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

Stem definitionDrug idCAS RN
antiepileptics, hydantoin derivatives 2152 57-41-0

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • fenitoin
  • sodium diphenylhydantoinate
  • phenytoin
  • diphantoin
  • diphenylan
  • diphenylhydantoin
  • phenytoine
  • phenytoinum
  • phenytoin sodium
An anticonvulsant that is used to treat a wide variety of seizures. It is also an anti-arrhythmic and a muscle relaxant. The mechanism of therapeutic action is not clear, although several cellular actions have been described including effects on ion channels, active transport, and general membrane stabilization. The mechanism of its muscle relaxant effect appears to involve a reduction in the sensitivity of muscle spindles to stretch. Phenytoin has been proposed for several other therapeutic uses, but its use has been limited by its many adverse effects and interactions with other drugs.
  • Molecular weight: 252.27
  • Formula: C15H12N2O2
  • CLOGP: 2.08
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 2
  • TPSA: 58.20
  • ALOGS: -3.55
  • ROTB: 2

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
0.30 g O
0.30 g P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.02 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 2 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 19.82 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 90 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.43 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 0.37 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.13 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 16.80 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Jan. 6, 1953 FDA PARKE DAVIS

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 1980.20 11.50 1192 37909 116682 50449341
Anticonvulsant drug level increased 647.70 11.50 161 38940 1223 50564800
Status epilepticus 537.94 11.50 244 38857 13162 50552861
Toxicity to various agents 493.21 11.50 707 38394 211792 50354231
Drug reaction with eosinophilia and systemic symptoms 481.24 11.50 290 38811 28134 50537889
Ataxia 457.35 11.50 220 38881 13566 50552457
Anticonvulsant drug level decreased 448.10 11.50 116 38985 1055 50564968
Generalised tonic-clonic seizure 431.39 11.50 263 38838 26047 50539976
Nystagmus 345.30 11.50 138 38963 5423 50560600
Drug interaction 344.79 11.50 580 38521 199041 50366982
Anticonvulsant drug level below therapeutic 337.90 11.50 81 39020 518 50565505
Stevens-Johnson syndrome 307.59 11.50 198 38903 21554 50544469
Product complaint 255.50 11.50 140 38961 11326 50554697
Drug hypersensitivity 252.33 11.50 581 38520 250429 50315594
Anticonvulsant drug level above therapeutic 251.70 11.50 62 39039 451 50565572
Epilepsy 244.13 11.50 171 38930 21396 50544627
Multiple-drug resistance 236.59 11.50 91 39010 3223 50562800
Purple glove syndrome 213.31 11.50 46 39055 167 50565856
Drug level decreased 194.86 11.50 97 39004 6436 50559587
Cerebellar atrophy 170.18 11.50 48 39053 619 50565404
Toxic epidermal necrolysis 148.68 11.50 126 38975 20866 50545157
Partial seizures 126.93 11.50 66 39035 4799 50561224
Drug level increased 125.00 11.50 110 38991 19158 50546865
Arthralgia 114.00 11.50 103 38998 438599 50127424
Electroencephalogram abnormal 107.45 11.50 53 39048 3446 50562577
Anticonvulsant drug level abnormal 106.27 11.50 20 39081 27 50565996
Drug level changed 100.99 11.50 24 39077 147 50565876
Alopecia 100.77 11.50 32 39069 245015 50321008
Joint swelling 99.16 11.50 33 39068 245253 50320770
Diarrhoea 98.93 11.50 191 38910 588285 49977738
Pain 98.09 11.50 187 38914 578716 49987307
Gingival hypertrophy 95.16 11.50 37 39064 1349 50564674
Arthropathy 89.71 11.50 9 39092 157897 50408126
Focal dyscognitive seizures 88.74 11.50 43 39058 2689 50563334
Drug level below therapeutic 87.00 11.50 47 39054 3693 50562330
Rash maculo-papular 86.76 11.50 105 38996 26536 50539487
Dysarthria 84.16 11.50 123 38978 37280 50528743
Diplopia 83.35 11.50 88 39013 19172 50546851
Fatigue 82.33 11.50 277 38824 707324 49858699
Dyspnoea 80.90 11.50 191 38910 547417 50018606
Pemphigus 76.37 11.50 4 39097 120162 50445861
Contraindicated product administered 73.88 11.50 13 39088 148945 50417078
Erythema multiforme 73.86 11.50 59 39042 8991 50557032
Drug level fluctuating 72.87 11.50 22 39079 365 50565658
Abdominal discomfort 72.08 11.50 45 39056 231596 50334427
Intra-abdominal pressure increased 70.87 11.50 19 39082 200 50565823
Infusion related reaction 69.91 11.50 22 39079 169535 50396488
Encephalopathy 67.50 11.50 105 38996 33606 50532417
Coma 66.27 11.50 140 38961 56739 50509284
Sinusitis 65.37 11.50 25 39076 170533 50395490
Renal ischaemia 64.04 11.50 22 39079 560 50565463
Drug resistance 63.72 11.50 76 39025 18913 50547110
Pneumatosis 62.24 11.50 20 39081 411 50565612
Rheumatoid arthritis 62.11 11.50 40 39061 202510 50363513
Discomfort 62.00 11.50 6 39095 108374 50457649
Diabetes insipidus 61.46 11.50 32 39069 2332 50563691
Peripheral swelling 58.73 11.50 44 39057 205892 50360131
Product substitution issue 58.65 11.50 63 39038 13994 50552029
Drug ineffective for unapproved indication 58.37 11.50 77 39024 21204 50544819
Glossodynia 57.48 11.50 10 39091 115559 50450464
Mental status changes 56.57 11.50 101 39000 36171 50529852
Dyskinesia 56.09 11.50 87 39014 27774 50538249
Porphyria acute 55.52 11.50 19 39082 478 50565545
Cerebellar ataxia 55.22 11.50 22 39079 856 50565167
Wound 55.22 11.50 8 39093 105786 50460237
Brain oedema 54.37 11.50 57 39044 12313 50553710
Necrosis ischaemic 53.69 11.50 21 39080 778 50565245
Systemic lupus erythematosus 53.24 11.50 21 39080 140601 50425422
PO2 increased 53.11 11.50 21 39080 801 50565222
Injection site pain 50.25 11.50 12 39089 111012 50455011
PCO2 increased 49.63 11.50 22 39079 1121 50564902
Drug intolerance 49.32 11.50 58 39043 219046 50346977
Balance disorder 47.56 11.50 141 38960 70449 50495574
Coordination abnormal 46.90 11.50 51 39050 11483 50554540
Aura 46.28 11.50 20 39081 958 50565065
Choreoathetosis 45.93 11.50 16 39085 425 50565598
Bradycardia neonatal 45.68 11.50 19 39082 827 50565196
Somnolence 45.40 11.50 238 38863 154747 50411276
Neurodegenerative disorder 43.88 11.50 14 39087 281 50565742
Respiratory disorder neonatal 43.73 11.50 19 39082 922 50565101
Pericarditis 43.35 11.50 5 39096 78684 50487339
Nasopharyngitis 42.43 11.50 52 39049 192875 50373148
Hepatitis 42.07 11.50 82 39019 31371 50534652
Nervous system disorder 41.89 11.50 57 39044 16166 50549857
Eosinophilia 41.45 11.50 61 39040 18591 50547432
Weight gain poor 40.66 11.50 17 39084 750 50565273
Multiple organ dysfunction syndrome 40.24 11.50 107 38994 50230 50515793
Lower respiratory tract infection 39.85 11.50 12 39089 95189 50470834
Stupor 39.57 11.50 28 39073 3555 50562468
Pain in extremity 39.48 11.50 96 39005 272769 50293254
Petit mal epilepsy 39.35 11.50 27 39074 3262 50562761
Nausea 39.18 11.50 353 38748 705045 49860978
Hyperammonaemia 38.98 11.50 31 39070 4693 50561330
Blood bicarbonate decreased 38.97 11.50 25 39076 2700 50563323
Cytomegalovirus hepatitis 38.88 11.50 13 39088 304 50565719
Blood pH decreased 38.81 11.50 24 39077 2431 50563592
Brain herniation 38.46 11.50 26 39075 3066 50562957
Encephalitis autoimmune 38.46 11.50 19 39082 1239 50564784
Foetal anticonvulsant syndrome 38.31 11.50 15 39086 557 50565466
Respiratory acidosis 38.26 11.50 34 39067 5994 50560029
Selective eating disorder 37.06 11.50 21 39080 1811 50564212
Neurotoxicity 36.87 11.50 51 39050 14689 50551334
Angiofibroma 36.82 11.50 10 39091 111 50565912
Foetal death 36.50 11.50 38 39063 8142 50557881
Medication error 35.43 11.50 83 39018 36021 50530002
Aggression 34.47 11.50 60 39041 21056 50544967
Acute hepatic failure 34.45 11.50 51 39050 15626 50550397
Oxygen saturation abnormal 34.28 11.50 23 39078 2679 50563344
Ultrasound ovary abnormal 34.26 11.50 9 39092 87 50565936
Drug ineffective 33.84 11.50 849 38252 818484 49747539
Cardiac arrest neonatal 33.81 11.50 9 39092 92 50565931
Lymphangioleiomyomatosis 33.69 11.50 10 39091 156 50565867
Product dose omission issue 33.09 11.50 57 39044 183781 50382242
Speech disorder 31.96 11.50 79 39022 35469 50530554
Haemophagocytic lymphohistiocytosis 31.37 11.50 36 39065 8597 50557426
Cerebral atrophy 31.30 11.50 27 39074 4574 50561449
Aplasia pure red cell 31.28 11.50 26 39075 4189 50561834
Intestinal ischaemia 31.25 11.50 32 39069 6725 50559298
Therapeutic response unexpected 31.06 11.50 49 39052 15866 50550157
Angiomyolipoma 30.87 11.50 10 39091 211 50565812
Drug level above therapeutic 30.80 11.50 25 39076 3895 50562128
Lethargy 30.72 11.50 96 39005 49336 50516687
Brain injury 30.61 11.50 30 39071 5984 50560039
Swelling 30.37 11.50 69 39032 200803 50365220
Anti-erythropoietin antibody negative 29.20 11.50 8 39093 92 50565931
Porphyria 29.18 11.50 9 39092 161 50565862
Irritable bowel syndrome 29.01 11.50 3 39098 51438 50514585
Urine copper increased 27.90 11.50 5 39096 4 50566019
Depressed level of consciousness 27.89 11.50 96 39005 51857 50514166
Propofol infusion syndrome 27.76 11.50 13 39088 753 50565270
Myoclonic epilepsy 27.67 11.50 14 39087 961 50565062
Unresponsive to stimuli 27.49 11.50 68 39033 30541 50535482
Urine delta aminolevulinate increased 27.37 11.50 5 39096 5 50566018
Laryngeal stenosis 27.27 11.50 13 39088 784 50565239
Blood alkaline phosphatase increased 27.23 11.50 77 39024 37449 50528574
