumonia 57.02 14.42 93 23766 422056 42175420
Coma 54.22 14.42 103 23756 53451 42544025
Irritability 50.24 14.42 70 23789 28058 42569418
Neuroleptic malignant syndrome 50.15 14.42 61 23798 21411 42576065
Diarrhoea 49.69 14.42 116 23743 460733 42136743
Diplopia 49.55 14.42 59 23800 20257 42577219
Memory impairment 48.88 14.42 95 23764 50127 42547349
Intellectual disability 48.46 14.42 23 23836 1904 42595572
Treatment failure 47.56 14.42 107 23752 62517 42534959
Behaviour disorder 47.54 14.42 36 23823 7018 42590458
Agitation 45.66 14.42 107 23752 64207 42533269
Suicidal ideation 44.33 14.42 89 23770 48072 42549404
Hyperammonaemic encephalopathy 43.40 14.42 24 23835 2734 42594742
Hyperammonaemia 41.98 14.42 35 23824 7831 42589645
Depression 41.59 14.42 147 23712 111216 42486260
Wrong patient received product 40.09 14.42 25 23834 3558 42593918
Psychomotor hyperactivity 39.30 14.42 39 23820 10919 42586557
Educational problem 39.07 14.42 14 23845 564 42596912
Sepsis 38.51 14.42 33 23826 199301 42398175
Blood sodium decreased 38.26 14.42 49 23810 18113 42579363
Cognitive disorder 37.42 14.42 68 23791 34104 42563372
Bradykinesia 37.20 14.42 28 23831 5408 42592068
Psychotic disorder 37.03 14.42 62 23797 29146 42568330
Drug eruption 36.20 14.42 54 23805 23021 42574455
Colitis ischaemic 36.19 14.42 31 23828 7195 42590281
Myoclonic epilepsy 36.14 14.42 18 23841 1656 42595820
Infantile spasms 36.00 14.42 11 23848 267 42597209
Dizziness 35.58 14.42 250 23609 249004 42348472
Sedation 35.11 14.42 62 23797 30413 42567063
Balance disorder 34.61 14.42 80 23779 47565 42549911
Depressed mood 34.24 14.42 53 23806 23331 42574145
Drug withdrawal convulsions 33.74 14.42 16 23843 1322 42596154
Intentional self-injury 33.58 14.42 42 23817 15160 42582316
Speech disorder developmental 33.55 14.42 19 23840 2266 42595210
Arthralgia 32.80 14.42 40 23819 205198 42392278
Developmental delay 32.60 14.42 21 23838 3161 42594315
Anticonvulsant drug level decreased 31.97 14.42 15 23844 1210 42596266
Aura 31.41 14.42 11 23848 414 42597062
Simple partial seizures 31.04 14.42 11 23848 429 42597047
Tic 30.18 14.42 18 23841 2365 42595111
Drug resistance 29.98 14.42 62 23797 34186 42563290
Impulsive behaviour 29.89 14.42 18 23841 2407 42595069
Polyserositis 29.67 14.42 10 23849 335 42597141
Cardiac failure congestive 29.49 14.42 6 23853 85596 42511880
Dissociation 29.23 14.42 21 23838 3777 42593699
Sleep deficit 28.97 14.42 13 23846 946 42596530
Autism spectrum disorder 28.85 14.42 19 23840 2969 42594507
Polydipsia 28.26 14.42 22 23837 4466 42593010
Autonomic nervous system imbalance 28.12 14.42 19 23840 3097 42594379
Malignant neoplasm progression 27.70 14.42 13 23846 108387 42489089
Disturbance in attention 27.24 14.42 55 23804 29811 42567665
Brain malformation 27.05 14.42 8 23851 173 42597303
Wrong patient 27.05 14.42 11 23848 628 42596848
Speech disorder 27.01 14.42 54 23805 29067 42568409
Seizure cluster 26.89 14.42 9 23850 295 42597181
Sopor 26.84 14.42 35 23824 13167 42584309
Thyroxine free decreased 26.71 14.42 9 23850 301 42597175
Benign cardiac neoplasm 26.48 14.42 6 23853 42 42597434
Astrocytoma, low grade 26.32 14.42 7 23852 101 42597375
Drug level decreased 26.03 14.42 30 23829 9947 42587529
Tremor 25.72 14.42 115 23744 96814 42500662
Platelet count decreased 25.48 14.42 24 23835 138557 42458919
Gait disturbance 25.05 14.42 115 23744 97885 42499591
Developmental coordination disorder 25.03 14.42 8 23851 226 42597250
Dysmorphism 24.75 14.42 18 23841 3298 42594178
Anger 24.14 14.42 33 23826 12985 42584491
Coordination abnormal 24.08 14.42 26 23833 8024 42589452
Dysarthria 23.76 14.42 62 23797 39745 42557731
Hallucination, auditory 23.62 14.42 35 23824 14829 42582647
Oedema peripheral 23.38 14.42 25 23834 136051 42461425
Pancytopenia 23.32 14.42 19 23840 117724 42479752
Back pain 23.31 14.42 27 23832 141749 42455727
Neutropenia 23.21 14.42 48 23811 199383 42398093
Anxiety 23.18 14.42 129 23730 118431 42479045
Tuberous sclerosis complex 23.14 14.42 6 23853 78 42597398
Gastrointestinal haemorrhage 23.06 14.42 13 23846 97713 42499763
Psychogenic seizure 22.96 14.42 9 23850 466 42597010
Cardiac failure 22.76 14.42 16 23843 106840 42490636
Drug ineffective for unapproved indication 22.71 14.42 67 23792 46096 42551380
COVID-19 22.61 14.42 19 23840 115929 42481547
Drug withdrawal syndrome 22.48 14.42 42 23817 21507 42575969
Hypothermia 22.12 14.42 31 23828 12484 42584992
