phenytoin 🐶 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) 0.03 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

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 2182.26 11.54 1249 40386 131385 63316002
Anticonvulsant drug level increased 736.28 11.54 176 41459 1341 63446046
Status epilepticus 667.52 11.54 281 41354 14952 63432435
Toxicity to various agents 549.64 11.54 740 40895 246510 63200877
Drug reaction with eosinophilia and systemic symptoms 535.94 11.54 312 41323 33524 63413863
Ataxia 527.82 11.54 238 41397 14957 63432430
Anticonvulsant drug level decreased 469.20 11.54 118 41517 1134 63446253
Generalised tonic-clonic seizure 463.31 11.54 269 41366 28747 63418640
Drug interaction 447.91 11.54 645 40990 228486 63218901
Nystagmus 384.26 11.54 147 41488 6073 63441314
Multiple-drug resistance 373.37 11.54 137 41498 5033 63442354
Anticonvulsant drug level below therapeutic 351.17 11.54 82 41553 557 63446830
Stevens-Johnson syndrome 335.12 11.54 207 41428 24743 63422644
Anticonvulsant drug level above therapeutic 264.76 11.54 63 41572 469 63446918
Product complaint 262.49 11.54 140 41495 12669 63434718
Epilepsy 250.43 11.54 178 41457 26887 63420500
Drug hypersensitivity 247.18 11.54 594 41041 310093 63137294
Purple glove syndrome 220.83 11.54 46 41589 167 63447220
Cerebellar atrophy 209.84 11.54 56 41579 692 63446695
Drug level decreased 201.08 11.54 100 41535 7819 63439568
Partial seizures 167.01 11.54 80 41555 5762 63441625
Toxic epidermal necrolysis 164.61 11.54 135 41500 25199 63422188
Gingival hypertrophy 149.83 11.54 52 41583 1619 63445768
Arthralgia 129.95 11.54 110 41525 569600 62877787
Drug level increased 128.87 11.54 112 41523 22624 63424763
Joint swelling 120.45 11.54 33 41602 327633 63119754
Alopecia 120.38 11.54 36 41599 337500 63109887
Electroencephalogram abnormal 119.51 11.54 55 41580 3617 63443770
Arthropathy 116.88 11.54 10 41625 234782 63212605
Focal dyscognitive seizures 115.04 11.54 50 41585 2871 63444516
Pain 112.85 11.54 196 41439 740432 62706955
Drug resistance 110.31 11.54 103 41532 22830 63424557
Anticonvulsant drug level abnormal 109.54 11.54 20 41615 27 63447360
Pemphigus 103.03 11.54 4 41631 183722 63263665
Diarrhoea 102.09 11.54 197 41438 715169 62732218
Drug level changed 98.57 11.54 24 41611 199 63447188
Diplopia 97.99 11.54 98 41537 23630 63423757
Fatigue 96.95 11.54 282 41353 887746 62559641
Dysarthria 96.15 11.54 129 41506 42582 63404805
Infusion related reaction 95.45 11.54 22 41613 245499 63201888
Abdominal discomfort 94.81 11.54 46 41589 320839 63126548
Rash maculo-papular 90.30 11.54 108 41527 31788 63415599
Contraindicated product administered 89.75 11.54 17 41618 217631 63229756
Discomfort 86.45 11.54 6 41629 167368 63280019
Intra-abdominal pressure increased 86.04 11.54 22 41613 227 63447160
Drug level below therapeutic 82.64 11.54 47 41588 4819 63442568
Drug level fluctuating 81.04 11.54 24 41611 442 63446945
Erythema multiforme 80.73 11.54 61 41574 10108 63437279
Glossodynia 80.40 11.54 11 41624 178865 63268522
Product substitution issue 79.16 11.54 73 41562 15923 63431464
Wound 78.43 11.54 8 41627 163255 63284132
Diabetes insipidus 78.24 11.54 37 41598 2588 63444799
Encephalopathy 76.96 11.54 110 41525 38510 63408877
Dyspnoea 76.46 11.54 204 41431 661109 62786278
Sinusitis 75.76 11.54 27 41608 226626 63220761
Systemic lupus erythematosus 74.93 11.54 22 41613 208896 63238491
Coma 73.82 11.54 143 41492 64221 63383166
Renal ischaemia 73.80 11.54 24 41611 609 63446778
Rheumatoid arthritis 68.19 11.54 41 41594 253778 63193609
Drug ineffective for unapproved indication 67.84 11.54 97 41538 33966 63413421
Mental status changes 67.74 11.54 105 41530 39494 63407893
Pericarditis 67.13 11.54 5 41630 131574 63315813
Necrosis ischaemic 66.59 11.54 24 41611 836 63446551
Peripheral swelling 65.97 11.54 47 41588 265895 63181492
Pneumatosis 65.29 11.54 20 41615 415 63446972
Brain oedema 64.91 11.54 62 41573 14133 63433254
Drug ineffective 62.19 11.54 994 40641 1043771 62403616
Drug intolerance 61.56 11.54 67 41568 308594 63138793
PCO2 increased 61.48 11.54 25 41610 1214 63446173
Myoclonic epilepsy 61.19 11.54 25 41610 1229 63446158
Dyskinesia 60.63 11.54 89 41546 31913 63415474
PO2 increased 58.71 11.54 22 41613 857 63446530
Somnolence 58.36 11.54 252 41383 178433 63268954
Cerebellar ataxia 58.15 11.54 22 41613 880 63446507
Coordination abnormal 57.07 11.54 57 41578 13716 63433671
Multiple organ dysfunction syndrome 56.62 11.54 119 41516 56633 63390754
Nasopharyngitis 52.01 11.54 54 41581 254203 63193184
Hyperammonaemia 49.73 11.54 35 41600 5197 63442190
Propofol infusion syndrome 49.35 11.54 20 41615 963 63446424
Lower respiratory tract infection 49.15 11.54 13 41622 132294 63315093
Balance disorder 49.11 11.54 144 41491 84278 63363109
Aura 47.65 11.54 20 41615 1053 63446334
Blood pH decreased 46.67 11.54 26 41609 2561 63444826
Bradycardia neonatal 46.52 11.54 19 41616 933 63446454
Blood bicarbonate decreased 46.19 11.54 27 41608 2914 63444473
Injection site pain 45.91 11.54 14 41621 129786 63317601
Choreoathetosis 45.65 11.54 16 41619 513 63446874
Petit mal epilepsy 44.72 11.54 29 41606 3765 63443622
Neurodegenerative disorder 43.98 11.54 14 41621 331 63447056
Swelling 43.45 11.54 71 41564 275307 63172080
Brain herniation 43.08 11.54 28 41607 3649 63443738
Nervous system disorder 42.71 11.54 57 41578 18709 63428678
Porphyria acute 42.64 11.54 19 41616 1158 63446229