Overdose 27.04 11.50 150 38951 99577 50466446
Musculoskeletal pain 26.94 11.50 11 39090 72166 50493857
Back pain 26.88 11.50 84 39017 219946 50346077
Seizure cluster 26.81 11.50 9 39092 213 50565810
Hypersensitivity 26.39 11.50 82 39019 215079 50350944
Bradyarrhythmia 26.19 11.50 17 39084 1873 50564150
Injection site erythema 25.51 11.50 13 39088 74923 50491100
Ischaemic cerebral infarction 25.46 11.50 14 39087 1139 50564884
Glioblastoma multiforme 25.13 11.50 12 39089 726 50565297
Psoriasis 24.98 11.50 11 39090 68989 50497034
Dermatitis exfoliative 24.96 11.50 25 39076 5117 50560906
Perforation 24.92 11.50 13 39088 951 50565072
Atonic seizures 24.09 11.50 11 39090 601 50565422
Bronchitis 24.03 11.50 27 39074 104132 50461891
Hypotension 23.65 11.50 282 38819 235187 50330836
Psoriatic arthropathy 23.53 11.50 4 39097 47028 50518995
Myoclonus 23.47 11.50 41 39060 14429 50551594
COVID-19 23.27 11.50 4 39097 46658 50519365
Hyperreflexia 23.24 11.50 24 39077 5094 50560929
Abdominal pain upper 23.05 11.50 56 39045 159253 50406770
Autism spectrum disorder 22.64 11.50 11 39090 692 50565331
Lymphadenopathy 22.63 11.50 67 39034 33432 50532591
Plasmodium falciparum infection 22.61 11.50 5 39096 21 50566002
Loss of consciousness 22.57 11.50 148 38953 104205 50461818
Rash morbilliform 22.05 11.50 18 39083 2828 50563195
Vomiting projectile 22.02 11.50 13 39088 1211 50564812
Confusional state 22 11.50 230 38871 185698 50380325
Euthyroid sick syndrome 21.98 11.50 6 39095 68 50565955
Asthma 21.90 11.50 22 39079 89315 50476708
Oropharyngeal oedema 21.80 11.50 8 39093 248 50565775
Malabsorption 21.74 11.50 20 39081 3686 50562337
Disease recurrence 21.74 11.50 48 39053 20033 50545990
Systemic inflammatory response syndrome 21.71 11.50 23 39078 5026 50560997
Hypotonia 21.64 11.50 29 39072 8105 50557918
Incoherent 21.34 11.50 21 39080 4209 50561814
Adverse drug reaction 21.29 11.50 8 39093 55214 50510809
Musculoskeletal stiffness 21.19 11.50 42 39059 128439 50437584
Porphyrins stool increased 21.13 11.50 5 39096 30 50565993
Impaired healing 21.06 11.50 14 39087 69772 50496251
Chorea 20.93 11.50 13 39088 1327 50564696
Ophthalmoplegia 20.93 11.50 13 39088 1327 50564696
Tremor 20.77 11.50 156 38945 114747 50451276
Encephalitis 20.69 11.50 27 39074 7353 50558670
Hyperammonaemic encephalopathy 20.65 11.50 15 39086 1984 50564039
Paranoia 20.38 11.50 32 39069 10316 50555707
Areflexia 20.32 11.50 17 39084 2763 50563260
Pyrexia 20.29 11.50 409 38692 379794 50186229
Psychotic disorder 20.16 11.50 49 39052 21763 50544260
Magnetic resonance imaging head abnormal 19.88 11.50 14 39087 1763 50564260
Gamma-glutamyltransferase increased 19.77 11.50 59 39042 29564 50536459
Clonus 19.72 11.50 20 39081 4155 50561868
Blood albumin decreased 19.54 11.50 36 39065 13200 50552823
Arthritis 19.44 11.50 23 39078 86698 50479325
Disorientation 19.42 11.50 66 39035 35418 50530605
Calcinosis 19.16 11.50 14 39087 1868 50564155
Hallucination, tactile 19.07 11.50 7 39094 217 50565806
Herpes zoster 19.05 11.50 16 39085 70770 50495253
Injection site pruritus 19.01 11.50 4 39097 40407 50525616
Abdominal pain 19.00 11.50 106 38995 236122 50329901
Malaise 18.92 11.50 167 38934 335365 50230658
Gait disturbance 18.90 11.50 188 38913 149817 50416206
Mucosal erosion 18.88 11.50 12 39089 1275 50564748
Neonatal seizure 18.69 11.50 8 39093 374 50565649
Left ventricular dysfunction 18.66 11.50 31 39070 10475 50555548
Rasmussen encephalitis 18.50 11.50 3 39098 0 50566023
Cerebellar cognitive affective syndrome 18.50 11.50 3 39098 0 50566023
Hemiparesis 18.49 11.50 45 39056 20003 50546020
Aphasia 18.31 11.50 56 39045 28438 50537585
Creutzfeldt-Jakob disease 18.00 11.50 6 39095 139 50565884
Injection site swelling 17.96 11.50 5 39096 41768 50524255
Torticollis 17.87 11.50 13 39088 1723 50564300
Chronic graft versus host disease 17.85 11.50 16 39085 2851 50563172
Cardiac arrest 17.70 11.50 118 38983 83533 50482490
Ammonia increased 17.67 11.50 19 39082 4222 50561801
Cognitive disorder 17.46 11.50 74 39027 44049 50521974
Left ventricular hypertrophy 17.26 11.50 20 39081 4825 50561198
Ventricular dysfunction 17.06 11.50 15 39086 2606 50563417
General physical health deterioration 16.94 11.50 55 39046 142379 50423644
Cough 16.92 11.50 113 38988 241151 50324872
Intensive care unit acquired weakness 16.88 11.50 9 39092 688 50565335
Hallucination, auditory 16.88 11.50 30 39071 10698 50555325
Enterocolitis 16.84 11.50 23 39078 6544 50559479
Illusion 16.77 11.50 10 39091 949 50565074
Hepatic failure 16.75 11.50 59 39042 32224 50533799
Linear IgA disease 16.69 11.50 11 39090 1243 50564780
Therapeutic product effect decreased 16.56 11.50 52 39049 135998 50430025
Cross sensitivity reaction 16.41 11.50 13 39088 1956 50564067
Palpitations 16.36 11.50 30 39071 94476 50471547
Brain operation 16.29 11.50 8 39093 515 50565508
Idiopathic pneumonia syndrome 16.24 11.50 7 39094 333 50565690
Product use issue 16.24 11.50 60 39041 149415 50416608
Blood magnesium decreased 16.03 11.50 30 39071 11130 50554893
Dry mouth 15.99 11.50 12 39089 56166 50509857
Product formulation issue 15.98 11.50 8 39093 537 50565486
Abnormal behaviour 15.92 11.50 42 39059 19616 50546407
Brain neoplasm 15.89 11.50 17 39084 3756 50562267
Rash erythematous 15.82 11.50 61 39040 34791 50531232
Intention tremor 15.78 11.50 7 39094 357 50565666
Agitation 15.61 11.50 82 39019 53302 50512721
Chest pain 15.54 11.50 77 39024 176805 50389218
Fluid retention 15.50 11.50 10 39091 50639 50515384
Lip erosion 15.48 11.50 9 39092 815 50565208
Weight increased 15.47 11.50 92 39009 201799 50364224
Aplastic anaemia 15.42 11.50 24 39077 7679 50558344
Epileptic psychosis 15.29 11.50 4 39097 38 50565985
Intestinal dilatation 15.13 11.50 11 39090 1457 50564566
Periorbital oedema 15.10 11.50 19 39082 4993 50561030
Intensive care unit delirium 15.02 11.50 4 39097 41 50565982
Tongue ulceration 15.00 11.50 15 39086 3065 50562958
Influenza 14.99 11.50 29 39072 89509 50476514
Coagulation time prolonged 14.96 11.50 10 39091 1158 50564865
CSF oligoclonal band present 14.79 11.50 5 39096 121 50565902
Asterixis 14.78 11.50 10 39091 1181 50564842
Chest discomfort 14.70 11.50 31 39070 92691 50473332
Osteoarthritis 14.53 11.50 19 39082 68587 50497436
Oromandibular dystonia 14.51 11.50 7 39094 433 50565590
Dyspnoea exertional 14.51 11.50 11 39090 51222 50514801
Anaemia 14.50 11.50 125 38976 252331 50313692
Mental impairment 14.43 11.50 30 39071 12014 50554009
Stomatitis 14.35 11.50 36 39065 101308 50464715
Posterior reversible encephalopathy syndrome 14.30 11.50 34 39067 14894 50551129
Epileptic encephalopathy 14.24 11.50 6 39095 270 50565753
Hospitalisation 14.20 11.50 19 39082 67918 50498105
Thrombocytopenia 14.18 11.50 156 38945 127517 50438506
Allodynia 14.18 11.50 8 39093 684 50565339
Central nervous system infection 14.17 11.50 8 39093 685 50565338
Cerebellar syndrome 14.09 11.50 15 39086 3296 50562727
Potentiating drug interaction 14.01 11.50 16 39085 3800 50562223
Hirsutism 13.85 11.50 9 39092 994 50565029
Joint contracture 13.78 11.50 11 39090 1673 50564350
Enzyme induction 13.75 11.50 4 39097 58 50565965
Biopsy brain 13.68 11.50 3 39098 12 50566011
Hypoventilation 13.66 11.50 16 39085 3905 50562118
C-reactive protein increased 13.48 11.50 19 39082 66455 50499568
Lactose intolerance 13.41 11.50 13 39088 2557 50563466
Impaired self-care 13.41 11.50 11 39090 1740 50564283
Cachexia 13.36 11.50 17 39084 4516 50561507
Type 2 diabetes mellitus 13.22 11.50 5 39096 34370 50531653
Treatment failure 13.21 11.50 58 39043 137579 50428444
Epileptic aura 13.21 11.50 4 39097 67 50565956
Altered state of consciousness 13.10 11.50 42 39059 21868 50544155
Injection site bruising 13.09 11.50 6 39095 36762 50529261
Reflexes abnormal 13.07 11.50 7 39094 540 50565483
Liver function test abnormal 12.89 11.50 68 39033 44271 50521752
Staring 12.87 11.50 10 39091 1464 50564559
Febrile neutropenia 12.84 11.50 36 39065 97631 50468392
Infrequent bowel movements 12.81 11.50 9 39092 1129 50564894
Laryngeal pain 12.78 11.50 16 39085 4183 50561840
Vitamin B6 deficiency 12.74 11.50 4 39097 76 50565947
Extensor plantar response 12.70 11.50 9 39092 1145 50564878
Movement disorder 12.61 11.50 36 39065 17596 50548427
Catatonia 12.61 11.50 15 39086 3721 50562302
Amnesia 12.42 11.50 65 39036 42195 50523828
Face oedema 12.35 11.50 36 39065 17803 50548220
Fibromyalgia 12.30 11.50 10 39091 44968 50521055
Memory impairment 12.29 11.50 104 38997 79256 50486767
Insomnia 12.20 11.50 82 39019 174783 50391240
Toxic encephalopathy 12.20 11.50 18 39083 5497 50560526
Post-traumatic epilepsy 12.16 11.50 3 39098 22 50566001
Apallic syndrome 12.12 11.50 7 39094 626 50565397
Incontinence 12.11 11.50 25 39076 9960 50556063
Drug level abnormal 12.07 11.50 4 39097 91 50565932
Dehydration 11.92 11.50 69 39032 152380 50413643
Postictal state 11.84 11.50 8 39093 942 50565081
Cardiomegaly 11.84 11.50 33 39068 15912 50550111
Pyroglutamate increased 11.83 11.50 6 39095 414 50565609
Productive cough 11.78 11.50 14 39087 52680 50513343
Hypersensitivity vasculitis 11.74 11.50 15 39086 4000 50562023
Alanine aminotransferase increased 11.74 11.50 112 38989 88247 50477776
Dose calculation error 11.71 11.50 4 39097 100 50565923
Product dispensing error 11.67 11.50 23 39078 8868 50557155
Methylobacterium infection 11.61 11.50 3 39098 27 50565996
Tachycardia 11.59 11.50 123 38978 99640 50466383