Nervousness 21.70 14.42 32 23827 13500 42583976
Blood chloride decreased 21.22 14.42 18 23841 4121 42593355
Dyskinesia 21.10 14.42 45 23814 25345 42572131
Otitis media 20.93 14.42 17 23842 3666 42593810
Suicide attempt 20.88 14.42 65 23794 46035 42551441
Enuresis 20.70 14.42 15 23844 2733 42594743
Interstitial lung disease 20.68 14.42 9 23850 78453 42519023
Idiopathic generalised epilepsy 20.48 14.42 5 23854 50 42597426
Irregular sleep phase 20.41 14.42 6 23853 127 42597349
Large granular lymphocytosis 20.18 14.42 7 23852 256 42597220
Tardive dyskinesia 20.08 14.42 22 23837 6902 42590574
Renal failure 19.94 14.42 31 23828 143695 42453781
Mental disorder 19.89 14.42 36 23823 17993 42579483
Tonic convulsion 19.64 14.42 12 23847 1647 42595829
Motor developmental delay 19.47 14.42 9 23850 702 42596774
Thrombosis 19.47 14.42 7 23852 68504 42528972
Confusional state 19.32 14.42 160 23699 167437 42430039
Atrial septal defect 19.31 14.42 23 23836 7896 42589580
Affective disorder 19.16 14.42 20 23839 5940 42591536
Change in seizure presentation 18.82 14.42 7 23852 314 42597162
Sleep apnoea syndrome 18.77 14.42 39 23820 21569 42575907
Drooling 18.65 14.42 17 23842 4282 42593194
Condition aggravated 18.46 14.42 225 23634 260529 42336947
Therapeutic response unexpected 18.37 14.42 27 23832 11354 42586122
Neuropathy peripheral 18.30 14.42 18 23841 101835 42495641
Application site pain 18.20 14.42 13 23846 2316 42595160
Severe myoclonic epilepsy of infancy 18.04 14.42 4 23855 25 42597451
Granulocytopenia 17.90 14.42 21 23838 7093 42590383
Overweight 17.79 14.42 13 23846 2399 42595077
Thinking abnormal 17.79 14.42 21 23838 7140 42590336
Vagal nerve stimulator implantation 17.67 14.42 5 23854 92 42597384
Infusion related reaction 17.64 14.42 6 23853 60800 42536676
Multiple organ dysfunction syndrome 17.60 14.42 17 23842 97018 42500458
Staring 17.60 14.42 11 23848 1572 42595904
Panic attack 17.54 14.42 26 23833 11019 42586457
Disruptive mood dysregulation disorder 17.39 14.42 3 23856 3 42597473
Anticonvulsant drug level increased 17.22 14.42 11 23848 1632 42595844
Malaise 17.19 14.42 61 23798 212095 42385381
Drug reaction with eosinophilia and systemic symptoms 16.95 14.42 57 23802 42018 42555458
Rash 16.68 14.42 232 23627 276722 42320754
Eye movement disorder 16.63 14.42 17 23842 4928 42592548
Hypotension 16.58 14.42 81 23778 257550 42339926
Encephalitis autoimmune 16.40 14.42 10 23849 1367 42596109
Pulmonary embolism 16.40 14.42 26 23833 119586 42477890
Craniocerebral injury 16.32 14.42 15 23844 3819 42593657
Congenital scoliosis 16.30 14.42 5 23854 123 42597353
Parasomnia 16.25 14.42 7 23852 462 42597014
Congenital knee deformity 16.22 14.42 5 23854 125 42597351
Bipolar disorder 16.02 14.42 15 23844 3907 42593569
Pain 15.74 14.42 77 23782 244771 42352705
Hand fracture 15.65 14.42 13 23846 2893 42594583
Product complaint 15.64 14.42 18 23841 5959 42591517
Mania 15.57 14.42 24 23835 10523 42586953
Body mass index decreased 15.49 14.42 6 23853 301 42597175
Chronic obstructive pulmonary disease 15.46 14.42 8 23851 63106 42534370
Lid lag 15.31 14.42 3 23856 9 42597467
Product quality issue 15.21 14.42 32 23827 17850 42579626
Trigeminal neuralgia 15.20 14.42 10 23849 1559 42595917
Cryptorchism 15.12 14.42 11 23848 2016 42595460
Central pain syndrome 15.08 14.42 5 23854 159 42597317
Hippocampal sclerosis 15.08 14.42 5 23854 159 42597317
Application site erythema 14.91 14.42 12 23847 2554 42594922
Chronic kidney disease 14.90 14.42 4 23855 47237 42550239
Enzyme induction 14.90 14.42 4 23855 60 42597416
Prescribed overdose 14.50 14.42 26 23833 12901 42584575

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 1739.91 13.04 1114 46137 220071 110321977
Hyponatraemia 1011.31 13.04 796 46455 216857 110325191
Multiple-drug resistance 473.24 13.04 187 47064 13048 110529000
Completed suicide 355.06 13.04 476 46775 241905 110300143
Status epilepticus 342.38 13.04 196 47055 31375 110510673
Generalised tonic-clonic seizure 338.28 13.04 238 47013 54442 110487606
Aggression 312.31 13.04 234 47017 58976 110483072
Drug interaction 278.74 13.04 641 46610 499542 110042506
Somnolence 271.71 13.04 469 46782 296980 110245068
Focal dyscognitive seizures 244.19 13.04 83 47168 3766 110538282
Petit mal epilepsy 243.33 13.04 99 47152 7448 110534600
Partial seizures 238.35 13.04 110 47141 11239 110530809