Irritable bowel syndrome 42.40 11.54 3 41632 82409 63364978
Respiratory acidosis 41.97 11.54 35 41600 6680 63440707
Respiratory disorder neonatal 41.62 11.54 19 41616 1226 63446161
Encephalitis autoimmune 41.41 11.54 20 41615 1466 63445921
Eosinophilia 41.25 11.54 62 41573 22694 63424693
Weight gain poor 40.43 11.54 17 41618 899 63446488
Psoriatic arthropathy 40.24 11.54 6 41629 91514 63355873
Foetal anticonvulsant syndrome 39.89 11.54 15 41620 590 63446797
Aggression 39.75 11.54 62 41573 23436 63423951
Foetal death 39.28 11.54 42 41593 10938 63436449
Neurotoxicity 39.27 11.54 52 41583 16938 63430449
Stupor 39.25 11.54 28 41607 4247 63443140
Hepatitis 39.18 11.54 83 41552 39705 63407682
Cytomegalovirus hepatitis 39.14 11.54 13 41622 353 63447034
Hypersensitivity 38.66 11.54 84 41551 292601 63154786
Angiofibroma 38.45 11.54 10 41625 111 63447276
Product dose omission issue 38.29 11.54 59 41576 234254 63213133
Selective eating disorder 37.86 11.54 21 41614 2051 63445336
Acute hepatic failure 37.68 11.54 53 41582 18274 63429113
Partial seizures with secondary generalisation 37.60 11.54 13 41622 400 63446987
COVID-19 36.87 11.54 14 41621 113089 63334298
Pain in extremity 36.86 11.54 104 41531 331382 63116005
Oxygen saturation abnormal 36.82 11.54 25 41610 3504 63443883
Overdose 36.55 11.54 161 41474 114917 63332470
Nausea 35.97 11.54 373 41262 854098 62593289
Speech disorder 35.74 11.54 81 41554 40548 63406839
Ultrasound ovary abnormal 35.63 11.54 9 41626 88 63447299
Haemophagocytic lymphohistiocytosis 35.14 11.54 39 41596 10588 63436799
Lethargy 34.95 11.54 98 41537 55909 63391478
Cardiac arrest neonatal 34.93 11.54 9 41626 96 63447291
Cardiac arrest 34.49 11.54 136 41499 92409 63354978
CSF oligoclonal band present 34.14 11.54 12 41623 388 63446999
Lymphangioleiomyomatosis 33.88 11.54 10 41625 182 63447205
Hypotension 33.73 11.54 299 41336 272305 63175082
Musculoskeletal stiffness 33.63 11.54 43 41592 184575 63262812
Encephalitis 33.61 11.54 35 41600 8845 63438542
Aplasia pure red cell 33.60 11.54 26 41609 4461 63442926
Intestinal ischaemia 32.97 11.54 32 41603 7436 63439951
Cerebral atrophy 32.90 11.54 27 41608 5039 63442348
Brain injury 32.65 11.54 31 41604 7012 63440375
Angiomyolipoma 32.44 11.54 10 41625 212 63447175
Drug level above therapeutic 32.03 11.54 26 41609 4779 63442608
Tremor 31.91 11.54 171 41464 132068 63315319
Ischaemic cerebral infarction 31.24 11.54 16 41619 1330 63446057
Therapeutic response unexpected 31.04 11.54 49 41586 18710 63428677
Asthma 31 11.54 23 41612 127538 63319849
Musculoskeletal pain 30.79 11.54 11 41624 92266 63355121
Porphyria 30.43 11.54 9 41626 165 63447222
Unresponsive to stimuli 30.40 11.54 68 41567 33748 63413639
Impaired healing 29.77 11.54 15 41620 102527 63344860
Blood alkaline phosphatase increased 29.63 11.54 78 41557 42889 63404498
Dwarfism 29.30 11.54 5 41630 3 63447384
Depressed level of consciousness 28.84 11.54 98 41537 61980 63385407
Urine copper increased 28.72 11.54 5 41630 4 63447383
Product use issue 28.52 11.54 64 41571 220456 63226931
Systemic inflammatory response syndrome 28.48 11.54 26 41609 5595 63441792
Myoclonus 28.43 11.54 43 41592 15825 63431562
Anti-erythropoietin antibody negative 28.30 11.54 8 41627 124 63447263
Urine delta aminolevulinate increased 28.19 11.54 5 41630 5 63447382
Psoriasis 27.95 11.54 11 41624 86946 63360441
Adverse drug reaction 27.46 11.54 9 41626 79705 63367682
Abdominal pain upper 27.45 11.54 59 41576 206385 63241002
Medication error 27.40 11.54 86 41549 52198 63395189
Paranoia 27.38 11.54 36 41599 11643 63435744
Loss of consciousness 27.32 11.54 151 41484 117970 63329417
Seizure cluster 27.29 11.54 9 41626 239 63447148
Hyperreflexia 27.28 11.54 26 41609 5908 63441479
Dermatitis exfoliative 27.17 11.54 25 41610 5434 63441953
Back pain 27.09 11.54 86 41549 264059 63183328
Bradyarrhythmia 26.99 11.54 17 41618 2098 63445289
Euthyroid sick syndrome 26.89 11.54 7 41628 78 63447309
General physical health deterioration 26.41 11.54 58 41577 201344 63246043
Type 2 diabetes mellitus 26.27 11.54 5 41630 63863 63383524
Fibromyalgia 26.13 11.54 10 41625 80410 63366977
Glioblastoma multiforme 26.04 11.54 12 41623 791 63446596
Laryngeal stenosis 25.56 11.54 13 41622 1065 63446322
Pleocytosis 25.46 11.54 12 41623 833 63446554
Atonic seizures 25.37 11.54 11 41624 628 63446759
Left ventricular dysfunction 25.14 11.54 35 41600 11953 63435434
Therapeutic product effect decreased 25.03 11.54 56 41579 193131 63254256
Clonus 24.59 11.54 22 41613 4614 63442773
Disorientation 24.58 11.54 69 41566 39383 63408004
Perforation 24.42 11.54 13 41622 1170 63446217
Hypotonia 23.94 11.54 30 41605 9255 63438132
Lymphadenopathy 23.70 11.54 67 41568 38391 63408996
Arthritis 23.25 11.54 25 41610 115896 63331491
Chorea 23.13 11.54 14 41621 1610 63445777
Incoherent 23.05 11.54 21 41614 4509 63442878
Malabsorption 22.94 11.54 20 41615 4052 63443335
Plasmodium falciparum infection 22.88 11.54 5 41630 24 63447363
Bronchitis 22.85 11.54 29 41606 124906 63322481
Blood cholesterol increased 22.78 11.54 17 41618 94015 63353372
Vomiting projectile 22.67 11.54 13 41622 1353 63446034
Mitochondrial DNA mutation 22.62 11.54 9 41626 413 63446974
Hyperammonaemic encephalopathy 22.48 11.54 16 41619 2418 63444969
Blood albumin decreased 22.29 11.54 37 41598 14729 63432658
Rash morbilliform 22.18 11.54 18 41617 3307 63444080
Autism spectrum disorder 22.12 11.54 11 41624 859 63446528