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 1852.86 12.54 1243 35139 91880 29446265
Anticonvulsant drug level increased 692.52 12.54 189 36193 1277 29536868
Nystagmus 635.60 12.54 228 36154 4081 29534064
Status epilepticus 631.01 12.54 294 36088 10500 29527645
Toxicity to various agents 530.55 12.54 841 35541 172820 29365325
Anticonvulsant drug level decreased 517.00 12.54 139 36243 880 29537265
Ataxia 502.20 12.54 261 36121 11842 29526303
Drug reaction with eosinophilia and systemic symptoms 497.41 12.54 350 36032 27642 29510503
Anticonvulsant drug level above therapeutic 421.06 12.54 105 36277 469 29537676
Generalised tonic-clonic seizure 316.06 12.54 229 36153 18910 29519235
Anticonvulsant drug level below therapeutic 273.60 12.54 76 36306 552 29537593
Product complaint 251.51 12.54 126 36256 5279 29532866
Drug interaction 236.14 12.54 651 35731 196734 29341411
Drug level decreased 209.43 12.54 117 36265 6130 29532015
Stevens-Johnson syndrome 205.57 12.54 167 36215 16330 29521815
Cerebellar atrophy 171.75 12.54 50 36332 438 29537707
Epilepsy 158.20 12.54 151 36231 18281 29519864
Partial seizures 147.12 12.54 79 36303 3824 29534321
Diarrhoea 131.27 12.54 130 36252 332568 29205577
Multiple-drug resistance 122.48 12.54 70 36312 3830 29534315
Drug level below therapeutic 113.99 12.54 69 36313 4202 29533943
Purple glove syndrome 113.36 12.54 24 36358 40 29538105
Drug level fluctuating 112.07 12.54 36 36346 451 29537694
Drug hypersensitivity 111.15 12.54 254 36128 68152 29469993
Dysarthria 111.03 12.54 162 36220 30749 29507396
Drug level increased 102.56 12.54 121 36261 18666 29519479
Drug ineffective 101.29 12.54 777 35605 362393 29175752
Dyspnoea 101.05 12.54 154 36228 326578 29211567
Coordination abnormal 99.26 12.54 77 36305 7037 29531108
Gingival hypertrophy 89.97 12.54 43 36339 1622 29536523
Hyperammonaemia 87.18 12.54 65 36317 5598 29532547
Sudden unexplained death in epilepsy 85.99 12.54 29 36353 427 29537718
Drug level above therapeutic 84.55 12.54 52 36330 3258 29534887
Drug level changed 82.03 12.54 26 36356 311 29537834
Mental status changes 80.66 12.54 150 36232 34777 29503368
Confusional state 76.74 12.54 336 36046 127541 29410604
Drug resistance 76.04 12.54 112 36270 21428 29516717
Gait disturbance 72.91 12.54 227 36155 73122 29465023
Anaemia 70.76 12.54 86 36296 200865 29337280
Arthralgia 66.70 12.54 45 36337 139572 29398573
Somnolence 65.03 12.54 258 36124 93697 29444448
Acute kidney injury 62.54 12.54 147 36235 265120 29273025
Rash maculo-papular 60.74 12.54 108 36274 24181 29513964
Brain oedema 60.63 12.54 75 36307 12145 29526000
Anticonvulsant drug level abnormal 59.88 12.54 13 36369 26 29538119
Sedation 57.85 12.54 88 36294 17317 29520828
Cerebellar syndrome 57.54 12.54 34 36348 1980 29536165
Product substitution issue 56.67 12.54 63 36319 9109 29529036
Lethargy 56.01 12.54 135 36247 37445 29500700
Febrile neutropenia 53.83 12.54 36 36346 112204 29425941
Depressed level of consciousness 53.23 12.54 131 36251 36811 29501334
Intensive care unit acquired weakness 52.93 12.54 25 36357 918 29537227
Toxic epidermal necrolysis 51.00 12.54 85 36297 18068 29520077
Foetal anticonvulsant syndrome 50.82 12.54 26 36356 1138 29537007
Balance disorder 50.79 12.54 127 36255 36043 29502102
Death 47.07 12.54 239 36143 341845 29196300
Fatigue 46.68 12.54 216 36166 316605 29221540
Therapeutic response unexpected 46.07 12.54 55 36327 8583 29529562
Cough 45.86 12.54 53 36329 126674 29411471
Pneumonia 45.58 12.54 221 36161 319951 29218194
Urine copper increased 45.09 12.54 9 36373 9 29538136
Stupor 43.36 12.54 32 36350 2712 29535433
Fall 43.02 12.54 368 36014 176810 29361335
Gaze palsy 42.63 12.54 24 36358 1275 29536870
Petit mal epilepsy 41.35 12.54 31 36351 2691 29535454
Joint swelling 41.18 12.54 6 36376 49624 29488521
Cerebellar ataxia 40.84 12.54 21 36361 929 29537216
Focal dyscognitive seizures 40.83 12.54 23 36359 1223 29536922
Aura 39.82 12.54 15 36367 309 29537836
Cross sensitivity reaction 37.88 12.54 22 36360 1240 29536905
Barbiturates positive 36.75 12.54 7 36375 4 29538141
Choreoathetosis 36.64 12.54 20 36362 1000 29537145
Cerebral atrophy 36.13 12.54 34 36348 4038 29534107
Asterixis 35.31 12.54 20 36362 1075 29537070
Myalgia 35.12 12.54 24 36358 73995 29464150
Glioblastoma multiforme 35.11 12.54 17 36365 660 29537485
Porphyrins stool increased 35.07 12.54 7 36375 7 29538138
Simple partial seizures 34.91 12.54 13 36369 259 29537886
Cardiac failure 34.66 12.54 28 36354 79259 29458886
Interstitial lung disease 34.32 12.54 14 36368 57704 29480441
Chest pain 34.22 12.54 53 36329 111920 29426225
Pain 33.53 12.54 104 36278 171328 29366817
Hyperammonaemic encephalopathy 33.24 12.54 24 36358 1966 29536179
Diabetes insipidus 33.20 12.54 26 36356 2408 29535737
Blood homocysteine increased 33.05 12.54 12 36370 222 29537923
Necrosis ischaemic 32.85 12.54 12 36370 226 29537919
Hypotonia 32.06 12.54 41 36341 6861 29531284
Excessive eye blinking 31.78 12.54 14 36368 436 29537709
Agitation 31.60 12.54 136 36246 51168 29486977
Nervous system disorder 31.22 12.54 56 36326 12618 29525527
Extensor plantar response 31.01 12.54 15 36367 581 29537564
Acidosis hyperchloraemic 31 12.54 13 36369 358 29537787
Coagulopathy 30.70 12.54 68 36314 17839 29520306
Past-pointing 30.49 12.54 7 36375 20 29538125
Dysmetria 30.00 12.54 13 36369 389 29537756
Erythema multiforme 29.97 12.54 42 36340 7675 29530470
Inhibitory drug interaction 29.88 12.54 20 36362 1450 29536695
Overdose 29.85 12.54 184 36198 79635 29458510
Encephalopathy 29.81 12.54 95 36287 30948 29507197
Back pain 29.76 12.54 50 36332 102234 29435911
Hypoplastic left heart syndrome 29.60 12.54 11 36371 218 29537927
Hippocampal sclerosis 29.58 12.54 9 36373 93 29538052
Idiosyncratic drug reaction 29.27 12.54 13 36369 413 29537732
Postictal paralysis 28.96 12.54 11 36371 232 29537913
Unresponsive to stimuli 28.95 12.54 82 36300 25044 29513101
Dyskinesia 28.74 12.54 71 36311 19990 29518155
COVID-19 28.42 12.54 5 36377 36009 29502136
Hyperreflexia 28.22 12.54 25 36357 2747 29535398
Blood albumin decreased 27.95 12.54 51 36331 11644 29526501
Atrial fibrillation 27.75 12.54 55 36327 105591 29432554
Nausea 27.48 12.54 226 36156 289029 29249116
Myocardial infarction 26.80 12.54 60 36322 110236 29427909
Constipation 26.22 12.54 64 36318 114096 29424049
Intention tremor 25.80 12.54 11 36371 316 29537829
Malaise 25.74 12.54 105 36277 159497 29378648
Ophthalmoplegia 25.20 12.54 19 36363 1663 29536482
Dystonia 25.20 12.54 44 36338 9705 29528440
Abdominal pain 25.13 12.54 84 36298 135273 29402872
Dehydration 24.31 12.54 67 36315 114681 29423464
Atonic seizures 24.19 12.54 9 36373 179 29537966
Drug withdrawal convulsions 24.09 12.54 16 36366 1145 29537000
Aggression 24.06 12.54 97 36285 35444 29502701
Haemoglobin decreased 23.92 12.54 62 36320 108313 29429832
Oedema peripheral 23.82 12.54 58 36324 103499 29434646
Neonatal respiratory depression 23.36 12.54 11 36371 401 29537744
Autonomic nervous system imbalance 23.34 12.54 21 36361 2355 29535790
Hyperchloraemia 23.08 12.54 11 36371 412 29537733
