phenytoin 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | 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) 0.03 mg/mL Bocci G, Oprea TI, Benet LZ
EoM (Fraction excreted unchanged in urine) 2 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 19.82 µM/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

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 2.119 Moderate 0.79
caco2-efflux Caco-2 efflux ratio (BA/AB) 1.377 Moderate 0.79
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 49.774 10^-6 cm/s Moderate 0.79
dh-clint Dog hepatocyte intrinsic clearance 3.864 uL/min/10^6 cells Moderate 0.79
dppb Dog plasma protein binding (% unbound) 28.950 % Moderate 0.79
fcs-ppb Fetal calf serum protein binding (% unbound) 46.610 % Moderate 0.79
herg hERG pIC50 4.066 pIC50 Moderate 0.79
hh-clint Human hepatocyte intrinsic clearance 1.156 uL/min/10^6 cells Moderate 0.79
hlm-clint Human liver microsomal intrinsic clearance 3.062 uL/min/mg protein Moderate 0.79
hppb Human plasma protein binding (% unbound) 25.130 % Moderate 0.79
kinase-safety-class ACVR2B,AXL,BRAF,CAMK2D,CDK5,CDK9,EIF2AK3,ERBB2,GRK2,ITK,MAPK7,PDK1,PDK2,PDK4,PIK3CB,PRKDC 16
kinase-selectivity-class ACVR2A,AXL,ERBB2,GRK2,PDK4,SIK2,SIK3,TEK 8
mdck-mdr1-bcrp-efflux MDCK-MDR1-BCRP efflux ratio 0.851 High 1
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 2.636 Moderate 0.79
mh-clint Mouse hepatocyte intrinsic clearance 13.836 Moderate 0.79
mppb Mouse plasma protein binding (% unbound) 22.590 Moderate 0.79
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 5.284 Moderate 0.79
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pppb Pig plasma protein binding (% unbound) 29.660 % Moderate 0.79
rat-kpuu-brain Rat brain Kpuu 0.341 % High 1
rh-clint Rat hepatocyte intrinsic clearance 17.298 uL/min/10^6 cells Moderate 0.79
rh-fuinc Rat hepatocyte fraction unbound in incubation 90.060 % Moderate 0.79
rppb Rat plasma protein binding (% unbound) 25.920 % Moderate 0.79
solubility-dd Solubility at pH 7.4 in DMSO 354.813 uM Moderate 0.79

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 2503.52 11.84 1308 43943 151321 90431875
Status epilepticus 825.59 11.84 322 44929 18552 90564644
Anticonvulsant drug level increased 771.02 11.84 178 45073 1558 90581638
Toxicity to various agents 723.64 11.84 801 44450 287045 90296151
Drug reaction with eosinophilia and systemic symptoms 659.89 11.84 353 44898 42405 90540791
Drug interaction 639.57 11.84 737 44514 275716 90307480
Ataxia 617.23 11.84 258 44993 17784 90565412
Multiple-drug resistance 553.47 11.84 190 45061 7586 90575610
Generalised tonic-clonic seizure 512.90 11.84 279 44972 34624 90548572
Anticonvulsant drug level decreased 493.18 11.84 119 45132 1281 90581915
Nystagmus 443.00 11.84 158 45093 7069 90576127
Stevens-Johnson syndrome 429.31 11.84 234 45017 29142 90554054
Anticonvulsant drug level below therapeutic 366.44 11.84 82 45169 614 90582582
Product complaint 294.67 11.84 141 45110 13359 90569837
Anticonvulsant drug level above therapeutic 283.04 11.84 64 45187 505 90582691
Cerebellar atrophy 235.65 11.84 59 45192 748 90582448
Purple glove syndrome 231.43 11.84 46 45205 176 90583020
Drug level decreased 222.67 11.84 105 45146 9625 90573571
Toxic epidermal necrolysis 211.11 11.84 155 45096 32373 90550823
Drug hypersensitivity 208.31 11.84 604 44647 463005 90120191
Drug ineffective 207.63 11.84 1286 43965 1383012 89200184
Partial seizures 196.38 11.84 88 45163 7172 90576024
Gingival hypertrophy 177.17 11.84 59 45192 2141 90581055
Drug resistance 157.92 11.84 127 45124 30322 90552874
Drug level increased 150.83 11.84 119 45132 27643 90555553
Joint swelling 147.82 11.84 35 45216 503265 90079931
Epilepsy 147.07 11.84 193 45058 82013 90501183
Focal dyscognitive seizures 142.20 11.84 55 45196 3089 90580107
Pemphigus 141.05 11.84 5 45246 326859 90256337
Alopecia 140.41 11.84 37 45214 495034 90088162
Arthropathy 138.50 11.84 12 45239 366230 90216966
Infusion related reaction 137.05 11.84 22 45229 416758 90166438
Electroencephalogram abnormal 134.75 11.84 57 45194 4039 90579157
Arthralgia 128.48 11.84 120 45131 778402 89804794
Dysarthria 125.00 11.84 145 45106 54337 90528859
Glossodynia 120.42 11.84 11 45240 321768 90261428
Wound 119.99 11.84 8 45243 302972 90280224
Diplopia 116.51 11.84 104 45147 28610 90554586
Anticonvulsant drug level abnormal 114.99 11.84 20 45231 27 90583169
Pericarditis 113.60 11.84 5 45246 270146 90313050
Discomfort 112.40 11.84 6 45245 274329 90308867
Abdominal discomfort 112.22 11.84 49 45202 477279 90105917
Systemic lupus erythematosus 110.56 11.84 23 45228 361873 90221323
Intra-abdominal pressure increased 109.02 11.84 26 45225 265 90582931
Pain 108.16 11.84 209 45042 996132 89587064
Drug level changed 106.06 11.84 24 45227 190 90583006
Drug ineffective for unapproved indication 104.80 11.84 147 45104 66497 90516699
Contraindicated product administered 102.76 11.84 18 45233 320121 90263075
Rash maculo-papular 102.48 11.84 114 45137 40819 90542377
Product substitution issue 101.73 11.84 79 45172 17929 90565267
Drug level below therapeutic 100.98 11.84 52 45199 5762 90577434
Coma 99.37 11.84 150 45101 72482 90510714
Sinusitis 96.52 11.84 26 45225 343062 90240134
Mental status changes 96 11.84 115 45136 44564 90538632
Encephalopathy 90.83 11.84 114 45137 46330 90536866
Psoriatic arthropathy 90.47 11.84 6 45245 228329 90354867
Diarrhoea 90.17 11.84 211 45040 938979 89644217
Irritable bowel syndrome 90.07 11.84 3 45248 207445 90375751
Drug level fluctuating 89.03 11.84 25 45226 504 90582692
Somnolence 85.61 11.84 264 44987 208820 90374376
Erythema multiforme 85.46 11.84 61 45190 12185 90571011
Necrosis ischaemic 85.39 11.84 28 45223 967 90582229
Peripheral swelling 84.27 11.84 51 45200 413055 90170141
Diabetes insipidus 83.90 11.84 38 45213 3174 90580022
Lower respiratory tract infection 82.85 11.84 13 45238 250646 90332550
Dyskinesia 81.73 11.84 96 45155 36438 90546758
Type 2 diabetes mellitus 81.53 11.84 5 45246 203239 90379957
Fatigue 80.60 11.84 301 44950 1153722 89429474
Rheumatoid arthritis 79.38 11.84 41 45210 362573 90220623
Renal ischaemia 79.04 11.84 24 45227 642 90582554
Dyspnoea 73.71 11.84 212 45039 880743 89702453
Pneumatosis 73.57 11.84 21 45230 450 90582746
Myoclonic epilepsy 71.94 11.84 28 45223 1599 90581597
Cerebellar ataxia 71.36 11.84 24 45227 898 90582298
Petit mal epilepsy 71.02 11.84 39 45212 4919 90578277
Brain oedema 70.58 11.84 63 45188 17322 90565874
Fibromyalgia 69.77 11.84 10 45241 206259 90376937
Impaired healing 69.22 11.84 16 45235 234183 90349013
Cardiac arrest 68.92 11.84 158 45093 104777 90478419
Balance disorder 68.03 11.84 150 45101 96930 90486266
Drug intolerance 67.94 11.84 74 45177 447517 90135679
Nasopharyngitis 67.87 11.84 62 45189 407042 90176154
Multiple organ dysfunction syndrome 67.65 11.84 122 45129 68214 90514982
PCO2 increased 66.69 11.84 25 45226 1288 90581908
Hypotension 65.91 11.84 329 44922 325068 90258128
Choreoathetosis 64.59 11.84 20 45231 572 90582624
Hyperammonaemia 63.87 11.84 40 45211 6435 90576761
Stupor 62.10 11.84 37 45214 5445 90577751
Wheezing 61.58 11.84 21 45230 238059 90345137
PO2 increased 60.37 11.84 21 45230 871 90582325
Swelling 58.52 11.84 74 45177 418984 90164212
Tremor 56.81 11.84 187 45064 152986 90430210
Asthma 56.61 11.84 25 45226 242135 90341061
Blood cholesterol increased 56.18 11.84 17 45234 207995 90375201
Propofol infusion syndrome 55.53 11.84 22 45229 1317 90581879
General physical health deterioration 54.66 11.84 58 45193 355057 90228139
Coordination abnormal 54.34 11.84 60 45191 21296 90561900
Aura 54.01 11.84 21 45230 1196 90582000
Blood pH decreased 53.63 11.84 26 45225 2532 90580664
Musculoskeletal pain 52.01 11.84 11 45240 171240 90411956
Stomatitis 51.79 11.84 37 45214 274661 90308535
Dry mouth 51.63 11.84 14 45237 184045 90399151
Depressed level of consciousness 51.60 11.84 113 45138 72671 90510525
Blood bicarbonate decreased 51.59 11.84 27 45224 3092 90580104
Aggression 51.40 11.84 65 45186 26603 90556593
Speech disorder 51.13 11.84 86 45165 45499 90537697
Bursitis 50.58 11.84 4 45247 131650 90451546
Hypersensitivity 50.33 11.84 94 45157 454583 90128613
Bradycardia neonatal 49.00 11.84 19 45232 1074 90582122
Encephalitis 48.51 11.84 42 45209 11092 90572104
Nervous system disorder 47.07 11.84 56 45195 21537 90561659
Lethargy 47.02 11.84 100 45151 63039 90520157
Musculoskeletal stiffness 46.10 11.84 48 45203 296484 90286712
Acute hepatic failure 45.09 11.84 56 45195 22505 90560691
Neurodegenerative disorder 44.96 11.84 14 45237 408 90582788
Ill-defined disorder 44.95 11.84 18 45233 184873 90398323
Eosinophilia 44.93 11.84 63 45188 28470 90554726
Respiratory acidosis 44.51 11.84 35 45216 8084 90575112
Respiratory disorder neonatal 44.44 11.84 19 45232 1382 90581814
Unresponsive to stimuli 44.20 11.84 73 45178 38048 90545148
Abdominal pain upper 44.12 11.84 61 45190 332613 90250583
Night sweats 44.10 11.84 6 45245 128760 90454436
Brain injury 43.82 11.84 34 45217 7704 90575492
Selective eating disorder 43.45 11.84 21 45230 2032 90581164
Osteoarthritis 42.99 11.84 22 45229 195708 90387488
Partial seizures with secondary generalisation 42.93 11.84 14 45237 475 90582721
Overdose 42.80 11.84 174 45077 157535 90425661
Bradyarrhythmia 42.70 11.84 22 45229 2439 90580757
Joint range of motion decreased 42.68 11.84 8 45243 135635 90447561
Loss of consciousness 42.33 11.84 160 45091 140078 90443118