Intentional product use issue 22.05 11.54 31 41604 127861 63319526
Porphyrins stool increased 21.94 11.54 5 41630 30 63447357
Ophthalmoplegia 21.84 11.54 13 41622 1451 63445936
Aphasia 21.83 11.54 59 41576 32941 63414446
Dry mouth 21.70 11.54 12 41623 77851 63369536
Stomatitis 21.64 11.54 36 41599 138689 63308698
Malaise 21.58 11.54 172 41463 415782 63031605
Injection site erythema 21.53 11.54 14 41621 83160 63364227
Respiratory failure 21.44 11.54 127 41508 101731 63345656
Weight increased 21.44 11.54 93 41542 260699 63186688
Areflexia 21.05 11.54 17 41618 3101 63444286
Mental impairment 20.75 11.54 35 41600 14116 63433271
Gamma-glutamyltransferase increased 20.69 11.54 59 41576 33972 63413415
Oropharyngeal oedema 20.66 11.54 8 41627 341 63447046
Magnetic resonance imaging head abnormal 20.38 11.54 14 41621 1999 63445388
Tachycardia 20.35 11.54 140 41495 118016 63329371
Ventricular dysfunction 20.34 11.54 16 41619 2812 63444575
Left ventricular hypertrophy 20.20 11.54 21 41614 5294 63442093
Psychotic disorder 20.15 11.54 49 41586 25663 63421724
Hemiparesis 20.01 11.54 46 41589 23236 63424151
Intensive care unit acquired weakness 19.76 11.54 10 41625 811 63446576
Intensive care unit delirium 19.61 11.54 5 41630 51 63447336
Disease recurrence 19.44 11.54 51 41584 27979 63419408
Calcinosis 19.42 11.54 14 41621 2158 63445229
Abdominal pain 19.36 11.54 113 41522 293343 63154044
Agitation 19.26 11.54 84 41551 59673 63387714
Posterior reversible encephalopathy syndrome 19.22 11.54 38 41597 17307 63430080
Abnormal behaviour 19.16 11.54 43 41592 21383 63426004
Chronic graft versus host disease 19.04 11.54 16 41619 3086 63444301
Hepatic failure 19.01 11.54 59 41576 35597 63411790
Cerebellar cognitive affective syndrome 18.99 11.54 3 41632 0 63447387
Rasmussen encephalitis 18.99 11.54 3 41632 0 63447387
Rickets 18.94 11.54 5 41630 59 63447328
Liver function test abnormal 18.92 11.54 72 41563 48109 63399278
Mucosal erosion 18.89 11.54 12 41623 1504 63445883
Ammonia increased 18.79 11.54 19 41616 4637 63442750
Wheezing 18.74 11.54 21 41614 95574 63351813
Osteoarthritis 18.63 11.54 21 41614 95322 63352065
Blood magnesium decreased 18.51 11.54 32 41603 13166 63434221
Torticollis 18.43 11.54 13 41622 1936 63445451
C-reactive protein increased 18.36 11.54 21 41614 94686 63352701
Hallucination, tactile 18.00 11.54 7 41628 302 63447085
Confusional state 17.87 11.54 235 41400 236145 63211242
Hallucination, auditory 17.86 11.54 31 41604 12793 63434594
Ventricular tachycardia 17.76 11.54 40 41595 19939 63427448
Cognitive disorder 17.64 11.54 78 41557 55737 63391650
Creutzfeldt-Jakob disease 17.59 11.54 6 41629 177 63447210
Injection site pruritus 17.59 11.54 4 41631 45112 63402275
Neonatal seizure 17.56 11.54 8 41627 514 63446873
Herpes zoster 17.42 11.54 17 41618 82445 63364942
Hepatic enzyme increased 17.33 11.54 71 41564 202257 63245130
Gait disturbance 17.30 11.54 190 41445 182988 63264399
Illusion 17.27 11.54 10 41625 1060 63446327
Cross sensitivity reaction 17.23 11.54 13 41622 2149 63445238
Cerebellar syndrome 17.21 11.54 16 41619 3523 63443864
Rash erythematous 17.08 11.54 64 41571 42446 63404941
Idiopathic pneumonia syndrome 16.96 11.54 7 41628 353 63447034
Palpitations 16.91 11.54 30 41605 112740 63334647
Linear IgA disease 16.88 11.54 11 41624 1440 63445947
Product formulation issue 16.78 11.54 8 41627 570 63446817
Hypertension 16.63 11.54 111 41524 279192 63168195
Cough 16.61 11.54 118 41517 292625 63154762
Enterocolitis 16.56 11.54 23 41612 7835 63439552
Chest pain 16.56 11.54 79 41556 215880 63231507
Bradycardia 16.52 11.54 93 41542 73134 63374253
Hyporeflexia 16.46 11.54 12 41623 1883 63445504
Brain operation 16.38 11.54 8 41627 601 63446786
Intention tremor 16.29 11.54 7 41628 391 63446996
Brain neoplasm 16.15 11.54 17 41618 4349 63443038
Pyrexia 16.10 11.54 413 41222 470065 62977322
Ill-defined disorder 15.98 11.54 18 41617 81737 63365650
Night sweats 15.97 11.54 6 41629 48808 63398579
Epileptic psychosis 15.94 11.54 4 41631 38 63447349
Periorbital oedema 15.68 11.54 19 41616 5665 63441722
Knee arthroplasty 15.63 11.54 8 41627 54198 63393189
Fluid retention 15.51 11.54 10 41625 59676 63387711
Influenza 15.35 11.54 30 41605 108692 63338695
Injection site swelling 15.31 11.54 6 41629 47566 63399821
Thrombocytopenia 15.30 11.54 159 41476 150998 63296389
Hospitalisation 15.29 11.54 20 41615 85061 63362326
Lip erosion 15.29 11.54 9 41626 984 63446403
Tongue ulceration 15.22 11.54 15 41620 3551 63443836
Intestinal dilatation 15.17 11.54 11 41624 1711 63445676
Joint contracture 15.16 11.54 11 41624 1713 63445674
Toxic encephalopathy 14.99 11.54 20 41615 6559 63440828
Asterixis 14.81 11.54 10 41625 1389 63445998
Epileptic encephalopathy 14.76 11.54 6 41629 291 63447096
Central nervous system infection 14.75 11.54 8 41627 748 63446639
Altered state of consciousness 14.62 11.54 43 41592 25187 63422200
Coagulation time prolonged 14.49 11.54 10 41625 1438 63445949
Aplastic anaemia 14.47 11.54 24 41611 9545 63437842
Potentiating drug interaction 14.43 11.54 16 41619 4340 63443047
Oromandibular dystonia 14.41 11.54 7 41628 520 63446867
Enzyme induction 14.40 11.54 4 41631 58 63447329
Impaired self-care 14.36 11.54 11 41624 1859 63445528
Blood gases abnormal 14.35 11.54 8 41627 789 63446598
Biopsy brain 14.17 11.54 3 41632 12 63447375
Allodynia 14.15 11.54 8 41627 811 63446576