Pain in extremity 23.01 12.54 65 36317 110368 29427777
Hepatitis fulminant 22.87 12.54 25 36357 3546 29534599
Cognitive disorder 22.64 12.54 72 36310 23427 29514718
Hemiparesis 22.61 12.54 53 36329 14433 29523712
Injection site pain 22.56 12.54 6 36376 32440 29505705
Intestinal ischaemia 22.46 12.54 34 36348 6658 29531487
Gingival disorder 22.39 12.54 16 36366 1290 29536855
Gamma-glutamyltransferase increased 22.27 12.54 78 36304 26659 29511486
Encephalomalacia 22.27 12.54 13 36369 740 29537405
Muscle twitching 21.76 12.54 37 36345 7989 29530156
Speech disorder 21.70 12.54 71 36311 23445 29514700
Completed suicide 21.60 12.54 187 36195 90059 29448086
Aphasia 21.48 12.54 62 36320 19136 29519009
Eosinophilia 21.44 12.54 68 36314 22093 29516052
Gingival atrophy 21.20 12.54 6 36376 47 29538098
Postictal psychosis 21.14 12.54 8 36374 167 29537978
Macule 21.08 12.54 14 36368 1002 29537143
Blood ketone body increased 21.05 12.54 10 36372 372 29537773
Cerebral palsy 21.01 12.54 7 36375 99 29538046
Mucosal erosion 20.64 12.54 12 36370 678 29537467
Asthma 20.46 12.54 8 36374 33841 29504304
Mucosal ulceration 20.29 12.54 13 36369 875 29537270
Superinfection 20.28 12.54 18 36364 1983 29536162
Urine delta aminolevulinate increased 20.04 12.54 4 36378 4 29538141
Obliterative bronchiolitis 19.89 12.54 14 36368 1102 29537043
Postictal state 19.86 12.54 12 36370 728 29537417
Porphyria acute 19.76 12.54 8 36374 201 29537944
Tonic convulsion 19.66 12.54 13 36369 923 29537222
Treatment noncompliance 19.60 12.54 70 36312 24157 29513988
Hyperkinesia 19.51 12.54 16 36366 1583 29536562
Cytokine storm 19.17 12.54 11 36371 606 29537539
Brain herniation 19.15 12.54 23 36359 3610 29534535
Chest discomfort 19.15 12.54 17 36365 45966 29492179
Cardiac failure congestive 19.14 12.54 41 36341 76540 29461605
General physical health deterioration 18.96 12.54 64 36318 102793 29435352
Posture abnormal 18.71 12.54 17 36365 1930 29536215
Malabsorption 18.71 12.54 17 36365 1931 29536214
Ascites 18.56 12.54 11 36371 36608 29501537
Infusion related reaction 18.55 12.54 16 36366 43870 29494275
Product dose omission issue 18.44 12.54 59 36323 96324 29441821
Dysstasia 18.21 12.54 40 36342 10434 29527711
Haemophagocytic lymphohistiocytosis 18.13 12.54 40 36342 10464 29527681
Influenza like illness 18.04 12.54 4 36378 24466 29513679
Pneumonitis 18.02 12.54 6 36376 28038 29510107
Vasogenic cerebral oedema 18.01 12.54 10 36372 517 29537628
Blood glucose increased 17.93 12.54 28 36354 58956 29479189
C-reactive protein increased 17.68 12.54 17 36365 44246 29493899
Nephritis allergic 17.46 12.54 9 36373 400 29537745
Decreased appetite 17.45 12.54 106 36276 145236 29392909
Diplopia 17.45 12.54 46 36336 13472 29524673
Impetigo 17.41 12.54 12 36370 913 29537232
Intellectual disability 17.38 12.54 13 36369 1124 29537021
Labelled drug-drug interaction medication error 17.38 12.54 43 36339 12116 29526029
Areflexia 17.15 12.54 19 36363 2735 29535410
Methylenetetrahydrofolate reductase deficiency 17.11 12.54 3 36379 0 29538145
Fluid retention 17.07 12.54 4 36378 23556 29514589
Haematuria traumatic 17.07 12.54 7 36375 182 29537963
Rash morbilliform 16.93 12.54 18 36364 2475 29535670
Hypothermia 16.88 12.54 36 36346 9203 29528942
Acute generalised exanthematous pustulosis 16.84 12.54 27 36355 5556 29532589
Propofol infusion syndrome 16.45 12.54 11 36371 796 29537349
Plasma cell myeloma 16.34 12.54 13 36369 37102 29501043
Chills 16.34 12.54 40 36342 71260 29466885
Melaena 16.32 12.54 9 36373 31167 29506978
Angina pectoris 16.15 12.54 7 36375 27843 29510302
Muscle spasms 16.13 12.54 35 36347 65047 29473098
Lymphocyte morphology abnormal 16.09 12.54 9 36373 472 29537673
Soft tissue swelling 16.07 12.54 8 36374 330 29537815
Neurodegenerative disorder 16.04 12.54 7 36375 213 29537932
Peripheral swelling 16.03 12.54 34 36348 63705 29474440
Pancytopenia 15.84 12.54 51 36331 83117 29455028
Hospitalisation 15.80 12.54 20 36362 45968 29492177
Dyspnoea exertional 15.79 12.54 13 36369 36477 29501668
Ammonia increased 15.74 12.54 22 36360 4009 29534136
Soft tissue haemorrhage 15.65 12.54 6 36376 130 29538015
Weight decreased 15.64 12.54 115 36267 150790 29387355
Pulmonary vasculitis 15.60 12.54 6 36376 131 29538014
Memory impairment 15.51 12.54 87 36295 36383 29501762
Syncope 15.43 12.54 50 36332 81321 29456824
Open angle glaucoma 15.35 12.54 6 36376 137 29538008
Condition aggravated 15.34 12.54 259 36123 146036 29392109
Personality disorder 15.32 12.54 12 36370 1111 29537034
Encephalitis 15.31 12.54 28 36354 6402 29531743
Epistaxis 15.28 12.54 25 36357 51679 29486466
White blood cell count decreased 15.27 12.54 52 36330 83310 29454835
Pulmonary embolism 15.24 12.54 46 36336 76488 29461657
Intracranial pressure increased 15.09 12.54 20 36362 3465 29534680
Unmasking of previously unidentified disease 15.09 12.54 10 36372 713 29537432
Nasopharyngeal reflux 15.03 12.54 3 36379 3 29538142
Arthropathy 14.96 12.54 4 36378 21550 29516595
Hepatic necrosis 14.84 12.54 20 36362 3522 29534623
Neutropenia 14.81 12.54 98 36284 131613 29406532
Gliosis 14.59 12.54 6 36376 157 29537988
Familial periodic paralysis 14.56 12.54 5 36377 78 29538067
Psoriasis 14.55 12.54 11 36371 32216 29505929
Liver function test abnormal 14.36 12.54 72 36310 28846 29509299
Electroencephalogram abnormal 14.35 12.54 16 36366 2319 29535826
Wheezing 14.19 12.54 12 36370 33228 29504917
Abdominal pain upper 14.14 12.54 34 36348 60959 29477186
Coma 14.14 12.54 90 36292 39360 29498785
Learning disorder 14.12 12.54 11 36371 1011 29537134
Retinal vein occlusion 14.04 12.54 13 36369 1512 29536633
Cataract 14.01 12.54 5 36377 22373 29515772
Myoclonus 13.95 12.54 42 36340 13267 29524878
Chemical burn 13.89 12.54 6 36376 178 29537967
Ischaemic hepatitis 13.88 12.54 13 36369 1535 29536610
Haematochezia 13.87 12.54 15 36367 36968 29501177
Mydriasis 13.86 12.54 26 36356 6059 29532086
Open reduction of fracture 13.85 12.54 5 36377 91 29538054
Infantile spasms 13.74 12.54 6 36376 183 29537962
Blood creatinine increased 13.69 12.54 56 36326 85046 29453099
Malignant neoplasm progression 13.58 12.54 46 36336 73813 29464332
Cardiac arrest 13.57 12.54 163 36219 85428 29452717
Platelet count decreased 13.27 12.54 75 36307 104597 29433548
Drug abuse 13.20 12.54 52 36330 79831 29458314
Lymphocytosis 13.16 12.54 14 36368 1926 29536219
Tremor 12.98 12.54 143 36239 73395 29464750
Fibrous dysplasia of bone 12.96 12.54 3 36379 9 29538136
Vitamin B6 decreased 12.96 12.54 3 36379 9 29538136
Lid lag 12.96 12.54 3 36379 9 29538136
Muscle contracture 12.95 12.54 11 36371 1142 29537003
Congenital nail disorder 12.92 12.54 4 36378 44 29538101
Feeling of despair 12.90 12.54 10 36372 912 29537233
Acute myocardial infarction 12.89 12.54 25 36357 48413 29489732
Dermatitis exfoliative 12.87 12.54 26 36356 6399 29531746
Hypoglycaemia 12.82 12.54 25 36357 48321 29489824
Acute hepatic failure 12.79 12.54 38 36344 11914 29526231
Inflammation 12.73 12.54 6 36376 22722 29515423
Eye movement disorder 12.72 12.54 19 36363 3677 29534468

