oxcarbazepine ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | 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 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 95 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

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 1207.19 13.38 757 28930 131877 63327458
Hyponatraemia 579.82 13.38 453 29234 111447 63347888
Abortion spontaneous 261.23 13.38 199 29488 46996 63412339
Status epilepticus 231.91 13.38 122 29565 15111 63444224
Generalised tonic-clonic seizure 212.37 13.38 145 29542 28871 63430464
Multiple-drug resistance 202.46 13.38 80 29607 5090 63454245
Epilepsy 181.07 13.38 128 29559 26937 63432398
Focal dyscognitive seizures 175.98 13.38 62 29625 2859 63456476
Diplopia 167.54 13.38 116 29571 23612 63435723
Product substitution issue 164.33 13.38 99 29588 15897 63443438
Petit mal epilepsy 149.58 13.38 59 29628 3735 63455600
Completed suicide 149.00 13.38 254 29433 145419 63313916
Aggression 136.41 13.38 102 29585 23396 63435939
Drug interaction 124.00 13.38 307 29380 228824 63230511
Psychogenic seizure 121.68 13.38 41 29646 1651 63457684
Somnolence 120.38 13.38 261 29426 178424 63280911
Balance disorder 110.74 13.38 165 29522 84257 63375078
Partial seizures 109.92 13.38 54 29633 5788 63453547
Sedation 106.51 13.38 110 29577 38699 63420636
Blood sodium decreased 105.81 13.38 89 29598 24163 63435172
Inappropriate antidiuretic hormone secretion 105.42 13.38 74 29613 15388 63443947
Mitochondrial DNA mutation 91.43 13.38 24 29663 398 63458937
Myoclonic epilepsy 88.65 13.38 30 29657 1224 63458111
Abnormal behaviour 88.09 13.38 76 29611 21350 63437985
Psychotic disorder 87.54 13.38 82 29605 25630 63433705
Joint swelling 83.17 13.38 25 29662 327641 63131694
Exposure during pregnancy 82.55 13.38 207 29480 155340 63303995
Drug reaction with eosinophilia and systemic symptoms 82.37 13.38 90 29597 33746 63425589
Irritability 81.89 13.38 87 29600 31607 63427728
Propofol infusion syndrome 75.37 13.38 25 29662 958 63458377
Toxicity to various agents 75.03 13.38 270 29417 246980 63212355
Infusion related reaction 73.66 13.38 13 29674 245508 63213827
Ataxia 73.04 13.38 59 29628 15136 63444199
Cognitive disorder 71.60 13.38 108 29579 55707 63403628
Glossodynia 70.77 13.38 3 29684 178873 63280462
Suicidal ideation 70.63 13.38 114 29573 62307 63397028
Arthralgia 69.87 13.38 99 29588 569611 62889724
Mania 68.03 13.38 52 29635 12315 63447020
Contraindicated product administered 66.44 13.38 11 29676 217637 63241698
Arthropathy 65.08 13.38 15 29672 234777 63224558
Hyperammonaemic encephalopathy 62.83 13.38 28 29659 2406 63456929
Suicide attempt 61.88 13.38 106 29581 60812 63398523
Infantile spasms 60.18 13.38 15 29672 200 63459135
Sedation complication 58.79 13.38 50 29637 13772 63445563
Systemic lupus erythematosus 58.59 13.38 13 29674 208905 63250430
Creatinine renal clearance decreased 57.42 13.38 53 29634 16255 63443080
Speech disorder 56.98 13.38 82 29605 40547 63418788
Peripheral swelling 56.28 13.38 27 29660 265915 63193420
Blood gases abnormal 56.08 13.38 19 29668 778 63458557
Gene mutation 55.66 13.38 23 29664 1642 63457693
Drug ineffective for unapproved indication 55.65 13.38 74 29613 33989 63425346
Tremor 55.07 13.38 161 29526 132078 63327257
Nystagmus 55.00 13.38 35 29652 6185 63453150
Alopecia 54.10 13.38 47 29640 337489 63121846
Nasopharyngitis 53.51 13.38 26 29661 254231 63205104
Diarrhoea 52.68 13.38 166 29521 715200 62744135
Swelling 52.37 13.38 32 29655 275346 63183989
Infection 52.06 13.38 21 29666 229152 63230183
Bipolar disorder 51.72 13.38 37 29650 7923 63451412
Hypochloraemia 51.50 13.38 23 29664 1986 63457349
Dizziness 51.21 13.38 360 29327 429565 63029770
CSF oligoclonal band present 50.96 13.38 15 29672 385 63458950
Agitation 50.51 13.38 96 29591 59661 63399674
Sudden unexplained death in epilepsy 49.57 13.38 14 29673 309 63459026
Anticonvulsant drug level decreased 47.71 13.38 19 29668 1233 63458102
Intentional overdose 46.10 13.38 105 29582 74047 63385288
Rheumatoid arthritis 44.87 13.38 32 29655 253787 63205548
Pleocytosis 43.62 13.38 16 29671 829 63458506
Blood calcium decreased 42.49 13.38 57 29630 26394 63432941
Sopor 42.27 13.38 52 29635 22112 63437223
Orthostatic hypotension 42.20 13.38 67 29620 36093 63423242
Depressed level of consciousness 42.07 13.38 91 29596 61987 63397348
Simple partial seizures 41.66 13.38 14 29673 559 63458776
Drug level decreased 40.73 13.38 32 29655 7887 63451448
Overdose 39.47 13.38 131 29556 114947 63344388
Maternal exposure during pregnancy 39.37 13.38 205 29482 219857 63239478
Respiratory arrest 38.81 13.38 61 29626 32584 63426751
Gastric lavage 38.71 13.38 8 29679 42 63459293
Depression 37.92 13.38 187 29500 196305 63263030
Pneumonia 37.16 13.38 101 29586 456666 63002669
Tonic convulsion 36.97 13.38 16 29671 1281 63458054
Aura 36.47 13.38 15 29672 1058 63458277
Febrile neutropenia 36.09 13.38 6 29681 118443 63340892
Memory impairment 36.03 13.38 119 29568 104139 63355196
Paradoxical drug reaction 35.81 13.38 23 29664 4129 63455206
Sinusitis 35.75 13.38 32 29655 226621 63232714
Encephalitis 35.49 13.38 31 29656 8849 63450486