Foetal anticonvulsant syndrome 42.23 11.84 15 45236 662 90582534
Systemic inflammatory response syndrome 42.14 11.84 31 45220 6485 90576711
Injection site pain 42.08 11.84 17 45234 173682 90409514
Psoriasis 41.88 11.84 11 45240 147743 90435453
Brain herniation 41.56 11.84 26 45225 4174 90579022
Cardiac arrest neonatal 41.40 11.84 10 45241 108 90583088
Cytomegalovirus hepatitis 41.20 11.84 13 45238 396 90582800
Angiofibroma 41.15 11.84 10 45241 111 90583085
Weight gain poor 40.86 11.84 17 45234 1155 90582041
Neurotoxicity 40.86 11.84 52 45199 21415 90561781
Encephalitis autoimmune 40.40 11.84 20 45231 2038 90581158
CSF oligoclonal band present 39.95 11.84 13 45238 438 90582758
Intentional product use issue 39.85 11.84 30 45221 216862 90366334
Intestinal ischaemia 39.70 11.84 34 45217 8849 90574347
Hepatic enzyme increased 39.53 11.84 75 45176 360661 90222535
Hyperreflexia 39.33 11.84 30 45221 6627 90576569
Lip dry 38.97 11.84 3 45248 100952 90482244
Oxygen saturation abnormal 38.59 11.84 25 45226 4263 90578933
Ultrasound ovary abnormal 38.07 11.84 9 45242 88 90583108
Blood alkaline phosphatase increased 37.95 11.84 78 45173 48001 90535195
Facet joint syndrome 37.76 11.84 3 45248 98386 90484810
Seizure cluster 37.68 11.84 12 45239 377 90582819
Intraventricular haemorrhage neonatal 37.52 11.84 11 45240 260 90582936
C-reactive protein increased 37.49 11.84 22 45229 181367 90401829
Pulmonary fibrosis 36.84 11.84 5 45246 107498 90475698
Aplasia pure red cell 36.53 11.84 26 45225 5168 90578028
Sciatica 36.49 11.84 4 45247 101378 90481818
Treatment noncompliance 36.31 11.84 80 45171 51647 90531549
Respiratory failure 35.65 11.84 135 45116 118283 90464913
Cognitive disorder 35.50 11.84 95 45156 69312 90513884
Therapeutic response unexpected 35.48 11.84 49 45202 21831 90561365
Incoherent 35.21 11.84 25 45226 4952 90578244
Hypertension 34.66 11.84 115 45136 457417 90125779
Cerebral atrophy 34.59 11.84 26 45225 5620 90577576
Myoclonus 34.24 11.84 45 45206 19123 90564073
Drug level above therapeutic 33.93 11.84 26 45225 5783 90577413
Angiomyolipoma 33.73 11.84 10 45241 246 90582950
Epileptic encephalopathy 33.60 11.84 11 45240 378 90582818
Haemophagocytic lymphohistiocytosis 33.54 11.84 40 45211 15419 90567777
Altered state of consciousness 33.40 11.84 58 45193 31474 90551722
Disorientation 32.99 11.84 70 45181 44044 90539152
Pain in extremity 32.93 11.84 115 45136 450414 90132782
Dermatitis exfoliative 32.82 11.84 25 45226 5511 90577685
Lymphangioleiomyomatosis 32.70 11.84 10 45241 274 90582922
Psychotic disorder 32.50 11.84 57 45194 31173 90552023
Paranoia 32.38 11.84 36 45215 12872 90570324
Disease recurrence 32.01 11.84 63 45188 37590 90545606
Mitochondrial DNA mutation 31.84 11.84 11 45240 447 90582749
Porphyria 31.26 11.84 9 45242 199 90582997
Mental impairment 31.03 11.84 40 45211 16680 90566516
Therapeutic product effect decreased 31.02 11.84 57 45194 277514 90305682
Sleep disorder 30.83 11.84 32 45219 197998 90385198
Dwarfism 30.67 11.84 5 45246 3 90583193
Anti-erythropoietin antibody negative 30.46 11.84 8 45243 124 90583072
Lymphadenopathy 30.12 11.84 69 45182 45706 90537490
Urine copper increased 30.08 11.84 5 45246 4 90583192
Product use issue 30.03 11.84 76 45175 329843 90253353
Hyperammonaemic encephalopathy 30.01 11.84 18 45233 2681 90580515
Pleocytosis 29.78 11.84 13 45238 995 90582201
Dyspepsia 29.76 11.84 33 45218 198127 90385069
Urine delta aminolevulinate increased 29.55 11.84 5 45246 5 90583191
Hypoventilation 29.40 11.84 23 45228 5273 90577923
Mobility decreased 29.36 11.84 50 45201 250684 90332512
Brain neoplasm 28.92 11.84 22 45229 4842 90578354
Hypotonia 28.89 11.84 32 45219 11394 90571802
Malaise 28.84 11.84 173 45078 585813 89997383
Left ventricular dysfunction 28.66 11.84 36 45215 14633 90568563
Foetal death 28.61 11.84 43 45208 20680 90562516
Chorea 28.58 11.84 16 45235 2094 90581102
Euthyroid sick syndrome 28.54 11.84 7 45244 81 90583115
Abnormal behaviour 28.50 11.84 45 45206 22583 90560613
Liver function test abnormal 28.47 11.84 72 45179 50773 90532423
Weight increased 28.35 11.84 110 45141 417817 90165379
Gamma-glutamyltransferase increased 28.12 11.84 60 45191 37892 90545304
Ischaemic cerebral infarction 27.69 11.84 14 45237 1492 90581704
Agitation 27.67 11.84 85 45166 67013 90516183
Inflammation 27.64 11.84 29 45222 178563 90404633
Nausea 26.46 11.84 393 44858 1109923 89473273
Blood albumin decreased 26.30 11.84 37 45214 16766 90566430
Laryngeal stenosis 26.25 11.84 13 45238 1326 90581870
Migraine 26.15 11.84 34 45217 190358 90392838
Obesity 26.08 11.84 10 45241 105497 90477699
Rhabdomyolysis 26.05 11.84 70 45181 51186 90532010
Grip strength decreased 26.03 11.84 7 45244 92569 90490627
Product dose omission issue 25.92 11.84 68 45183 291619 90291577
Clonus 25.68 11.84 22 45229 5728 90577468
Atonic seizures 25.66 11.84 11 45240 805 90582391
Malabsorption 25.58 11.84 21 45230 5157 90578039
Hypothermia 25.43 11.84 35 45216 15540 90567656
Oromandibular dystonia 25.33 11.84 10 45241 593 90582603
Leukocytosis 25.32 11.84 51 45200 30939 90552257
Autoimmune disorder 25.29 11.84 4 45247 76740 90506456
Bradycardia 24.74 11.84 95 45156 83752 90499444
Lung disorder 24.73 11.84 23 45228 149860 90433336
Left ventricular hypertrophy 24.41 11.84 22 45229 6122 90577074
Blood creatine phosphokinase increased 24.31 11.84 53 45198 33970 90549226
Postictal paralysis 24.27 11.84 8 45243 281 90582915
Fall 24.24 11.84 356 44895 481454 90101742
Hepatitis 24.12 11.84 84 45167 70655 90512541
Hepatic failure 24.08 11.84 58 45193 39670 90543526
Coma scale abnormal 24.06 11.84 21 45230 5605 90577591
Perforation 24.01 11.84 14 45237 1980 90581216
Blister 23.77 11.84 58 45193 254940 90328256
Gait disturbance 23.71 11.84 216 45035 260280 90322916
Gingival disorder 23.61 11.84 18 45233 3973 90579223
Tachycardia 23.57 11.84 147 45104 157526 90425670
Posterior reversible encephalopathy syndrome 23.54 11.84 41 45210 22298 90560898
Contusion 23.53 11.84 57 45194 251159 90332037
Rash morbilliform 23.46 11.84 18 45233 4011 90579185
Gastrointestinal disorder 23.45 11.84 59 45192 256628 90326568
Porphyrins stool increased 23.30 11.84 5 45246 30 90583166
Creutzfeldt-Jakob disease 23.28 11.84 7 45244 181 90583015
Gene mutation 23.15 11.84 14 45237 2116 90581080
Chest pain 23.06 11.84 82 45169 319563 90263633
Ophthalmoplegia 22.98 11.84 13 45238 1736 90581460
Areflexia 22.77 11.84 17 45234 3636 90579560
Hypercholesterolaemia 22.66 11.84 11 45240 100881 90482315
Vomiting projectile 22.57 11.84 13 45238 1796 90581400
Oropharyngeal oedema 22.37 11.84 8 45243 360 90582836
Mucosal erosion 22.33 11.84 13 45238 1832 90581364
Aphasia 22.29 11.84 59 45192 42753 90540443
Ammonia increased 22.11 11.84 19 45232 4967 90578229
Myocardial depression 21.46 11.84 9 45242 624 90582572
Blood gases abnormal 21.26 11.84 10 45241 911 90582285
Brain operation 21.11 11.84 9 45242 650 90582546
Glioblastoma multiforme 21.08 11.84 10 45241 928 90582268
White matter lesion 20.99 11.84 14 45237 2507 90580689
Hemiparesis 20.97 11.84 48 45203 31771 90551425
Hallucination, tactile 20.95 11.84 8 45243 434 90582762
Blood magnesium decreased 20.87 11.84 32 45219 15661 90567535
Autism spectrum disorder 20.84 11.84 11 45240 1282 90581914
Magnetic resonance imaging head abnormal 20.81 11.84 14 45237 2542 90580654
Ventricular tachycardia 20.59 11.84 41 45210 24667 90558529
Plasmodium falciparum infection 20.54 11.84 5 45246 56 90583140
Joint contracture 20.49 11.84 12 45239 1710 90581486
Prescribed underdose 20.48 11.84 6 45245 75013 90508183
Abdominal pain 20.42 11.84 115 45136 395606 90187590
Knee arthroplasty 20.37 11.84 8 45243 83174 90500022
Intensive care unit acquired weakness 20.37 11.84 10 45241 1001 90582195
Intensive care unit delirium 20.30 11.84 5 45246 59 90583137
Ventricular dysfunction 20.27 11.84 16 45235 3715 90579481
Colitis ulcerative 20.18 11.84 3 45248 60263 90522933
Calcinosis 20.14 11.84 14 45237 2681 90580515
Alanine aminotransferase increased 20.04 11.84 114 45137 118224 90464972
Metabolic acidosis 19.76 11.84 67 45184 55609 90527587
Cerebellar syndrome 19.75 11.84 16 45235 3856 90579340
Paradoxical drug reaction 19.74 11.84 19 45232 5747 90577449
Nail disorder 19.64 11.84 3 45248 59064 90524132
Hypersomnia 19.49 11.84 37 45214 21494 90561702
Bronchitis 19.31 11.84 29 45222 152898 90430298
Dystonia 19.21 11.84 32 45219 16787 90566409
Fluid retention 19.18 11.84 10 45241 88081 90495115
Rickets 19.13 11.84 5 45246 76 90583120
Injury 19.10 11.84 44 45207 197305 90385891
Hallucination, auditory 19.07 11.84 31 45220 15944 90567252
Arthritis 19.00 11.84 34 45217 167281 90415915
Cardiomegaly 18.99 11.84 34 45217 18891 90564305
Medication error 18.82 11.84 88 45163 84564 90498632
Chronic graft versus host disease 18.82 11.84 16 45235 4123 90579073
Live birth 18.74 11.84 8 45243 79099 90504097
Frequent bowel movements 18.69 11.84 3 45248 56932 90526264
COVID-19 18.56 11.84 35 45216 168808 90414388
Torticollis 18.44 11.84 13 45238 2545 90580651
Ovarian failure 18.38 11.84 11 45240 1632 90581564
Neonatal seizure 18.36 11.84 8 45243 609 90582587
Illusion 18.26 11.84 10 45241 1254 90581942
Lower limb fracture 18.00 11.84 10 45241 85003 90498193
Adverse drug reaction 17.99 11.84 19 45232 116682 90466514
Aspartate aminotransferase increased 17.98 11.84 100 45151 102837 90480359
Hirsutism 17.97 11.84 11 45240 1699 90581497
Completed suicide 17.93 11.84 129 45122 144929 90438267
Laryngeal pain 17.90 11.84 16 45235 4406 90578790
