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

Stem definitionDrug idCAS RN
2872 68291-97-4

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • zonisamide
  • exceglan
  • excegram
  • excegran
  • zonegran
an antiseizure drug chemically classified as a sulfonamide and unrelated to other antiseizure agents, blocks sodium channels and reduces voltage-dependent, transient inward currents (T-type Ca2+ currents), consequently stabilizing neuronal membranes and suppressing neuronal hypersynchronization
  • Molecular weight: 212.22
  • Formula: C8H8N2O3S
  • CLOGP: -0.36
  • LIPINSKI: 0
  • HAC: 5
  • HDO: 1
  • TPSA: 86.19
  • ALOGS: -2.01
  • ROTB: 2

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.20 g O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.80 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 22 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 40.39 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 99 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

DateAgencyCompanyOrphan
March 27, 2000 FDA EISAI INC
March 10, 2005 EMA
Dec. 4, 2008 PMDA Dainippon Sumitomo Pharma Co., Ltd.

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 857.13 15.46 457 12854 132177 63343534
Multiple-drug resistance 274.07 15.46 82 13229 5088 63470623
Status epilepticus 171.46 15.46 77 13234 15156 63460555
Generalised tonic-clonic seizure 156.14 15.46 89 13222 28927 63446784
Drug reaction with eosinophilia and systemic symptoms 153.69 15.46 93 13218 33743 63441968
Epilepsy 150.98 15.46 85 13226 26980 63448731
Atonic seizures 121.75 15.46 28 13283 611 63475100
Irritability 96.93 15.46 68 13243 31626 63444085
Aggression 90.05 15.46 58 13253 23440 63452271
Drug ineffective 84.98 15.46 436 12875 1044329 62431382
Stevens-Johnson syndrome 84.47 15.46 57 13254 24893 63450818
Somnolence 83.75 15.46 141 13170 178544 63297167
Cognitive disorder 74.33 15.46 74 13237 55741 63419970
Partial seizures 73.67 15.46 32 13279 5810 63469901
Focal dyscognitive seizures 72.10 15.46 26 13285 2895 63472816
Product substitution issue 67.57 15.46 42 13269 15954 63459757
Petit mal epilepsy 65.48 15.46 26 13285 3768 63471943
Drug eruption 64.10 15.46 51 13260 28643 63447068
Ataxia 61.92 15.46 39 13272 15156 63460555
Psychotic disorder 60.23 15.46 47 13264 25665 63450046
Suicidal behaviour 59.60 15.46 22 13289 2617 63473094
Drug withdrawal convulsions 56.08 15.46 18 13293 1407 63474304
Choroidal effusion 55.32 15.46 14 13297 462 63475249
Dyskinesia 55.20 15.46 49 13262 31953 63443758
Therapeutic response unexpected 54.45 15.46 39 13272 18720 63456991
Vestibular migraine 54.00 15.46 12 13299 223 63475488
Drug resistance 47.49 15.46 39 13272 22894 63452817
Tonic convulsion 45.43 15.46 15 13296 1282 63474429
Infantile spasms 44.07 15.46 10 13301 205 63475506
Hyperammonaemic encephalopathy 43.12 15.46 17 13294 2417 63473294
Drug interaction 42.80 15.46 125 13186 229006 63246705
Change in seizure presentation 42.12 15.46 11 13300 412 63475299
Depression 41.40 15.46 112 13199 196380 63279331
Ovarian granulosa-theca cell tumour 41.24 15.46 7 13304 27 63475684
Joint swelling 39.56 15.46 10 13301 327656 63148055
Epilepsy with myoclonic-atonic seizures 38.60 15.46 8 13303 105 63475606
Myoclonic epilepsy 34.12 15.46 12 13299 1242 63474469
Bipolar disorder 33.86 15.46 21 13290 7939 63467772
Epileptic psychosis 33.16 15.46 6 13305 36 63475675
Toxic epidermal necrolysis 32.62 15.46 33 13278 25301 63450410
Diplopia 32.57 15.46 32 13279 23696 63452015