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 2310.61 11.20 1637 61745 165255 64270095
Anticonvulsant drug level increased 1005.91 11.20 268 63114 2109 64433241
Status epilepticus 967.20 11.20 457 62925 21206 64414144
Drug reaction with eosinophilia and systemic symptoms 950.04 11.20 617 62765 53600 64381750
Nystagmus 944.56 11.20 350 63032 8718 64426632
Ataxia 895.17 11.20 436 62946 21648 64413702
Toxicity to various agents 880.89 11.20 1402 61980 362111 64073239
Anticonvulsant drug level decreased 646.54 11.20 179 63203 1651 64433699
Anticonvulsant drug level above therapeutic 600.97 11.20 150 63232 880 64434470
Generalised tonic-clonic seizure 590.72 11.20 409 62973 39448 64395902
Drug interaction 513.20 11.20 1110 62272 360973 64074377
Stevens-Johnson syndrome 446.31 11.20 325 63057 33924 64401426
Anticonvulsant drug level below therapeutic 445.32 11.20 118 63264 906 64434444
Multiple-drug resistance 326.80 11.20 149 63233 6353 64428997
Drug hypersensitivity 321.22 11.20 716 62666 237099 64198251
Epilepsy 312.51 11.20 261 63121 33270 64402080
Purple glove syndrome 303.91 11.20 67 63315 203 64435147
Drug level decreased 286.14 11.20 164 63218 11339 64424011
Cerebellar atrophy 276.49 11.20 82 63300 986 64434364
Partial seizures 250.91 11.20 129 63253 7178 64428172
Diarrhoea 187.52 11.20 263 63119 722441 63712909
Arthralgia 184.19 11.20 103 63279 442157 63993193
Dysarthria 178.16 11.20 254 63128 59152 64376198
Toxic epidermal necrolysis 171.73 11.20 197 63185 36969 64398381
Drug level increased 171.22 11.20 189 63193 34007 64401343
Dyspnoea 170.51 11.20 278 63104 718396 63716954
Gingival hypertrophy 157.37 11.20 69 63313 2678 64432672
Product complaint 150.12 11.20 111 63271 11843 64423507
Rash maculo-papular 145.33 11.20 204 63178 46822 64388528
Hyperammonaemia 135.82 11.20 97 63285 9807 64425543
Joint swelling 135.69 11.20 24 63358 215358 64219992
Anticonvulsant drug level abnormal 122.46 11.20 25 63357 45 64435305
Fatigue 120.28 11.20 359 63023 748371 63686979
Drug ineffective 114.80 11.20 1294 62088 838953 63596397
Mental status changes 114.26 11.20 211 63171 60951 64374399
Coordination abnormal 112.26 11.20 103 63279 14861 64420489
Pain 109.95 11.20 238 63144 553273 63882077
Electroencephalogram abnormal 105.41 11.20 65 63317 5138 64430212
Rheumatoid arthritis 101.95 11.20 19 63363 164275 64271075
Drug level above therapeutic 100.21 11.20 70 63312 6831 64428519
Erythema multiforme 98.66 11.20 98 63284 15603 64419747
Drug resistance 97.80 11.20 145 63237 34957 64400393
Encephalopathy 97.64 11.20 193 63189 58626 64376724
Alopecia 96.94 11.20 22 63360 165668 64269682
Drug level below therapeutic 95.95 11.20 70 63312 7314 64428036
Diabetes insipidus 92.92 11.20 57 63325 4464 64430886
Brain oedema 91.97 11.20 111 63271 21964 64413386
Focal dyscognitive seizures 90.18 11.20 50 63332 3240 64432110
Cerebellar ataxia 90.03 11.20 41 63341 1742 64433608
Diplopia 88.51 11.20 120 63262 26645 64408705
Somnolence 86.71 11.20 413 62969 203232 64232118
Necrosis ischaemic 84.50 11.20 33 63349 950 64434400
Confusional state 83.34 11.20 489 62893 260655 64174695
Sudden unexplained death in epilepsy 79.57 11.20 28 63354 597 64434753
Arthropathy 79.45 11.20 12 63370 120955 64314395
Stupor 75.68 11.20 56 63326 5979 64429371
Choreoathetosis 75.36 11.20 34 63348 1413 64433937
Infusion related reaction 74.75 11.20 34 63348 164433 64270917
Balance disorder 74.58 11.20 216 63166 83710 64351640
Overdose 74.09 11.20 332 63050 159234 64276116
Urine copper increased 73.79 11.20 14 63368 13 64435337
Drug level changed 73.78 11.20 25 63357 474 64434876
Depressed level of consciousness 73.73 11.20 211 63171 81225 64354125
Gait disturbance 71.71 11.20 347 63035 171808 64263542
Intensive care unit acquired weakness 69.62 11.20 34 63348 1693 64433657
Injection site pain 68.85 11.20 13 63369 111395 64323955
Cerebral atrophy 68.44 11.20 57 63325 7228 64428122
Porphyria acute 68.42 11.20 26 63356 694 64434656
Nervous system disorder 66.69 11.20 97 63285 22981 64412369
Peripheral swelling 65.86 11.20 65 63317 209088 64226262
Abdominal discomfort 65.48 11.20 50 63332 182272 64253078
Lethargy 64.65 11.20 187 63195 72407 64362943
Nausea 64.18 11.20 481 62901 785319 63650031
Intra-abdominal pressure increased 64.09 11.20 19 63363 228 64435122
Cerebellar syndrome 63.93 11.20 47 63335 4969 64430381
Pain in extremity 63.68 11.20 126 63256 302959 64132391
Anaemia 63.16 11.20 178 63204 378502 64056848
Sinusitis 62.02 11.20 33 63349 145895 64289455
Intestinal ischaemia 61.57 11.20 66 63316 11483 64423867
Eosinophilia 60.85 11.20 123 63259 37953 64397397
Acute kidney injury 58.63 11.20 235 63147 449005 63986345
Product substitution issue 57.42 11.20 79 63303 17782 64417568
Drug ineffective for unapproved indication 56.36 11.20 106 63276 31027 64404323
Aggression 55.35 11.20 133 63249 46099 64389251
Back pain 55.16 11.20 101 63281 250070 64185280
Dyskinesia 54.54 11.20 120 63262 39268 64396082
Porphyrins stool increased 54.27 11.20 12 63370 37 64435313
Cross sensitivity reaction 53.25 11.20 36 63346 3331 64432019
Discomfort 53.15 11.20 8 63374 80870 64354480
Malaise 53.14 11.20 205 63177 396042 64039308
Coma 53.09 11.20 198 63184 87417 64347933
Petit mal epilepsy 52.81 11.20 42 63340 4990 64430360
Cough 52.62 11.20 139 63243 302009 64133341
Haemophagocytic lymphohistiocytosis 52.32 11.20 75 63307 17534 64417816
Pneumatosis 51.67 11.20 22 63360 794 64434556
Ophthalmoplegia 50.32 11.20 32 63350 2670 64432680
Febrile neutropenia 49.68 11.20 67 63315 187590 64247760
Neurodegenerative disorder 49.47 11.20 18 63364 424 64434926
Contraindicated product administered 49.43 11.20 22 63360 107807 64327543
Hyperammonaemic encephalopathy 49.42 11.20 37 63345 4021 64431329
Hypotonia 49.37 11.20 58 63324 11154 64424196
Hepatitis 49.16 11.20 126 63256 45456 64389894
Asterixis 49.09 11.20 30 63352 2333 64433017
Unresponsive to stimuli 48.97 11.20 134 63248 50259 64385091
Lower respiratory tract infection 48.87 11.20 16 63366 94598 64340752
Extensor plantar response 47.92 11.20 26 63356 1614 64433736
Urine delta aminolevulinate increased 47.11 11.20 9 63373 9 64435341
Nasopharyngitis 47.02 11.20 75 63307 195998 64239352
Acute hepatic failure 46.14 11.20 88 63294 26024 64409326
Renal ischaemia 45.70 11.20 22 63360 1061 64434289
Hyperreflexia 45.61 11.20 45 63337 7103 64428247
Gamma-glutamyltransferase increased 45.17 11.20 127 63255 48383 64386967
Coagulopathy 45.04 11.20 98 63284 31822 64403528
Chest pain 44.63 11.20 104 63278 235876 64199474
Malabsorption 44.61 11.20 36 63346 4367 64430983
Glioblastoma multiforme 44.56 11.20 22 63360 1122 64434228
Brain herniation 43.32 11.20 42 63340 6491 64428859
Abdominal pain 42.89 11.20 160 63222 312215 64123135
Abdominal pain upper 42.87 11.20 66 63316 174964 64260386
Speech disorder 42.37 11.20 124 63258 48317 64387033
Pemphigus 42.28 11.20 5 63377 60696 64374654
Neurotoxicity 41.98 11.20 87 63295 27317 64408033
PO2 increased 41.79 11.20 23 63359 1469 64433881
Drug withdrawal convulsions 41.63 11.20 26 63356 2102 64433248
COVID-19 41.55 11.20 7 63375 65133 64370217
Glossodynia 41.16 11.20 7 63375 64689 64370661
Propofol infusion syndrome 40.06 11.20 23 63359 1594 64433756
PCO2 increased 39.41 11.20 23 63359 1644 64433706
Wound 39.37 11.20 13 63369 76464 64358886
Atonic seizures 39.05 11.20 17 63365 648 64434702
Multiple organ dysfunction syndrome 39.05 11.20 200 63182 101213 64334137
Mucosal erosion 38.77 11.20 24 63358 1910 64433440
Acidosis hyperchloraemic 38.40 11.20 17 63365 675 64434675
Asthma 38.34 11.20 23 63359 95202 64340148
Intention tremor 38.31 11.20 17 63365 679 64434671
Dermatitis exfoliative 38.22 11.20 49 63333 10303 64425047
Aura 37.90 11.20 18 63364 842 64434508
Angiofibroma 37.89 11.20 11 63371 122 64435228
Drug intolerance 37.87 11.20 80 63302 187912 64247438
Dystonia 37.64 11.20 67 63315 18798 64416552
Gaze palsy 37.34 11.20 26 63356 2524 64432826
Pericarditis 37.15 11.20 8 63374 62508 64372842