Gastrooesophageal reflux disease 17.83 11.84 35 45216 166302 90416894
Impaired self-care 17.67 11.84 11 45240 1751 90581445
Product formulation issue 17.58 11.84 8 45243 675 90582521
Oedema 17.55 11.84 47 45204 200248 90382948
Hyporeflexia 17.47 11.84 12 45239 2254 90580942
Face oedema 17.43 11.84 37 45214 23281 90559915
Endotracheal intubation 17.37 11.84 14 45237 3350 90579846
Intention tremor 17.31 11.84 7 45244 442 90582754
Idiopathic pneumonia syndrome 17.28 11.84 7 45244 444 90582752
Pruritus 17.24 11.84 180 45071 541345 90041851
Hypoxic-ischaemic encephalopathy 17.16 11.84 16 45235 4652 90578544
Cross sensitivity reaction 17.15 11.84 13 45238 2844 90580352
Periorbital oedema 17.12 11.84 19 45232 6780 90576416
Red blood cell sedimentation rate increased 17.08 11.84 10 45241 82585 90500611
Epileptic psychosis 16.75 11.84 4 45247 41 90583155
Hypersensitivity vasculitis 16.74 11.84 15 45236 4144 90579052
Tongue ulceration 16.71 11.84 15 45236 4153 90579043
SJS-TEN overlap 16.66 11.84 9 45242 1099 90582097
Insomnia 16.61 11.84 98 45153 333376 90249820
Rasmussen encephalitis 16.52 11.84 3 45248 6 90583190
Toxic encephalopathy 16.44 11.84 21 45230 8678 90574518
Irritability 16.43 11.84 47 45204 35615 90547581
Shock 16.37 11.84 41 45210 28737 90554459
Enterocolitis 16.27 11.84 23 45228 10467 90572729
Head injury 16.26 11.84 43 45208 31145 90552051
Muscle spasms 15.99 11.84 68 45183 251815 90331381
Electrocardiogram QT prolonged 15.87 11.84 75 45176 72381 90510815
Foot deformity 15.87 11.84 5 45246 59646 90523550
Inappropriate antidiuretic hormone secretion 15.81 11.84 32 45219 19473 90563723
Hallucination 15.73 11.84 70 45181 65889 90517307
Lip erosion 15.72 11.84 9 45242 1229 90581967
Caesarean section 15.69 11.84 31 45220 18546 90564650
Labelled drug-drug interaction medication error 15.67 11.84 27 45224 14555 90568641
Central nervous system infection 15.65 11.84 8 45243 873 90582323
Asterixis 15.60 11.84 10 45241 1675 90581521
Coagulation time prolonged 15.57 11.84 10 45241 1680 90581516
Hypomagnesaemia 15.53 11.84 46 45205 35542 90547654
Aspiration 15.50 11.84 28 45223 15665 90567531
Hospitalisation 15.49 11.84 25 45226 128075 90455121
Enzyme induction 15.48 11.84 4 45247 58 90583138
Cerebellar cognitive affective syndrome 15.41 11.84 3 45248 10 90583186
Behaviour disorder 15.35 11.84 15 45236 4620 90578576
Pyroglutamate increased 15.28 11.84 6 45245 351 90582845
Lactose intolerance 15.27 11.84 13 45238 3356 90579840
Cachexia 15.26 11.84 18 45233 6860 90576336
Injection site erythema 15.23 11.84 16 45235 98486 90484710
Premature menopause 15.13 11.84 9 45242 1320 90581876
Linear IgA disease 15.12 11.84 11 45240 2263 90580933
International normalised ratio increased 15.11 11.84 55 45196 47261 90535935
Decreased appetite 15.10 11.84 118 45133 376422 90206774
Adverse event 15.08 11.84 22 45229 117396 90465800
Biopsy brain 14.99 11.84 3 45248 12 90583184
Intestinal dilatation 14.96 11.84 11 45240 2299 90580897
Premature delivery 14.96 11.84 48 45203 38714 90544482
Liver injury 14.96 11.84 40 45211 170527 90412669
Product dispensing error 14.90 11.84 24 45227 12249 90570947
Back pain 14.86 11.84 95 45156 317080 90266116
Rash erythematous 14.71 11.84 68 45183 65036 90518160
Cerebral venous sinus thrombosis 14.69 11.84 11 45240 2365 90580831
Thrombocytopenia 14.61 11.84 164 45087 208561 90374635
Incontinence 14.60 11.84 25 45226 13410 90569786
Epileptic aura 14.57 11.84 4 45247 74 90583122
Potentiating drug interaction 14.56 11.84 16 45235 5646 90577550
Extensor plantar response 14.54 11.84 9 45242 1418 90581778
Allodynia 14.51 11.84 8 45243 1016 90582180
Urticaria 14.49 11.84 94 45157 312640 90270556
Myoglobinuria 14.47 11.84 6 45245 404 90582792
Haemorrhagic stroke 14.41 11.84 17 45234 6479 90576717
Transaminases increased 14.31 11.84 46 45205 37146 90546050
Hallucination, visual 14.30 11.84 34 45217 23058 90560138
Injection site swelling 14.25 11.84 6 45245 59833 90523363
Intestinal infarction 14.21 11.84 8 45243 1059 90582137
Blepharospasm 14.13 11.84 5 45246 55440 90527756
Tardive dyskinesia 14.13 11.84 22 45229 10908 90572288
Drug withdrawal convulsions 14.13 11.84 9 45242 1491 90581705
Coagulopathy 14.11 11.84 34 45217 23255 90559941
Agranulocytosis 14.11 11.84 44 45207 34958 90548238
Hepatic function abnormal 14.11 11.84 53 45198 46235 90536961
Joint stiffness 14.06 11.84 11 45240 78031 90505165
Infrequent bowel movements 14.05 11.84 9 45242 1505 90581691
Pyrexia 14.00 11.84 430 44821 660055 89923141
Laryngitis 13.96 11.84 4 45247 50749 90532447
Antinuclear antibody positive 13.95 11.84 20 45231 9221 90573975
Sepsis 13.85 11.84 144 45107 179670 90403526
Infection 13.81 11.84 115 45136 361979 90221217
Clumsiness 13.78 11.84 11 45240 2596 90580600
Hypernatraemia 13.71 11.84 20 45231 9367 90573829
Reflexes abnormal 13.71 11.84 7 45244 762 90582434
Communication disorder 13.58 11.84 12 45239 3254 90579942
Post-traumatic epilepsy 13.58 11.84 3 45248 21 90583175
Cardio-respiratory arrest 13.57 11.84 65 45186 63075 90520121
Aplastic anaemia 13.52 11.84 24 45227 13245 90569951
Dry eye 13.49 11.84 6 45245 57925 90525271
Apallic syndrome 13.48 11.84 7 45244 789 90582407
Injection site pruritus 13.48 11.84 5 45246 53829 90529367
Ear pain 13.40 11.84 6 45245 57696 90525500
Electrocardiogram ST segment elevation 13.31 11.84 13 45238 4003 90579193
Staring 13.25 11.84 9 45242 1661 90581535
Blood calcium decreased 13.16 11.84 39 45212 30143 90553053
Subdural haematoma 13.13 11.84 27 45224 16618 90566578
Hypertrophic cardiomyopathy 13.07 11.84 10 45241 2218 90580978
Vertebral osteophyte 13.01 11.84 6 45245 522 90582674
Haemodynamic instability 12.96 11.84 22 45229 11717 90571479
Methylobacterium infection 12.91 11.84 3 45248 27 90583169
Fulminant type 1 diabetes mellitus 12.83 11.84 7 45244 871 90582325
Palpitations 12.81 11.84 31 45220 136697 90446499
Hypoaesthesia 12.81 11.84 98 45153 314112 90269084
Nodal arrhythmia 12.73 11.84 8 45243 1295 90581901
Loss of personal independence in daily activities 12.64 11.84 31 45220 136074 90447122
Respiratory tract infection 12.44 11.84 7 45244 59071 90524125
Treatment failure 12.29 11.84 95 45156 303833 90279363
Refusal of treatment by relative 12.27 11.84 5 45246 322 90582874
Postictal state 12.24 11.84 8 45243 1385 90581811
Antipsychotic drug level below therapeutic 12.23 11.84 5 45246 325 90582871
Low birth weight baby 12.16 11.84 19 45232 9448 90573748
Sedation 12.15 11.84 52 45199 48119 90535077
Pharyngeal disorder 12.12 11.84 10 45241 2473 90580723
Catatonia 12.05 11.84 15 45236 6041 90577155
Pseudolymphoma 11.92 11.84 6 45245 634 90582562
Prescribed overdose 11.85 11.84 19 45232 97606 90485590

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 2080.77 13.32 1367 41613 119194 42459161
Anticonvulsant drug level increased 760.80 13.32 200 42780 1443 42576912
Status epilepticus 747.09 13.32 348 42632 15230 42563125
Nystagmus 743.79 13.32 258 42722 5138 42573217
Toxicity to various agents 700.12 13.32 998 41982 228138 42350217
Ataxia 698.98 13.32 336 42644 15789 42562566
Drug reaction with eosinophilia and systemic symptoms 626.38 13.32 437 42543 41638 42536717
Anticonvulsant drug level decreased 523.71 13.32 140 42840 1085 42577270
Anticonvulsant drug level above therapeutic 469.48 13.32 115 42865 598 42577757
Generalised tonic-clonic seizure 399.36 13.32 277 42703 26102 42552253
Drug interaction 385.36 13.32 837 42143 266162 42312193
Drug ineffective 298.01 13.32 1336 41644 628861 41949494
Multiple-drug resistance 297.32 13.32 146 42834 7176 42571179
Anticonvulsant drug level below therapeutic 283.24 13.32 77 42903 640 42577715
Stevens-Johnson syndrome 269.72 13.32 204 42776 21974 42556381
Product complaint 266.28 13.32 127 42853 5850 42572505
Partial seizures 262.57 13.32 125 42855 5734 42572621
Epilepsy 227.75 13.32 198 42782 25973 42552382
Inspiratory capacity decreased 219.43 13.32 90 42890 2877 42575478
Drug level decreased 207.77 13.32 128 42852 9849 42568506
Cerebellar atrophy 206.96 13.32 61 42919 697 42577658
Purple glove syndrome 172.44 13.32 34 42946 44 42578311
Diarrhoea 146.27 13.32 150 42830 460699 42117656
Dysarthria 136.53 13.32 184 42796 39623 42538732
Drug level below therapeutic 136.34 13.32 84 42896 6461 42571894
Drug level increased 126.76 13.32 144 42836 26056 42552299
Dyspnoea 119.08 13.32 164 42816 442457 42135898
Gingival hypertrophy 118.40 13.32 55 42925 2384 42575971
Hyperammonaemia 115.20 13.32 81 42899 7785 42570570
Coordination abnormal 108.93 13.32 79 42901 7971 42570384
Drug level fluctuating 107.60 13.32 36 42944 638 42577717
Drug resistance 96.28 13.32 144 42836 34104 42544251
Drug hypersensitivity 95.16 13.32 267 42713 99122 42479233
Confusional state 93.37 13.32 375 42605 167222 42411133
Mental status changes 90.89 13.32 157 42823 41958 42536397
Arthralgia 87.66 13.32 49 42931 205189 42373166
Sudden unexplained death in epilepsy 87.42 13.32 29 42951 500 42577855
Diabetes insipidus 85.96 13.32 51 42929 3662 42574693
Product substitution issue 83.54 13.32 78 42902 11212 42567143
Drug level changed 82.47 13.32 26 42954 378 42577977
Drug level above therapeutic 82.29 13.32 59 42921 5847 42572508
Drug ineffective for unapproved indication 75.74 13.32 153 42827 46010 42532345
Gait disturbance 75.60 13.32 244 42736 97756 42480599
Febrile neutropenia 75.52 13.32 47 42933 185656 42392699
Sedation 68.90 13.32 116 42864 30359 42547996
Cerebral atrophy 66.80 13.32 49 42931 5030 42573325