Blood creatine phosphokinase increased 14.09 11.54 48 41587 30382 63417005
Treatment noncompliance 14.02 11.54 55 41580 37270 63410117
Laryngeal pain 14.01 11.54 16 41619 4482 63442905
Cachexia 13.97 11.54 18 41617 5708 63441679
Cerebral venous sinus thrombosis 13.84 11.54 11 41624 1961 63445426
Epileptic aura 13.75 11.54 4 41631 69 63447318
Lactose intolerance 13.60 11.54 13 41622 2965 63444422
Premature menopause 13.56 11.54 8 41627 878 63446509
Communication disorder 13.53 11.54 12 41623 2488 63444899
Hypersensitivity vasculitis 13.44 11.54 15 41620 4097 63443290
Staring 13.43 11.54 10 41625 1620 63445767
Paradoxical drug reaction 13.32 11.54 15 41620 4137 63443250
Hypoventilation 13.29 11.54 16 41619 4738 63442649
Dyspnoea exertional 13.24 11.54 12 41623 60290 63387097
Gene mutation 13.24 11.54 10 41625 1655 63445732
Face oedema 13.23 11.54 36 41599 20176 63427211
Cardiomegaly 13.20 11.54 33 41602 17581 63429806
Product dispensing error 13.18 11.54 24 41611 10281 63437106
Infrequent bowel movements 13.05 11.54 9 41626 1293 63446094
Extensor plantar response 13.00 11.54 9 41626 1302 63446085
Dyspepsia 12.92 11.54 30 41605 102166 63345221
Pulmonary fibrosis 12.85 11.54 5 41630 39804 63407583
Rhabdomyolysis 12.83 11.54 60 41575 43891 63403496
Behaviour disorder 12.81 11.54 13 41622 3186 63444201
Reflexes abnormal 12.71 11.54 7 41628 674 63446713
Post-traumatic epilepsy 12.65 11.54 3 41632 22 63447365
Insomnia 12.58 11.54 86 41549 215166 63232221
Chest discomfort 12.57 11.54 34 41601 109935 63337452
Haemodynamic instability 12.52 11.54 22 41613 9168 63438219
Hirsutism 12.49 11.54 9 41626 1386 63446001
Pyroglutamate increased 12.48 11.54 6 41629 435 63446952
Catatonia 12.40 11.54 15 41620 4462 63442925
Treatment failure 12.40 11.54 78 41557 198965 63248422
Alanine aminotransferase increased 12.38 11.54 113 41522 103657 63343730
Postictal state 12.36 11.54 8 41627 1035 63446352
Apallic syndrome 12.34 11.54 7 41628 714 63446673
Drug withdrawal convulsions 12.32 11.54 9 41626 1416 63445971
Intestinal infarction 12.31 11.54 8 41627 1042 63446345
Incontinence 12.31 11.54 25 41610 11607 63435780
Anaemia 12.29 11.54 128 41507 293302 63154085
Productive cough 12.26 11.54 14 41621 63194 63384193
Coma scale abnormal 12.26 11.54 16 41619 5137 63442250
Methylobacterium infection 12.10 11.54 3 41632 27 63447360
Leukocytosis 12.09 11.54 41 41594 25894 63421493
Eye movement disorder 12.08 11.54 16 41619 5212 63442175
Vitamin B6 deficiency 12.03 11.54 4 41631 109 63447278
Contusion 12.02 11.54 54 41581 149990 63297397
Pruritus 11.96 11.54 166 41469 361287 63086100
Loss of personal independence in daily activities 11.95 11.54 29 41606 97261 63350126
Hypothermia 11.86 11.54 27 41608 13554 63433833
Febrile neutropenia 11.82 11.54 39 41596 118410 63328977
Hepatic function abnormal 11.80 11.54 52 41583 37090 63410297
Migraine 11.77 11.54 32 41603 103314 63344073
Dry eye 11.77 11.54 6 41629 40755 63406632
Blood pressure fluctuation 11.71 11.54 8 41627 46309 63401078
Movement disorder 11.69 11.54 36 41599 21625 63425762
Head injury 11.64 11.54 42 41593 27354 63420033
Hypertrichosis 11.62 11.54 8 41627 1146 63446241
Sciatica 11.60 11.54 4 41631 34320 63413067
Nodal arrhythmia 11.57 11.54 8 41627 1155 63446232
Dystonia 11.54 11.54 27 41608 13792 63433595

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 1924.40 12.77 1284 37793 103573 34814281
Anticonvulsant drug level increased 734.29 12.77 198 38879 1418 34916436
Status epilepticus 719.51 12.77 328 38749 12286 34905568
Nystagmus 705.43 12.77 246 38831 4469 34913385
Toxicity to various agents 588.72 12.77 905 38172 199457 34718397
Ataxia 579.08 12.77 291 38786 13562 34904292
Drug reaction with eosinophilia and systemic symptoms 570.44 12.77 391 38686 32621 34885233
Anticonvulsant drug level decreased 530.13 12.77 141 38936 951 34916903
Anticonvulsant drug level above therapeutic 457.78 12.77 114 38963 568 34917286
Generalised tonic-clonic seizure 354.22 12.77 246 38831 20928 34896926
Drug interaction 288.57 12.77 719 38358 225227 34692627
Anticonvulsant drug level below therapeutic 283.22 12.77 77 39000 570 34917284
Product complaint 255.63 12.77 127 38950 5763 34912091
Stevens-Johnson syndrome 242.35 12.77 186 38891 18453 34899401
Partial seizures 222.59 12.77 108 38969 4652 34913202
Epilepsy 206.81 12.77 180 38897 21315 34896539
Drug level decreased 205.48 12.77 121 38956 7725 34910129
Multiple-drug resistance 204.06 12.77 105 38972 5134 34912720
Cerebellar atrophy 192.42 12.77 55 39022 499 34917355
Drug ineffective 174.41 12.77 983 38094 455768 34462086
Diarrhoea 141.46 12.77 137 38940 389775 34528079
Purple glove syndrome 120.72 12.77 25 39052 41 34917813
Drug level below therapeutic 119.87 12.77 76 39001 5539 34912315
Gingival hypertrophy 115.34 12.77 51 39026 1770 34916084
Drug level fluctuating 113.48 12.77 36 39041 479 34917375
Dysarthria 111.14 12.77 164 38913 34618 34883236
Drug level increased 110.74 12.77 130 38947 21966 34895888
Dyspnoea 109.17 12.77 158 38919 376624 34541230
Drug hypersensitivity 108.30 12.77 262 38815 80267 34837587
Coordination abnormal 100.89 12.77 77 39000 7567 34910287
Drug resistance 98.77 12.77 133 38944 25794 34892060
Hyperammonaemia 94.90 12.77 69 39008 6298 34911556
Mental status changes 88.03 12.77 155 38922 37928 34879926
Sudden unexplained death in epilepsy 87.37 12.77 29 39048 449 34917405
Confusional state 83.85 12.77 351 38726 143809 34774045