Inappropriate antidiuretic hormone secretion 222.57 13.04 153 47098 33698 110508350
Ataxia 214.45 13.04 143 47108 29965 110512083
Product substitution issue 207.66 13.04 127 47124 22934 110519114
Balance disorder 203.58 13.04 250 47001 116310 110425738
Sedation 195.92 13.04 192 47059 69491 110472557
Epilepsy 181.59 13.04 219 47032 99990 110442058
Drug ineffective 177.53 13.04 1181 46070 1519359 109022689
Diplopia 166.02 13.04 140 47111 41754 110500294
Sudden unexplained death in epilepsy 154.48 13.04 41 47210 782 110541266
Stevens-Johnson syndrome 152.35 13.04 140 47111 46761 110495287
Cognitive disorder 150.03 13.04 186 47065 87325 110454723
Psychogenic seizure 146.14 13.04 50 47201 2314 110539734
Drug reaction with eosinophilia and systemic symptoms 144.79 13.04 177 47074 81918 110460130
Nystagmus 142.13 13.04 78 47173 11499 110530549
Myoclonic epilepsy 139.80 13.04 50 47201 2641 110539407
Toxicity to various agents 125.30 13.04 470 46781 480085 110061963
Abnormal behaviour 121.89 13.04 114 47137 38925 110503123
Sedation complication 119.43 13.04 85 47166 19770 110522278
Psychotic disorder 115.39 13.04 125 47126 50812 110491236
Hypochloraemia 115.05 13.04 47 47204 3571 110538477
Suicide attempt 113.03 13.04 177 47074 103217 110438831
Infantile spasms 110.48 13.04 27 47224 364 110541684
Creatinine renal clearance decreased 110.06 13.04 84 47167 21731 110520317
Drug resistance 108.34 13.04 127 47124 56247 110485801
Infusion related reaction 107.67 13.04 17 47234 381145 110160903
Suicidal ideation 105.74 13.04 163 47088 93774 110448274
Behaviour disorder 104.84 13.04 60 47191 9587 110532461
Irritability 100.81 13.04 113 47138 47696 110494352
Mitochondrial DNA mutation 100.33 13.04 26 47225 450 110541598
Agitation 100.04 13.04 176 47075 112875 110429173
Hyperammonaemic encephalopathy 99.73 13.04 48 47203 5386 110536662
Depressed level of consciousness 98.33 13.04 174 47077 112104 110429944
Febrile neutropenia 96.90 13.04 11 47240 316756 110225292
Creatinine renal clearance increased 94.88 13.04 41 47210 3584 110538464
Neuroleptic malignant syndrome 94.12 13.04 93 47158 33966 110508082
Joint swelling 87.29 13.04 40 47211 442805 110099243
Arthralgia 86.05 13.04 125 47126 779507 109762541
Overdose 86.02 13.04 257 46994 233537 110308511
Renal function test abnormal 84.99 13.04 51 47200 8895 110533153
Sopor 83.32 13.04 90 47161 36456 110505592
Glossodynia 81.58 13.04 3 47248 222001 110320047
Blood sodium decreased 79.81 13.04 90 47161 38229 110503819
Electroencephalogram abnormal 79.68 13.04 43 47208 6130 110535918
Arthropathy 78.57 13.04 14 47237 287508 110254540
Drug ineffective for unapproved indication 78.23 13.04 150 47101 102688 110439360
Lower respiratory tract infection 78.09 13.04 7 47244 243099 110298949
Blood calcium decreased 77.76 13.04 86 47165 35759 110506289
Pericarditis 77.09 13.04 4 47247 219110 110322938
Propofol infusion syndrome 76.79 13.04 32 47219 2557 110539491
Intentional overdose 72.58 13.04 169 47082 132332 110409716
Pneumonia 72.33 13.04 168 47083 876546 109665502
General physical health deterioration 71.35 13.04 47 47204 425248 110116800
Dizziness 71.19 13.04 526 46725 697667 109844381
Swelling 70.26 13.04 31 47220 351010 110191038
Peripheral swelling 68.66 13.04 44 47207 403990 110138058
Coma 68.61 13.04 154 47097 117715 110424333
Psoriatic arthropathy 67.96 13.04 4 47247 196757 110345291
Contraindicated product administered 65.88 13.04 13 47238 248254 110293794
Anticonvulsant drug level decreased 65.38 13.04 27 47224 2109 110539939
Systemic lupus erythematosus 64.06 13.04 15 47236 254323 110287725
Speech disorder 62.59 13.04 102 47149 61467 110480581
Stomatitis 62.28 13.04 19 47232 270223 110271825
Helicobacter infection 61.90 13.04 4 47247 181873 110360175
Diarrhoea 61.82 13.04 264 46987 1139241 109402807
Multiple drug therapy 61.76 13.04 40 47211 7974 110534074
Mania 61.61 13.04 59 47192 20737 110521311
Anaemia 60.01 13.04 88 47163 546998 109995050
Impaired healing 59.72 13.04 7 47244 196710 110345338
Orthostatic hypotension 59.70 13.04 104 47147 66145 110475903
Alopecia 58.91 13.04 42 47209 364711 110177337
Hypothermia 58.60 13.04 64 47187 26238 110515810
CSF oligoclonal band present 58.59 13.04 17 47234 455 110541593
Blood gases abnormal 58.56 13.04 22 47229 1336 110540712
Mental disorder 57.88 13.04 77 47174 38714 110503334
Drug level decreased 57.57 13.04 54 47197 18494 110523554
Developmental delay 56.94 13.04 22 47229 1443 110540605