Somnolence 63.38 13.32 296 42684 140809 42437546
Intensive care unit acquired weakness 62.59 13.32 29 42951 1249 42577106
Anticonvulsant drug level abnormal 62.12 13.32 13 42967 27 42578328
Toxic epidermal necrolysis 62.04 13.32 103 42877 26647 42551708
Brain oedema 59.84 13.32 78 42902 16249 42562106
Anaemia 58.44 13.32 122 42858 280156 42298199
Lethargy 58.27 13.32 139 42841 46751 42531604
Fall 58.11 13.32 420 42560 234100 42344255
Foetal anticonvulsant syndrome 58.01 13.32 27 42953 1175 42577180
Cross sensitivity reaction 58.01 13.32 30 42950 1645 42576710
Balance disorder 56.80 13.32 139 42841 47506 42530849
Rash maculo-papular 56.46 13.32 120 42860 37383 42540972
Acute kidney injury 56.00 13.32 187 42793 367150 42211205
Fatigue 55.91 13.32 238 42742 435403 42142952
Focal dyscognitive seizures 55.82 13.32 28 42952 1439 42576916
Cerebellar ataxia 55.12 13.32 26 42954 1167 42577188
Cough 53.99 13.32 60 42920 178043 42400312
Dyskinesia 53.91 13.32 94 42886 25296 42553059
COVID-19 53.46 13.32 25 42955 115923 42462432
Cerebellar syndrome 52.83 13.32 34 42946 2821 42575534
Gaze palsy 51.65 13.32 29 42951 1876 42576479
Hyperammonaemic encephalopathy 51.42 13.32 33 42947 2725 42575630
Petit mal epilepsy 49.79 13.32 36 42944 3614 42574741
Death 49.14 13.32 277 42703 470908 42107447
Depressed level of consciousness 48.96 13.32 132 42848 47838 42530517
Agitation 48.54 13.32 159 42821 64155 42514200
Pain 47.38 13.32 111 42869 244737 42333618
Urine copper increased 46.88 13.32 9 42971 9 42578346
Excessive eye blinking 45.83 13.32 19 42961 624 42577731
Stupor 45.08 13.32 32 42948 3121 42575234
Nervous system disorder 45.06 13.32 70 42910 17125 42561230
Therapeutic response unexpected 44.26 13.32 56 42924 11325 42567030
Joint swelling 43.45 13.32 8 42972 68014 42510341
Overdose 43.03 13.32 215 42765 105049 42473306
Pneumonia 42.46 13.32 251 42729 421898 42156457
Tonic convulsion 41.60 13.32 24 42956 1635 42576720
Postictal paralysis 40.51 13.32 15 42965 362 42577993
Necrosis ischaemic 39.98 13.32 15 42965 376 42577979
Back pain 39.50 13.32 51 42929 141725 42436630
Cardiac failure 39.47 13.32 30 42950 106826 42471529
Coagulopathy 39.40 13.32 76 42904 22086 42556269
Choreoathetosis 38.80 13.32 20 42960 1089 42577266
Aura 38.76 13.32 15 42965 410 42577945
Asthma 38.38 13.32 8 42972 62306 42516049
Simple partial seizures 38.26 13.32 15 42965 425 42577930
Barbiturates positive 38.14 13.32 7 42973 4 42578351
Interstitial lung disease 37.59 13.32 16 42964 78446 42499909
Myalgia 36.75 13.32 26 42954 96054 42482301
Past-pointing 36.65 13.32 8 42972 22 42578333
Injection site pain 36.48 13.32 7 42973 57791 42520564
Porphyrins stool increased 36.46 13.32 7 42973 7 42578348
Chest pain 35.08 13.32 54 42926 139476 42438879
Mucosal erosion 34.80 13.32 18 42962 987 42577368
Asterixis 34.74 13.32 20 42960 1357 42576998
Hypothermia 34.27 13.32 52 42928 12463 42565892
Hypotonia 34.21 13.32 45 42935 9454 42568901
Diplopia 34.09 13.32 68 42912 20248 42558107
Glioblastoma multiforme 34.05 13.32 17 42963 865 42577490
Abdominal pain 33.97 13.32 90 42890 190381 42387974
Gamma-glutamyltransferase increased 33.73 13.32 90 42890 32407 42545948
Product dose omission issue 33.13 13.32 66 42914 154299 42424056
Encephalopathy 32.82 13.32 104 42876 41229 42537126
Dysmetria 32.74 13.32 16 42964 777 42577578
Blood homocysteine increased 32.59 13.32 12 42968 285 42578070
Completed suicide 32.58 13.32 187 42793 96278 42482077
Malaise 32.25 13.32 108 42872 212048 42366307
Dystonia 32.03 13.32 51 42929 12739 42565616
Inhibitory drug interaction 31.46 13.32 21 42959 1853 42576502
Hypoplastic left heart syndrome 31.41 13.32 11 42969 225 42578130
Hippocampal sclerosis 31.19 13.32 10 42970 154 42578201
Posture abnormal 30.20 13.32 23 42957 2498 42575857
Hemiparesis 30.17 13.32 59 42921 17317 42561038
Cognitive disorder 29.94 13.32 89 42891 34083 42544272
Aphasia 29.48 13.32 71 42909 24012 42554343
Nausea 29.15 13.32 258 42722 396541 42181814
Idiosyncratic drug reaction 29.12 13.32 13 42967 513 42577842
Extensor plantar response 28.82 13.32 14 42966 671 42577684
Constipation 28.69 13.32 77 42903 162214 42416141
Obliterative bronchiolitis 28.53 13.32 18 42962 1443 42576912
Pain in extremity 28.52 13.32 69 42911 150535 42427820
Erythema multiforme 28.09 13.32 42 42938 9935 42568420
Myelosuppression 27.53 13.32 4 42976 40457 42537898
Drug withdrawal convulsions 27.42 13.32 17 42963 1321 42577034
Inappropriate schedule of product administration 27.21 13.32 34 42946 95868 42482487
Atrial fibrillation 27.19 13.32 63 42917 139530 42438825
Labelled drug-drug interaction medication error 27.17 13.32 53 42927 15529 42562826
Hyperreflexia 26.83 13.32 25 42955 3582 42574773
Unresponsive to stimuli 26.77 13.32 81 42899 31322 42547033
Ascites 26.45 13.32 12 42968 56666 42521689
Aggression 26.28 13.32 101 42879 44062 42534293
Chorea 26.24 13.32 17 42963 1427 42576928
Acidosis hyperchloraemic 25.94 13.32 13 42967 667 42577688
Loss of consciousness 25.50 13.32 170 42810 92184 42486171
Porphyria acute 25.35 13.32 11 42969 405 42577950
Blood albumin decreased 25.18 13.32 51 42929 15351 42563004
Superinfection 24.99 13.32 22 42958 2929 42575426
Treatment noncompliance 24.79 13.32 89 42891 37583 42540772
Mucosal ulceration 24.75 13.32 16 42964 1338 42577017
Electroencephalogram abnormal 24.73 13.32 22 42958 2970 42575385
Chest discomfort 24.60 13.32 17 42963 63599 42514756
Pneumonitis 24.40 13.32 6 42974 41712 42536643
Liver function test abnormal 24.35 13.32 80 42900 32311 42546044
Intestinal ischaemia 24.29 13.32 38 42942 9350 42569005
Neonatal respiratory depression 24.16 13.32 11 42969 455 42577900
Ophthalmoplegia 24.03 13.32 19 42961 2181 42576174
Haematuria traumatic 23.93 13.32 10 42970 335 42578020
Propofol infusion syndrome 23.87 13.32 15 42965 1194 42577161
Infusion related reaction 23.85 13.32 16 42964 60790 42517565
Gliosis 23.54 13.32 9 42971 238 42578117
Wheezing 23.46 13.32 13 42967 54768 42523587
Haematochezia 23.43 13.32 15 42965 58421 42519934
Prostate cancer 23.21 13.32 8 42972 44635 42533720
Intention tremor 23.21 13.32 11 42969 499 42577856
Encephalomalacia 23.07 13.32 14 42966 1047 42577308
Dehydration 23.04 13.32 70 42910 141697 42436658
Drug eruption 23.04 13.32 63 42917 23012 42555343
Oedema peripheral 22.97 13.32 66 42914 136010 42442345
Malignant neoplasm progression 22.69 13.32 47 42933 108353 42470002
Gingival disorder 22.56 13.32 16 42964 1558 42576797
Gingival atrophy 22.49 13.32 6 42974 46 42578309
Pulmonary embolism 22.48 13.32 55 42925 119557 42458798
Autonomic nervous system imbalance 22.04 13.32 21 42959 3095 42575260
Eosinophilia 21.88 13.32 78 42902 32821 42545534
Hyperchloraemia 21.79 13.32 11 42969 573 42577782
Myoclonic epilepsy 21.67 13.32 16 42964 1658 42576697
Myoclonus 21.63 13.32 51 42929 17014 42561341
Muscle contracture 21.53 13.32 15 42965 1420 42576935
Postictal state 21.01 13.32 13 42967 1007 42577348
Decreased appetite 20.88 13.32 112 42868 193025 42385330
Postictal psychosis 20.87 13.32 8 42972 213 42578142
Urine delta aminolevulinate increased 20.83 13.32 4 42976 4 42578351
Chills 20.35 13.32 40 42940 94026 42484329
Eye movement disorder 20.29 13.32 25 42955 4920 42573435
Hepatitis fulminant 20.24 13.32 25 42955 4934 42573421
Malabsorption 20.21 13.32 19 42961 2754 42575601
Speech disorder 20.19 13.32 70 42910 29051 42549304
Psoriasis 20.14 13.32 12 42968 48592 42529763
Influenza like illness 19.79 13.32 4 42976 31836 42546519
Haemoglobin decreased 19.72 13.32 68 42912 132403 42445952
Blood ketone body increased 19.69 13.32 10 42970 528 42577827
Fluid retention 19.59 13.32 4 42976 31615 42546740
Abnormal behaviour 19.59 13.32 65 42915 26386 42551969
Wrong patient received product 19.58 13.32 21 42959 3562 42574793
Encephalitis 19.56 13.32 34 42946 9124 42569231
Coma 19.52 13.32 106 42874 53448 42524907
Lymphocyte morphology abnormal 19.44 13.32 10 42970 542 42577813
Muscle twitching 19.25 13.32 39 42941 11741 42566614
Cardiac arrest 19.05 13.32 181 42799 109139 42469216
Atonic seizures 19.01 13.32 9 42971 407 42577948
Peripheral swelling 19.00 13.32 39 42941 90231 42488124
Myocardial infarction 18.91 13.32 63 42917 123946 42454409
Partial seizures with secondary generalisation 18.83 13.32 9 42971 416 42577939
Serotonin syndrome 18.69 13.32 63 42917 25782 42552573
Tremor 18.67 13.32 164 42816 96765 42481590
Pancytopenia 18.51 13.32 59 42921 117684 42460671
Accidental death 18.51 13.32 19 42961 3064 42575291
Hyperkinesia 18.49 13.32 16 42964 2082 42576273
Open reduction of fracture 18.33 13.32 6 42974 99 42578256
White blood cell count decreased 18.30 13.32 54 42926 110342 42468013
Muscle spasms 18.26 13.32 37 42943 86007 42492348
Ammonia increased 18.23 13.32 23 42957 4636 42573719
Conjunctival hyperaemia 18.03 13.32 19 42961 3157 42575198
Plasma cell myeloma 18.02 13.32 13 42967 47565 42530790
Arthropathy 17.82 13.32 4 42976 29593 42548762
Synkinesis 17.70 13.32 3 42977 0 42578355
Methylenetetrahydrofolate reductase deficiency 17.70 13.32 3 42977 0 42578355
Abdominal compartment syndrome 17.64 13.32 12 42968 1093 42577262
Vitamin B6 deficiency 17.61 13.32 8 42972 329 42578026
Brain herniation 17.60 13.32 23 42957 4800 42573555
C-reactive protein increased 17.54 13.32 23 42957 63537 42514818
Hospitalisation 17.51 13.32 30 42950 74300 42504055
Platelet count decreased 17.50 13.32 76 42904 138505 42439850
Dyspnoea exertional 17.36 13.32 15 42965 50133 42528222