Hallucination, visual 32.19 15.46 29 13282 19269 63456442
Rheumatoid arthritis 32.10 15.46 7 13304 253812 63221899
Arthralgia 31.72 15.46 44 13267 569666 62906045
Oculomucocutaneous syndrome 31.71 15.46 7 13304 126 63475585
Abortion spontaneous 31.59 15.46 44 13267 47151 63428560
Suicidal ideation 31.51 15.46 51 13260 62370 63413341
Brown tumour 31.43 15.46 6 13305 50 63475661
Arthropathy 30.67 15.46 6 13305 234786 63240925
Placental infarction 30.44 15.46 8 13303 307 63475404
Systemic lupus erythematosus 30.29 15.46 4 13307 208914 63266797
Retinogram abnormal 29.96 15.46 7 13304 164 63475547
Agitation 29.05 15.46 48 13263 59709 63416002
Herpes oesophagitis 28.59 15.46 7 13304 201 63475510
Swelling 28.58 15.46 11 13300 275367 63200344
Therapeutic response changed 28.43 15.46 10 13301 1035 63474676
Mood altered 28.30 15.46 24 13287 14719 63460992
Therapeutic product effective for unapproved indication 27.84 15.46 6 13305 96 63475615
Abnormal behaviour 27.75 15.46 28 13283 21398 63454313
Diarrhoea 27.66 15.46 69 13242 715297 62760414
Intentional overdose 27.60 15.46 53 13258 74099 63401612
Hepatic function abnormal 26.94 15.46 36 13275 37106 63438605
Lichen planus 26.87 15.46 12 13299 2326 63473385
Infusion related reaction 26.85 15.46 9 13302 245512 63230199
Depressed mood 26.20 15.46 37 13274 40154 63435557
Dyspnoea 26.17 15.46 63 13248 661250 62814461
Calculus urinary 25.69 15.46 10 13301 1374 63474337
Anger 25.40 15.46 21 13290 12435 63463276
Magnetic resonance imaging head abnormal 25.29 15.46 11 13300 2002 63473709
Encapsulating peritoneal sclerosis 24.98 15.46 7 13304 343 63475368
Myoclonus 24.81 15.46 23 13288 15845 63459866
Anticonvulsant drug level increased 24.80 15.46 10 13301 1507 63474204
Disturbance in attention 24.66 15.46 35 13276 38154 63437557
Exposure during pregnancy 24.49 15.46 80 13231 155467 63320244
Pneumonia aspiration 24.32 15.46 33 13278 34507 63441204
Migraine 23.87 15.46 61 13250 103285 63372426
Withdrawal syndrome 23.85 15.46 25 13286 19972 63455739
Renal tubular acidosis 23.75 15.46 10 13301 1682 63474029
Severe myoclonic epilepsy of infancy 23.70 15.46 5 13306 72 63475639
Suicide attempt 23.23 15.46 44 13267 60874 63414837
Endometrial cancer 23.20 15.46 12 13299 3213 63472498
Therapeutic product ineffective for unapproved indication 23.10 15.46 6 13305 220 63475491
Upper respiratory tract inflammation 22.92 15.46 11 13300 2512 63473199
Hallucination, auditory 22.83 15.46 20 13291 12804 63462907
Coma 22.73 15.46 45 13266 64319 63411392
Altered state of consciousness 22.32 15.46 27 13284 25203 63450508
Delusion 21.92 15.46 19 13292 11998 63463713
Neuroleptic malignant syndrome 21.86 15.46 19 13292 12037 63463674
Microcephaly 21.83 15.46 8 13303 932 63474779
Stress cardiomyopathy 21.53 15.46 17 13294 9433 63466278
Placental disorder 21.48 15.46 9 13302 1495 63474216
Hallucination 21.41 15.46 40 13271 54777 63420934
Depressed level of consciousness 20.25 15.46 42 13269 62036 63413675
Pain 19.86 15.46 84 13227 740544 62735167
Anticonvulsant drug level decreased 19.60 15.46 8 13303 1244 63474467
Aphasia 19.50 15.46 29 13282 32971 63442740
Immunoglobulins decreased 19.36 15.46 8 13303 1284 63474427
Product complaint 18.94 15.46 18 13293 12791 63462920
Abdominal discomfort 18.61 15.46 24 13287 320861 63154850
Sinus arrhythmia 18.35 15.46 8 13303 1465 63474246
Restless legs syndrome 18.33 15.46 21 13290 18510 63457201
Developmental delay 18.29 15.46 8 13303 1475 63474236
Tremor 18.16 15.46 65 13246 132174 63343537