Intentional self-injury 56.93 13.04 75 47176 37354 110504694
Simple partial seizures 56.66 13.04 20 47231 1016 110541032
Partial seizures with secondary generalisation 56.36 13.04 19 47232 840 110541208
Dyskinesia 56.10 13.04 88 47163 51358 110490690
Drug eruption 56.05 13.04 90 47161 53569 110488479
Bipolar disorder 55.18 13.04 39 47212 8968 110533080
Electrocardiogram QRS complex prolonged 54.65 13.04 45 47206 12976 110529072
Atonic seizures 54.55 13.04 20 47231 1134 110540914
Folliculitis 53.37 13.04 5 47246 167648 110374400
Tonic convulsion 52.94 13.04 26 47225 3048 110539000
Irritable bowel syndrome 52.00 13.04 5 47246 164210 110377838
Psychomotor hyperactivity 49.87 13.04 52 47199 20225 110521823
Respiratory arrest 49.29 13.04 89 47162 58210 110483838
Rheumatoid arthritis 49.03 13.04 34 47217 299579 110242469
Drug withdrawal syndrome 48.48 13.04 70 47181 37984 110504064
Wrong patient received product 48.23 13.04 32 47219 6642 110535406
Gene mutation 47.40 13.04 25 47226 3404 110538644
Fall 47.05 13.04 428 46823 603054 109938994
Drug withdrawal convulsions 46.06 13.04 22 47229 2427 110539621
Infection 45.07 13.04 53 47198 362147 110179901
Dyspnoea 44.99 13.04 283 46968 1106589 109435459
Nasopharyngitis 44.63 13.04 62 47189 394299 110147749
Musculoskeletal pain 43.75 13.04 12 47239 183011 110359037
Anger 43.65 13.04 47 47204 18960 110523088
Malaise 43.24 13.04 145 47106 671674 109870374
Cardio-respiratory arrest 43.18 13.04 128 47123 115708 110426340
Tremor 43.12 13.04 186 47065 202046 110340002
Hyperammonaemia 42.66 13.04 40 47211 13692 110528356
Acute kidney injury 42.37 13.04 135 47116 635295 109906753
Postictal paralysis 41.79 13.04 14 47237 607 110541441
Fibromyalgia 41.24 13.04 11 47240 170898 110371150
Tardive dyskinesia 41.12 13.04 39 47212 13540 110528508
Bursitis 41.02 13.04 4 47247 129914 110412134
Joint range of motion decreased 40.52 13.04 3 47248 121829 110420219
Pleocytosis 40.27 13.04 18 47233 1706 110540342
Oedema peripheral 39.92 13.04 49 47202 328611 110213437
Rash maculo-papular 39.89 13.04 94 47157 74128 110467920
Dysphoria 39.77 13.04 28 47223 6400 110535648
Granulocytopenia 39.43 13.04 37 47214 12678 110529370
Thyroxine free decreased 39.31 13.04 16 47235 1204 110540844
Asthma 38.87 13.04 30 47221 250261 110291787
Discomfort 38.38 13.04 22 47229 214685 110327363
Seizure cluster 37.77 13.04 14 47237 819 110541229
Change in seizure presentation 37.75 13.04 14 47237 820 110541228
Blood creatine phosphokinase increased 37.60 13.04 91 47160 72986 110469062
Paradoxical drug reaction 37.23 13.04 32 47219 9785 110532263
Dissociation 37.16 13.04 32 47219 9810 110532238
Brain malformation 37.09 13.04 8 47243 59 110541989
Gastric lavage 37.09 13.04 8 47243 59 110541989
Parkinsonism 36.15 13.04 46 47205 22141 110519907
Malignant neoplasm progression 35.57 13.04 15 47236 174552 110367496
Night sweats 35.56 13.04 7 47244 133976 110408072
Death 35.33 13.04 166 47085 698703 109843345
Catatonia 35.26 13.04 33 47218 11267 110530781
Hallucination 34.92 13.04 109 47142 101323 110440725
Intellectual disability 34.87 13.04 17 47234 1962 110540086
Depressed mood 34.86 13.04 79 47172 60730 110481318
Therapeutic product effective for unapproved indication 34.83 13.04 9 47242 154 110541894
Cardiac arrest 34.57 13.04 171 47080 196582 110345466
Drug level increased 34.32 13.04 68 47183 47651 110494397
Hallucination, auditory 34.27 13.04 49 47202 26348 110515700
Loss of consciousness 34.05 13.04 170 47081 196136 110345912
Gaze palsy 33.86 13.04 20 47231 3387 110538661
Cross sensitivity reaction 33.86 13.04 24 47227 5543 110536505
Aura 33.70 13.04 14 47237 1110 110540938
Blood osmolarity decreased 33.15 13.04 15 47236 1463 110540585
Temporal lobe epilepsy 32.61 13.04 11 47240 487 110541561
Memory impairment 32.38 13.04 168 47083 196776 110345272
Dysarthria 32.35 13.04 94 47157 84027 110458021
Anticonvulsant drug level above therapeutic 32.14 13.04 14 47237 1248 110540800
Nervousness 32.10 13.04 57 47194 36794 110505254
Sepsis 31.77 13.04 57 47194 327289 110214759
Impulsive behaviour 31.75 13.04 19 47232 3296 110538752
Inflammation 31.51 13.04 22 47229 193216 110348832
Lung disorder 31.39 13.04 19 47232 180028 110362020
Depression 31.05 13.04 237 47014 317098 110224950
Pain in extremity 30.72 13.04 106 47145 487012 110055036
Treatment noncompliance 30.45 13.04 84 47167 72906 110469142