Toxic encephalopathy 37.09 11.20 47 63335 9768 64425582
Dehydration 36.74 11.20 101 63281 216662 64218688
Cardiac arrest 35.98 11.20 267 63115 153797 64281553
Rash morbilliform 35.88 11.20 34 63348 5107 64430243
Myalgia 35.87 11.20 63 63319 158554 64276796
Drug level fluctuating 35.73 11.20 16 63366 653 64434697
Cognitive disorder 35.47 11.20 127 63255 54960 64380390
Weight increased 34.98 11.20 101 63281 213247 64222103
Blood albumin decreased 34.77 11.20 69 63313 21004 64414346
Medication error 34.60 11.20 118 63264 49848 64385502
Chest discomfort 34.36 11.20 38 63344 116068 64319282
Encephalitis autoimmune 34.31 11.20 22 63360 1862 64433488
Myoclonus 34.18 11.20 76 63306 25042 64410308
Lymphadenopathy 33.87 11.20 112 63270 46574 64388776
Psoriasis 33.86 11.20 14 63368 71689 64363661
Inhibitory drug interaction 33.28 11.20 28 63354 3599 64431751
Swelling 33.27 11.20 67 63315 160151 64275199
Porphyria 33.20 11.20 11 63371 194 64435156
Anti-erythropoietin antibody negative 33.05 11.20 12 63370 281 64435069
Hippocampal sclerosis 32.79 11.20 10 63372 133 64435217
Agitation 32.45 11.20 172 63210 88195 64347155
Lymphangioleiomyomatosis 32.39 11.20 10 63372 139 64435211
Ultrasound ovary abnormal 32.12 11.20 9 63373 87 64435263
Hemiparesis 31.69 11.20 82 63300 29745 64405605
Psoriatic arthropathy 31.59 11.20 3 63379 43278 64392072
General physical health deterioration 31.21 11.20 100 63282 204325 64231025
Muscle twitching 31.10 11.20 62 63320 18936 64416414
Systemic inflammatory response syndrome 31.00 11.20 44 63338 10191 64425159
Encephalitis 30.88 11.20 49 63333 12522 64422828
Dyspnoea exertional 30.83 11.20 17 63365 73713 64361637
Cardiac arrest neonatal 30.66 11.20 7 63375 26 64435324
Blood homocysteine increased 30.48 11.20 12 63370 353 64434997
Pneumonia 30.06 11.20 379 63003 559197 63876153
Foetal death 30.05 11.20 33 63349 5897 64429453
Interstitial lung disease 30.02 11.20 31 63351 97701 64337649
Hyperchloraemia 29.94 11.20 16 63366 963 64434387
Product dose omission issue 29.92 11.20 95 63287 194652 64240698
Intellectual disability 29.48 11.20 16 63366 994 64434356
Angiomyolipoma 29.40 11.20 10 63372 192 64435158
Liver function test abnormal 29.36 11.20 126 63256 59275 64376075
Aplasia pure red cell 28.77 11.20 35 63347 6979 64428371
Chorea 28.37 11.20 20 63362 1980 64433370
Herpes zoster 28.05 11.20 22 63360 79165 64356185
Atrial fibrillation 28.04 11.20 81 63301 171008 64264342
Past-pointing 27.92 11.20 9 63373 145 64435205
Cytomegalovirus hepatitis 27.66 11.20 13 63369 594 64434756
Bronchitis 27.59 11.20 40 63342 108703 64326647
Postictal paralysis 27.55 11.20 11 63371 336 64435014
Completed suicide 27.40 11.20 339 63043 224075 64211275
Osteoarthritis 27.37 11.20 14 63368 63322 64372028
Injection site erythema 27.26 11.20 18 63364 70782 64364568
Laryngeal stenosis 26.99 11.20 14 63368 793 64434557
Idiosyncratic drug reaction 26.92 11.20 16 63366 1183 64434167
Fall 26.84 11.20 566 62816 416260 64019090
Myocardial infarction 26.81 11.20 79 63303 165742 64269608
Blood pH decreased 26.77 11.20 27 63355 4375 64430975
Constipation 26.77 11.20 125 63257 229212 64206138
Simple partial seizures 26.42 11.20 13 63369 658 64434692
Cardiac failure 26.09 11.20 57 63325 132316 64303034
Psychotic disorder 26.03 11.20 84 63298 34494 64400856
Fluid retention 26.02 11.20 13 63369 59593 64375757
Loss of consciousness 25.99 11.20 241 63141 148124 64287226
Systemic lupus erythematosus 25.72 11.20 23 63359 77589 64357761
Dysmetria 25.61 11.20 14 63368 882 64434468
Cardiac failure congestive 25.11 11.20 57 63325 130523 64304827
Tremor 25.08 11.20 239 63143 147991 64287359
Memory impairment 25.06 11.20 157 63225 85525 64349825
Respiratory acidosis 25.02 11.20 39 63343 9816 64425534
Blood bicarbonate decreased 24.69 11.20 27 63355 4802 64430548
Treatment noncompliance 24.46 11.20 96 63286 43386 64391964
Arthritis 24.18 11.20 28 63354 83786 64351564
Areflexia 23.89 11.20 27 63355 4980 64430370
Postictal psychosis 23.79 11.20 8 63374 148 64435202
Oxygen saturation abnormal 23.76 11.20 23 63359 3548 64431802
Seizure cluster 23.67 11.20 10 63372 354 64434996
Incoherent 23.66 11.20 32 63350 7086 64428264
Aphasia 23.57 11.20 91 63291 40815 64394535
Influenza 23.46 11.20 43 63339 106488 64328862
Influenza like illness 23.33 11.20 16 63366 61686 64373664
Disease recurrence 23.22 11.20 76 63306 31434 64403916
Palpitations 23.16 11.20 42 63340 104446 64330904
Weight decreased 23.14 11.20 175 63207 285564 64149786
Blood alkaline phosphatase increased 23.07 11.20 113 63269 56166 64379184
Encephalomalacia 23.05 11.20 14 63368 1077 64434273
Melaena 22.90 11.20 12 63370 53536 64381814
Hypertension 22.83 11.20 155 63227 259106 64176244
Gastrooesophageal reflux disease 22.69 11.20 29 63353 83114 64352236
Leukocytosis 22.60 11.20 85 63297 37655 64397695
Oedema peripheral 22.60 11.20 118 63264 210199 64225151
Intracranial pressure increased 22.59 11.20 31 63351 6958 64428392
Creutzfeldt-Jakob disease 22.59 11.20 8 63374 174 64435176
Hypothermia 22.56 11.20 56 63326 19800 64415550
Death 22.29 11.20 337 63045 482368 63952982
Postictal state 22.23 11.20 16 63366 1637 64433713
Muscle spasms 22.21 11.20 68 63314 140955 64294395
Wheezing 22.10 11.20 28 63354 80551 64354799
C-reactive protein increased 22.08 11.20 37 63345 94872 64340478
Irritable bowel syndrome 21.76 11.20 5 63377 37364 64397986
Productive cough 21.61 11.20 24 63358 73179 64362171
Musculoskeletal pain 21.52 11.20 29 63353 81265 64354085
Euthyroid sick syndrome 21.41 11.20 6 63376 58 64435292
Injection site swelling 21.34 11.20 7 63375 41346 64394004
Clonus 21.28 11.20 28 63354 6039 64429311
Potentiating drug interaction 21.24 11.20 32 63350 7820 64427530
Excessive eye blinking 21.20 11.20 14 63368 1246 64434104
Ammonia increased 21.14 11.20 30 63352 6947 64428403
Autonomic nervous system imbalance 20.95 11.20 23 63359 4109 64431241
Blood zinc increased 20.94 11.20 4 63378 4 64435346
Inflammation 20.87 11.20 20 63362 65280 64370070
Brain injury 20.67 11.20 36 63346 9929 64425421
Wrong technique in product usage process 20.65 11.20 20 63362 64954 64370396
Blood pressure fluctuation 20.22 11.20 13 63369 51858 64383492
Gingival atrophy 20.09 11.20 6 63376 74 64435276
Oropharyngeal oedema 19.96 11.20 8 63374 247 64435103
Perforation 19.91 11.20 13 63369 1135 64434215
Bone pain 19.84 11.20 11 63371 47561 64387789
Learning disorder 19.79 11.20 10 63372 536 64434814
Gliosis 19.77 11.20 9 63373 382 64434968
Autism spectrum disorder 19.68 11.20 12 63370 929 64434421
Chills 19.67 11.20 69 63313 137195 64298155
Acute generalised exanthematous pustulosis 19.65 11.20 43 63339 14015 64421335
Calcinosis 19.60 11.20 16 63366 1972 64433378
Hypersensitivity 19.58 11.20 113 63269 196339 64239011
Haemoglobin decreased 19.55 11.20 112 63270 194951 64240399
Gingival disorder 19.41 11.20 20 63362 3324 64432026
Face oedema 19.41 11.20 61 63321 24700 64410650
Mucosal ulceration 19.39 11.20 15 63367 1712 64433638
Neuroleptic malignant syndrome 19.06 11.20 61 63321 24935 64410415
Chronic graft versus host disease 19.04 11.20 27 63355 6249 64429101
Vitamin B6 deficiency 18.94 11.20 8 63374 283 64435067
Gastric disorder 18.92 11.20 3 63379 29194 64406156
Decreased appetite 18.85 11.20 181 63201 281108 64154242
Macule 18.78 11.20 17 63365 2409 64432941
Rash erythematous 18.77 11.20 96 63286 48537 64386813
Hospitalisation 18.75 11.20 28 63354 75179 64360171
Abnormal behaviour 18.72 11.20 74 63308 33548 64401802
Linear IgA disease 18.70 11.20 18 63364 2756 64432594
Stomatitis 18.61 11.20 51 63331 109554 64325796
Haematuria traumatic 18.56 11.20 7 63375 183 64435167
Fibromyalgia 18.52 11.20 6 63376 35725 64399625
Blood ketone body increased 18.41 11.20 10 63372 622 64434728
Product dispensing error 18.30 11.20 37 63345 11413 64423937
Myoclonic epilepsy 18.12 11.20 14 63368 1594 64433756
Pyrexia 18.07 11.20 695 62687 557949 63877401
Angina pectoris 17.99 11.20 11 63371 45070 64390280
Enzyme induction 17.95 11.20 6 63376 109 64435241