Cross sensitivity reaction 34.85 13.38 18 29669 2144 63457191
Pain 34.70 13.38 204 29483 740424 62718911
Cough 34.68 13.38 52 29635 292691 63166644
Mental disorder 34.43 13.38 51 29636 25868 63433467
Abdominal discomfort 34.27 13.38 61 29626 320824 63138511
Trigeminal neuralgia 34.13 13.38 21 29666 3498 63455837
Discomfort 33.87 13.38 18 29669 167356 63291979
Abortion induced 33.58 13.38 32 29655 10210 63449125
Dyskinesia 32.90 13.38 56 29631 31946 63427389
Hypothermia 32.83 13.38 36 29651 13545 63445790
Atonic seizures 32.62 13.38 12 29675 627 63458708
General physical health deterioration 32.29 13.38 28 29659 201374 63257961
Fall 31.73 13.38 301 29386 392033 63067302
Impaired healing 31.68 13.38 5 29682 102537 63356798
Aphasia 31.64 13.38 56 29631 32944 63426391
Stomatitis 31.02 13.38 13 29674 138712 63320623
Unmasking of previously unidentified disease 31.00 13.38 13 29674 963 63458372
Electroencephalogram abnormal 30.83 13.38 20 29667 3652 63455683
Helicobacter infection 29.88 13.38 4 29683 92781 63366554
Pregnancy 29.67 13.38 58 29629 36778 63422557
Partial seizures with secondary generalisation 29.67 13.38 10 29677 403 63458932
Neurotoxicity 29.43 13.38 38 29649 16952 63442383
Drug intolerance 29.22 13.38 63 29624 308598 63150737
Dyspnoea 28.94 13.38 186 29501 661127 62798208
Drug resistance 28.86 13.38 44 29643 22889 63436446
Stevens-Johnson syndrome 28.80 13.38 46 29641 24904 63434431
Reversible cerebral vasoconstriction syndrome 28.72 13.38 17 29670 2641 63456694
Therapeutic product effect decreased 28.45 13.38 29 29658 193158 63266177
Electrocardiogram QRS complex prolonged 28.41 13.38 23 29664 5915 63453420
Blood osmolarity decreased 28.27 13.38 12 29675 916 63458419
Multiple sclerosis 28.22 13.38 45 29642 24327 63435008
Neuroleptic malignant syndrome 27.49 13.38 31 29656 12025 63447310
Anaemia 26.86 13.38 61 29626 293369 63165966
Blood lactic acid increased 26.84 13.38 24 29663 7062 63452273
Brown tumour 26.63 13.38 6 29681 50 63459285
Intentional self-injury 26.47 13.38 45 29642 25642 63433693
Drug withdrawal convulsions 26.29 13.38 13 29674 1412 63457923
Wound 25.80 13.38 23 29664 163240 63296095
Dysmorphism 25.63 13.38 15 29672 2281 63457054
Change in seizure presentation 25.56 13.38 9 29678 414 63458921
Low set ears 25.32 13.38 8 29679 262 63459073
Lennox-Gastaut syndrome 25.12 13.38 8 29679 269 63459066
Hypersensitivity 25.07 13.38 63 29624 292622 63166713
Catatonia 25.01 13.38 19 29668 4458 63454877
Tardive dyskinesia 24.95 13.38 25 29662 8477 63450858
Coma blister 24.85 13.38 7 29680 153 63459182
Loss of consciousness 24.63 13.38 115 29572 118006 63341329
Poisoning 24.30 13.38 31 29656 13669 63445666
Electrocardiogram repolarisation abnormality 24.25 13.38 12 29675 1305 63458030
Cardio-respiratory arrest 23.98 13.38 72 29615 59887 63399448
Multiple drug therapy 23.80 13.38 17 29670 3629 63455706
Renal impairment 23.76 13.38 6 29681 88349 63370986
Psychomotor hyperactivity 23.60 13.38 27 29660 10636 63448699
Gaze palsy 23.40 13.38 12 29675 1408 63457927
Dysphoria 23.26 13.38 19 29668 4947 63454388
Phobia 23.19 13.38 8 29679 346 63458989
Therapeutic product effective for unapproved indication 23.06 13.38 6 29681 96 63459239
Herpes oesophagitis 23.03 13.38 7 29680 201 63459134
Bipolar I disorder 22.78 13.38 13 29674 1886 63457449
Arthritis 22.67 13.38 13 29674 115908 63343427
Therapeutic product ineffective for unapproved indication 22.46 13.38 7 29680 219 63459116
Parkinsonism 22.38 13.38 26 29661 10413 63448922
Brain operation 22.37 13.38 9 29678 600 63458735
Drug level increased 22.34 13.38 39 29648 22697 63436638
Ventricular hypokinesia 22.25 13.38 18 29669 4626 63454709
Immune thrombocytopenia 22.14 13.38 26 29661 10530 63448805
Drug withdrawal syndrome 22.12 13.38 43 29644 27151 63432184
Hallucination 22.08 13.38 66 29621 54751 63404584
Systolic dysfunction 22.06 13.38 12 29675 1587 63457748
Musculoskeletal stiffness 21.64 13.38 33 29654 184585 63274750
Paranoia 21.62 13.38 27 29660 11652 63447683
Intentional product use issue 21.45 13.38 17 29670 127875 63331460
Psoriatic arthropathy 21.40 13.38 8 29679 91512 63367823
Irritable bowel syndrome 21.39 13.38 6 29681 82406 63376929
Hypoxic-ischaemic encephalopathy 21.35 13.38 17 29670 4270 63455065
Screaming 20.82 13.38 15 29672 3247 63456088
Atrioventricular block first degree 20.64 13.38 21 29666 7252 63452083
Caesarean section 20.48 13.38 32 29655 17000 63442335
Electrocardiogram ST segment elevation 20.48 13.38 16 29671 3911 63455424
Chronic papillomatous dermatitis 20.47 13.38 5 29682 61 63459274
Crying 20.33 13.38 38 29649 23305 63436030
Anger 20.24 13.38 27 29660 12429 63446906
Follicular mucinosis 20.01 13.38 3 29684 0 63459335
Congenital epiglottal anomaly 20.01 13.38 3 29684 0 63459335
Mood altered 19.57 13.38 29 29658 14714 63444621
Head injury 19.52 13.38 41 29646 27355 63431980
Strabismus 19.48 13.38 12 29675 2002 63457333
Hepatic enzyme increased 19.37 13.38 41 29646 202287 63257048
Coma 19.21 13.38 70 29617 64294 63395041
Visual impairment 18.93 13.38 84 29603 84362 63374973
Epilepsy surgery 18.90 13.38 4 29683 24 63459311
Cardiac arrest 18.49 13.38 89 29598 92456 63366879