Insomnia 18.03 15.46 91 13220 215161 63260550
Drug level increased 17.98 15.46 23 13288 22713 63452998
Dysmetria 17.97 15.46 6 13305 531 63475180
Myopia 17.45 15.46 8 13303 1647 63474064
Overdose 17.04 15.46 58 13253 115020 63360691
Discomfort 16.84 15.46 7 13304 167367 63308344
Human herpes virus 6 serology positive 16.83 15.46 4 13307 101 63475610
Gestational diabetes 16.80 15.46 14 13297 8382 63467329
Sudden unexplained death in epilepsy 16.58 15.46 5 13306 318 63475393
Hypothermia 16.23 15.46 17 13294 13564 63462147
Electrocardiogram PR prolongation 16.22 15.46 6 13305 718 63474993
Ureterolithiasis 16.19 15.46 8 13303 1944 63473767
Hypertension 16.08 15.46 21 13290 279282 63196429
Affective disorder 16.07 15.46 12 13299 6134 63469577
Abdominal pain 15.95 15.46 23 13288 293433 63182278
Nystagmus 15.94 15.46 12 13299 6208 63469503
Encephalocele 15.63 15.46 4 13307 138 63475573
Illiteracy 15.51 15.46 3 13308 27 63475684

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 533.99 17.99 332 8650 104525 34843424
Status epilepticus 281.58 17.99 110 8872 12504 34935445
Multiple-drug resistance 161.79 17.99 58 8924 5181 34942768
Drug ineffective 132.16 17.99 331 8651 456420 34491529
Generalised tonic-clonic seizure 130.12 17.99 76 8906 21098 34926851
Somnolence 118.31 17.99 144 8838 110972 34836977
Partial seizures 104.31 17.99 41 8941 4719 34943230
Aggression 98.64 17.99 81 8901 38883 34909066
Epilepsy 93.63 17.99 62 8920 21433 34926516
Ataxia 70.29 17.99 44 8938 13809 34934140
Neonatal pneumonia 64.09 17.99 13 8969 122 34947827
Drug reaction with eosinophilia and systemic symptoms 62.12 17.99 58 8924 32954 34914995
Neonatal hypotension 61.72 17.99 13 8969 149 34947800
Nystagmus 61.18 17.99 28 8954 4687 34943262
Stevens-Johnson syndrome 60.69 17.99 45 8937 18594 34929355
Choroidal effusion 59.46 17.99 13 8969 180 34947769
Postictal psychosis 58.67 17.99 13 8969 192 34947757
Focal dyscognitive seizures 57.00 17.99 19 8963 1362 34946587
Hyperammonaemic encephalopathy 54.38 17.99 21 8961 2303 34945646
Pneumonia aspiration 53.98 17.99 60 8922 41843 34906106
Dyspnoea 52.38 17.99 16 8966 376766 34571183
Developmental delay 50.77 17.99 21 8961 2754 34945195
Irritability 49.59 17.99 45 8937 24645 34923304
Altered state of consciousness 46.52 17.99 42 8940 22851 34925098
Calculus urinary 45.02 17.99 16 8966 1391 34946558
Psychotic disorder 44.15 17.99 42 8940 24410 34923539
Petit mal epilepsy 42.21 17.99 19 8963 3059 34944890
Abnormal behaviour 41.53 17.99 41 8941 24928 34923021
Vitamin D deficiency 41.29 17.99 24 8958 6584 34941365
Product substitution issue 41.24 17.99 28 8954 10067 34937882
Toxic epidermal necrolysis 36.85 17.99 36 8946 21610 34926339
Nephrolithiasis 36.60 17.99 42 8940 30291 34917658
Encephalopathy 36.20 17.99 45 8937 35274 34912675
Tonic convulsion 35.95 17.99 13 8969 1188 34946761
Delusion 35.61 17.99 28 8954 12607 34935342
Respiratory disorder neonatal 35.56 17.99 14 8968 1616 34946333
Fanconi syndrome 34.83 17.99 14 8968 1706 34946243
Sudden unexplained death in epilepsy 34.12 17.99 10 8972 468 34947481
Dyskinesia 33.97 17.99 35 8947 22378 34925571
Salivary hypersecretion 33.01 17.99 23 8959 8621 34939328
Drug withdrawal convulsions 32.48 17.99 12 8970 1165 34946784
Myoclonus 29.87 17.99 27 8955 14698 34933251
Myoclonic epilepsy 29.02 17.99 11 8971 1146 34946803
Condition aggravated 28.50 17.99 111 8871 192085 34755864
Drug eruption 28.23 17.99 30 8952 19868 34928081
Cytotoxic oedema 28.15 17.99 7 8975 174 34947775