Lymphocyte morphology abnormal 17.93 11.20 11 63371 861 64434489
Partial seizures with secondary generalisation 17.80 11.20 9 63373 483 64434867
Hepatic failure 17.78 11.20 104 63278 55290 64380060
Cerebellar cognitive affective syndrome 17.78 11.20 3 63379 0 64435350
Urine zinc 17.78 11.20 3 63379 0 64435350
Methylenetetrahydrofolate reductase deficiency 17.78 11.20 3 63379 0 64435350
Impaired healing 17.66 11.20 20 63362 60453 64374897
Hepatitis fulminant 17.59 11.20 26 63356 6248 64429102
Pulmonary embolism 17.52 11.20 79 63303 146277 64289073
Bradyarrhythmia 17.48 11.20 20 63362 3738 64431612
Hot flush 17.47 11.20 12 63370 46223 64389127
Anxiety 17.41 11.20 122 63260 202527 64232823
Injection site bruising 17.34 11.20 7 63375 36366 64398984
Sinus arrest 17.07 11.20 18 63364 3072 64432278
Alanine aminotransferase increased 16.94 11.20 210 63172 138821 64296529
Staring 16.94 11.20 16 63366 2394 64432956
Haemodynamic instability 16.88 11.20 42 63340 14870 64420480
Plasmodium falciparum infection 16.64 11.20 5 63377 63 64435287
Metabolic acidosis 16.56 11.20 123 63259 70835 64364515
Dry mouth 16.56 11.20 21 63361 60397 64374953
Insomnia 16.56 11.20 120 63262 197716 64237634
Orthostatic hypotension 16.53 11.20 13 63369 46725 64388625
Nodal arrhythmia 16.44 11.20 14 63368 1829 64433521
Aspartate aminotransferase increased 16.39 11.20 185 63197 119603 64315747
Sleep disorder due to general medical condition, insomnia type 16.36 11.20 3 63379 26267 64409083
Platelet aggregation inhibition 16.35 11.20 6 63376 145 64435205
Brain neoplasm 16.32 11.20 22 63360 4856 64430494
Haematochezia 16.26 11.20 25 63357 66348 64369002
Hyperkinesia 16.19 11.20 16 63366 2530 64432820
Hyporeflexia 16.08 11.20 18 63364 3286 64432064
Nasal congestion 16.08 11.20 21 63361 59637 64375713
Blood pressure systolic increased 15.97 11.20 15 63367 49438 64385912
Bacterial toxaemia 15.90 11.20 6 63376 157 64435193
Head injury 15.72 11.20 69 63313 32773 64402577
Barbiturates positive 15.70 11.20 3 63379 3 64435347
Post-traumatic epilepsy 15.67 11.20 4 63378 26 64435324
Posture abnormal 15.63 11.20 18 63364 3388 64431962
Hypoventilation 15.57 11.20 24 63358 5982 64429368
Apallic syndrome 15.57 11.20 10 63372 849 64434501
Disorientation 15.52 11.20 101 63281 55727 64379623
Pulmonary fibrosis 15.51 11.20 5 63377 29873 64405477
Osteonecrosis of jaw 15.50 11.20 10 63372 39815 64395535
Pyroglutamate increased 15.47 11.20 9 63373 639 64434711
Nephritis allergic 15.47 11.20 9 63373 639 64434711
Upper respiratory tract infection 15.47 11.20 30 63352 72755 64362595
Altered state of consciousness 15.46 11.20 76 63306 37826 64397524
Superinfection 15.31 11.20 19 63363 3867 64431483
Eye movement disorder 15.24 11.20 26 63356 7053 64428297
Drug eruption 15.13 11.20 73 63309 36063 64399287
Hallucination, tactile 15.07 11.20 8 63374 475 64434875
Ischaemic cerebral infarction 15.03 11.20 14 63368 2058 64433292
Intentional product use issue 15.00 11.20 46 63336 95318 64340032
Knee arthroplasty 14.97 11.20 4 63378 26995 64408355
Tongue biting 14.95 11.20 13 63369 1747 64433603
Malignant neoplasm progression 14.70 11.20 59 63323 112812 64322538
Ischaemic hepatitis 14.64 11.20 17 63365 3229 64432121
Hypernatraemia 14.51 11.20 35 63347 12154 64423196
Muscle injury 14.50 11.20 4 63378 26433 64408917
Rasmussen encephalitis 14.49 11.20 3 63379 6 64435344
Neutropenia 14.48 11.20 158 63224 239466 64195884
Hirsutism 14.43 11.20 10 63372 963 64434387
Periorbital oedema 14.37 11.20 26 63356 7388 64427962
Vasogenic cerebral oedema 14.34 11.20 10 63372 973 64434377
Pneumonitis 14.34 11.20 17 63365 50348 64385002
Ovarian failure 14.17 11.20 8 63374 537 64434813
Injection site reaction 14.10 11.20 15 63367 46649 64388701
Genital erythema 14.03 11.20 6 63376 219 64435131
Pseudolymphoma 13.93 11.20 10 63372 1019 64434331
Open angle glaucoma 13.91 11.20 7 63375 372 64434978
Cataract 13.86 11.20 18 63364 51244 64384106
Hypoxic-ischaemic encephalopathy 13.75 11.20 25 63357 7127 64428223
Acute myocardial infarction 13.75 11.20 30 63352 69688 64365662
Pneumocystis jirovecii pneumonia 13.70 11.20 5 63377 27629 64407721
Unmasking of previously unidentified disease 13.66 11.20 12 63370 1635 64433715
Intensive care unit delirium 13.65 11.20 4 63378 46 64435304
Pulmonary vasculitis 13.63 11.20 6 63376 235 64435115
Colitis ulcerative 13.57 11.20 3 63379 23025 64412325
Movement disorder 13.55 11.20 50 63332 21950 64413400
Mental impairment 13.49 11.20 41 63341 16302 64419048
Visual evoked potentials abnormal 13.49 11.20 4 63378 48 64435302
Paranoia 13.48 11.20 41 63341 16311 64419039
Vitamin B6 decreased 13.39 11.20 3 63379 10 64435340
Rhinorrhoea 13.38 11.20 24 63358 59945 64375405
Pleocytosis 13.27 11.20 10 63372 1097 64434253
Device issue 13.25 11.20 3 63379 22645 64412705
Eosinophil count increased 13.18 11.20 37 63345 14075 64421275
Posterior reversible encephalopathy syndrome 13.18 11.20 51 63331 22895 64412455
Urticaria papular 13.17 11.20 5 63377 133 64435217
Hepatic necrosis 13.09 11.20 27 63355 8446 64426904
Flushing 13.05 11.20 37 63345 78611 64356739
Poor feeding infant 13 11.20 5 63377 138 64435212
CSF oligoclonal band present 12.97 11.20 5 63377 139 64435211
Factor VIII deficiency 12.93 11.20 5 63377 140 64435210
Cytokine storm 12.88 11.20 9 63373 878 64434472
Ejaculation delayed 12.80 11.20 5 63377 144 64435206
Night sweats 12.78 11.20 10 63372 36036 64399314
Biopsy brain 12.77 11.20 3 63379 13 64435337
Epileptic psychosis 12.74 11.20 4 63378 59 64435291
Infantile spasms 12.71 11.20 6 63376 277 64435073
Product use issue 12.70 11.20 92 63290 151623 64283727
Grimacing 12.69 11.20 8 63374 657 64434693
Chemical burn 12.68 11.20 7 63375 450 64434900
Amnesia 12.62 11.20 86 63296 48183 64387167
Torticollis 12.60 11.20 13 63369 2164 64433186
Pulmonary mass 12.50 11.20 4 63378 24012 64411338
Apnoea 12.49 11.20 30 63352 10392 64424958
Lactic acidosis 12.46 11.20 26 63356 61384 64373966
Irritability 12.45 11.20 70 63312 36676 64398674
Ill-defined disorder 12.40 11.20 15 63367 44037 64391313
Cerebral palsy 12.37 11.20 5 63377 158 64435192
Pneumonia aspiration 12.31 11.20 100 63282 59171 64376179
Tonic convulsion 12.30 11.20 12 63370 1869 64433481
Chronic kidney disease 12.20 11.20 24 63358 57895 64377455
Oxygen saturation decreased 12.15 11.20 59 63323 107117 64328233
Hip arthroplasty 12.15 11.20 3 63379 21348 64414002
Diverticulitis 12.14 11.20 12 63370 38606 64396744
Presyncope 12.11 11.20 10 63372 35079 64400271
Vomiting projectile 12.01 11.20 11 63371 1582 64433768
Epileptic aura 12.00 11.20 4 63378 72 64435278
Lip erosion 12.00 11.20 10 63372 1269 64434081
Acute myeloid leukaemia 11.97 11.20 6 63376 27457 64407893
Urinary tract infection 11.97 11.20 158 63224 231438 64203912
Symblepharon 11.91 11.20 5 63377 174 64435176
Hypometabolism 11.85 11.20 4 63378 75 64435275
Microcephaly 11.83 11.20 5 63377 177 64435173
Radiation necrosis 11.80 11.20 6 63376 326 64435024
Drug abuse 11.70 11.20 79 63303 132295 64303055
Blood glucose increased 11.70 11.20 53 63329 98020 64337330
Hypokalaemia 11.67 11.20 71 63311 121832 64313518
Viral infection 11.63 11.20 11 63371 36129 64399221
Developmental delay 11.63 11.20 9 63373 1028 64434322
Therapy cessation 11.54 11.20 9 63373 32480 64402870
Blood creatinine increased 11.53 11.20 82 63300 135700 64299650
Haemoptysis 11.52 11.20 19 63363 49029 64386321
Rash macular 11.51 11.20 50 63332 23635 64411715
Conjunctivitis 11.50 11.20 45 63337 20309 64415041
Soft tissue haemorrhage 11.48 11.20 6 63376 345 64435005
Pleural effusion 11.46 11.20 75 63307 126484 64308866
Encephalocele 11.44 11.20 3 63379 22 64435328
Mydriasis 11.34 11.20 37 63345 15275 64420075
Respiratory tract infection 11.33 11.20 12 63370 37395 64397955
Skin ulcer 11.32 11.20 16 63366 43958 64391392
Anaphylactic shock 11.29 11.20 8 63374 30320 64405030
Paradoxical drug reaction 11.28 11.20 21 63361 6099 64429251
Oropharyngeal pain 11.22 11.20 47 63335 88820 64346530
Febrile convulsion 11.21 11.20 8 63374 807 64434543