Colitis 17.28 13.32 13 42967 46559 42531796
Cytokine storm 17.26 13.32 11 42969 897 42577458
Metabolic acidosis 17.15 13.32 100 42880 51758 42526597
Treatment failure 17.11 13.32 115 42865 62509 42515846
Personality disorder 17.08 13.32 12 42968 1151 42577204
Macule 16.89 13.32 15 42965 2020 42576335
Echopraxia 16.80 13.32 4 42976 18 42578337
Cataract 16.77 13.32 5 42975 30599 42547756
Dysstasia 16.67 13.32 41 42939 14045 42564310
Unmasking of previously unidentified disease 16.49 13.32 12 42968 1217 42577138
Gout 16.47 13.32 4 42976 28051 42550304
Vitamin B6 decreased 16.46 13.32 4 42976 20 42578335
Dermatitis exfoliative 16.44 13.32 27 42953 6920 42571435
Hepatic necrosis 16.41 13.32 20 42960 3893 42574462
Abdominal pain upper 16.30 13.32 37 42943 82572 42495783
Abdominal discomfort 16.28 13.32 32 42948 75223 42503132
Chronic obstructive pulmonary disease 16.26 13.32 24 42956 63090 42515265
Memory impairment 16.06 13.32 96 42884 50126 42528229
Inflammation 16.05 13.32 7 42973 33840 42544515
Cerebral ataxia 15.99 13.32 4 42976 23 42578332
Staring 15.86 13.32 13 42967 1570 42576785
Nightmare 15.84 13.32 3 42977 25009 42553346
Haemoptysis 15.75 13.32 14 42966 46153 42532202
Prescribed overdose 15.70 13.32 38 42942 12889 42565466
Soft tissue haemorrhage 15.68 13.32 6 42974 159 42578196
Pleomorphic adenoma 15.63 13.32 3 42977 3 42578352
Nasopharyngeal reflux 15.63 13.32 3 42977 3 42578352
Haemophagocytic lymphohistiocytosis 15.52 13.32 47 42933 18175 42560180
Areflexia 15.48 13.32 19 42961 3724 42574631
Tubulointerstitial nephritis 15.48 13.32 68 42912 31480 42546875
Hypocalcaemic seizure 15.48 13.32 5 42975 79 42578276
Rash morbilliform 15.46 13.32 20 42960 4133 42574222
Drug abuse 15.44 13.32 54 42926 104717 42473638
Blood glucose increased 15.38 13.32 32 42948 73667 42504688
Impetigo 15.35 13.32 12 42968 1354 42577001
Learning disorder 15.23 13.32 11 42969 1102 42577253
Lymphocytosis 15.23 13.32 17 42963 3014 42575341
Intentional product use issue 15.15 13.32 31 42949 71802 42506553
Intracranial pressure increased 15.09 13.32 21 42959 4653 42573702
General physical health deterioration 15.09 13.32 90 42890 151156 42427199
Pleocytosis 15.04 13.32 9 42971 656 42577699
Hypernatraemia 14.97 13.32 32 42948 10000 42568355
Weight decreased 14.87 13.32 136 42844 207812 42370543
Colitis ulcerative 14.85 13.32 4 42976 26171 42552184
Epistaxis 14.82 13.32 28 42952 66798 42511557
Dizziness 14.77 13.32 342 42638 248912 42329443
Eczema 14.72 13.32 8 42972 34078 42544277
Alcohol withdrawal syndrome 14.72 13.32 12 42968 1439 42576916
Blood creatinine increased 14.71 13.32 59 42921 109944 42468411
Acute generalised exanthematous pustulosis 14.70 13.32 29 42951 8566 42569789
Nephritis allergic 14.66 13.32 9 42971 687 42577668
Neutrophil count decreased 14.57 13.32 26 42954 63389 42514966
Anaphylactic shock 14.52 13.32 3 42977 23514 42554841
Febrile convulsion 14.51 13.32 9 42971 700 42577655
Skin warm 14.47 13.32 16 42964 2807 42575548
Fibrous dysplasia of bone 14.41 13.32 3 42977 6 42578349
Pseudostroke 14.33 13.32 5 42975 101 42578254
Pneumonia aspiration 14.31 13.32 93 42887 49985 42528370
Syncope 14.14 13.32 52 42928 99354 42479001
Thrombosis 14.08 13.32 30 42950 68481 42509874
Pneumocystis jirovecii pneumonia 14.01 13.32 4 42976 25177 42553178
Hypertension 13.93 13.32 105 42875 167099 42411256
Influenza 13.83 13.32 26 42954 62149 42516206
Angina pectoris 13.80 13.32 8 42972 32888 42545467
Congenital nail disorder 13.71 13.32 4 42976 44 42578311
Grimacing 13.69 13.32 7 42973 375 42577980
Intellectual disability 13.65 13.32 13 42967 1914 42576441
Vasogenic cerebral oedema 13.63 13.32 10 42970 1026 42577329
Lid lag 13.55 13.32 3 42977 9 42578346
Lower respiratory tract infection 13.46 13.32 13 42967 41193 42537162
Orthostatic hypotension 13.46 13.32 7 42973 30563 42547792
Cerebral palsy 13.40 13.32 7 42973 392 42577963
Cardiac failure congestive 13.38 13.32 43 42937 85559 42492796
Retinal vein occlusion 13.35 13.32 13 42967 1968 42576387

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 2880.25 11.91 1813 72898 219372 110295216
Status epilepticus 1372.41 11.91 584 74127 30987 110483601
Toxicity to various agents 1354.30 11.91 1641 73070 478914 110035674
Drug reaction with eosinophilia and systemic symptoms 1298.72 11.91 764 73947 81331 110433257
Ataxia 1272.55 11.91 546 74165 29562 110485026
Anticonvulsant drug level increased 1191.08 11.91 295 74416 2563 110512025
Nystagmus 1163.04 11.91 395 74316 11182 110503406
Drug interaction 983.34 11.91 1433 73278 498750 110015838
Generalised tonic-clonic seizure 745.82 11.91 463 74248 54217 110460371
Multiple-drug resistance 731.93 11.91 291 74420 12944 110501644
Anticonvulsant drug level decreased 709.73 11.91 184 74527 1952 110512636
Anticonvulsant drug level above therapeutic 689.06 11.91 162 74549 1100 110513488
Stevens-Johnson syndrome 629.12 11.91 393 74318 46508 110468080
Anticonvulsant drug level below therapeutic 484.43 11.91 120 74591 1042 110513546
Drug ineffective 445.52 11.91 2112 72599 1518428 108996160
Partial seizures 421.39 11.91 188 74523 11161 110503427
Purple glove syndrome 381.39 11.91 77 74634 220 110514368
Cerebellar atrophy 358.80 11.91 99 74612 1354 110513234
Drug level decreased 315.05 11.91 181 74530 18367 110496221
Epilepsy 273.69 11.91 338 74373 99871 110414717
Dysarthria 249.70 11.91 296 74415 83825 110430763
Toxic epidermal necrolysis 246.28 11.91 244 74467 56483 110458105
Gingival hypertrophy 235.13 11.91 94 74617 4237 110510351
Drug level increased 231.15 11.91 218 74493 47501 110467087
Arthralgia 228.83 11.91 121 74590 779511 109735077
Drug hypersensitivity 222.31 11.91 743 73968 453347 110061241
Inspiratory capacity decreased 208.50 11.91 75 74636 2520 110512068
Joint swelling 205.34 11.91 28 74683 442817 110071771
Drug resistance 197.16 11.91 216 74495 56158 110458430
Hyperammonaemia 194.00 11.91 119 74592 13613 110500975
Diarrhoea 187.65 11.91 301 74410 1139204 109375384
Drug ineffective for unapproved indication 181.44 11.91 281 74430 102557 110412031
Diabetes insipidus 179.34 11.91 88 74623 6482 110508106
Product complaint 174.56 11.91 112 74599 13860 110500728
Dyspnoea 169.67 11.91 306 74405 1106566 109408022
Mental status changes 166.17 11.91 230 74481 75892 110438696
Rash maculo-papular 163.13 11.91 225 74486 73997 110440591
Alopecia 160.04 11.91 27 74684 364726 110149862
Infusion related reaction 155.00 11.91 34 74677 381128 110133460
Pain 148.94 11.91 261 74450 954694 109559894
Focal dyscognitive seizures 146.85 11.91 65 74646 3784 110510804
Arthropathy 143.64 11.91 14 74697 287508 110227080
Electroencephalogram abnormal 143.03 11.91 74 74637 6099 110508489
Somnolence 140.30 11.91 481 74230 296968 110217620
Rheumatoid arthritis 138.68 11.91 19 74692 299594 110214994
Diplopia 135.29 11.91 154 74557 41740 110472848
Fatigue 133.37 11.91 402 74309 1215556 109299032
Anticonvulsant drug level abnormal 132.53 11.91 25 74686 43 110514545
Encephalopathy 128.55 11.91 211 74500 80844 110433744
Necrosis ischaemic 123.34 11.91 43 74668 1316 110513272
Cerebellar ataxia 122.73 11.91 48 74663 2040 110512548
Abdominal discomfort 121.55 11.91 57 74654 393801 110120787
Overdose 118.12 11.91 387 74324 233407 110281181
Drug level below therapeutic 117.94 11.91 82 74629 11591 110502997
Pemphigus 116.87 11.91 7 74704 214563 110300025
Pericarditis 116.82 11.91 8 74703 219106 110295482
Glossodynia 115.79 11.91 9 74702 221995 110292593
Psoriatic arthropathy 111.63 11.91 5 74706 196756 110317832
Discomfort 111.16 11.91 9 74702 214698 110299890
Wound 110.56 11.91 14 74697 234423 110280165
Erythema multiforme 109.13 11.91 100 74611 20997 110493591
Lower respiratory tract infection 108.82 11.91 17 74694 243089 110271499
Coordination abnormal 108.51 11.91 108 74603 25120 110489468
Brain oedema 108.44 11.91 119 74592 30979 110483609
Dyskinesia 107.13 11.91 152 74559 51294 110463294
Drug level above therapeutic 104.61 11.91 76 74635 11512 110503076
Sinusitis 102.81 11.91 36 74675 296652 110217936
Peripheral swelling 102.63 11.91 74 74637 403960 110110628
Cerebral atrophy 99.31 11.91 67 74644 9018 110505570
Systemic lupus erythematosus 98.78 11.91 25 74686 254313 110260275
Depressed level of consciousness 97.84 11.91 227 74484 112051 110402537
Stupor 97.71 11.91 64 74647 8201 110506387
Choreoathetosis 96.17 11.91 38 74673 1660 110512928
Cardiac arrest 96.07 11.91 322 74389 196431 110318157
Product substitution issue 96.01 11.91 97 74614 22964 110491624
Balance disorder 95.43 11.91 230 74481 116330 110398258
Asthma 94.55 11.91 26 74685 250265 110264323
Intra-abdominal pressure increased 94.19 11.91 26 74685 356 110514232
Nervous system disorder 93.05 11.91 111 74600 31610 110482978
Fibromyalgia 91.80 11.91 6 74705 170903 110343685
Intensive care unit acquired weakness 90.52 11.91 40 74671 2319 110512269
Irritable bowel syndrome 90.52 11.91 5 74706 164210 110350378
Wheezing 90.10 11.91 30 74681 255200 110259388
Contraindicated product administered 89.73 11.91 28 74683 248239 110266349
Lethargy 87.99 11.91 195 74516 93381 110421207
Coma 87.45 11.91 224 74487 117645 110396943
Sudden unexplained death in epilepsy 86.24 11.91 29 74682 794 110513794
Petit mal epilepsy 85.72 11.91 57 74654 7490 110507098
Type 2 diabetes mellitus 82.55 11.91 11 74700 177221 110337367
Swelling 81.93 11.91 70 74641 350971 110163617
Hyperammonaemic encephalopathy 81.66 11.91 49 74662 5385 110509203