Temporal lobe epilepsy 28.03 17.99 7 8975 177 34947772
Drug interaction 26.89 17.99 122 8860 225824 34722125
Lymphocyte stimulation test positive 26.15 17.99 9 8973 711 34947238
Anticonvulsant drug level increased 25.47 17.99 11 8971 1605 34946344
Atonic seizures 25.32 17.99 7 8975 265 34947684
Premature baby 25.06 17.99 28 8954 19605 34928344
Retinogram abnormal 25.05 17.99 6 8976 127 34947822
Parkinsonism 25.04 17.99 19 8963 8119 34939830
Foetal exposure during pregnancy 24.74 17.99 39 8943 38062 34909887
Arthralgia 23.95 17.99 7 8975 170034 34777915
Small for dates baby 23.84 17.99 14 8968 3913 34944036
Hallucination 23.37 17.99 45 8937 51453 34896496
Congenital inguinal hernia 23.11 17.99 6 8976 178 34947771
Wrong schedule 23.11 17.99 6 8976 178 34947771
Death 23.10 17.99 42 8940 398007 34549942
Hepatic function abnormal 22.93 17.99 41 8941 44322 34903627
Congenital cutis laxa 22.68 17.99 5 8977 72 34947877
Infantile spasms 22.32 17.99 6 8976 204 34947745
Tachyarrhythmia 22.26 17.99 13 8969 3595 34944354
Aminoaciduria 20.41 17.99 6 8976 284 34947665
Drug resistance 20.35 17.99 29 8953 25898 34922051
Product lot number issue 20.18 17.99 4 8978 33 34947916
Angle closure glaucoma 20.11 17.99 8 8974 949 34947000
Implant site pruritus 19.72 17.99 3 8979 3 34947946
Partial seizures with secondary generalisation 19.54 17.99 6 8976 330 34947619
Aura 19.43 17.99 6 8976 336 34947613
Language disorder 19.06 17.99 10 8972 2246 34945703
Idiopathic generalised epilepsy 18.90 17.99 4 8978 47 34947902
Hallucination, visual 18.75 17.99 23 8959 17768 34930181
Febrile neutropenia 18.60 17.99 6 8976 136843 34811106
Implant site rash 18.51 17.99 3 8979 6 34947943
Assisted delivery 18.51 17.99 3 8979 6 34947943
Oculomucocutaneous syndrome 18.49 17.99 5 8977 174 34947775
Electroencephalogram abnormal 18.18 17.99 10 8972 2468 34945481

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 766.49 15.40 490 17054 188344 79538500
Status epilepticus 375.09 15.40 157 17387 24884 79701960
Multiple-drug resistance 316.45 15.40 105 17439 8703 79718141
Generalised tonic-clonic seizure 212.81 15.40 128 17416 43782 79683062
Epilepsy 208.15 15.40 123 17421 40737 79686107
Drug reaction with eosinophilia and systemic symptoms 204.88 15.40 144 17400 64100 79662744
Drug ineffective 179.24 15.40 581 16963 1080332 78646512
Somnolence 164.40 15.40 231 17313 238750 79488094
Aggression 161.91 15.40 114 17430 50844 79676000
Partial seizures 143.48 15.40 59 17485 8919 79717925
Stevens-Johnson syndrome 127.61 15.40 89 17455 39077 79687767
Choroidal effusion 113.57 15.40 27 17517 650 79726194
Irritability 112.35 15.40 84 17460 41060 79685784
Ataxia 106.01 15.40 67 17477 24972 79701872
Focal dyscognitive seizures 103.10 15.40 36 17508 3476 79723368
Petit mal epilepsy 96.17 15.40 39 17505 5688 79721156
Psychotic disorder 94.47 15.40 76 17468 41326 79685518
Atonic seizures 89.93 15.40 23 17521 754 79726090
Dyskinesia 87.22 15.40 75 17469 44698 79682146
Hyperammonaemic encephalopathy 81.79 15.40 33 17511 4749 79722095
Tonic convulsion 77.85 15.40 26 17518 2194 79724650
Pneumonia aspiration 77.09 15.40 84 17460 66883 79659961
Drug eruption 72.48 15.40 67 17477 43868 79682976
Drug interaction 70.60 15.40 226 17318 414957 79311887
Nystagmus 67.18 15.40 36 17508 9868 79716976
Drug resistance 65.08 15.40 62 17482 42151 79684693
Altered state of consciousness 63.11 15.40 62 17482 43760 79683084
Postictal psychosis 62.88 15.40 13 17531 160 79726684
Dyspnoea 62.66 15.40 58 17486 856967 78869877