Muscle twitching 18.37 13.38 33 29654 19635 63439700
Fatigue 18.27 13.38 299 29388 887729 62571606
Normal newborn 18.26 13.38 21 29666 8320 63451015
Ammonia increased 18.09 13.38 16 29671 4640 63454695
Hypotonia 18.05 13.38 22 29665 9263 63450072
Acute kidney injury 17.99 13.38 63 29624 263352 63195983
Malignant neoplasm progression 17.87 13.38 8 29679 82113 63377222
Pain in extremity 17.83 13.38 87 29600 331399 63127936
Seizure cluster 17.79 13.38 6 29681 242 63459093
Shock 17.76 13.38 36 29651 23427 63435908
Atrial fibrillation 17.75 13.38 17 29670 116619 63342716
Developmental delay 17.38 13.38 10 29677 1473 63457862
Hypogammaglobulinaemia 17.35 13.38 19 29668 7136 63452199
Musculoskeletal pain 17.13 13.38 11 29676 92266 63367069
Logorrhoea 17.07 13.38 12 29675 2498 63456837
Therapeutic response unexpected 16.92 13.38 31 29656 18728 63440607
Neonatal seizure 16.74 13.38 7 29680 515 63458820
Coordination abnormal 16.73 13.38 26 29661 13747 63445588
Anticonvulsant drug level above therapeutic 16.61 13.38 7 29680 525 63458810
Stillbirth 16.50 13.38 18 29669 6732 63452603
Rash maculo-papular 16.41 13.38 42 29645 31854 63427481
Gun shot wound 16.18 13.38 5 29682 152 63459183
Gastrointestinal disorder 15.82 13.38 23 29664 131216 63328119
Asthma 15.73 13.38 22 29665 127539 63331796
Productive cough 15.68 13.38 5 29682 63203 63396132
Antinuclear antibody positive 15.63 13.38 19 29668 7980 63451355
Automatism 15.49 13.38 4 29683 62 63459273
Granulocytopenia 15.41 13.38 16 29671 5656 63453679
Treatment failure 15.41 13.38 45 29642 198998 63260337
Restlessness 15.38 13.38 39 29648 29414 63429921
Hallucination, auditory 15.29 13.38 24 29663 12800 63446535
Cardiopulmonary failure 15.22 13.38 13 29674 3599 63455736
Sleep paralysis 15.16 13.38 7 29680 653 63458682
Drug ineffective 15.16 13.38 614 29073 1044151 62415184
Delusion 15.04 13.38 23 29664 11994 63447341
Mood swings 15.02 13.38 29 29658 18219 63441116
Learning disorder 14.91 13.38 7 29680 678 63458657
Educational problem 14.91 13.38 6 29681 400 63458935
Pleural effusion 14.87 13.38 13 29674 93197 63366138
Postictal state 14.87 13.38 8 29679 1035 63458300
Thyroxine free decreased 14.79 13.38 7 29680 691 63458644
Sepsis 14.68 13.38 31 29656 153092 63306243
Behaviour disorder 14.48 13.38 12 29675 3187 63456148
Disturbance in attention 14.46 13.38 45 29642 38144 63421191
Retrognathia 14.26 13.38 6 29681 448 63458887
Impulsive behaviour 14.22 13.38 9 29678 1574 63457761
Social fear 14.18 13.38 3 29684 18 63459317
Viral titre decreased 14.18 13.38 3 29684 18 63459317
Immunodeficiency common variable 14.06 13.38 5 29682 237 63459098
Hyperkalaemia 13.97 13.38 4 29683 54199 63405136
Product complaint 13.94 13.38 23 29664 12786 63446549
Fever neonatal 13.90 13.38 3 29684 20 63459315
Blood prolactin increased 13.54 13.38 12 29675 3491 63455844
Lethargy 13.54 13.38 57 29630 55950 63403385
Gait disturbance 13.52 13.38 138 29549 183040 63276295
Poisoning deliberate 13.38 13.38 21 29666 11197 63448138

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 1068.95 13.61 689 19123 104168 34832951
Hyponatraemia 357.12 13.61 327 19485 82364 34854755
Product substitution issue 197.79 13.61 102 19710 9993 34927126
Aggression 195.52 13.61 168 19644 38796 34898323
Generalised tonic-clonic seizure 180.25 13.61 125 19687 21049 34916070
Epilepsy 171.58 13.61 122 19690 21373 34915746
Multiple-drug resistance 151.14 13.61 69 19743 5170 34931949
Drug ineffective 124.76 13.61 549 19263 456202 34480917
Status epilepticus 122.91 13.61 81 19731 12533 34924586
Partial seizures 119.66 13.61 57 19755 4703 34932416
Stevens-Johnson syndrome 117.85 13.61 92 19720 18547 34918572
Petit mal epilepsy 106.32 13.61 46 19766 3032 34934087
Somnolence 102.83 13.61 207 19605 110909 34826210
Sudden unexplained death in epilepsy 102.16 13.61 28 19784 450 34936669
Ataxia 74.05 13.61 62 19750 13791 34923328
Abnormal behaviour 72.84 13.61 80 19732 24889 34912230
Nystagmus 70.95 13.61 40 19772 4675 34932444
Inappropriate antidiuretic hormone secretion 70.08 13.61 58 19754 12695 34924424
Death 68.58 13.61 75 19737 397974 34539145
Drug interaction 66.91 13.61 279 19533 225667 34711452
Focal dyscognitive seizures 62.40 13.61 25 19787 1356 34935763
Electroencephalogram abnormal 57.22 13.61 28 19784 2450 34934669
Febrile neutropenia 56.33 13.61 6 19806 136843 34800276
Intellectual disability 56.25 13.61 23 19789 1315 34935804
Pneumonia 54.34 13.61 76 19736 362551 34574568
Acute kidney injury 52.96 13.61 57 19755 304931 34632188
Irritability 51.99 13.61 67 19745 24623 34912496
Neuroleptic malignant syndrome 51.50 13.61 57 19755 17877 34919242
Hypochloraemia 48.65 13.61 17 19795 628 34936491
Coma 48.13 13.61 90 19722 45588 34891531
Hyperammonaemic encephalopathy 46.99 13.61 24 19788 2300 34934819
Behaviour disorder 46.53 13.61 31 19781 4879 34932240
Anaemia 45.84 13.61 39 19773 233296 34703823
Memory impairment 45.21 13.61 85 19727 43233 34893886
Dyspnoea 43.61 13.61 93 19719 376689 34560430
Myoclonic epilepsy 42.29 13.61 18 19794 1139 34935980
Agitation 40.52 13.61 96 19716 57303 34879816
Diarrhoea 39.71 13.61 103 19709 389809 34547310