Nasopharyngitis 81.15 11.91 88 74623 394273 110120315
Gait disturbance 80.73 11.91 387 74324 277821 110236767
Malaise 79.36 11.91 214 74497 671605 109842983
Urine copper increased 79.02 11.91 14 74697 13 110514575
Muscle injury 78.51 11.91 4 74707 140803 110373785
Drug level changed 77.65 11.91 25 74686 595 110513993
Abdominal pain upper 77.42 11.91 73 74638 349038 110165550
Drug intolerance 76.89 11.91 97 74614 406415 110108173
Osteoarthritis 76.85 11.91 15 74696 182608 110331980
Aggression 76.71 11.91 141 74570 59069 110455519
Multiple organ dysfunction syndrome 76.45 11.91 251 74460 151459 110363129
Completed suicide 76.07 11.91 345 74366 242036 110272552
Intestinal ischaemia 74.69 11.91 72 74639 16107 110498481
Impaired healing 73.23 11.91 21 74690 196696 110317892
Cerebellar syndrome 72.55 11.91 48 74663 6254 110508334
Gamma-glutamyltransferase increased 71.99 11.91 140 74571 61169 110453419
Propofol infusion syndrome 71.63 11.91 35 74676 2554 110512034
Eosinophilia 70.11 11.91 134 74577 57802 110456786
Injection site pain 70.02 11.91 17 74694 177905 110336683
Confusional state 69.59 11.91 548 74163 468132 110046456
Inflammation 69.45 11.91 22 74689 193216 110321372
Cross sensitivity reaction 67.99 11.91 44 74667 5523 110509065
Agitation 67.09 11.91 198 74513 112853 110401735
Stomatitis 66.64 11.91 51 74660 270191 110244397
Unresponsive to stimuli 65.77 11.91 138 74573 63652 110450936
Loss of consciousness 65.04 11.91 284 74427 196022 110318566
Coagulopathy 64.17 11.91 106 74605 40805 110473783
Pain in extremity 63.84 11.91 147 74564 486971 110027617
Encephalitis 63.80 11.91 71 74640 18768 110495820
Ill-defined disorder 63.69 11.91 14 74697 156839 110357749
Bursitis 63.11 11.91 7 74704 129911 110384677
Dry mouth 63.09 11.91 28 74683 199920 110314668
Tremor 62.80 11.91 287 74424 201945 110312643
Partial seizures with secondary generalisation 62.22 11.91 23 74688 836 110513752
Speech disorder 62.09 11.91 132 74579 61437 110453151
Myoclonic epilepsy 61.60 11.91 32 74679 2659 110511929
Postictal paralysis 61.60 11.91 21 74690 600 110513988
Hypotonia 61.51 11.91 64 74647 15681 110498907
Cognitive disorder 61.50 11.91 163 74548 87348 110427240
Fall 61.29 11.91 650 74061 602832 109911756
Acute hepatic failure 59.24 11.91 96 74615 36372 110478216
Hyperreflexia 59.15 11.91 50 74661 9435 110505153
Sleep disorder due to general medical condition, insomnia type 58.89 11.91 3 74708 105640 110408948
Pneumatosis 58.79 11.91 23 74688 978 110513610
Porphyrins stool increased 58.75 11.91 12 74699 37 110514551
Treatment noncompliance 58.62 11.91 143 74568 72847 110441741
Neurotoxicity 57.84 11.91 103 74608 42104 110472484
Hypertension 57.57 11.91 166 74545 509918 110004670
Mucosal erosion 57.34 11.91 31 74680 2793 110511795
Systemic inflammatory response syndrome 56.39 11.91 56 74655 12987 110501601
Night sweats 56.37 11.91 11 74700 133972 110380616
Liver function test abnormal 56.35 11.91 136 74575 68814 110445774
Dystonia 56.33 11.91 78 74633 25727 110488861
General physical health deterioration 55.99 11.91 128 74583 425167 110089421
Nausea 55.85 11.91 550 74161 1235140 109279448
Febrile neutropenia 55.40 11.91 80 74631 316687 110197901
Intentional product use issue 54.75 11.91 52 74659 247854 110266734
Gaze palsy 54.54 11.91 32 74679 3375 110511213
Chest pain 53.94 11.91 108 74603 376267 110138321
Haemophagocytic lymphohistiocytosis 53.90 11.91 85 74626 31474 110483114
Weight increased 53.88 11.91 128 74583 419516 110095072
Hypothermia 53.70 11.91 77 74634 26225 110488363
Abdominal pain 53.57 11.91 173 74538 512816 110001772
Joint range of motion decreased 53.42 11.91 9 74702 121823 110392765
Ophthalmoplegia 53.32 11.91 32 74679 3518 110511070
Facet joint syndrome 53.19 11.91 3 74708 96825 110417763
PCO2 increased 52.53 11.91 26 74685 1951 110512637
Myoclonus 52.43 11.91 86 74625 32912 110481676
Psoriasis 52.00 11.91 15 74696 139978 110374610
Asterixis 51.44 11.91 30 74681 3128 110511460
Dermatitis exfoliative 51.44 11.91 50 74661 11297 110503291
Musculoskeletal pain 51.22 11.91 30 74681 182993 110331595
Lung disorder 51.11 11.91 29 74682 180018 110334570
Malabsorption 50.98 11.91 39 74672 6386 110508202
Pulmonary fibrosis 50.85 11.91 5 74706 102037 110412551
Chorea 50.77 11.91 30 74681 3205 110511383
Blood cholesterol increased 50.71 11.91 31 74680 184754 110329834
Urine delta aminolevulinate increased 50.47 11.91 9 74702 9 110514579
C-reactive protein increased 50.15 11.91 44 74667 217875 110296713
Drug withdrawal convulsions 50.05 11.91 27 74684 2422 110512166
Wound infection 50.03 11.91 4 74707 96461 110418127
COVID-19 50.03 11.91 55 74656 245005 110269583
Extensor plantar response 49.84 11.91 25 74686 1930 110512658
Back pain 49.36 11.91 111 74600 370885 110143703
PO2 increased 48.98 11.91 23 74688 1536 110513052
Cough 48.67 11.91 155 74556 461486 110053102
Obesity 48.34 11.91 9 74702 113342 110401246
Metabolic acidosis 47.55 11.91 162 74549 99582 110415006
Lip dry 47.11 11.91 6 74705 100077 110414511
Hypersensitivity 46.65 11.91 130 74581 403868 110110720
Neurodegenerative disorder 45.93 11.91 18 74693 769 110513819
Encephalitis autoimmune 45.85 11.91 29 74682 3499 110511089
Brain herniation 45.81 11.91 42 74669 8821 110505767
Hippocampal sclerosis 45.34 11.91 13 74698 206 110514382
Hypotension 45.34 11.91 547 74164 523302 109991286
Leukocytosis 44.88 11.91 107 74604 53721 110460867
Gastrooesophageal reflux disease 44.31 11.91 34 74677 179942 110334646
Lymphadenopathy 43.94 11.91 118 74593 63717 110450871
Pleocytosis 43.82 11.91 22 74689 1702 110512886
Renal ischaemia 43.03 11.91 24 74687 2299 110512289
Incoherent 42.02 11.91 39 74672 8319 110506269
Hemiparesis 41.83 11.91 92 74619 43811 110470777
Angiofibroma 41.65 11.91 11 74700 126 110514462
Blood albumin decreased 41.17 11.91 70 74641 27582 110487006
Glioblastoma multiforme 40.79 11.91 20 74691 1470 110513118
Muscle spasms 40.54 11.91 79 74632 278078 110236510
Intention tremor 40.34 11.91 17 74694 877 110513711
Aura 39.74 11.91 18 74693 1106 110513482
Toxic encephalopathy 39.39 11.91 50 74661 15164 110499424
Atonic seizures 39.29 11.91 18 74693 1136 110513452
Inhibitory drug interaction 39.19 11.91 30 74681 4917 110509671
Sleep disorder 39.00 11.91 46 74665 198598 110315990
Dysmetria 38.96 11.91 19 74692 1380 110513208
Drug level fluctuating 38.72 11.91 17 74694 970 110513618
Blood pH decreased 38.50 11.91 29 74682 4640 110509948
Rash morbilliform 37.87 11.91 36 74675 7915 110506673
Mobility decreased 37.66 11.91 64 74647 237358 110277230
Abnormal behaviour 37.41 11.91 82 74629 38957 110475631
Gingival disorder 36.94 11.91 27 74684 4126 110510462
Disorientation 36.55 11.91 118 74593 70553 110444035
Excessive eye blinking 36.51 11.91 20 74691 1850 110512738
Anti-erythropoietin antibody negative 36.38 11.91 12 74699 309 110514279
Musculoskeletal stiffness 36.17 11.91 85 74626 279737 110234851
Sciatica 36.01 11.91 9 74702 92390 110422198
Past-pointing 35.57 11.91 10 74701 147 110514441
CSF oligoclonal band present 35.52 11.91 13 74698 459 110514129
Blood alkaline phosphatase increased 35.39 11.91 117 74594 70818 110443770
Porphyria 35.37 11.91 11 74700 233 110514355
Ultrasound ovary abnormal 35.37 11.91 9 74702 88 110514500
Anaemia 35.10 11.91 221 74490 546865 109967723
Migraine 34.50 11.91 39 74672 171613 110342975
Idiosyncratic drug reaction 34.40 11.91 18 74693 1518 110513070
Cardiac arrest neonatal 34.17 11.91 7 74704 22 110514566
Hypoaesthesia 34.15 11.91 104 74607 314119 110200469
Product dose omission issue 33.92 11.91 108 74603 321674 110192914
Chest discomfort 33.34 11.91 41 74670 173807 110340781
Colitis ulcerative 33.29 11.91 6 74705 77357 110437231
Product use issue 33.28 11.91 104 74607 311591 110202997
Hypernatraemia 33.22 11.91 50 74661 17783 110496805
Autoimmune disorder 33.18 11.91 3 74708 65480 110449108
Taste disorder 33.12 11.91 3 74708 65384 110449204
Blood bicarbonate decreased 32.98 11.91 29 74682 5768 110508820
Altered state of consciousness 32.36 11.91 99 74612 57527 110457061
Blood homocysteine increased 32.00 11.91 12 74699 454 110514134
Psychotic disorder 31.93 11.91 91 74620 50846 110463742
Frequent bowel movements 31.91 11.91 5 74706 71385 110443203
Dyspepsia 31.66 11.91 50 74661 190915 110323673
Arthritis 31.64 11.91 40 74671 167546 110347042
Lymphangioleiomyomatosis 31.59 11.91 10 74701 225 110514363
Seizure cluster 31.56 11.91 14 74697 819 110513769
Hyperchloraemia 31.25 11.91 16 74695 1290 110513298
Acidosis hyperchloraemic 31.06 11.91 17 74694 1569 110513019
Posture abnormal 31.02 11.91 25 74686 4413 110510175
Aphasia 30.95 11.91 99 74612 58898 110455690
Grip strength decreased 30.88 11.91 8 74703 80166 110434422
Bradyarrhythmia 30.74 11.91 26 74685 4908 110509680
Haematuria traumatic 30.73 11.91 11 74700 364 110514224
Aplasia pure red cell 30.56 11.91 35 74676 9543 110505045
Bradycardia 30.10 11.91 194 74517 155323 110359265
Disease recurrence 30.09 11.91 100 74611 60684 110453904
Posterior reversible encephalopathy syndrome 30.07 11.91 69 74642 33792 110480796
Fluid retention 30.07 11.91 13 74698 94294 110420294
Myalgia 29.99 11.91 66 74645 222315 110292273
Gliosis 29.99 11.91 13 74698 719 110513869
Neuroleptic malignant syndrome 29.80 11.91 69 74642 33990 110480598
Tonic convulsion 29.67 11.91 21 74690 3053 110511535
Alanine aminotransferase increased 29.51 11.91 219 74492 183554 110331034
Vitamin B6 deficiency 29.14 11.91 12 74699 584 110514004