Toxic epidermal necrolysis 60.37 15.40 61 17483 44520 79682324
Calculus urinary 60.06 15.40 22 17522 2438 79724406
Cognitive disorder 59.30 15.40 75 17469 69851 79656993
Delusion 58.66 15.40 43 17501 20380 79706464
Drug withdrawal convulsions 54.75 15.40 20 17524 2200 79724644
Retinogram abnormal 53.65 15.40 13 17531 340 79726504
Myoclonic epilepsy 53.27 15.40 19 17525 1951 79724893
Hepatic function abnormal 52.09 15.40 72 17472 73035 79653809
Suicidal behaviour 50.73 15.40 21 17523 3226 79723618
Abnormal behaviour 47.79 15.40 49 17495 36372 79690472
Hallucination, visual 46.55 15.40 46 17498 32683 79694161
Arthralgia 46.26 15.40 35 17509 571768 79155076
Myoclonus 45.26 15.40 42 17502 27618 79699226
Change in seizure presentation 43.91 15.40 12 17532 510 79726334
Fanconi syndrome 43.03 15.40 18 17526 2838 79724006
Lymphocyte stimulation test positive 42.65 15.40 14 17530 1119 79725725
Ovarian granulosa-theca cell tumour 41.55 15.40 7 17537 24 79726820
Neonatal pneumonia 40.12 15.40 7 17537 31 79726813
Neonatal hypotension 39.94 15.40 7 17537 32 79726812
Joint swelling 39.02 15.40 8 17536 288638 79438206
Salivary hypersecretion 38.72 15.40 29 17515 14195 79712649
Vitamin D deficiency 38.62 15.40 29 17515 14250 79712594
Epilepsy with myoclonic-atonic seizures 38.01 15.40 8 17536 108 79726736
Anticonvulsant drug level increased 37.57 15.40 16 17528 2637 79724207
Nephrolithiasis 37.23 15.40 52 17492 53239 79673605
Placental infarction 37.10 15.40 8 17536 122 79726722
Hallucination 36.85 15.40 67 17477 85678 79641166
Respiratory disorder neonatal 36.05 15.40 7 17537 61 79726783
Infantile spasms 35.67 15.40 9 17535 279 79726565
Oculomucocutaneous syndrome 34.22 15.40 9 17535 330 79726514
Upper respiratory tract inflammation 34.09 15.40 17 17527 4018 79722826
Product substitution issue 33.61 15.40 31 17513 20225 79706619
Angle closure glaucoma 32.63 15.40 15 17529 2961 79723883
Neuroleptic malignant syndrome 32.45 15.40 35 17509 27524 79699320
Sudden unexplained death in epilepsy 32.35 15.40 10 17534 658 79726186
Encephalopathy 31.97 15.40 55 17489 67342 79659502
Temporal lobe epilepsy 31.77 15.40 9 17535 437 79726407
Brown tumour 30.83 15.40 6 17538 53 79726791
Magnetic resonance imaging head abnormal 30.71 15.40 14 17530 2712 79724132
Diplopia 30.12 15.40 37 17507 33429 79693415
Vestibular migraine 30.09 15.40 7 17537 153 79726691
Febrile neutropenia 30.00 15.40 7 17537 230992 79495852
Swelling 29.29 15.40 6 17538 216705 79510139
Partial seizures with secondary generalisation 28.55 15.40 9 17535 632 79726212
Infusion related reaction 27.94 15.40 8 17536 230229 79496615
Therapeutic product effective for unapproved indication 26.79 15.40 6 17538 110 79726734
Mood swings 26.54 15.40 27 17517 19853 79706991
Developmental delay 26.36 15.40 10 17534 1221 79725623
Bronchial hyperreactivity 26.25 15.40 13 17531 3027 79723817
Disturbance in attention 26.14 15.40 43 17501 50758 79676086
Suicidal ideation 25.90 15.40 54 17490 76286 79650558
Depression 25.65 15.40 105 17439 216685 79510159
Hallucination, auditory 25.63 15.40 27 17517 20666 79706178
Placental disorder 25.23 15.40 9 17535 924 79725920
Anticonvulsant drug level decreased 25.21 15.40 11 17533 1923 79724921
Parkinsonism 24.87 15.40 24 17520 16560 79710284
Therapeutic response unexpected 24.66 15.40 26 17518 19920 79706924
Hyperammonaemia 24.52 15.40 20 17524 11073 79715771
Breast disorder 24.43 15.40 11 17533 2070 79724774
Agitation 24.40 15.40 62 17482 99653 79627191
Cytotoxic oedema 23.78 15.40 7 17537 390 79726454