Educational problem 39.29 13.61 14 19798 548 34936571
Blood sodium decreased 38.85 13.61 47 19765 16204 34920915
Colitis ischaemic 38.84 13.61 31 19781 6444 34930675
Cognitive disorder 38.64 13.61 63 19749 28630 34908489
Intentional self-injury 38.21 13.61 43 19769 13728 34923391
Psychomotor hyperactivity 35.55 13.61 35 19777 9587 34927532
Completed suicide 34.42 13.61 128 19684 98040 34839079
Aura 33.62 13.61 11 19801 331 34936788
Drug level decreased 31.73 13.61 30 19782 7816 34929303
Autonomic nervous system imbalance 31.39 13.61 19 19793 2532 34934587
Simple partial seizures 31.18 13.61 10 19802 282 34936837
Depressed mood 31.01 13.61 46 19766 19271 34917848
Psychotic disorder 30.66 13.61 52 19760 24400 34912719
Autism spectrum disorder 30.60 13.61 18 19794 2278 34934841
Anticonvulsant drug level decreased 30.29 13.61 14 19798 1078 34936041
Sepsis 28.98 13.61 31 19781 166530 34770589
Impulsive behaviour 28.94 13.61 17 19795 2145 34934974
Cardiac failure congestive 28.86 13.61 6 19806 83264 34853855
Depression 28.69 13.61 120 19692 96978 34840141
Speech disorder developmental 28.67 13.61 17 19795 2183 34934936
Dissociation 27.50 13.61 15 19797 1643 34935476
Tic 27.07 13.61 16 19796 2042 34935077
Hyperammonaemia 27.01 13.61 25 19787 6342 34930777
Suicidal ideation 26.83 13.61 66 19746 40322 34896797
Thyroxine free decreased 26.63 13.61 9 19803 300 34936819
Drug withdrawal convulsions 26.28 13.61 13 19799 1164 34935955
Developmental coordination disorder 26.13 13.61 8 19804 193 34936926
Platelet count decreased 26.03 13.61 18 19794 119699 34817420
Anxiety 25.66 13.61 118 19694 99310 34837809
Arthralgia 25.02 13.61 36 19776 170005 34767114
Disturbance in attention 24.71 13.61 49 19763 25896 34911223
Otitis media 24.52 13.61 17 19795 2855 34934264
Irregular sleep phase 24.42 13.61 6 19806 61 34937058
Seizure cluster 24.10 13.61 7 19805 140 34936979
Diplopia 24.06 13.61 38 19774 16805 34920314
Hypothermia 23.94 13.61 30 19782 10718 34926401
Gait disturbance 23.43 13.61 103 19709 85037 34852082
Drug withdrawal syndrome 23.32 13.61 41 19771 19793 34917326
Coordination abnormal 23.16 13.61 25 19787 7619 34929500
Brain malformation 23.10 13.61 7 19805 163 34936956
Dysmorphism 23.07 13.61 17 19795 3139 34933980
Hallucination, auditory 23.01 13.61 31 19781 11886 34925233
Enuresis 22.64 13.61 15 19797 2338 34934781
Sopor 22.57 13.61 31 19781 12105 34925014
Pancytopenia 22.48 13.61 13 19799 95144 34841975
Affective disorder 22.23 13.61 19 19793 4341 34932778
Condition aggravated 22.06 13.61 185 19627 192011 34745108
Speech disorder 21.51 13.61 46 19766 25640 34911479
Balance disorder 21.47 13.61 61 19751 40593 34896526
Psychogenic seizure 21.39 13.61 8 19804 360 34936759
Gastrointestinal haemorrhage 21.02 13.61 12 19800 88465 34848654
Wrong patient received product 21.01 13.61 15 19797 2639 34934480
Renal failure 20.86 13.61 26 19786 130531 34806588
Malignant neoplasm progression 20.84 13.61 12 19800 88034 34849085
Dizziness 20.82 13.61 202 19610 218319 34718800
Idiopathic generalised epilepsy 20.80 13.61 5 19807 46 34937073
Nervousness 20.20 13.61 30 19782 12576 34924543
Oedema peripheral 20.06 13.61 23 19789 119789 34817330
Trigeminal neuralgia 20.05 13.61 11 19801 1218 34935901
Bradykinesia 19.92 13.61 17 19795 3876 34933243
Motor developmental delay 19.90 13.61 9 19803 659 34936460
Back pain 19.72 13.61 24 19788 121765 34815354
Hypotension 19.24 13.61 63 19749 221586 34715533
Granulocytopenia 19.07 13.61 21 19791 6546 34930573
Anger 18.64 13.61 28 19784 11856 34925263
Cardiac failure 18.18 13.61 15 19797 91233 34845886
Overweight 18.07 13.61 12 19800 1878 34935241
Dyskinesia 17.47 13.61 39 19773 22374 34914745
Congenital scoliosis 17.26 13.61 5 19807 99 34937020
Anticonvulsant drug level increased 17.26 13.61 11 19801 1605 34935514
Large granular lymphocytosis 17.26 13.61 6 19806 218 34936901
Parasomnia 17.17 13.61 7 19805 397 34936722
Suicide attempt 17.17 13.61 55 19757 39061 34898058
Interstitial lung disease 16.77 13.61 8 19804 65274 34871845
Bipolar disorder 16.72 13.61 15 19797 3654 34933465
Drug abuse 16.61 13.61 19 19793 99077 34838042
Craniocerebral injury 16.19 13.61 14 19798 3249 34933870
Confusional state 16.12 13.61 138 19674 144022 34793097
Congenital knee deformity 16.09 13.61 5 19807 127 34936992
Mental disorder 16.05 13.61 30 19782 15179 34921940
Psychomotor skills impaired 15.92 13.61 15 19797 3891 34933228
Colitis microscopic 15.77 13.61 12 19800 2325 34934794
Tremor 15.70 13.61 90 19722 82497 34854622
Staring 15.69 13.61 10 19802 1460 34935659
Haemoglobin decreased 15.46 13.61 28 19784 120744 34816375
Neutropenia 15.44 13.61 42 19770 156736 34780383
Therapeutic response unexpected 15.32 13.61 23 19789 9734 34927385
General physical health deterioration 15.32 13.61 31 19781 128238 34808881
Hyperthermia 15.30 13.61 24 19788 10553 34926566
Lid lag 15.28 13.61 3 19809 9 34937110
Change in seizure presentation 15.02 13.61 5 19807 159 34936960
Loss of consciousness 15.00 13.61 89 19723 82578 34854541
Thrombosis 14.89 13.61 5 19807 50453 34886666
Dystonia 14.85 13.61 24 19788 10821 34926298
Lethargy 14.70 13.61 54 19758 41068 34896051