Wound infection 30.37 13.04 3 47248 96462 110445586
Arthritis 30.19 13.04 17 47234 167569 110374479
Cough 30.10 13.04 99 47152 461542 110080506
Reversible cerebral vasoconstriction syndrome 30.06 13.04 21 47230 4740 110537308
Anticonvulsant drug level below therapeutic 29.95 13.04 13 47238 1149 110540899
Aphasia 29.85 13.04 73 47178 58924 110483124
Dysmorphism 29.52 13.04 11 47240 653 110541395
Wound 29.48 13.04 34 47217 234403 110307645
Trigeminal neuralgia 29.37 13.04 20 47231 4332 110537716
Lennox-Gastaut syndrome 29.07 13.04 9 47242 302 110541746
Gait disturbance 29.04 13.04 211 47040 277997 110264051
Therapeutic product ineffective for unapproved indication 28.99 13.04 9 47242 305 110541743
Bradykinesia 28.95 13.04 29 47222 10759 110531289
Disturbance in attention 28.54 13.04 74 47177 61921 110480127
Cardiac failure 28.48 13.04 23 47228 187603 110354445
Encephalitis autoimmune 28.15 13.04 18 47233 3510 110538538
Benign cardiac neoplasm 28.09 13.04 6 47245 42 110542006
Wheezing 27.99 13.04 41 47210 255189 110286859
Poisoning 27.94 13.04 47 47204 29058 110512990
Educational problem 27.78 13.04 10 47241 538 110541510
Mood swings 27.66 13.04 41 47210 22771 110519277
Sleep deficit 27.45 13.04 14 47237 1778 110540270
Abortion spontaneous 27.29 13.04 51 47200 34231 110507817
Blood chloride decreased 27.26 13.04 26 47225 9089 110532959
Disorientation 27.20 13.04 79 47172 70592 110471456
Electrocardiogram QT prolonged 26.99 13.04 105 47146 108855 110433193
Bipolar I disorder 26.97 13.04 15 47236 2268 110539780
Astrocytoma, low grade 26.97 13.04 7 47244 122 110541926
Paranoia 26.82 13.04 40 47211 22334 110519714
Hypersensitivity 26.78 13.04 86 47165 403912 110138136
Hepatic enzyme increased 26.77 13.04 61 47190 320831 110221217
Delusion 26.40 13.04 41 47210 23714 110518334
Mental status changes 26.38 13.04 82 47169 76040 110466008
Lethargy 26.37 13.04 94 47157 93482 110448566
Staring 26.21 13.04 16 47235 2876 110539172
Affective disorder 26.17 13.04 28 47223 11213 110530835
Therapeutic product effect decreased 26.06 13.04 40 47211 244276 110297772
Speech disorder developmental 26.05 13.04 11 47240 908 110541140
Encephalitis 25.98 13.04 36 47215 18803 110523245
Sinusitis 25.89 13.04 55 47196 296633 110245415
Dyspepsia 25.89 13.04 26 47225 190939 110351109
Tic 25.85 13.04 17 47234 3476 110538572
Eye movement disorder 25.83 13.04 26 47225 9702 110532346
Gastrointestinal disorder 25.44 13.04 40 47211 241912 110300136
Multiple sclerosis 25.34 13.04 42 47209 25656 110516392
Drug intolerance 25.26 13.04 89 47162 406423 110135625
Polyserositis 24.81 13.04 11 47240 1023 110541025
Abdominal pain upper 24.78 13.04 72 47179 349039 110193009
Product colour issue 24.77 13.04 11 47240 1027 110541021
Parasomnia 24.46 13.04 10 47241 761 110541287
Autonomic nervous system imbalance 24.31 13.04 20 47231 5760 110536288
Sciatica 24.16 13.04 5 47246 92394 110449654
Abdominal discomfort 23.96 13.04 87 47164 393771 110148277
Conversion disorder 23.79 13.04 14 47237 2356 110539692
Hypercholesterolaemia 23.58 13.04 5 47246 90832 110451216
Musculoskeletal stiffness 23.49 13.04 53 47198 279769 110262279
Hippocampal sclerosis 23.30 13.04 7 47244 212 110541836
Facial spasm 23.16 13.04 10 47241 872 110541176
Pain 23.15 13.04 279 46972 954676 109587372
Hypotonia 23.10 13.04 31 47220 15714 110526334
Fear 22.99 13.04 38 47213 23155 110518893
Coma blister 22.90 13.04 7 47244 225 110541823
Screaming 22.89 13.04 18 47233 4863 110537185
Colitis ulcerative 22.87 13.04 3 47248 77360 110464688
Psychomotor skills impaired 22.77 13.04 21 47230 7037 110535011
Head injury 22.59 13.04 54 47197 42963 110499085
Herpes oesophagitis 22.58 13.04 8 47243 411 110541637
Mood altered 22.52 13.04 36 47215 21339 110520709
Brown tumour 22.29 13.04 6 47245 121 110541927
C-reactive protein increased 22.00 13.04 37 47214 217882 110324166
Drug level below therapeutic 21.92 13.04 26 47225 11647 110530401
Hypertension 21.91 13.04 128 47123 509956 110032092
Ammonia increased 21.81 13.04 22 47229 8228 110533820
Craniocerebral injury 21.81 13.04 19 47232 5915 110536133
Leukopenia 21.79 13.04 123 47128 148668 110393380
Rasmussen encephalitis 21.75 13.04 4 47247 11 110542037
Grip strength decreased 21.68 13.04 4 47247 80170 110461878
Gastrooesophageal reflux disease 21.67 13.04 27 47224 179949 110362099
Colitis ischaemic 21.66 13.04 32 47219 17718 110524330
Papule 21.44 13.04 24 47227 10109 110531939