Herpes oesophagitis 23.74 15.40 7 17537 392 79726452
Arthropathy 23.73 15.40 5 17539 177106 79549738
Therapeutic product ineffective for unapproved indication 23.51 15.40 6 17538 195 79726649
Human herpes virus 6 serology positive 23.05 15.40 6 17538 211 79726633
Small for dates baby 22.52 15.40 7 17537 469 79726375
Overdose 22.40 15.40 90 17454 184116 79542728
Diarrhoea 22.24 15.40 109 17435 880380 78846464
Therapeutic response shortened 22.01 15.40 22 17522 15841 79711003
Human herpesvirus 6 infection reactivation 21.22 15.40 7 17537 568 79726276
Peripheral swelling 21.12 15.40 17 17527 269600 79457244
Low birth weight baby 20.67 15.40 7 17537 616 79726228
Ureterolithiasis 20.67 15.40 12 17532 3836 79723008
Jealous delusion 20.56 15.40 6 17538 324 79726520
Depressed level of consciousness 20.51 15.40 57 17487 96595 79630249
Dysmetria 20.44 15.40 8 17536 1063 79725781
Illiteracy 20.39 15.40 4 17540 37 79726807
Abdominal pain 20.35 15.40 34 17510 389535 79337309
Speech disorder 20.23 15.40 40 17504 54405 79672439
Cough 20.11 15.40 31 17513 366758 79360086
Developmental regression 19.93 15.40 4 17540 42 79726802
Wrong schedule 19.90 15.40 6 17538 363 79726481
Mood altered 19.85 15.40 22 17522 17825 79709019
Gestational diabetes 19.78 15.40 14 17530 6279 79720565
Encephalocele 19.68 15.40 4 17540 45 79726799
Aminoaciduria 19.51 15.40 6 17538 388 79726456
Malaise 19.47 15.40 50 17494 489819 79237025
Electroencephalogram abnormal 19.22 15.40 13 17531 5421 79721423
Brain neoplasm 18.77 15.40 13 17531 5633 79721211
Lower respiratory tract infection 18.70 15.40 3 17541 129217 79597627
Haemoglobin decreased 18.69 15.40 13 17531 222106 79504738
Idiopathic generalised epilepsy 18.67 15.40 4 17540 59 79726785
Condition aggravated 18.63 15.40 180 17364 500944 79225900
Encapsulating peritoneal sclerosis 18.54 15.40 7 17537 844 79726000
Lichen planus 18.52 15.40 10 17534 2781 79724063
Stress cardiomyopathy 18.35 15.40 17 17527 11149 79715695
Hypotonia 18.13 15.40 18 17526 12852 79713992
Persecutory delusion 17.98 15.40 12 17532 4897 79721947
Osteomalacia 17.94 15.40 8 17536 1472 79725372
Personality change 17.72 15.40 16 17528 10154 79716690
Immunoglobulins decreased 17.54 15.40 8 17536 1552 79725292
Behaviour disorder 17.47 15.40 13 17531 6300 79720544
Atrial fibrillation 17.43 15.40 11 17533 197875 79528969
Electrocardiogram PR prolongation 17.42 15.40 8 17536 1575 79725269
Hypertension 17.17 15.40 29 17515 330963 79395881
Torticollis 17.10 15.40 9 17535 2378 79724466
Neutropenia 17.06 15.40 23 17521 287687 79439157
Drug level increased 17.05 15.40 31 17513 39620 79687224
Human herpesvirus 6 infection 17.00 15.40 12 17532 5358 79721486
Aphasia 16.96 15.40 34 17510 46698 79680146
Akinesia 16.92 15.40 10 17534 3302 79723542
Tremor 16.76 15.40 78 17466 170005 79556839
Pain 16.68 15.40 89 17455 703713 79023131
Impulse-control disorder 16.55 15.40 8 17536 1766 79725078
Cerebellar atrophy 16.43 15.40 7 17537 1154 79725690
Insomnia 16.36 15.40 101 17443 245069 79481775
Affective disorder 16.32 15.40 14 17530 8305 79718539
Coma 16.31 15.40 54 17490 100595 79626249
Staring 16.23 15.40 9 17535 2636 79724208
Renal tubular acidosis 16.12 15.40 10 17534 3604 79723240
Dyscalculia 16.11 15.40 4 17540 116 79726728
Anaemia 15.76 15.40 48 17496 444967 79281877
Suicide attempt 15.74 15.40 47 17497 82885 79643959
Stoma site extravasation 15.74 15.40 5 17539 360 79726484
Intentional product use issue 15.53 15.40 7 17537 152105 79574739
Dysarthria 15.46 15.40 41 17503 67581 79659263