Drug level changed 82.51 12.77 26 39051 338 34917516
Drug level above therapeutic 79.49 12.77 53 39024 4208 34913646
Arthralgia 79.08 12.77 46 39031 169995 34747859
Gait disturbance 70.13 12.77 232 38845 84908 34832946
Diabetes insipidus 68.47 12.77 42 39035 2886 34914968
Anaemia 65.30 12.77 100 38977 233235 34684619
Somnolence 64.12 12.77 270 38807 110846 34807008
Brain oedema 60.58 12.77 76 39001 13745 34904109
Product substitution issue 60.13 12.77 65 39012 10030 34907824
Sedation 59.93 12.77 94 38983 20912 34896942
Anticonvulsant drug level abnormal 59.85 12.77 13 39064 30 34917824
Rash maculo-papular 59.63 12.77 111 38966 28340 34889514
Febrile neutropenia 59.49 12.77 40 39037 136809 34781045
Lethargy 57.59 12.77 136 38941 40986 34876868
Foetal anticonvulsant syndrome 55.69 12.77 27 39050 1160 34916694
Cerebellar syndrome 55.20 12.77 34 39043 2354 34915500
Toxic epidermal necrolysis 55.13 12.77 92 38985 21554 34896300
Balance disorder 54.29 12.77 132 38945 40522 34877332
Cerebral atrophy 53.88 12.77 43 39034 4509 34913345
Fatigue 53.66 12.77 223 38854 370430 34547424
Intensive care unit acquired weakness 53.18 12.77 25 39052 1002 34916852
Gaze palsy 51.75 12.77 29 39048 1683 34916171
Depressed level of consciousness 50.83 12.77 133 38944 42708 34875146
Acute kidney injury 49.58 12.77 175 38902 304813 34613041
COVID-19 49.09 12.77 13 39064 77537 34840317
Cerebellar ataxia 49.01 12.77 24 39053 1054 34916800
Fall 48.01 12.77 389 38688 202496 34715358
Petit mal epilepsy 47.34 12.77 34 39043 3044 34914810
Stupor 46.92 12.77 33 39044 2858 34914996
Joint swelling 46.52 12.77 6 39071 59884 34857970
Excessive eye blinking 46.51 12.77 19 39058 540 34917314
Cough 46.27 12.77 60 39017 150080 34767774
Hyperammonaemic encephalopathy 46.00 12.77 30 39047 2294 34915560
Urine copper increased 45.95 12.77 9 39068 9 34917845
Therapeutic response unexpected 44.92 12.77 55 39022 9702 34908152
Death 44.10 12.77 263 38814 397786 34520068
Focal dyscognitive seizures 43.40 12.77 24 39053 1357 34916497
Cross sensitivity reaction 43.14 12.77 24 39053 1373 34916481
Dyskinesia 41.51 12.77 83 38994 22330 34895524
Pneumonia 40.99 12.77 238 38839 362389 34555465
Tonic convulsion 40.87 12.77 22 39055 1179 34916675
Pain 40.67 12.77 107 38970 204568 34713286
Aura 40.43 12.77 15 39062 327 34917527
Agitation 39.95 12.77 148 38929 57251 34860603
Necrosis ischaemic 38.95 12.77 14 39063 278 34917576
Simple partial seizures 38.95 12.77 14 39063 278 34917576
Choreoathetosis 37.64 12.77 20 39057 1044 34916810
Barbiturates positive 37.42 12.77 7 39070 4 34917850
Overdose 36.99 12.77 200 38877 90859 34826995
Cardiac failure 36.60 12.77 29 39048 91219 34826635
Myalgia 35.97 12.77 25 39052 84085 34833769
Porphyrins stool increased 35.74 12.77 7 39070 7 34917847
Chest pain 35.71 12.77 54 39023 126708 34791146
Encephalopathy 35.30 12.77 103 38974 35216 34882638
Glioblastoma multiforme 35.26 12.77 17 39060 721 34917133
Asterixis 34.88 12.77 20 39057 1213 34916641
Back pain 34.19 12.77 52 39025 121737 34796117
Hypotonia 34.12 12.77 43 39034 7810 34910044
Coagulopathy 33.95 12.77 71 39006 19718 34898136
Abdominal pain 32.89 12.77 85 38992 163533 34754321
Blood homocysteine increased 32.76 12.77 12 39065 252 34917602
Interstitial lung disease 32.74 12.77 16 39061 65266 34852588
Nausea 32.32 12.77 235 38842 339673 34578181
Inhibitory drug interaction 31.49 12.77 21 39056 1667 34916187
Malaise 31.23 12.77 105 38972 185720 34732134
Past-pointing 31.16 12.77 7 39070 20 34917834
Nervous system disorder 30.79 12.77 57 39020 14486 34903368
Extensor plantar response 30.62 12.77 15 39062 659 34917195
Mucosal erosion 30.24 12.77 16 39061 828 34917026
Hypoplastic left heart syndrome 30.16 12.77 11 39066 228 34917626
Acidosis hyperchloraemic 29.98 12.77 13 39064 430 34917424
Hippocampal sclerosis 29.45 12.77 9 39068 105 34917749
Erythema multiforme 29.37 12.77 42 39035 8607 34909247
Postictal paralysis 29.10 12.77 11 39066 253 34917601
Unresponsive to stimuli 29.10 12.77 82 38995 27487 34890367
Idiosyncratic drug reaction 29.08 12.77 13 39064 463 34917391
Drug ineffective for unapproved indication 28.50 12.77 74 39003 23641 34894213
Constipation 28.42 12.77 70 39007 136912 34780942
Posture abnormal 28.33 12.77 22 39055 2217 34915637
Atrial fibrillation 28.27 12.77 59 39018 122334 34795520
Aphasia 27.93 12.77 69 39008 21385 34896469
Hyperreflexia 27.15 12.77 25 39052 3181 34914673
Gamma-glutamyltransferase increased 27.08 12.77 83 38994 29148 34888706
Aggression 26.71 12.77 100 38977 38864 34878990
Dehydration 26.51 12.77 67 39010 129902 34787952
Dystonia 26.16 12.77 45 39032 10800 34907054
Blood albumin decreased 26.02 12.77 51 39026 13521 34904333
Dysmetria 25.97 12.77 13 39064 599 34917255
Injection site pain 25.72 12.77 6 39071 38999 34878855
Asthma 25.42 12.77 8 39069 42648 34875206
Ophthalmoplegia 25.30 12.77 19 39058 1821 34916033
Drug withdrawal convulsions 25.29 12.77 16 39061 1161 34916693
Intestinal ischaemia 25.23 12.77 37 39040 7757 34910097
Hemiparesis 25.21 12.77 55 39022 15723 34902131
Mucosal ulceration 25.14 12.77 15 39062 980 34916874
Oedema peripheral 25.03 12.77 61 39016 119751 34798103
Myocardial infarction 25.02 12.77 62 39015 121023 34796831
Pain in extremity 24.44 12.77 67 39010 126446 34791408
Product dose omission issue 24.19 12.77 62 39015 119649 34798205
Haemoglobin decreased 24.06 12.77 63 39014 120709 34797145