Sleep deficit 14.68 13.61 7 19805 578 34936541
Terminal insomnia 14.65 13.61 7 19805 581 34936538
Head banging 14.51 13.61 5 19807 177 34936942
Catatonia 14.47 13.61 16 19796 5009 34932110
Infusion related reaction 14.41 13.61 6 19806 53051 34884068
Mania 14.34 13.61 22 19790 9489 34927630
Tardive dyskinesia 14.25 13.61 17 19795 5773 34931346
Hand fracture 14.24 13.61 11 19801 2181 34934938
Croup infectious 14.04 13.61 6 19806 383 34936736
Product complaint 14.02 13.61 17 19795 5873 34931246
Anticonvulsant drug level below therapeutic 14.01 13.61 7 19805 640 34936479
Mood altered 13.91 13.61 21 19791 8931 34928188
Disease progression 13.88 13.61 25 19787 108052 34829067
Epileptic encephalopathy 13.86 13.61 5 19807 203 34936916
Thrombotic thrombocytopenic purpura 13.85 13.61 13 19799 3357 34933762
Infantile spasms 13.81 13.61 5 19807 205 34936914
Drug eruption 13.72 13.61 33 19779 19865 34917254
Wrong product administered 13.69 13.61 16 19796 5318 34931801
Withdrawal syndrome 13.68 13.61 25 19787 12430 34924689
Product quality issue 13.68 13.61 30 19782 17005 34920114
Cross sensitivity reaction 13.67 13.61 9 19803 1388 34935731
Anticonvulsant drug level above therapeutic 13.66 13.61 7 19805 675 34936444

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 1399.92 12.63 960 37593 187874 79517961
Hyponatraemia 769.28 12.63 657 37896 177191 79528644
Generalised tonic-clonic seizure 295.26 12.63 211 38342 43699 79662136
Multiple-drug resistance 288.41 12.63 121 38432 8687 79697148
Aggression 273.72 12.63 214 38339 50744 79655091
Status epilepticus 273.21 12.63 163 38390 24878 79680957
Epilepsy 235.60 12.63 179 38374 40681 79665154
Completed suicide 212.77 12.63 406 38147 245361 79460474
Focal dyscognitive seizures 203.32 12.63 73 38480 3439 79702396
Partial seizures 199.52 12.63 94 38459 8884 79696951
Product substitution issue 195.69 12.63 122 38431 20134 79685701
Petit mal epilepsy 191.94 12.63 80 38473 5647 79700188
Somnolence 190.07 12.63 381 38172 238600 79467235
Drug interaction 186.74 12.63 530 38023 414653 79291182
Inappropriate antidiuretic hormone secretion 155.47 12.63 117 38436 26196 79679639
Psychogenic seizure 138.15 12.63 47 38506 1884 79703951
Diplopia 134.77 12.63 119 38434 33347 79672488
Stevens-Johnson syndrome 129.99 12.63 125 38428 39041 79666794
Nystagmus 125.30 12.63 71 38482 9833 79696002
Sudden unexplained death in epilepsy 124.66 12.63 34 38519 634 79705201
Balance disorder 118.90 12.63 189 38364 98668 79607167
Ataxia 114.98 12.63 96 38457 24943 79680892
Psychotic disorder 104.45 12.63 114 38439 41288 79664547
Hyperammonaemic encephalopathy 102.97 12.63 49 38504 4733 79701102
Abnormal behaviour 101.99 12.63 106 38447 36315 79669520
Myoclonic epilepsy 99.38 12.63 37 38516 1933 79703902
Sedation 96.17 12.63 122 38431 51773 79654062
Hypochloraemia 90.60 12.63 37 38516 2478 79703357
Mitochondrial DNA mutation 90.02 12.63 24 38529 409 79705426
Neuroleptic malignant syndrome 89.64 12.63 87 38466 27472 79678363
Cognitive disorder 88.65 12.63 137 38416 69789 79636046
Irritability 86.36 12.63 103 38450 41041 79664794
Drug reaction with eosinophilia and systemic symptoms 85.87 12.63 129 38424 64115 79641720
Suicidal ideation 83.70 12.63 140 38413 76200 79629635
Drug ineffective 83.08 12.63 841 37712 1080072 78625763
Agitation 80.31 12.63 160 38393 99555 79606280
Blood sodium decreased 77.74 12.63 88 38465 33167 79672668
Febrile neutropenia 77.68 12.63 10 38543 230989 79474846
Electroencephalogram abnormal 71.57 12.63 40 38513 5394 79700441
Arthralgia 71.16 12.63 104 38449 571699 79134136
Infantile spasms 69.66 12.63 18 38535 270 79705565
Suicide attempt 67.90 12.63 134 38419 82798 79623037
Pneumonia 66.75 12.63 137 38416 660109 79045726
Drug level decreased 63.61 12.63 54 38499 14348 79691487
Sopor 63.37 12.63 79 38474 32931 79672904
Infusion related reaction 62.48 12.63 17 38536 230220 79475615
Joint swelling 62.06 12.63 31 38522 288615 79417220
Anticonvulsant drug level decreased 61.40 12.63 26 38527 1908 79703927
Propofol infusion syndrome 60.77 12.63 26 38527 1957 79703878
Diarrhoea 59.70 12.63 222 38331 880267 78825568
Anaemia 57.24 12.63 79 38474 444936 79260899
Memory impairment 56.31 12.63 149 38404 111585 79594250
Mania 56.31 12.63 56 38497 18204 79687631
Hypothermia 56.26 12.63 62 38491 22684 79683151
Coma 55.66 12.63 139 38414 100510 79605325
Dyspnoea 55.56 12.63 220 38333 856805 78849030
Toxicity to various agents 54.22 12.63 369 38184 421171 79284664
Bipolar disorder 53.99 12.63 38 38515 7669 79698166
Sedation complication 53.85 12.63 51 38502 15618 79690217
Intentional self-injury 53.49 12.63 72 38481 32347 79673488
Speech disorder 52.03 12.63 94 38459 54351 79651484
Blood gases abnormal 51.72 12.63 20 38533 1160 79704675
Creatinine renal clearance decreased 50.86 12.63 54 38499 18948 79686887
Dizziness 50.42 12.63 430 38123 526011 79179824
Intentional overdose 50.08 12.63 138 38415 105822 79600013
CSF oligoclonal band present 49.71 12.63 15 38538 406 79705429
Behaviour disorder 48.63 12.63 33 38520 6280 79699555
Acute kidney injury 48.13 12.63 113 38440 519291 79186544