Learning disorder 21.32 13.04 9 47242 743 110541305
Strabismus 21.09 13.04 15 47236 3484 110538564
Myelosuppression 21.07 13.04 7 47244 94333 110447715
Adactyly 21.02 13.04 4 47247 14 110542034
Psychomotor retardation 21.01 13.04 21 47230 7771 110534277
Thinking abnormal 20.98 13.04 29 47222 15111 110526937
Product administration error 20.94 13.04 48 47203 37169 110504879
Wrong patient 20.92 13.04 11 47240 1488 110540560
Abdominal pain 20.84 13.04 131 47120 512858 110029190
Restlessness 20.80 13.04 62 47189 56197 110485851
Irregular sleep phase 20.70 13.04 6 47245 160 110541888
Idiopathic generalised epilepsy 20.70 13.04 5 47246 64 110541984
Back pain 20.60 13.04 85 47166 370911 110171137
Frequent bowel movements 20.55 13.04 3 47248 71387 110470661
Drug screen positive 20.54 13.04 19 47232 6391 110535657
Macule 20.29 13.04 15 47236 3698 110538350
Blood antidiuretic hormone decreased 20.28 13.04 3 47248 0 110542048
Live birth 19.82 13.04 3 47248 69481 110472567
Decreased appetite 19.59 13.04 121 47130 475725 110066323
Muscle twitching 19.56 13.04 41 47210 29894 110512154
Disruptive mood dysregulation disorder 19.56 13.04 4 47247 22 110542026
Neuropathy peripheral 19.46 13.04 29 47222 179248 110362800
Extrapyramidal disorder 19.40 13.04 40 47211 28827 110513221
Blood cholesterol increased 19.00 13.04 31 47220 184754 110357294
Application site pain 19.00 13.04 17 47234 5482 110536566
Anticonvulsant drug level increased 18.97 13.04 13 47238 2845 110539203
Cardiopulmonary failure 18.96 13.04 20 47231 7883 110534165
Unmasking of previously unidentified disease 18.93 13.04 13 47238 2855 110539193
Type 2 diabetes mellitus 18.91 13.04 29 47222 177203 110364845
Atrial fibrillation 18.86 13.04 44 47207 229598 110312450
Electrocardiogram repolarisation abnormality 18.85 13.04 12 47239 2323 110539725
Dystonia 18.83 13.04 37 47214 25768 110516280
Drooling 18.81 13.04 19 47232 7120 110534928
Unresponsive to stimuli 18.76 13.04 65 47186 63725 110478323
Appetite disorder 18.75 13.04 22 47229 9747 110532301
Liver disorder 18.56 13.04 20 47231 142223 110399825
Constipation 18.56 13.04 234 47017 357552 110184496
Gamma-glutamyltransferase increased 18.50 13.04 63 47188 61246 110480802
Ill-defined disorder 18.39 13.04 24 47227 156829 110385219
Postictal state 18.34 13.04 12 47239 2434 110539614
Terminal insomnia 18.28 13.04 11 47240 1927 110540121
Vagal nerve stimulator implantation 18.28 13.04 6 47245 244 110541804
Antinuclear antibody positive 18.18 13.04 21 47230 9147 110532901
Neurotoxicity 18.02 13.04 49 47202 42158 110499890
Atrioventricular block first degree 17.87 13.04 26 47225 14199 110527849
Gastrointestinal haemorrhage 17.74 13.04 27 47224 165491 110376557
Postictal psychosis 17.67 13.04 6 47245 271 110541777
Dermatitis exfoliative 17.66 13.04 23 47228 11324 110530724
Dry mouth 17.50 13.04 37 47214 199911 110342137
Hypogammaglobulinaemia 17.41 13.04 31 47220 20045 110522003
Productive cough 17.36 13.04 14 47237 114291 110427757
Immune thrombocytopenia 17.33 13.04 33 47218 22461 110519587
Large granular lymphocytosis 17.32 13.04 7 47244 517 110541531
Therapeutic response unexpected 17.17 13.04 34 47217 23809 110518239
Injury 17.07 13.04 31 47220 177234 110364814
Muscle rigidity 16.98 13.04 34 47217 23997 110518051
Developmental coordination disorder 16.98 13.04 3 47248 6 110542042
Tuberous sclerosis complex 16.98 13.04 5 47246 141 110541907
Nausea 16.84 13.04 401 46850 1235289 109306759
Dyspnoea exertional 16.76 13.04 12 47239 104048 110438000
Abdominal distension 16.52 13.04 31 47220 175072 110366976
Sleep paralysis 16.52 13.04 8 47243 910 110541138
Logorrhoea 16.48 13.04 15 47236 4942 110537106
Fluid retention 16.37 13.04 10 47241 94297 110447751
Sleep apnoea syndrome 16.32 13.04 46 47205 40401 110501647
Haemorrhagic diathesis 16.26 13.04 18 47233 7490 110534558
Blood pressure fluctuation 15.94 13.04 6 47245 74818 110467230
Off label use 15.94 13.04 788 46463 1499397 109042651
Antipsychotic drug level decreased 15.93 13.04 9 47242 1403 110540645
Coordination abnormal 15.84 13.04 34 47217 25194 110516854
Cardiac failure congestive 15.83 13.04 25 47226 150975 110391073
Myoclonus 15.82 13.04 40 47211 32958 110509090
Bradypnoea 15.81 13.04 19 47232 8630 110533418
Extensor plantar response 15.66 13.04 10 47241 1945 110540103
Mucosal inflammation 15.59 13.04 11 47240 96130 110445918
Crying 15.48 13.04 34 47217 25594 110516454