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC N03AX15 NERVOUS SYSTEM
ANTIEPILEPTICS
ANTIEPILEPTICS
Other antiepileptics
FDA CS M0020790 Sulfonamides
FDA MoA N0000000235 Carbonic Anhydrase Inhibitors
FDA PE N0000008486 Decreased Central Nervous System Disorganized Electrical Activity
MeSH PA D000927 Anticonvulsants
MeSH PA D002121 Calcium Channel Blockers
MeSH PA D000077264 Calcium-Regulating Hormones and Agents
MeSH PA D002317 Cardiovascular Agents
MeSH PA D002491 Central Nervous System Agents
MeSH PA D049990 Membrane Transport Modulators
CHEBI has role CHEBI:22586 antioxidants
CHEBI has role CHEBI:35470 central nervous system agents
CHEBI has role CHEBI:35623 anticonvulsants
CHEBI has role CHEBI:50267 protective agents
CHEBI has role CHEBI:194338 T-type calcium channel blockers
FDA EPC N0000175753 Anti-epileptic Agent
FDA MoA N0000185503 P-Glycoprotein Inhibitors

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

DiseaseRelationSNOMED_IDDOID
Diffuse Lewy body disease indication 80098002
Partial Epilepsy Treatment Adjunct indication
Suicidal thoughts contraindication 6471006
Agranulocytosis contraindication 17182001 DOID:12987
Mood swings contraindication 18963009
Depressive disorder contraindication 35489007
Metabolic acidosis contraindication 59455009
Diarrhea contraindication 62315008
Psychotic disorder contraindication 69322001
Kidney disease contraindication 90708001 DOID:557
Kidney stone contraindication 95570007
Diminished sweating contraindication 111980002
Disease of liver contraindication 235856003 DOID:409
Aplastic anemia contraindication 306058006 DOID:12449
Severe chronic obstructive pulmonary disease contraindication 313299006
Fever contraindication 386661006
Surgical procedure contraindication 387713003




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 10.47 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
100MG/5ML ZONISADE AZURITY N214273 July 15, 2022 RX SUSPENSION ORAL 11478456 Aug. 18, 2038 A METHOD OF TREATING SEIZURES

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Sodium channel protein type 1 subunit alpha Ion channel BLOCKER WOMBAT-PK CHEMBL
Carbonic anhydrase 2 Enzyme Ki 6.99 WOMBAT-PK
Voltage-dependent T-type calcium channel subunit alpha-1G Ion channel WOMBAT-PK
Carbonic anhydrase 1 Enzyme Ki 7.25 WOMBAT-PK
Carbonic anhydrase 4 Enzyme Ki 5.07 CHEMBL
Amine oxidase [flavin-containing] B Enzyme Ki 5.51 CHEMBL
Carbonic anhydrase 9 Enzyme Ki 8.30 WOMBAT-PK
Carbonic anhydrase 12 Enzyme INHIBITOR Ki 4.96 IUPHAR
Carbonic anhydrase 5A, mitochondrial Enzyme Ki 7.70 CHEMBL
Carbonic anhydrase 5B, mitochondrial Enzyme Ki 5.22 CHEMBL
Carbonic anhydrase 7 Enzyme Ki 6.93 CHEMBL
Carbonic anhydrase 6 Enzyme Ki 7.05 CHEMBL
Carbonic anhydrase 14 Enzyme Ki 5.28 CHEMBL
Carbonic anhydrase 13 Enzyme Ki 6.37 CHEMBL
Carbonic anhydrase V Enzyme Ki 7.69 CHEMBL
Carbonic anhydrase Enzyme Ki 6.66 CHEMBL
Amine oxidase [flavin-containing] B Enzyme Ki 5.54 CHEMBL
Carbonic anhydrase 15 Enzyme Ki 6.20 CHEMBL
Carbonic anhydrase Enzyme Ki 6.97 CHEMBL
Carbonic anhydrase Enzyme Ki 7.46 CHEMBL
Probable transmembrane carbonic anhydrase (Carbonate dehydratase) (Carbonic dehydratase); Transmembrane carbonic anhydrase Enzyme Ki 6.68 CHEMBL
Carbonic anhydrase Enzyme Ki 6.94 CHEMBL
Alpha carbonic anhydrase Enzyme Ki 6.59 CHEMBL
Carbonic anhydrase Enzyme Ki 6.19 CHEMBL
Carbonic anhydrase 2 Enzyme Ki 6.01 CHEMBL
Astrosclerin-3 Enzyme Ki 6.78 CHEMBL
Beta-carbonic anhydrase 1 Enzyme Ki 4.54 CHEMBL