Contraindicated product administered 48.00 12.63 9 38544 157529 79548306
Dyskinesia 47.58 12.63 81 38472 44692 79661143
Drug ineffective for unapproved indication 47.11 12.63 87 38466 51151 79654684
Arthropathy 46.34 12.63 14 38539 177097 79528738
Lower respiratory tract infection 44.89 12.63 5 38548 129215 79576620
Gene mutation 44.41 12.63 23 38530 2663 79703172
Swelling 44.03 12.63 25 38528 216686 79489149
Peripheral swelling 43.20 12.63 40 38513 269577 79436258
Drug withdrawal syndrome 42.56 12.63 67 38486 34651 79671184
Drug withdrawal convulsions 42.53 12.63 21 38532 2199 79703636
Simple partial seizures 42.13 12.63 15 38538 689 79705146
Death 41.53 12.63 138 38415 566376 79139459
Rheumatoid arthritis 41.01 12.63 25 38528 208445 79497390
Mental disorder 40.60 12.63 62 38491 31240 79674595
General physical health deterioration 40.48 12.63 44 38509 275194 79430641
Cross sensitivity reaction 40.04 12.63 24 38529 3688 79702147
Intellectual disability 39.44 12.63 17 38536 1303 79704532
Pericarditis 38.96 12.63 3 38550 104233 79601602
Granulocytopenia 38.89 12.63 37 38516 11394 79694441
Glossodynia 38.55 12.63 3 38550 103334 79602501
Dissociation 38.27 12.63 24 38529 3997 79701838
Trigeminal neuralgia 38.06 12.63 23 38530 3586 79702249
Depression 37.47 12.63 205 38348 216585 79489250
Depressed level of consciousness 37.18 12.63 117 38436 96535 79609300
Catatonia 36.97 12.63 32 38521 8724 79697111
Tremor 36.53 12.63 171 38382 169912 79535923
Gastric lavage 36.11 12.63 8 38545 59 79705776
Thyroxine free decreased 36.07 12.63 15 38538 1052 79704783
Drug resistance 35.49 12.63 69 38484 42144 79663691
Multiple drug therapy 35.48 12.63 23 38530 4055 79701780
Psychomotor hyperactivity 35.05 12.63 42 38511 16807 79689028
Pleocytosis 34.87 12.63 16 38537 1423 79704412
Anger 34.43 12.63 42 38511 17120 79688715
Seizure cluster 33.59 12.63 11 38542 391 79705444
Reversible cerebral vasoconstriction syndrome 33.58 12.63 20 38533 3037 79702798
Sepsis 33.44 12.63 49 38504 269379 79436456
Blood calcium decreased 33.06 12.63 57 38496 31762 79674073
Cardiac failure 32.70 12.63 17 38536 154825 79551010
Infection 31.95 12.63 42 38511 241670 79464165
Brain malformation 31.55 12.63 7 38546 52 79705783
Anticonvulsant drug level above therapeutic 31.48 12.63 14 38539 1157 79704678
Respiratory arrest 31.30 12.63 79 38474 57471 79648364
Electrocardiogram QRS complex prolonged 31.16 12.63 32 38521 10801 79695034
Tonic convulsion 31.04 12.63 17 38536 2203 79703632
Lennox-Gastaut syndrome 30.97 12.63 9 38544 213 79705622
Cough 30.68 12.63 84 38469 366705 79339130
Hyperammonaemia 30.53 12.63 32 38521 11061 79694774
Overdose 30.36 12.63 172 38381 184034 79521801
Oedema peripheral 30.22 12.63 47 38506 252241 79453594
Malignant neoplasm progression 30.13 12.63 14 38539 135976 79569859
Paradoxical drug reaction 29.82 12.63 26 38527 7159 79698676
Alopecia 29.77 12.63 41 38512 231314 79474521
Hallucination, auditory 29.72 12.63 43 38510 20650 79685185
Stomatitis 29.70 12.63 17 38536 146740 79559095
Fall 29.65 12.63 363 38190 487266 79218569
Aphasia 29.55 12.63 68 38485 46664 79659171
Impulsive behaviour 29.35 12.63 18 38535 2882 79702953
Educational problem 29.31 12.63 10 38543 404 79705431
Gait disturbance 29.25 12.63 186 38367 207320 79498515
Nasopharyngitis 28.82 12.63 49 38504 253832 79452003
Temporal lobe epilepsy 28.59 12.63 10 38543 436 79705399
Partial seizures with secondary generalisation 28.58 12.63 11 38542 630 79705205
Tardive dyskinesia 28.22 12.63 30 38523 10541 79695294
Malaise 27.81 12.63 132 38421 489737 79216098
Aura 27.72 12.63 12 38541 930 79704905
Back pain 27.47 12.63 67 38486 304113 79401722
Paranoia 27.36 12.63 40 38513 19392 79686443
Bradykinesia 27.30 12.63 26 38527 8017 79697818
Blood creatine phosphokinase increased 27.27 12.63 82 38471 66008 79639827
Blood osmolarity decreased 26.72 12.63 13 38540 1318 79704517
Anticonvulsant drug level below therapeutic 26.13 12.63 12 38541 1069 79704766
Brown tumour 26.12 12.63 6 38547 53 79705782
Wrong patient received product 26.09 12.63 20 38533 4598 79701237
Dysmorphism 26.01 12.63 10 38543 571 79705264
Multiple sclerosis 25.93 12.63 42 38511 22240 79683595
Poisoning 25.90 12.63 45 38508 25227 79680608
Disturbance in attention 25.84 12.63 68 38485 50733 79655102
Drug level increased 25.40 12.63 58 38495 39593 79666242
Encephalitis autoimmune 25.18 12.63 15 38538 2279 79703556
Psoriatic arthropathy 24.75 12.63 4 38549 77995 79627840
Cardio-respiratory arrest 24.70 12.63 111 38442 108399 79597436
Encephalitis 24.68 12.63 33 38520 14727 79691108
Parkinsonism 24.61 12.63 35 38518 16549 79689286
Systemic lupus erythematosus 24.56 12.63 14 38539 121135 79584700
Atrial fibrillation 24.53 12.63 36 38517 197850 79507985
Autonomic nervous system imbalance 23.88 12.63 19 38534 4611 79701224
Strabismus 23.87 12.63 15 38538 2506 79703329
Gaze palsy 23.84 12.63 16 38537 2989 79702846
Pain 23.64 12.63 222 38331 703580 79002255
Bipolar I disorder 23.57 12.63 14 38539 2115 79703720
Change in seizure presentation 23.42 12.63 9 38544 513 79705322
Loss of consciousness 23.33 12.63 150 38403 167793 79538042
Abortion spontaneous 23.32 12.63 47 38506 29460 79676375