Drug eruption 29.03 11.91 91 74620 53568 110461020
Aspartate aminotransferase increased 28.83 11.91 196 74515 159740 110354848
Muscle twitching 28.82 11.91 63 74648 29872 110484716
Simple partial seizures 28.64 11.91 14 74697 1022 110513566
Oedema 28.58 11.91 62 74649 209914 110304674
Gastrointestinal disorder 28.55 11.91 77 74634 241875 110272713
Angiomyolipoma 28.50 11.91 10 74701 312 110514276
Hypoventilation 28.30 11.91 31 74680 8050 110506538
Hypercholesterolaemia 28.21 11.91 13 74698 90824 110423764
Mitochondrial DNA mutation 28.18 11.91 11 74700 465 110514123
Hepatitis 28.08 11.91 128 74583 89926 110424662
Knee arthroplasty 28.03 11.91 5 74706 64943 110449645
Inappropriate schedule of product administration 27.82 11.91 60 74651 203577 110311011
Intellectual disability 27.57 11.91 17 74694 1962 110512626
Epileptic encephalopathy 27.53 11.91 12 74699 673 110513915
Respiratory acidosis 27.53 11.91 40 74671 13786 110500802
Labelled drug-drug interaction medication error 27.46 11.91 61 74650 29241 110485347
Cytomegalovirus hepatitis 27.34 11.91 13 74698 893 110513695
Creutzfeldt-Jakob disease 27.28 11.91 9 74702 232 110514356
Hepatic failure 27.12 11.91 105 74606 68634 110445954
Mucosal ulceration 27.10 11.91 18 74693 2361 110512227
Acute kidney injury 26.86 11.91 287 74424 635143 109879445
Brain injury 26.85 11.91 39 74672 13437 110501151
Anxiety 26.69 11.91 131 74580 344947 110169641
Decreased appetite 26.65 11.91 200 74511 475646 110038942
Live birth 26.63 11.91 7 74704 69477 110445111
Interstitial lung disease 26.57 11.91 33 74678 139301 110375287
Hepatic enzyme increased 26.48 11.91 119 74592 320773 110193815
Dyspnoea exertional 26.46 11.91 19 74692 104041 110410547
Therapeutic product effect decreased 26.44 11.91 81 74630 244235 110270353
Encephalomalacia 26.42 11.91 15 74696 1487 110513101
Intracranial pressure increased 26.29 11.91 34 74677 10501 110504087
Adverse event 26.22 11.91 21 74690 108788 110405800
Pneumonia 26.08 11.91 426 74285 876288 109638300
Ammonia increased 26.07 11.91 30 74681 8220 110506368
Oxygen saturation abnormal 25.95 11.91 25 74686 5586 110509002
Irritability 25.79 11.91 81 74630 47728 110466860
Mental impairment 25.73 11.91 51 74660 22588 110492000
Myelosuppression 25.64 11.91 16 74695 94324 110420264
Areflexia 25.52 11.91 27 74684 6742 110507846
Contusion 25.52 11.91 77 74634 233284 110281304
Euthyroid sick syndrome 25.35 11.91 7 74704 96 110514492
Eye movement disorder 25.23 11.91 32 74679 9696 110504892
Palpitations 25.16 11.91 43 74668 159169 110355419
Insomnia 25.03 11.91 142 74569 360448 110154140
Febrile convulsion 24.84 11.91 13 74698 1097 110513491
Clonus 24.74 11.91 30 74681 8686 110505902
Hip arthroplasty 24.74 11.91 4 74707 55809 110458779
Laryngeal stenosis 24.69 11.91 14 74697 1384 110513204
Psychomotor hyperactivity 24.65 11.91 47 74664 20230 110494358
Accidental death 24.47 11.91 23 74688 4986 110509602
Bronchitis 24.28 11.91 43 74668 156989 110357599
Postictal state 24.28 11.91 17 74694 2429 110512159
Pneumonia aspiration 24.24 11.91 114 74597 81119 110433469
Face oedema 24.18 11.91 63 74648 33406 110481182
Staring 23.93 11.91 18 74693 2874 110511714
International normalised ratio increased 23.90 11.91 119 74592 86653 110427935
Constipation 23.72 11.91 143 74568 357643 110156945
Haematochezia 23.48 11.91 26 74685 115498 110399090
Brain neoplasm 23.40 11.91 25 74686 6312 110508276
SJS-TEN overlap 23.35 11.91 15 74696 1859 110512729
Head injury 23.31 11.91 73 74638 42944 110471644
Lymphocyte morphology abnormal 23.03 11.91 12 74699 1003 110513585
Injection site reaction 22.99 11.91 16 74695 89054 110425534
Rhabdomyolysis 22.56 11.91 149 74562 120252 110394336
Weight decreased 22.45 11.91 205 74506 467852 110046736
Urticaria 22.44 11.91 125 74586 318732 110195856
Cerebral ataxia 22.24 11.91 5 74706 27 110514561
Postictal psychosis 22.23 11.91 8 74703 269 110514319
Muscle contracture 22.18 11.91 17 74694 2791 110511797
Injection site pruritus 22.00 11.91 4 74707 51254 110463334
Gingival atrophy 21.88 11.91 6 74705 80 110514508
Superinfection 21.75 11.91 23 74688 5740 110508848
Sinus arrest 21.73 11.91 20 74691 4222 110510366
Autonomic nervous system imbalance 21.69 11.91 23 74688 5757 110508831
Lower limb fracture 21.57 11.91 12 74699 75336 110439252
Conjunctival hyperaemia 21.53 11.91 23 74688 5808 110508780
Perforation 21.36 11.91 14 74697 1796 110512792
Acute generalised exanthematous pustulosis 21.32 11.91 46 74665 21618 110492970
Nodal arrhythmia 21.26 11.91 15 74696 2169 110512419
Hypoxic-ischaemic encephalopathy 21.22 11.91 28 74683 8819 110505769
Blood zinc increased 21.16 11.91 4 74707 7 110514581
Hospitalisation 21.16 11.91 40 74671 142453 110372135
Oedema peripheral 20.93 11.91 133 74578 328527 110186061
Potentiating drug interaction 20.77 11.91 32 74679 11611 110502977
Basal cell carcinoma 20.62 11.91 3 74708 45267 110469321
Ovarian failure 20.62 11.91 11 74700 965 110513623
Clonic convulsion 20.57 11.91 13 74698 1567 110513021
Respiratory arrest 20.56 11.91 86 74625 58213 110456375
Injection site swelling 20.53 11.91 8 74703 61782 110452806
Foetal death 20.51 11.91 38 74673 16007 110498581
Respiratory failure 20.43 11.91 229 74482 215103 110299485
Hypertrophic cardiomyopathy 20.39 11.91 17 74694 3146 110511442
Deep vein thrombosis 20.39 11.91 163 74548 139724 110374864
Foot deformity 20.35 11.91 4 74707 48476 110466112
Learning disorder 20.31 11.91 10 74701 742 110513846
Joint stiffness 20.30 11.91 10 74701 67233 110447355
Haemodialysis 20.23 11.91 40 74671 17679 110496909
Cerebellar cognitive affective syndrome 20.20 11.91 4 74707 10 110514578
Influenza like illness 20.15 11.91 18 74693 88394 110426194
Macule 19.98 11.91 18 74693 3695 110510893
Dehydration 19.98 11.91 109 74602 279402 110235186
Influenza 19.80 11.91 54 74657 169047 110345541
Calcinosis 19.80 11.91 16 74695 2836 110511752
Blood gases abnormal 19.77 11.91 12 74699 1346 110513242
Enzyme induction 19.67 11.91 6 74705 119 110514469
Respiratory tract infection 19.66 11.91 12 74699 71605 110442983
Haemodynamic instability 19.62 11.91 46 74665 22842 110491746
Upper respiratory tract infection 19.38 11.91 37 74674 131291 110383297
Psychomotor retardation 19.22 11.91 25 74686 7767 110506821
Paranoia 19.21 11.91 45 74666 22329 110492259
Coma scale abnormal 19.16 11.91 28 74683 9698 110504890
Cardiac failure 19.05 11.91 64 74647 187562 110327026
Red blood cell sedimentation rate increased 19.00 11.91 15 74696 78287 110436301
Infection 18.98 11.91 155 74556 362045 110152543
Synkinesis 18.90 11.91 3 74708 0 110514588
Urine zinc 18.90 11.91 3 74708 0 110514588
Cortical laminar necrosis 18.90 11.91 3 74708 0 110514588
Methylenetetrahydrofolate reductase deficiency 18.90 11.91 3 74708 0 110514588
Hepatitis fulminant 18.87 11.91 26 74685 8534 110506054
Blood pressure systolic increased 18.79 11.91 17 74694 82974 110431614
Hepatic necrosis 18.74 11.91 28 74683 9894 110504694
Blood ketone body increased 18.74 11.91 10 74701 878 110513710
Pyroglutamate increased 18.62 11.91 9 74702 641 110513947
Headache 18.61 11.91 454 74257 881923 109632665
Paraesthesia 18.59 11.91 110 74601 276411 110238177
Blood pressure fluctuation 18.58 11.91 14 74697 74810 110439778
Blood lactic acid increased 18.41 11.91 36 74675 15785 110498803
Underdose 18.37 11.91 10 74701 63544 110451044
Oromandibular dystonia 18.34 11.91 11 74700 1208 110513380
Chronic graft versus host disease 18.31 11.91 27 74684 9430 110505158
Injection site erythema 18.27 11.91 22 74689 94154 110420434
Hyperkinesia 18.26 11.91 16 74695 3168 110511420
Hyporeflexia 18.24 11.91 18 74693 4142 110510446
Oropharyngeal oedema 18.21 11.91 8 74703 457 110514131
Intensive care unit delirium 18.21 11.91 5 74706 67 110514521
Obliterative bronchiolitis 18.00 11.91 17 74694 3706 110510882
Nasal congestion 17.99 11.91 24 74687 98258 110416330
Neck pain 17.90 11.91 35 74676 123095 110391493
Rhinorrhoea 17.86 11.91 26 74685 102640 110411948
Pruritus 17.79 11.91 281 74430 581279 109933309
Illusion 17.74 11.91 13 74698 1994 110512594
Back injury 17.74 11.91 5 74706 47394 110467194
Bacterial toxaemia 17.71 11.91 6 74705 168 110514420
Temporal lobe epilepsy 17.69 11.91 8 74703 490 110514098
Myocardial depression 17.61 11.91 9 74702 723 110513865
Product dispensing error 17.59 11.91 36 74675 16309 110498279
Ear pain 17.51 11.91 7 74704 53219 110461369
Linear IgA disease 17.43 11.91 18 74693 4371 110510217
Pyrexia 17.36 11.91 757 73954 897508 109617080
Dry eye 17.30 11.91 8 74703 55785 110458803
Medication error 17.15 11.91 126 74585 105240 110409348
Adverse drug reaction 17.15 11.91 28 74683 105531 110409057
Hepatic function abnormal 17.03 11.91 111 74600 89184 110425404
Rash erythematous 17.02 11.91 104 74607 81728 110432860
Hot flush 16.86 11.91 12 74699 66024 110448564
Electrocardiogram QRS complex prolonged 16.85 11.91 31 74680 12990 110501598
Barbiturates positive 16.83 11.91 3 74708 3 110514585
Apallic syndrome 16.69 11.91 10 74701 1096 110513492
Platelet aggregation inhibition 16.61 11.91 6 74705 204 110514384
Behaviour disorder 16.50 11.91 26 74685 9621 110504967
Developmental delay 16.48 11.91 11 74700 1454 110513134
Bone pain 16.42 11.91 12 74699 65121 110449467
Grimacing 16.15 11.91 9 74702 861 110513727
Eczema 16.14 11.91 15 74696 72278 110442310
Post-traumatic epilepsy 16.12 11.91 4 74707 35 110514553
Malignant neoplasm progression 16.09 11.91 62 74649 174505 110340083
Clumsiness 15.92 11.91 16 74695 3764 110510824