Delta carbonic anhydrase Unclassified Ki 6.39 CHEMBL
Carbonic anhydrase 2 Enzyme Ki 6.06 CHEMBL
Carbonic anhydrase 3 Enzyme Ki 5.07 CHEMBL
Amine oxidase [flavin-containing] Enzyme Ki 4.51 CHEMBL
Carbonic anhydrase Enzyme Ki 6.58 CHEMBL
Carbonic anhydrase, alpha family Unclassified Ki 6.39 CHEMBL
Carbonate dehydratase Enzyme Ki 6.85 CHEMBL
Amine oxidase [flavin-containing] B Enzyme IC50 4.61 CHEMBL

External reference:

IDSource
4021224 VUID
N0000148668 NUI
D00538 KEGG_DRUG
4021224 VANDF
C0078844 UMLSCUI
CHEBI:10127 CHEBI
ZON PDB_CHEM_ID
CHEMBL750 ChEMBL_ID
DB00909 DRUGBANK_ID
D000078305 MESH_DESCRIPTOR_UI
5734 PUBCHEM_CID
7047 IUPHAR_LIGAND_ID
5575 INN_ID
459384H98V UNII
261708 RXNORM
31898 MMSL
73622 MMSL
8781 MMSL
d04527 MMSL
008137 NDDF
125693002 SNOMEDCT_US
398762003 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
zonisamide HUMAN PRESCRIPTION DRUG LABEL 1 0615-8266 CAPSULE 100 mg ORAL ANDA 23 sections
zonisamide HUMAN PRESCRIPTION DRUG LABEL 1 0615-8266 CAPSULE 100 mg ORAL ANDA 23 sections
ZONISAMIDE HUMAN PRESCRIPTION DRUG LABEL 1 16590-539 CAPSULE 100 mg ORAL ANDA 16 sections
ZONISAMIDE HUMAN PRESCRIPTION DRUG LABEL 1 16590-724 CAPSULE 25 mg ORAL ANDA 13 sections
ZONISAMIDE HUMAN PRESCRIPTION DRUG LABEL 1 21695-155 CAPSULE 100 mg ORAL ANDA 28 sections
ZONISAMIDE HUMAN PRESCRIPTION DRUG LABEL 1 21695-654 CAPSULE 50 mg ORAL ANDA 28 sections
Zonisamide HUMAN PRESCRIPTION DRUG LABEL 1 29300-428 CAPSULE 25 mg ORAL ANDA 12 sections
Zonisamide HUMAN PRESCRIPTION DRUG LABEL 1 29300-428 CAPSULE 25 mg ORAL ANDA 12 sections
Zonisamide HUMAN PRESCRIPTION DRUG LABEL 1 29300-429 CAPSULE 50 mg ORAL ANDA 12 sections
Zonisamide HUMAN PRESCRIPTION DRUG LABEL 1 29300-429 CAPSULE 50 mg ORAL ANDA 12 sections
Zonisamide HUMAN PRESCRIPTION DRUG LABEL 1 29300-430 CAPSULE 100 mg ORAL ANDA 12 sections
Zonisamide HUMAN PRESCRIPTION DRUG LABEL 1 29300-430 CAPSULE 100 mg ORAL ANDA 12 sections
Zonisamide HUMAN PRESCRIPTION DRUG LABEL 1 31722-228 CAPSULE 100 mg ORAL ANDA 25 sections
ZONISAMIDE HUMAN PRESCRIPTION DRUG LABEL 1 33261-843 CAPSULE 100 mg ORAL ANDA 13 sections
ZONISAMIDE HUMAN PRESCRIPTION DRUG LABEL 1 35356-143 CAPSULE 100 mg ORAL ANDA 16 sections
ZONISAMIDE HUMAN PRESCRIPTION DRUG LABEL 1 35356-143 CAPSULE 100 mg ORAL ANDA 16 sections
Zonisamide HUMAN PRESCRIPTION DRUG LABEL 1 43063-932 CAPSULE 25 mg ORAL ANDA 22 sections
Zonisamide HUMAN PRESCRIPTION DRUG LABEL 1 50268-816 CAPSULE 100 mg ORAL ANDA 26 sections
Zonisamide HUMAN PRESCRIPTION DRUG LABEL 1 51407-137 CAPSULE 25 mg ORAL ANDA 22 sections
Zonisamide HUMAN PRESCRIPTION DRUG LABEL 1 51407-137 CAPSULE 25 mg ORAL ANDA 22 sections
Zonisamide HUMAN PRESCRIPTION DRUG LABEL 1 51407-138 CAPSULE 50 mg ORAL ANDA 22 sections
Zonisamide HUMAN PRESCRIPTION DRUG LABEL 1 51407-138 CAPSULE 50 mg ORAL ANDA 22 sections
Zonisamide HUMAN PRESCRIPTION DRUG LABEL 1 51407-139 CAPSULE 100 mg ORAL ANDA 22 sections
Zonisamide HUMAN PRESCRIPTION DRUG LABEL 1 51407-139 CAPSULE 100 mg ORAL ANDA 22 sections
ZONISADE HUMAN PRESCRIPTION DRUG LABEL 1 52652-8001 SUSPENSION 100 mg ORAL NDA 30 sections
ZONISADE HUMAN PRESCRIPTION DRUG LABEL 1 52652-8001 SUSPENSION 100 mg ORAL NDA 30 sections
zonisamide HUMAN PRESCRIPTION DRUG LABEL 1 53217-301 CAPSULE 100 mg ORAL ANDA 24 sections
Zonisamide HUMAN PRESCRIPTION DRUG LABEL 1 54868-5789 CAPSULE 100 mg ORAL ANDA 14 sections
Zonisamide HUMAN PRESCRIPTION DRUG LABEL 1 54868-6221 CAPSULE 50 mg ORAL ANDA 14 sections
ZONISAMIDE HUMAN PRESCRIPTION DRUG LABEL 1 55648-945 CAPSULE 25 mg ORAL ANDA 13 sections