Staring 23.21 12.63 15 38538 2630 79703205
Therapeutic product ineffective for unapproved indication 23.04 12.63 7 38546 194 79705641
Irregular sleep phase 22.92 12.63 6 38547 95 79705740
Parasomnia 22.79 12.63 9 38544 552 79705283
Impaired healing 22.79 12.63 7 38546 87648 79618187
Pain in extremity 22.62 12.63 95 38458 364443 79341392
Learning disorder 22.52 12.63 9 38544 570 79705265
Arthritis 22.27 12.63 14 38539 114866 79590969
Colitis ischaemic 22.18 12.63 32 38521 15327 79690508
Screaming 22.15 12.63 17 38536 3916 79701919
Therapeutic product effective for unapproved indication 22.09 12.63 6 38547 110 79705725
Hypotonia 21.87 12.63 29 38524 12841 79692994
Psychomotor skills impaired 21.83 12.63 19 38534 5218 79700617
Terminal insomnia 21.80 12.63 11 38542 1206 79704629
Coma blister 21.79 12.63 7 38546 234 79705601
Asthma 21.67 12.63 20 38533 135075 79570760
Tic 21.56 12.63 15 38538 2971 79702864
Unmasking of previously unidentified disease 21.41 12.63 13 38540 2044 79703791
Helicobacter infection 21.19 12.63 4 38549 69700 79636135
Affective disorder 21.13 12.63 23 38530 8296 79697539
Speech disorder developmental 21.07 12.63 9 38544 675 79705160
Fear 21.05 12.63 38 38515 21948 79683887
Discomfort 20.87 12.63 18 38535 125599 79580236
Dysarthria 20.83 12.63 76 38477 67546 79638289
Orthostatic hypotension 20.69 12.63 67 38486 56097 79649738
Lethargy 20.68 12.63 86 38467 81206 79624629
Coordination abnormal 20.65 12.63 33 38520 17279 79688556
Idiopathic generalised epilepsy 20.54 12.63 5 38548 58 79705777
Musculoskeletal pain 20.50 12.63 12 38541 102342 79603493
Hallucination 20.48 12.63 89 38464 85656 79620179
Delusion 20.45 12.63 36 38517 20387 79685448
Neurotoxicity 20.21 12.63 47 38506 32471 79673364
Gastrointestinal haemorrhage 20.20 12.63 25 38528 147694 79558141
Atonic seizures 19.96 12.63 9 38544 768 79705067
Craniocerebral injury 19.96 12.63 18 38535 5178 79700657
Blood antidiuretic hormone decreased 19.91 12.63 3 38550 0 79705835
Mood altered 19.90 12.63 33 38520 17814 79688021
Depressed mood 19.85 12.63 60 38493 48420 79657415
Hypersensitivity 19.78 12.63 63 38490 262176 79443659
Postictal psychosis 19.72 12.63 6 38547 167 79705668
Cardiac failure congestive 19.58 12.63 24 38529 142378 79563457
Drug eruption 19.55 12.63 56 38497 43879 79661956
Drug intolerance 19.54 12.63 64 38489 264055 79441780
Dysphoria 19.38 12.63 17 38536 4717 79701118
Leukopenia 19.32 12.63 109 38444 116404 79589431
Head injury 18.98 12.63 50 38503 37319 79668516
Rash maculo-papular 18.97 12.63 65 38488 56013 79649822
Nausea 18.78 12.63 338 38215 956858 78748977
Herpes zoster 18.52 12.63 11 38542 93072 79612763
Haemoglobin decreased 18.45 12.63 51 38502 222068 79483767
Anticonvulsant drug level increased 18.39 12.63 13 38540 2640 79703195
Sleep paralysis 18.35 12.63 8 38545 630 79705205
Herpes oesophagitis 18.33 12.63 7 38546 392 79705443
Productive cough 18.20 12.63 10 38543 88321 79617514
Blood chloride decreased 18.03 12.63 21 38532 8156 79697679
Dystonia 18.01 12.63 35 38518 21364 79684471
Muscle twitching 17.87 12.63 38 38515 24726 79681109
Electrocardiogram repolarisation abnormality 17.82 12.63 12 38541 2255 79703580
Agranulocytosis 17.76 12.63 55 38498 44975 79660860
Product administration error 17.61 12.63 44 38509 31802 79674033
Drug screen positive 17.60 12.63 18 38535 6045 79699790
Poisoning deliberate 17.34 12.63 32 38521 18796 79687039
Disorientation 17.23 12.63 68 38485 62708 79643127
Myocardial infarction 17.05 12.63 40 38513 184089 79521746
Eye movement disorder 16.71 12.63 20 38533 7991 79697844
Rasmussen encephalitis 16.61 12.63 3 38550 6 79705829
Developmental coordination disorder 16.61 12.63 3 38550 6 79705829
Atrioventricular block first degree 16.56 12.63 25 38528 12466 79693369
Logorrhoea 16.53 12.63 15 38538 4350 79701485
Dyspnoea exertional 16.35 12.63 11 38542 87062 79618773
Blood pressure fluctuation 16.34 12.63 6 38547 67139 79638696
Enuresis 16.31 12.63 13 38540 3163 79702672
Neuropathy peripheral 16.27 12.63 27 38526 141278 79564557
Nervousness 16.25 12.63 44 38509 33371 79672464
Acidosis hyperchloraemic 16.23 12.63 8 38545 834 79705001
Pancytopenia 16.17 12.63 35 38518 165710 79540125
Developmental delay 16.04 12.63 9 38544 1222 79704613
Product colour issue 15.90 12.63 8 38545 872 79704963
Hippocampal sclerosis 15.89 12.63 5 38548 156 79705679
Mental status changes 15.61 12.63 69 38484 66890 79638945
Musculoskeletal stiffness 15.43 12.63 39 38514 174969 79530866
Renal failure 15.34 12.63 48 38505 200920 79504915
Antinuclear antibody positive 15.33 12.63 19 38534 7871 79697964
Normal newborn 15.32 12.63 18 38535 7054 79698781
Extensor plantar response 15.18 12.63 10 38543 1811 79704024
Crying 15.08 12.63 34 38519 23009 79682826
Exposure during pregnancy 15.08 12.63 92 38461 101040 79604795
Anxiety 15.06 12.63 185 38368 248327 79457508
Large granular lymphocytosis 15.06 12.63 6 38547 377 79705458
Macule 14.96 12.63 12 38541 2945 79702890
Restlessness 14.95 12.63 53 38500 46439 79659396
Mucosal inflammation 14.94 12.63 9 38544 75571 79630264
Weight increased 14.91 12.63 202 38351 277184 79428651