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC N03AB02 NERVOUS SYSTEM
ANTIEPILEPTICS
ANTIEPILEPTICS
Hydantoin derivatives
ATC N03AB52 NERVOUS SYSTEM
ANTIEPILEPTICS
ANTIEPILEPTICS
Hydantoin 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 D065694 Cytochrome P-450 CYP1A2 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:38633 sodium channel blockers
CHEBI has role CHEBI:50905 teratogeno
CHEBI has role CHEBI:88188 allergenic drug
FDA EPC N0000175753 Anti-epileptic Agent
FDA MoA N0000185507 Cytochrome P450 2C9 Inducers
FDA MoA N0000185607 Cytochrome P450 2C19 Inducers
FDA MoA N0000187063 Cytochrome P450 2C8 Inducers
FDA MoA N0000187064 Cytochrome P450 2B6 Inducers
FDA MoA N0000190118 Cytochrome P450 3A Inducers
FDA MoA N0000191266 Cytochrome P450 1A2 Inducers
FDA MoA N0000191267 Cytochrome P450 2D6 Inducers

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

DiseaseRelationSNOMED_IDDOID
Tonic-clonic seizure indication 54200006
Epilepsy indication 84757009 DOID:1826
Bipolar disorder in remission indication 85248005
Localization-related epilepsy indication 230381009 DOID:2234
Lennox-Gastaut syndrome indication 230418006
Status epilepticus indication 230456007 DOID:1824
Motor cortex epilepsy indication 267592003
Tonic-clonic epilepsy indication 352818000 DOID:7725
Epilepsy characterized by intractable complex partial seizures indication 442481002
Simple partial seizure indication 117891000119100
Seizures in Neurosurgery indication
Prevention of Seizures following Cranial Trauma or Surgery indication
Bipolar affective disorder, current episode depression off-label use 191627008 DOID:3312
Wound care off-label use 225358003
Neuropathic pain off-label use 247398009
Rapid Cycling Bipolar Affective Disorder off-label use
Osteomalacia contraindication 4598005 DOID:10573
Suicidal thoughts contraindication 6471006
Alcoholism contraindication 7200002
Hyperammonemia contraindication 9360008
Hepatic encephalopathy contraindication 13920009 DOID:13413
Disorder of thyroid gland contraindication 14304000 DOID:50
Agranulocytosis contraindication 17182001 DOID:12987
Hyperphosphatemia contraindication 20165001 DOID:0050459
Myocardial infarction contraindication 22298006 DOID:5844
Alcohol intoxication contraindication 25702006
Complete atrioventricular block contraindication 27885002
Lymphadenopathy contraindication 30746006
Torsades de pointes contraindication 31722008
Depressive disorder contraindication 35489007
Conduction disorder of the heart contraindication 44808001
Low blood pressure contraindication 45007003
Stokes-Adams syndrome contraindication 46935006
Sinus bradycardia contraindication 49710005
Megaloblastic anemia contraindication 53165003 DOID:13382
Systemic lupus erythematosus contraindication 55464009 DOID:9074
Acute nephropathy contraindication 58574008
Hepatic failure contraindication 59927004
Sinus node dysfunction contraindication 60423000
Poisoning by phenobarbital contraindication 64921004
Substance abuse contraindication 66214007
Hepatic coma contraindication 72836002 DOID:12550
Diabetes mellitus contraindication 73211009 DOID:9351
Sleep apnea contraindication 73430006 DOID:0050847
Hyperglycemia contraindication 80394007 DOID:4195
Decreased respiratory function contraindication 80954004
Leukopenia contraindication 84828003 DOID:615
Kidney disease contraindication 90708001 DOID:557
Prolonged QT interval contraindication 111975006
Hypoalbuminemia contraindication 119247004
Pancytopenia contraindication 127034005 DOID:12450
Purple glove syndrome contraindication 129576003
Second degree atrioventricular block contraindication 195042002
Decompensated cardiac failure contraindication 195111005
Non-infective meningitis contraindication 230155003
Disease of liver contraindication 235856003 DOID:409
Dyspnea contraindication 267036007
Anemia contraindication 271737000 DOID:2355
Pregnancy, function contraindication 289908002
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Neutropenic disorder contraindication 303011007 DOID:1227
Aplastic anemia contraindication 306058006 DOID:12449
Osteopenia contraindication 312894000
Breastfeeding (mother) contraindication 413712001
Granulocytopenic disorder contraindication 417672002
Porphyria contraindication 418470004
Fever greater than 100.4 Fahrenheit contraindication 426000000
Hyperplasia of gingiva contraindication 441798003
Congenital long QT syndrome contraindication 442917000
HLA-B 1502 Positive Status contraindication




๐Ÿถ Veterinary Drug Use

SpeciesUseRelation
Dogs Euthanasia Indication

๐Ÿถ Veterinary products

ProductApplicantIngredients
Beuthanasia-D Special Intervet Inc. 2
Euthasol Virbac AH Inc. 2
Euthanasia-III Solution Med-Pharmex Inc. 2
Pentobarbital Sodium and Phenytoin Sodium Akorn Animal Health Inc. 2

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 7.8 acidic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Sodium channel protein type 9 subunit alpha Ion channel BLOCKER CHEMBL CHEMBL
Sodium channel protein type 5 subunit alpha Ion channel BLOCKER WOMBAT-PK CHEMBL
Sodium channel protein type 1 subunit alpha Ion channel BLOCKER CHEMBL CHEMBL
Sodium channel protein type 2 subunit alpha Ion channel BLOCKER IC50 4.90 IUPHAR CHEMBL
Sodium channel protein type 3 subunit alpha Ion channel BLOCKER CHEMBL CHEMBL
Sodium channel protein type 4 subunit alpha Ion channel BLOCKER Ki 4.62 CHEMBL CHEMBL
Sodium channel protein type 8 subunit alpha Ion channel BLOCKER CHEMBL CHEMBL
Nuclear receptor subfamily 1 group I member 3 Nuclear hormone receptor WOMBAT-PK
Sodium channel alpha subunits; brain (Types I, II, III) Ion channel IC50 4.40 CHEMBL
Sodium channel protein type 2 subunit alpha Ion channel IC50 4.66 CHEMBL

External reference:

IDSource
4017856 VUID
N0000146211 NUI
D00512 KEGG_DRUG
630-93-3 SECONDARY_CAS_RN
4017856 VANDF
4017857 VANDF
C0031507 UMLSCUI
CHEBI:8107 CHEBI
CHEMBL16 ChEMBL_ID
DB00252 DRUGBANK_ID
CHEMBL1611 ChEMBL_ID
D010672 MESH_DESCRIPTOR_UI
1775 PUBCHEM_CID
2624 IUPHAR_LIGAND_ID
416 INN_ID
6158TKW0C5 UNII
71227 RXNORM
1366 MMSL
5292 MMSL
5293 MMSL
72015 MMSL
d00143 MMSL
001617 NDDF
001619 NDDF
387220006 SNOMEDCT_US
387416005 SNOMEDCT_US
40556005 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Dilantin Infatabs HUMAN PRESCRIPTION DRUG LABEL 1 0071-0007 TABLET, CHEWABLE 50 mg ORAL ANDA 27 sections
Dilantin Infatabs HUMAN PRESCRIPTION DRUG LABEL 1 0071-0007 TABLET, CHEWABLE 50 mg ORAL ANDA 27 sections
Dilantin HUMAN PRESCRIPTION DRUG LABEL 1 0071-0369 CAPSULE 100 mg ORAL ANDA 28 sections
Dilantin HUMAN PRESCRIPTION DRUG LABEL 1 0071-0369 CAPSULE 100 mg ORAL ANDA 28 sections
Dilantin-125 HUMAN PRESCRIPTION DRUG LABEL 1 0071-2214 SUSPENSION 125 mg ORAL NDA 28 sections
Dilantin-125 HUMAN PRESCRIPTION DRUG LABEL 1 0071-2214 SUSPENSION 125 mg ORAL NDA 28 sections
Dilantin HUMAN PRESCRIPTION DRUG LABEL 1 0071-3740 CAPSULE 30 mg ORAL ANDA 28 sections
Dilantin HUMAN PRESCRIPTION DRUG LABEL 1 0071-3740 CAPSULE 30 mg ORAL ANDA 28 sections
Phenytoin HUMAN PRESCRIPTION DRUG LABEL 1 0121-0892 SUSPENSION 125 mg ORAL ANDA 27 sections
Phenytoin Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0378-1560 CAPSULE, EXTENDED RELEASE 100 mg ORAL ANDA 26 sections
Phenytek HUMAN PRESCRIPTION DRUG LABEL 1 0378-2670 CAPSULE, EXTENDED RELEASE 200 mg ORAL ANDA 26 sections
Phenytek HUMAN PRESCRIPTION DRUG LABEL 1 0378-3750 CAPSULE, EXTENDED RELEASE 300 mg ORAL ANDA 26 sections
Phenytoin HUMAN PRESCRIPTION DRUG LABEL 1 0378-3850 TABLET, CHEWABLE 50 mg ORAL ANDA 26 sections
Phenytoin Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0404-9932 INJECTION 50 mg INTRAMUSCULAR ANDA 16 sections
Phenytoin Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0404-9933 INJECTION 250 mg INTRAMUSCULAR ANDA 16 sections
Phenytoin Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0615-8020 CAPSULE, EXTENDED RELEASE 100 mg ORAL ANDA 26 sections
Phenytoin Infatabs HUMAN PRESCRIPTION DRUG LABEL 1 0615-8260 TABLET, CHEWABLE 50 mg ORAL ANDA 26 sections
Phenytoin Infatabs HUMAN PRESCRIPTION DRUG LABEL 1 0615-8424 TABLET, CHEWABLE 50 mg ORAL ANDA 27 sections
Phenytoin Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0641-0493 INJECTION 50 mg INTRAMUSCULAR ANDA 25 sections
Phenytoin Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0641-2555 INJECTION 50 mg INTRAMUSCULAR ANDA 25 sections
Phenytoin Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0641-6138 INJECTION 50 mg INTRAMUSCULAR ANDA 25 sections
Phenytoin Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0641-6138 INJECTION 50 mg INTRAMUSCULAR ANDA 25 sections
Phenytoin Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0641-6139 INJECTION 50 mg INTRAMUSCULAR ANDA 25 sections
Phenytoin Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0641-6139 INJECTION 50 mg INTRAMUSCULAR ANDA 25 sections
Extended Phenytoin Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0904-6187 CAPSULE 100 mg ORAL ANDA 23 sections
Phenytoin HUMAN PRESCRIPTION DRUG LABEL 1 0904-7079 SUSPENSION 100 mg ORAL ANDA 27 sections
Phenytoin HUMAN PRESCRIPTION DRUG LABEL 1 0904-7199 TABLET, CHEWABLE 50 mg ORAL ANDA 26 sections
Extended Phenytoin Sodium HUMAN PRESCRIPTION DRUG LABEL 1 10135-603 CAPSULE, EXTENDED RELEASE 100 mg ORAL ANDA 23 sections
PHENYTOINER HUMAN PRESCRIPTION DRUG LABEL 1 16590-815 CAPSULE 100 mg ORAL ANDA 3 sections
Phenytoin HUMAN PRESCRIPTION DRUG LABEL 1 17856-0067 SUSPENSION 125 mg ORAL ANDA 21 sections