Neonatal respiratory depression 24.04 12.77 11 39066 414 34917440
Superinfection 24.01 12.77 21 39056 2498 34915356
Hypothermia 23.86 12.77 43 39034 10705 34907149
Intention tremor 23.84 12.77 11 39066 422 34917432
Autonomic nervous system imbalance 23.79 12.77 21 39056 2530 34915324
Eosinophilia 22.95 12.77 73 39004 26149 34891705
Prostate cancer 22.64 12.77 8 39069 39641 34878213
Treatment noncompliance 22.59 12.77 76 39001 28024 34889830
General physical health deterioration 22.55 12.77 71 39006 128198 34789656
Completed suicide 22.49 12.77 187 38890 97981 34819873
Ascites 22.47 12.77 12 39065 46559 34871295
Infusion related reaction 22.37 12.77 16 39061 53041 34864813
Chest discomfort 22.27 12.77 17 39060 54513 34863341
Hyperchloraemia 22.21 12.77 11 39066 495 34917359
Speech disorder 22.01 12.77 71 39006 25615 34892239
C-reactive protein increased 21.93 12.77 17 39060 54081 34863773
Gingival disorder 21.90 12.77 16 39061 1471 34916383
Encephalomalacia 21.85 12.77 13 39064 845 34917009
Drug eruption 21.80 12.77 60 39017 19838 34898016
Coma 21.80 12.77 105 38972 45573 34872281
Atonic seizures 21.80 12.77 9 39068 263 34917591
Gingival atrophy 21.77 12.77 6 39071 47 34917807
Cognitive disorder 21.66 12.77 76 39001 28617 34889237
Hepatitis fulminant 21.56 12.77 25 39052 4165 34913689
Conjunctival hyperaemia 20.87 12.77 19 39058 2383 34915471
Pneumonitis 20.83 12.77 6 39071 33872 34883982
Gliosis 20.69 12.77 8 39069 196 34917658
Postictal psychosis 20.65 12.77 8 39069 197 34917657
Blood ketone body increased 20.55 12.77 10 39067 433 34917421
Decreased appetite 20.48 12.77 106 38971 166286 34751568
Urine delta aminolevulinate increased 20.42 12.77 4 39073 4 34917850
Muscle twitching 20.11 12.77 39 39038 10259 34907595
Encephalitis 19.97 12.77 32 39045 7245 34910609
Obliterative bronchiolitis 19.63 12.77 14 39063 1239 34916615
Hyperkinesia 19.44 12.77 16 39061 1752 34916102
Macule 19.40 12.77 15 39062 1502 34916352
Cerebral palsy 19.20 12.77 7 39070 145 34917709
Postictal state 19.17 12.77 12 39065 855 34916999
Lymphocyte morphology abnormal 19.14 12.77 10 39067 504 34917350
Malabsorption 19.13 12.77 18 39059 2354 34915500
Brain herniation 19.11 12.77 23 39054 3985 34913869
Drug abuse 18.75 12.77 53 39024 99043 34818811
Influenza like illness 18.72 12.77 4 39073 27630 34890224
Cytokine storm 18.71 12.77 11 39066 699 34917155
Weight decreased 18.64 12.77 118 38959 176183 34741671
Unmasking of previously unidentified disease 18.58 12.77 12 39065 902 34916952
Peripheral swelling 18.43 12.77 36 39041 76505 34841349
Haematochezia 18.38 12.77 15 39062 46519 34871335
Labelled drug-drug interaction medication error 18.35 12.77 47 39030 14892 34902962
Blood glucose increased 18.22 12.77 29 39048 66689 34851165
Arthropathy 18.02 12.77 4 39073 26903 34890951
Fluid retention 18.00 12.77 4 39073 26883 34890971
Propofol infusion syndrome 17.98 12.77 12 39065 954 34916900
Chills 17.93 12.77 40 39037 81003 34836851
Myoclonus 17.75 12.77 46 39031 14679 34903175
Cardiac failure congestive 17.69 12.77 42 39035 83228 34834626
Vitamin B6 decreased 17.66 12.77 4 39073 12 34917842
Open reduction of fracture 17.56 12.77 6 39071 102 34917752
Liver function test abnormal 17.49 12.77 75 39002 30999 34886855
Malignant neoplasm progression 17.47 12.77 46 39031 88000 34829854
Muscle spasms 17.44 12.77 36 39041 74965 34842889
Nephritis allergic 17.41 12.77 9 39068 444 34917410
Methylenetetrahydrofolate reductase deficiency 17.39 12.77 3 39074 0 34917854
Haematuria traumatic 17.37 12.77 7 39070 192 34917662
White blood cell count decreased 17.36 12.77 52 39025 95393 34822461
Psoriasis 17.31 12.77 11 39066 38801 34879053
Plasma cell myeloma 17.30 12.77 13 39064 42024 34875830
Melaena 17.24 12.77 9 39068 35371 34882483
Areflexia 17.15 12.77 19 39058 3012 34914842
Impetigo 17.14 12.77 12 39065 1031 34916823
Abnormal behaviour 17.04 12.77 64 39013 24905 34892949
Abdominal pain upper 16.89 12.77 34 39043 71456 34846398
Rash morbilliform 16.87 12.77 19 39058 3068 34914786
Vasogenic cerebral oedema 16.83 12.77 10 39067 648 34917206
Angina pectoris 16.79 12.77 7 39070 31356 34886498
Wheezing 16.79 12.77 13 39064 41389 34876465
Dysstasia 16.70 12.77 40 39037 12155 34905699
Intellectual disability 16.61 12.77 13 39064 1325 34916529
Porphyria acute 16.60 12.77 8 39069 339 34917515
Cardiac arrest 16.40 12.77 172 38905 95987 34821867
Echopraxia 16.39 12.77 4 39073 18 34917836
Neurodegenerative disorder 16.27 12.77 7 39070 227 34917627
Hospitalisation 16.24 12.77 24 39053 56878 34860976
Chorea 16.21 12.77 12 39065 1125 34916729
Epistaxis 16.21 12.77 25 39052 58226 34859628
Acute generalised exanthematous pustulosis 16.19 12.77 28 39049 6748 34911106
Tremor 16.16 12.77 152 38925 82435 34835419
Intracranial pressure increased 16.15 12.77 21 39056 3934 34913920
Memory impairment 16.14 12.77 93 38984 43225 34874629
Haemophagocytic lymphohistiocytosis 16.12 12.77 41 39036 12932 34904922
Lymphocytosis 16.06 12.77 17 39060 2560 34915294
Myoclonic epilepsy 16.03 12.77 12 39065 1145 34916709
Ammonia increased 16 12.77 22 39055 4347 34913507
Personality disorder 15.93 12.77 12 39065 1156 34916698
Dyspnoea exertional 15.83 12.77 15 39062 43264 34874590
Pancytopenia 15.80 12.77 54 39023 95103 34822751
Syncope 15.80 12.77 51 39026 91400 34826454
Diplopia 15.76 12.77 48 39029 16795 34901059
Soft tissue haemorrhage 15.67 12.77 6 39071 143 34917711
Cerebral ataxia 15.58 12.77 4 39073 23 34917831