Brain operation 14.89 12.63 7 38546 658 79705177
Postictal state 14.85 12.63 10 38543 1879 79703956
Dermatitis exfoliative 14.82 12.63 22 38531 10807 79695028
Gamma-glutamyltransferase increased 14.82 12.63 59 38494 54621 79651214
Abdominal pain 14.77 12.63 119 38434 389450 79316385
Sinusitis 14.71 12.63 47 38506 195454 79510381
Abnormal sensation in eye 14.63 12.63 10 38543 1925 79703910
Fever neonatal 14.54 12.63 3 38550 15 79705820
Drop attacks 14.53 12.63 8 38545 1047 79704788
Ammonia increased 14.21 12.63 18 38535 7617 79698218
Fatigue 14.17 12.63 342 38211 929385 78776450
Epistaxis 14.10 12.63 20 38533 111495 79594340
Viral titre decreased 14.08 12.63 3 38550 18 79705817
Therapeutic product effect decreased 14.08 12.63 37 38516 163826 79542009
Renal impairment 14.04 12.63 35 38518 157748 79548087
Libido decreased 14.02 12.63 15 38538 5306 79700529
Confusional state 13.74 12.63 223 38330 317774 79388061
Therapeutic response unexpected 13.70 12.63 30 38523 19916 79685919
Immune thrombocytopenia 13.64 12.63 28 38525 17777 79688058
Ascites 13.58 12.63 10 38543 75552 79630283
Social fear 13.56 12.63 3 38550 22 79705813
Blood lactic acid increased 13.46 12.63 23 38530 12721 79693114
Antipsychotic drug level decreased 13.43 12.63 8 38545 1216 79704619
Disease progression 13.40 12.63 45 38508 184317 79521518
Folliculitis 13.39 12.63 5 38548 55375 79650460
Follicular mucinosis 13.33 12.63 3 38550 24 79705811
Neutropenia 13.28 12.63 83 38470 287627 79418208
Pulmonary embolism 13.10 12.63 41 38512 171613 79534222
Head banging 13.06 12.63 6 38547 535 79705300
Heart rate decreased 13.04 12.63 9 38544 70307 79635528
Abdominal distension 12.75 12.63 24 38529 119626 79586209
Withdrawal syndrome 12.70 12.63 35 38518 26819 79679016
Product complaint 12.69 12.63 23 38530 13326 79692509
Nasal congestion 12.67 12.63 11 38542 76541 79629294
Muscle rigidity 12.64 12.63 29 38524 19853 79685982

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 D002491 Central Nervous System Agents
MeSH PA D065701 Cytochrome P-450 CYP3A Inducers
MeSH PA D049990 Membrane Transport Modulators
MeSH PA D065606 Metabolic Side Effects of Drugs and Substances
MeSH PA D026941 Sodium Channel Blockers
MeSH PA D061567 Voltage-Gated Sodium Channel Blockers
CHEBI has role CHEBI:35623 anticonvulsants
CHEBI has role CHEBI:88188 allergenic drug
FDA EPC N0000175753 Anti-epileptic Agent

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




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 12.9 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
Oxcarbazepine HUMAN PRESCRIPTION DRUG LABEL 1 0054-0199 SUSPENSION 300 mg ORAL ANDA 30 sections
Oxcarbazepine HUMAN PRESCRIPTION DRUG LABEL 1 0054-0199 SUSPENSION 300 mg ORAL ANDA 30 sections
Trileptal HUMAN PRESCRIPTION DRUG LABEL 1 0078-0337 TABLET, FILM COATED 300 mg ORAL NDA 33 sections
Trileptal HUMAN PRESCRIPTION DRUG LABEL 1 0078-0337 TABLET, FILM COATED 300 mg ORAL NDA 33 sections
Trileptal HUMAN PRESCRIPTION DRUG LABEL 1 0078-0337 TABLET, FILM COATED 300 mg ORAL NDA 33 sections
Trileptal HUMAN PRESCRIPTION DRUG LABEL 1 0078-0357 SUSPENSION 60 mg ORAL NDA 33 sections
Trileptal HUMAN PRESCRIPTION DRUG LABEL 1 0078-0357 SUSPENSION 60 mg ORAL NDA 33 sections
Trileptal HUMAN PRESCRIPTION DRUG LABEL 1 0078-0357 SUSPENSION 60 mg ORAL NDA 33 sections
Trileptal HUMAN PRESCRIPTION DRUG LABEL 1 0078-0456 TABLET, FILM COATED 150 mg ORAL NDA 33 sections
Trileptal HUMAN PRESCRIPTION DRUG LABEL 1 0078-0456 TABLET, FILM COATED 150 mg ORAL NDA 33 sections
Trileptal HUMAN PRESCRIPTION DRUG LABEL 1 0078-0456 TABLET, FILM COATED 150 mg ORAL NDA 33 sections
Trileptal HUMAN PRESCRIPTION DRUG LABEL 1 0078-0457 TABLET, FILM COATED 600 mg ORAL NDA 33 sections
Trileptal HUMAN PRESCRIPTION DRUG LABEL 1 0078-0457 TABLET, FILM COATED 600 mg ORAL NDA 33 sections
Trileptal HUMAN PRESCRIPTION DRUG LABEL 1 0078-0457 TABLET, FILM COATED 600 mg ORAL NDA 33 sections
Oxcarbazepine HUMAN PRESCRIPTION DRUG LABEL 1 0615-8153 TABLET, FILM COATED 150 mg ORAL ANDA 30 sections
Oxcarbazepine HUMAN PRESCRIPTION DRUG LABEL 1 0615-8153 TABLET, FILM COATED 150 mg ORAL ANDA 30 sections
Oxcarbazepine HUMAN PRESCRIPTION DRUG LABEL 1 0615-8292 TABLET, FILM COATED 300 mg ORAL ANDA 30 sections
Oxcarbazepine HUMAN PRESCRIPTION DRUG LABEL 1 0615-8292 TABLET, FILM COATED 300 mg ORAL ANDA 30 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 0781-6270 SUSPENSION 60 mg ORAL NDA authorized generic 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 32 sections
OXCARBAZEPINE HUMAN PRESCRIPTION DRUG LABEL 1 0904-7263 TABLET, FILM COATED 300 mg ORAL ANDA 32 sections
OXCARBAZEPINE HUMAN PRESCRIPTION DRUG LABEL 1 0904-7264 TABLET, FILM COATED 600 mg ORAL ANDA 32 sections
OXTELLAR XR HUMAN PRESCRIPTION DRUG LABEL 1 17772-121 TABLET 150 mg ORAL NDA 34 sections
OXTELLAR XR HUMAN PRESCRIPTION DRUG LABEL 1 17772-121 TABLET 150 mg ORAL NDA 34 sections
OXTELLAR XR HUMAN PRESCRIPTION DRUG LABEL 1 17772-121 TABLET 150 mg ORAL NDA 34 sections
OXTELLAR XR HUMAN PRESCRIPTION DRUG LABEL 1 17772-121 TABLET 150 mg ORAL NDA 34 sections
OXTELLAR XR HUMAN PRESCRIPTION DRUG LABEL 1 17772-122 TABLET 300 mg ORAL NDA 34 sections