Rectal haemorrhage 15.47 13.04 17 47234 119816 110422232
Anal incontinence 15.43 13.04 31 47220 21933 110520115
Drug abuse 15.42 13.04 129 47122 177282 110364766
Product complaint 15.37 13.04 24 47227 13948 110528100
Chest pain 15.33 13.04 96 47155 376279 110165769
Hepatic cirrhosis 15.13 13.04 5 47246 67621 110474427
Neutropenia 15.03 13.04 96 47155 374524 110167524
Drop attacks 14.96 13.04 8 47243 1120 110540928
Fever neonatal 14.91 13.04 3 47248 15 110542033
Enuresis 14.82 13.04 13 47238 4083 110537965
Arrhythmia 14.82 13.04 64 47187 69511 110472537
Abnormal sensation in eye 14.64 13.04 10 47241 2176 110539872
Chronic obstructive pulmonary disease 14.63 13.04 15 47236 109143 110432905
Hypoaesthesia 14.48 13.04 77 47174 314146 110227902
Autoimmune disorder 14.37 13.04 5 47246 65478 110476570
Taste disorder 14.34 13.04 5 47246 65382 110476666
COVID-19 14.32 13.04 55 47196 245005 110297043
Photophobia 14.24 13.04 33 47218 25738 110516310
Libido decreased 14.20 13.04 15 47236 5920 110536128
Vision blurred 14.11 13.04 99 47152 128923 110413125
Erectile dysfunction 14.02 13.04 27 47224 18529 110523519
Incorrect route of product administration 13.88 13.04 5 47246 64056 110477992
Suspected suicide 13.87 13.04 24 47227 15175 110526873
Follicular mucinosis 13.69 13.04 3 47248 24 110542024
Product supply issue 13.67 13.04 12 47239 3774 110538274
Brain operation 13.55 13.04 7 47244 913 110541135
Hepatocellular injury 13.53 13.04 50 47201 50592 110491456
Head banging 13.49 13.04 6 47245 562 110541486
Hypersomnia 13.43 13.04 34 47217 28027 110514021
Thrombosis 13.39 13.04 16 47235 108646 110433402
Dermatitis allergic 13.32 13.04 29 47222 21695 110520353
Ascites 13.32 13.04 12 47239 92796 110449252
Herpes zoster 13.31 13.04 16 47235 108363 110433685
Social fear 13.28 13.04 3 47248 28 110542020
Epistaxis 13.28 13.04 22 47229 130350 110411698
Pulmonary embolism 13.28 13.04 47 47204 214427 110327621
Somnambulism 13.26 13.04 15 47236 6390 110535658
Anxiety 13.21 13.04 214 47037 344864 110197184
Haemoglobin decreased 13.18 13.04 58 47193 248669 110293379
Blood lactic acid increased 13.17 13.04 24 47227 15797 110526251
Akathisia 13.05 13.04 25 47226 17088 110524960

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC N03AF02 NERVOUS SYSTEM
ANTIEPILEPTICS
ANTIEPILEPTICS
Carboxamide derivatives
FDA PE N0000008486 Decreased Central Nervous System Disorganized Electrical Activity
MeSH PA D000927 Anticonvulsants
MeSH PA D002317 Cardiovascular Agents
MeSH PA D026941 Sodium Channel Blockers
MeSH PA D049990 Membrane Transport Modulators
MeSH PA D061567 Voltage-Gated Sodium Channel Blockers
MeSH PA D065701 Cytochrome P-450 CYP3A Inducers
FDA EPC N0000175753 Anti-epileptic Agent
CHEBI has role CHEBI:35469 antidepressant
CHEBI has role CHEBI:35474 anxiolytic drug
CHEBI has role CHEBI:35476 antipsychotic agent
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:35623 anticonvulsant
CHEBI has role CHEBI:35705 immunosuppressive agent
CHEBI has role CHEBI:88188 drug allergen

Related Drugs by ATC class:

N03AF Carboxamide derivatives 3 drugs
carbamazepineeslicarbazepine acetaterufinamide

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

DiseaseRelationSNOMED_IDDOID
Localization-related epilepsy indication 230381009 DOID:2234
Epilepsy characterized by intractable complex partial seizures indication 442481002
Simple partial seizure indication 117891000119100
Suicidal thoughts contraindication 6471006
Mood swings contraindication 18963009
Depressive disorder contraindication 35489007
Syndrome of inappropriate vasopressin secretion contraindication 55004003 DOID:3401
Acute nephropathy contraindication 58574008
Hyponatremia contraindication 89627008
Impaired renal function disorder contraindication 197663003




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 12.9 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
150MG OXTELLAR XR SUPERNUS PHARMS N202810 Oct. 19, 2012 RX TABLET, EXTENDED RELEASE ORAL 10220042 April 13, 2027 TREATMENT OF PARTIAL-ONSET SEIZURES
150MG OXTELLAR XR SUPERNUS PHARMS N202810 Oct. 19, 2012 RX TABLET, EXTENDED RELEASE ORAL 7910131 April 13, 2027 TREATMENT OF PARTIAL-ONSET SEIZURES
150MG OXTELLAR XR SUPERNUS PHARMS N202810 Oct. 19, 2012 RX TABLET, EXTENDED RELEASE ORAL 9119791 April 13, 2027 TREATMENT OF PARTIAL-ONSET SEIZURES
300MG OXTELLAR XR SUPERNUS PHARMS N202810 Oct. 19, 2012 RX TABLET, EXTENDED RELEASE ORAL 10220042 April 13, 2027 TREATMENT OF PARTIAL-ONSET SEIZURES