Cataract 15.44 12.77 5 39072 26181 34891673
Eye movement disorder 15.44 12.77 21 39056 4106 34913748
Intentional product use issue 15.40 12.77 27 39050 59789 34858065
Nasopharyngeal reflux 15.32 12.77 3 39074 3 34917851
Dermatitis exfoliative 15.30 12.77 27 39050 6612 34911242
Hepatic necrosis 15.26 12.77 20 39057 3774 34914080
Open angle glaucoma 15.11 12.77 6 39071 158 34917696
Change in seizure presentation 15.11 12.77 6 39071 158 34917696
Loss of consciousness 15.11 12.77 150 38927 82517 34835337
Platelet count decreased 14.87 12.77 76 39001 119641 34798213
Electroencephalogram abnormal 14.83 12.77 16 39061 2462 34915392
Blood pressure fluctuation 14.58 12.77 5 39072 25244 34892610
Familial periodic paralysis 14.58 12.77 5 39072 86 34917768
Neutropenia 14.55 12.77 109 38968 156669 34761185
Learning disorder 14.41 12.77 11 39066 1080 34916774
Idiopathic interstitial pneumonia 14.35 12.77 6 39071 181 34917673
Inflammation 14.08 12.77 7 39070 28288 34889566
Acute hepatic failure 14.01 12.77 41 39036 14033 34903821
Colitis 13.90 12.77 13 39064 37737 34880117
Partial seizures with secondary generalisation 13.85 12.77 7 39070 329 34917525
Retinal vein occlusion 13.78 12.77 13 39064 1706 34916148
Blood creatinine increased 13.75 12.77 57 39020 94919 34822935
Infantile spasms 13.68 12.77 6 39071 204 34917650
Abdominal discomfort 13.67 12.77 29 39048 59806 34858048
Tubulointerstitial nephritis 13.61 12.77 53 39024 20971 34896883
Inappropriate schedule of product administration 13.57 12.77 31 39046 62265 34855589
Staring 13.50 12.77 12 39065 1458 34916396
Altered state of consciousness 13.46 12.77 56 39021 22837 34895017
Congenital nail disorder 13.30 12.77 4 39073 44 34917810
Metabolic acidosis 13.28 12.77 89 38988 43591 34874263
Fibrous dysplasia of bone 13.24 12.77 3 39074 9 34917845
Lid lag 13.24 12.77 3 39074 9 34917845
Feeling of despair 13.24 12.77 10 39067 967 34916887
Chronic kidney disease 13.16 12.77 16 39061 41194 34876660
Muscle contracture 13.14 12.77 11 39066 1233 34916621
Ischaemic hepatitis 13.10 12.77 13 39064 1815 34916039
Soft tissue swelling 13.06 12.77 8 39069 548 34917306
Hypometabolism 12.91 12.77 5 39072 123 34917731
Pulmonary embolism 12.90 12.77 54 39023 89692 34828162

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 2516.75 11.13 1713 66264 187121 79489290
Status epilepticus 1166.73 11.13 521 67456 24520 79651891
Anticonvulsant drug level increased 1130.21 11.13 292 67685 2361 79674050
Drug reaction with eosinophilia and systemic symptoms 1080.51 11.13 676 67301 63568 79612843
Nystagmus 1049.46 11.13 373 67604 9531 79666880
Ataxia 1046.51 11.13 483 67494 24556 79651855
Toxicity to various agents 1000.91 11.13 1492 66485 420048 79256363
Anticonvulsant drug level decreased 676.03 11.13 182 67795 1752 79674659
Drug interaction 666.88 11.13 1234 66743 413949 79262462
Anticonvulsant drug level above therapeutic 653.50 11.13 160 67817 1011 79675400
Generalised tonic-clonic seizure 646.12 11.13 425 67552 43485 79632926
Multiple-drug resistance 514.07 11.13 215 67762 8593 79667818
Stevens-Johnson syndrome 504.20 11.13 349 67628 38817 79637594
Anticonvulsant drug level below therapeutic 465.34 11.13 120 67857 961 79675450
Epilepsy 359.93 11.13 290 67687 40570 79635841
Partial seizures 358.77 11.13 168 67809 8810 79667601
Purple glove syndrome 318.58 11.13 68 67909 204 79676207
Cerebellar atrophy 316.97 11.13 90 67887 1071 79675340
Drug hypersensitivity 299.08 11.13 734 67243 298182 79378229
Drug level decreased 289.24 11.13 170 67807 14232 79662179
Arthralgia 214.73 11.13 110 67867 571693 79104718
Gingival hypertrophy 208.16 11.13 84 67893 3058 79673353
Diarrhoea 201.13 11.13 275 67702 880214 78796197
Drug ineffective 199.46 11.13 1585 66392 1079328 78597083
Dysarthria 192.64 11.13 262 67715 67360 79609051
Toxic epidermal necrolysis 192.36 11.13 213 67764 44368 79632043
Drug level increased 189.58 11.13 200 67777 39451 79636960
Dyspnoea 172.21 11.13 292 67685 856733 78819678
Joint swelling 166.56 11.13 24 67953 288622 79387789
Drug resistance 158.99 11.13 188 67789 42025 79634386
Hyperammonaemia 157.29 11.13 105 67872 10988 79665423
Product complaint 155.57 11.13 112 67865 13237 79663174
Diabetes insipidus 149.63 11.13 78 67899 5159 79671252
Rash maculo-papular 148.80 11.13 210 67767 55868 79620543
Fatigue 142.02 11.13 370 67607 929357 78747054
Pain 135.56 11.13 246 67731 703556 78972855
Mental status changes 131.41 11.13 218 67759 66741 79609670
Anticonvulsant drug level abnormal 125.66 11.13 25 67952 46 79676365
Alopecia 118.75 11.13 26 67951 231329 79445082
Focal dyscognitive seizures 116.92 11.13 58 67919 3454 79672957
Electroencephalogram abnormal 116.66 11.13 67 67910 5367 79671044
Encephalopathy 114.66 11.13 206 67771 67191 79609220
Rheumatoid arthritis 114.20 11.13 20 67957 208450 79467961
Coordination abnormal 113.89 11.13 104 67873 17208 79659203
Arthropathy 108.73 11.13 12 67965 177099 79499312
Erythema multiforme 104.50 11.13 100 67877 17551 79658860
Necrosis ischaemic 103.96 11.13 38 67939 1052 79675359
Infusion related reaction 102.85 11.13 34 67943 230203 79446208
Brain oedema 102.62 11.13 117 67860 25146 79651265
Cerebellar ataxia 102.46 11.13 44 67933 1877 79674534
Somnolence 102.18 11.13 439 67538 238542 79437869
Diplopia 98.82 11.13 132 67845 33334 79643077
Overdose 96.86 11.13 361 67616 183845 79492566
Drug level above therapeutic 96.67 11.13 71 67906 8652 79667759