Autism spectrum disorder 15.84 11.91 12 74699 1936 110512652
Apnoea 15.83 11.91 31 74680 13608 110500980
Wrong patient received product 15.82 11.91 21 74690 6653 110507935
Pneumonitis 15.80 11.91 17 74694 76514 110438074
Orthostatic hypotension 15.69 11.91 13 74698 66236 110448352
Pseudolymphoma 15.67 11.91 10 74701 1225 110513363
Unmasking of previously unidentified disease 15.63 11.91 14 74697 2854 110511734
Intentional overdose 15.45 11.91 147 74564 132354 110382234
Periorbital oedema 15.43 11.91 26 74685 10166 110504422
Sedation 15.41 11.91 90 74621 69593 110444995
Ischaemic cerebral infarction 15.31 11.91 14 74697 2931 110511657
Bone marrow transplant 15.24 11.91 11 74700 1649 110512939
Pneumocystis jirovecii pneumonia 15.11 11.91 5 74706 42730 110471858
Atrial fibrillation 15.09 11.91 92 74619 229550 110285038
Visual evoked potentials abnormal 15.05 11.91 4 74707 47 110514541
Hyperglycaemic hyperosmolar nonketotic syndrome 15.05 11.91 14 74697 2995 110511593
Angina pectoris 15.03 11.91 12 74699 62283 110452305
Hypocalcaemic seizure 14.97 11.91 5 74706 134 110514454
Laryngitis 14.93 11.91 5 74706 42406 110472182
Hallucination, tactile 14.86 11.91 9 74702 1006 110513582
Ischaemic hepatitis 14.85 11.91 17 74694 4631 110509957
Liver function test increased 14.85 11.91 23 74688 88525 110426063
Paradoxical drug reaction 14.81 11.91 25 74686 9792 110504796
Procedural pain 14.79 11.91 3 74708 35562 110479026
Vitamin B6 decreased 14.75 11.91 4 74707 51 110514537
Herpes zoster 14.74 11.91 32 74679 108347 110406241
Factor VIII deficiency 14.73 11.91 5 74706 141 110514447
Loss of personal independence in daily activities 14.66 11.91 52 74659 149968 110364620
Mutism 14.64 11.91 14 74697 3099 110511489
Cardiomegaly 14.48 11.91 48 74663 29082 110485506
Lymphocytosis 14.35 11.91 18 74693 5393 110509195
Nephritis allergic 14.35 11.91 9 74702 1070 110513518
Echopraxia 14.34 11.91 4 74707 57 110514531
Nosocomial infection 14.32 11.91 14 74697 3185 110511403
Rectal haemorrhage 14.23 11.91 38 74673 119795 110394793
Serotonin syndrome 14.14 11.91 78 74633 59075 110455513
Rasmussen encephalitis 14.08 11.91 3 74708 12 110514576
Prothrombin time prolonged 14.05 11.91 34 74677 17227 110497361
Vision blurred 14 11.91 141 74570 128881 110385707
Prescribed underdose 13.99 11.91 14 74697 65160 110449428
Cataract 13.95 11.91 20 74691 79465 110435123
Biopsy brain 13.89 11.91 3 74708 13 110514575
Pulmonary mass 13.84 11.91 4 74707 37297 110477291
Plasmodium falciparum infection 13.81 11.91 5 74706 171 110514417
Change in seizure presentation 13.79 11.91 8 74703 826 110513762
Skin laceration 13.68 11.91 52 74659 33701 110480887
Dry skin 13.66 11.91 33 74678 107620 110406968
Anaemia megaloblastic 13.66 11.91 8 74703 841 110513747
Anaphylactic shock 13.65 11.91 9 74702 51537 110463051
Conjunctivitis 13.64 11.91 52 74659 33740 110480848
Open angle glaucoma 13.64 11.91 7 74704 567 110514021
Cerebral venous sinus thrombosis 13.58 11.91 13 74698 2882 110511706
Epileptic psychosis 13.53 11.91 4 74707 71 110514517
Injection site bruising 13.51 11.91 9 74702 51254 110463334
Gastric disorder 13.49 11.91 3 74708 33354 110481234
Hypometabolism 13.42 11.91 5 74706 186 110514402
Tongue biting 13.41 11.91 13 74698 2926 110511662
Skin warm 13.37 11.91 23 74688 9147 110505441
Ventricular tachycardia 13.36 11.91 68 74643 49941 110464647
Mydriasis 13.32 11.91 39 74672 22118 110492470
Pseudostroke 13.22 11.91 5 74706 194 110514394
Epileptic aura 13.17 11.91 4 74707 78 110514510
Oral herpes 13.15 11.91 4 74707 36076 110478512
Poor feeding infant 13.12 11.91 5 74706 198 110514390
Ejaculation delayed 13.12 11.91 5 74706 198 110514390
Pyroglutamic acidosis 13.10 11.91 11 74700 2057 110512531
Carnitine decreased 13.08 11.91 3 74708 18 110514570
Brain operation 13.06 11.91 8 74703 912 110513676
Microcephaly 13.05 11.91 5 74706 201 110514387
Quadriparesis 13.03 11.91 16 74695 4691 110509897
Infantile spasms 13.00 11.91 6 74705 385 110514203
Laryngeal pain 12.95 11.91 18 74693 5957 110508631
Poisoning 12.76 11.91 46 74665 29059 110485529
Injury 12.73 11.91 69 74642 177196 110337392
Fibrous dysplasia of bone 12.68 11.91 3 74708 21 110514567
Hyperhomocysteinaemia 12.65 11.91 7 74704 660 110513928
Central nervous system infection 12.63 11.91 10 74701 1722 110512866
Eosinophil count increased 12.60 11.91 37 74674 21021 110493567
Endotracheal intubation 12.56 11.91 18 74693 6126 110508462
Pleomorphic adenoma 12.56 11.91 3 74708 22 110514566
Wrong technique in product usage process 12.55 11.91 25 74686 87323 110427265
Hirsutism 12.47 11.91 10 74701 1753 110512835
Torticollis 12.41 11.91 13 74698 3208 110511380
Hepatosplenomegaly 12.32 11.91 19 74692 6900 110507688
Prostate cancer 12.30 11.91 5 74706 37636 110476952
Productive cough 12.29 11.91 38 74673 114267 110400321
Vasogenic cerebral oedema 12.26 11.91 11 74700 2247 110512341
Premature delivery 12.25 11.91 47 74664 30585 110484003
Soft tissue haemorrhage 12.21 11.91 6 74705 443 110514145
Chills 12.19 11.91 77 74634 190503 110324085
Premature menopause 12.15 11.91 8 74703 1034 110513554
Lymphocyte stimulation test positive 12.05 11.91 8 74703 1048 110513540
COVID-19 pneumonia 12.03 11.91 5 74706 37138 110477450
Methylobacterium infection 12.01 11.91 3 74708 27 110514561
Vomiting projectile 12.01 11.91 11 74700 2307 110512281
Inappropriate antidiuretic hormone secretion 11.99 11.91 50 74661 33801 110480787
Lip erosion 11.97 11.91 10 74701 1856 110512732
Thrombotic thrombocytopenic purpura 11.93 11.91 19 74692 7092 110507496

FDA Adverse Event Reporting System (Pediatric)

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
Drug ineffective 53.17 38.87 36 212 1597 112108

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 D026941 Sodium Channel Blockers
MeSH PA D049990 Membrane Transport Modulators
MeSH PA D061567 Voltage-Gated Sodium Channel Blockers
MeSH PA D065694 Cytochrome P-450 CYP1A2 Inducers
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
CHEBI has role CHEBI:35469 antidepressant
CHEBI has role CHEBI:35474 anxiolytic drug
CHEBI has role CHEBI:35476 antipsychotic agent
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:35623 anticonvulsant
CHEBI has role CHEBI:38633 sodium channel blocker
CHEBI has role CHEBI:50905 teratogenic agent
CHEBI has role CHEBI:73336 vulnerary
CHEBI has role CHEBI:75835 anti-anaemic agent
CHEBI has role CHEBI:88188 drug allergen

Related Drugs by ATC class:

N03AB Hydantoin derivatives 4 drugs
amino(diphenylhydantoin) valeric acidethotoinfosphenytoinmephenytoin

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




🐶 Veterinary Drug Use

SpeciesUseRelation
Dogs Euthanasia Indication

🐶 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
6158TKW0C5 INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Dilantin Infatabs HUMAN PRESCRIPTION DRUG LABEL 1 0071-0007 TABLET, CHEWABLE 50 mg ORAL ANDA 26 sections
Phenytoin HUMAN PRESCRIPTION DRUG LABEL 1 0121-0892 SUSPENSION 125 mg ORAL ANDA 27 sections
Phenytek HUMAN PRESCRIPTION DRUG LABEL 1 0378-2670 CAPSULE, EXTENDED RELEASE 200 mg ORAL ANDA 25 sections
Phenytek HUMAN PRESCRIPTION DRUG LABEL 1 0378-3750 CAPSULE, EXTENDED RELEASE 300 mg ORAL ANDA 25 sections
PHENYTOIN SODIUM HUMAN PRESCRIPTION DRUG LABEL 1 0404-9808 INJECTION 50 mg INTRAMUSCULAR ANDA 17 sections
Phenytoin Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0404-9932 INJECTION 50 mg INTRAMUSCULAR ANDA 17 sections
Phenytoin Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0404-9932 INJECTION 50 mg INTRAMUSCULAR ANDA 17 sections
Phenytoin Infatabs HUMAN PRESCRIPTION DRUG LABEL 1 0615-8424 TABLET, CHEWABLE 50 mg ORAL ANDA 26 sections
Extended Phenytoin Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0615-8556 CAPSULE 100 mg ORAL ANDA 24 sections
Phenytoin HUMAN PRESCRIPTION DRUG LABEL 1 0615-8623 TABLET, CHEWABLE 50 mg ORAL ANDA 28 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 0641-6139 INJECTION 50 mg INTRAMUSCULAR ANDA 25 sections
Phenytoin HUMAN PRESCRIPTION DRUG LABEL 1 0904-7199 TABLET, CHEWABLE 50 mg ORAL ANDA 28 sections
Phenytoin Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0904-7416 CAPSULE, EXTENDED RELEASE 100 mg ORAL ANDA 27 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
Phenytoin HUMAN PRESCRIPTION DRUG LABEL 1 17856-4070 SUSPENSION 125 mg ORAL ANDA 28 sections
Phenytoin Sodium HUMAN PRESCRIPTION DRUG LABEL 1 21695-167 CAPSULE, EXTENDED RELEASE 100 mg ORAL ANDA 21 sections
Phenytoin Sodium HUMAN PRESCRIPTION DRUG LABEL 1 29300-379 CAPSULE, EXTENDED RELEASE 100 mg ORAL ANDA 22 sections
PHENYTOIN SODIUM HUMAN PRESCRIPTION DRUG LABEL 1 42192-614 INJECTION 50 mg INTRAMUSCULAR ANDA 16 sections
Extended Phenytoin Sodium HUMAN PRESCRIPTION DRUG LABEL 1 43063-492 CAPSULE 100 mg ORAL ANDA 23 sections
Dilantin HUMAN PRESCRIPTION DRUG LABEL 1 43353-131 CAPSULE, EXTENDED RELEASE 100 mg ORAL ANDA 24 sections
Dilantin HUMAN PRESCRIPTION DRUG LABEL 1 50090-0029 CAPSULE, EXTENDED RELEASE 100 mg ORAL ANDA 26 sections
Phenytoin Sodium HUMAN PRESCRIPTION DRUG LABEL 1 50090-3539 CAPSULE, EXTENDED RELEASE 100 mg ORAL ANDA 26 sections
Phenytoin Sodium HUMAN PRESCRIPTION DRUG LABEL 1 50090-5700 CAPSULE, EXTENDED RELEASE 100 mg ORAL ANDA 27 sections
Phenytoin Sodium HUMAN PRESCRIPTION DRUG LABEL 1 50268-719 CAPSULE, EXTENDED RELEASE 100 mg ORAL ANDA 27 sections
Phenytoin Sodium HUMAN PRESCRIPTION DRUG LABEL 1 51407-982 CAPSULE, EXTENDED RELEASE 100 mg ORAL ANDA 27 sections