300MG OXTELLAR XR SUPERNUS PHARMS N202810 Oct. 19, 2012 RX TABLET, EXTENDED RELEASE ORAL 7910131 April 13, 2027 TREATMENT OF PARTIAL-ONSET SEIZURES
300MG OXTELLAR XR SUPERNUS PHARMS N202810 Oct. 19, 2012 RX TABLET, EXTENDED RELEASE ORAL 9119791 April 13, 2027 TREATMENT OF PARTIAL-ONSET SEIZURES
600MG OXTELLAR XR SUPERNUS PHARMS N202810 Oct. 19, 2012 RX TABLET, EXTENDED RELEASE ORAL 10220042 April 13, 2027 TREATMENT OF PARTIAL-ONSET SEIZURES
600MG OXTELLAR XR SUPERNUS PHARMS N202810 Oct. 19, 2012 RX TABLET, EXTENDED RELEASE ORAL 7910131 April 13, 2027 TREATMENT OF PARTIAL-ONSET SEIZURES
600MG OXTELLAR XR SUPERNUS PHARMS N202810 Oct. 19, 2012 RX TABLET, EXTENDED RELEASE ORAL 9119791 April 13, 2027 TREATMENT OF PARTIAL-ONSET SEIZURES

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Sodium channel protein type 5 subunit alpha Ion channel BLOCKER WOMBAT-PK CHEMBL

External reference:

IDSource
4021196 VUID
N0000148642 NUI
D00533 KEGG_DRUG
4021196 VANDF
C0069751 UMLSCUI
CHEBI:7824 CHEBI
CHEMBL1068 ChEMBL_ID
DB00776 DRUGBANK_ID
D000078330 MESH_DESCRIPTOR_UI
34312 PUBCHEM_CID
7254 IUPHAR_LIGAND_ID
4585 INN_ID
VZI5B1W380 UNII
32624 RXNORM
121517 MMSL
8631 MMSL
d04513 MMSL
006035 NDDF
116511002 SNOMEDCT_US
387025007 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Trileptal HUMAN PRESCRIPTION DRUG LABEL 1 0078-0337 TABLET, FILM COATED 300 mg ORAL NDA 34 sections
Trileptal HUMAN PRESCRIPTION DRUG LABEL 1 0078-0357 SUSPENSION 60 mg ORAL NDA 34 sections
Trileptal HUMAN PRESCRIPTION DRUG LABEL 1 0078-0456 TABLET, FILM COATED 150 mg ORAL NDA 34 sections
Trileptal HUMAN PRESCRIPTION DRUG LABEL 1 0078-0457 TABLET, FILM COATED 600 mg ORAL NDA 34 sections
Oxcarbazepine HUMAN PRESCRIPTION DRUG LABEL 1 0615-8447 TABLET, FILM COATED 150 mg ORAL ANDA 28 sections
Oxcarbazepine HUMAN PRESCRIPTION DRUG LABEL 1 0615-8448 TABLET, FILM COATED 300 mg ORAL ANDA 28 sections
Oxcarbazepine HUMAN PRESCRIPTION DRUG LABEL 1 0615-8567 TABLET, FILM COATED 600 mg ORAL ANDA 28 sections
Oxcarbazepine HUMAN PRESCRIPTION DRUG LABEL 1 0615-8634 TABLET, FILM COATED 150 mg ORAL ANDA 31 sections
Oxcarbazepine HUMAN PRESCRIPTION DRUG LABEL 1 0615-8635 TABLET, FILM COATED 300 mg ORAL ANDA 31 sections
Oxcarbazepine HUMAN PRESCRIPTION DRUG LABEL 1 0615-8636 TABLET, FILM COATED 600 mg ORAL ANDA 31 sections
Oxcarbazepine HUMAN PRESCRIPTION DRUG LABEL 1 0781-6270 SUSPENSION 60 mg ORAL NDA authorized generic 31 sections
OXCARBAZEPINE HUMAN PRESCRIPTION DRUG LABEL 1 0904-7262 TABLET, FILM COATED 150 mg ORAL ANDA 34 sections
OXCARBAZEPINE HUMAN PRESCRIPTION DRUG LABEL 1 0904-7263 TABLET, FILM COATED 300 mg ORAL ANDA 34 sections
OXCARBAZEPINE HUMAN PRESCRIPTION DRUG LABEL 1 0904-7264 TABLET, FILM COATED 600 mg ORAL ANDA 34 sections
OXCARBAZEPINE HUMAN PRESCRIPTION DRUG LABEL 1 0904-7593 TABLET, FILM COATED 150 mg ORAL ANDA 35 sections
OXCARBAZEPINE HUMAN PRESCRIPTION DRUG LABEL 1 0904-7594 TABLET, FILM COATED 300 mg ORAL ANDA 35 sections
OXCARBAZEPINE HUMAN PRESCRIPTION DRUG LABEL 1 0904-7595 TABLET, FILM COATED 600 mg ORAL ANDA 35 sections
Oxcarbazepine HUMAN PRESCRIPTION DRUG LABEL 1 10135-798 SUSPENSION 300 mg ORAL ANDA 32 sections
OXTELLAR XR HUMAN PRESCRIPTION DRUG LABEL 1 17772-121 TABLET 150 mg ORAL NDA 35 sections
OXTELLAR XR HUMAN PRESCRIPTION DRUG LABEL 1 17772-121 TABLET 150 mg ORAL NDA 35 sections
OXTELLAR XR HUMAN PRESCRIPTION DRUG LABEL 1 17772-122 TABLET 300 mg ORAL NDA 35 sections
OXTELLAR XR HUMAN PRESCRIPTION DRUG LABEL 1 17772-122 TABLET 300 mg ORAL NDA 35 sections
OXTELLAR XR HUMAN PRESCRIPTION DRUG LABEL 1 17772-123 TABLET 600 mg ORAL NDA 35 sections
OXTELLAR XR HUMAN PRESCRIPTION DRUG LABEL 1 17772-123 TABLET 600 mg ORAL NDA 35 sections
Oxcarbazepine HUMAN PRESCRIPTION DRUG LABEL 1 21695-862 TABLET, FILM COATED 150 mg ORAL ANDA 30 sections
Oxcarbazepine HUMAN PRESCRIPTION DRUG LABEL 1 21695-863 TABLET, FILM COATED 300 mg ORAL ANDA 30 sections
Oxcarbazepine HUMAN PRESCRIPTION DRUG LABEL 1 21695-864 TABLET, FILM COATED 600 mg ORAL ANDA 30 sections
Oxcarbazepine Human Prescription Drug Label 1 27241-237 TABLET, EXTENDED RELEASE 150 mg ORAL ANDA 30 sections
Oxcarbazepine Human Prescription Drug Label 1 27241-238 TABLET, EXTENDED RELEASE 300 mg ORAL ANDA 30 sections
Oxcarbazepine Human Prescription Drug Label 1 27241-239 TABLET, EXTENDED RELEASE 600 mg ORAL ANDA 30 sections