Drug level below therapeutic 91.66 11.13 72 67905 9698 79666713
Cerebral atrophy 90.11 11.13 66 67911 8009 79668402
Abdominal discomfort 88.42 11.13 52 67925 250675 79425736
Drug ineffective for unapproved indication 85.09 11.13 155 67822 51083 79625328
Confusional state 83.83 11.13 510 67467 317487 79358924
Sudden unexplained death in epilepsy 81.64 11.13 28 67949 640 79675771
Stupor 78.57 11.13 57 67920 6815 79669596
Intra-abdominal pressure increased 77.76 11.13 22 67955 258 79676153
Balance disorder 77.45 11.13 222 67755 98635 79577776
Choreoathetosis 77.33 11.13 34 67943 1536 79674875
Peripheral swelling 76.80 11.13 70 67907 269547 79406864
Discomfort 75.86 11.13 9 67968 125608 79550803
Urine copper increased 75.77 11.13 14 67963 13 79676398
Drug level changed 73.79 11.13 25 67952 550 79675861
Intensive care unit acquired weakness 73.61 11.13 35 67942 1898 79674513
Depressed level of consciousness 72.78 11.13 214 67763 96438 79579973
Product substitution issue 72.62 11.13 88 67889 20168 79656243
Sinusitis 72.60 11.13 38 67939 195463 79480948
Dyskinesia 72.52 11.13 134 67843 44639 79631772
Lethargy 71.04 11.13 190 67787 81102 79595309
COVID-19 70.90 11.13 23 67954 157651 79518760
Nervous system disorder 70.37 11.13 100 67877 26756 79649655
Coma 69.35 11.13 216 67761 100433 79575978
Cerebellar syndrome 68.51 11.13 48 67929 5432 79670979
Nausea 68.41 11.13 507 67470 956689 78719722
Gait disturbance 68.03 11.13 353 67624 207153 79469258
Intestinal ischaemia 67.11 11.13 69 67908 13201 79663210
Pemphigus 65.78 11.13 5 67972 99577 79576834
Injection site pain 65.77 11.13 15 67962 129823 79546588
Hyperammonaemic encephalopathy 64.76 11.13 44 67933 4738 79671673
Contraindicated product administered 64.06 11.13 27 67950 157511 79518900
Eosinophilia 63.98 11.13 128 67849 45217 79631194
Malaise 63.55 11.13 210 67767 489659 79186752
Aggression 62.72 11.13 136 67841 50822 79625589
Pain in extremity 62.59 11.13 136 67841 364402 79312009
Multiple organ dysfunction syndrome 61.78 11.13 234 67743 120012 79556399
Pericarditis 61.64 11.13 8 67969 104228 79572183
Lower respiratory tract infection 61.45 11.13 17 67960 129203 79547208
Glossodynia 60.94 11.13 8 67969 103329 79573082
Propofol infusion syndrome 60.88 11.13 31 67946 1952 79674459
Back pain 60.46 11.13 104 67873 304076 79372335
Petit mal epilepsy 59.84 11.13 45 67932 5682 79670729
Cross sensitivity reaction 59.63 11.13 38 67939 3674 79672737
Cardiac arrest 57.94 11.13 295 67682 171801 79504610
Nasopharyngitis 57.94 11.13 79 67898 253802 79422609
Wound 57.70 11.13 14 67963 116165 79560246
Porphyrins stool increased 55.97 11.13 12 67965 37 79676374
Anaemia 55.51 11.13 194 67783 444821 79231590
Haemophagocytic lymphohistiocytosis 53.84 11.13 79 67898 21758 79654653
Asthma 53.58 11.13 24 67953 135071 79541340
Renal ischaemia 53.50 11.13 24 67953 1138 79675273
Porphyria acute 53.03 11.13 26 67951 1509 79674902
Hypotonia 52.94 11.13 60 67917 12810 79663601
Pneumatosis 52.87 11.13 22 67955 867 79675544
Cough 52.69 11.13 150 67827 366639 79309772
Febrile neutropenia 52.59 11.13 72 67905 230927 79445484
Partial seizures with secondary generalisation 52.55 11.13 20 67957 621 79675790
Unresponsive to stimuli 52.43 11.13 134 67843 55654 79620757
Acute hepatic failure 52.42 11.13 93 67884 30020 79646391
Ophthalmoplegia 52.30 11.13 32 67945 2880 79673531
Gamma-glutamyltransferase increased 52.07 11.13 132 67845 54548 79621863
Drug intolerance 51.84 11.13 91 67886 264028 79412383
Abdominal pain upper 51.72 11.13 69 67908 223750 79452661
Gaze palsy 51.37 11.13 32 67945 2973 79673438
Abdominal pain 51.18 11.13 166 67811 389403 79287008
Coagulopathy 50.03 11.13 101 67876 35905 79640506
Neurodegenerative disorder 49.91 11.13 18 67959 479 79675932
Encephalitis 49.48 11.13 62 67915 14698 79661713
Asterixis 49.26 11.13 30 67947 2677 79673734
Swelling 48.87 11.13 68 67909 216643 79459768
Extensor plantar response 48.83 11.13 26 67951 1795 79674616
Hyperreflexia 48.68 11.13 47 67930 8338 79668073
PCO2 increased 48.58 11.13 26 67951 1814 79674597
Psoriatic arthropathy 48.58 11.13 5 67972 77994 79598417
Encephalitis autoimmune 48.48 11.13 28 67949 2266 79674145
Urine delta aminolevulinate increased 48.38 11.13 9 67968 9 79676402
Mucosal erosion 48.21 11.13 28 67949 2290 79674121
Chest pain 47.87 11.13 106 67871 282198 79394213
Brain herniation 47.46 11.13 44 67933 7419 79668992
Speech disorder 47.30 11.13 127 67850 54318 79622093
Malabsorption 47.02 11.13 37 67940 4995 79671416
Hepatitis 46.43 11.13 128 67849 55599 79620812
PO2 increased 46.36 11.13 24 67953 1564 79674847
Glioblastoma multiforme 46.05 11.13 22 67955 1206 79675205
Neurotoxicity 44.92 11.13 91 67886 32427 79643984
Agitation 44.73 11.13 186 67791 99529 79576882
Systemic lupus erythematosus 44.30 11.13 24 67953 121125 79555286
Drug withdrawal convulsions 44.02 11.13 26 67951 2194 79674217
Weight increased 43.94 11.13 108 67869 277278 79399133
Dermatitis exfoliative 43.72 11.13 50 67927 10779 79665632
Acute kidney injury 43.01 11.13 263 67714 519141 79157270
Drug level fluctuating 42.06 11.13 18 67959 761 79675650
Hippocampal sclerosis 41.79 11.13 12 67965 149 79676262
Myoclonic epilepsy 41.52 11.13 24 67953 1946 79674465
General physical health deterioration 41.41 11.13 110 67867 275128 79401283
Systemic inflammatory response syndrome 41.40 11.13 50 67927 11415 79664996
Myoclonus 41.34 11.13 80 67897 27580 79648831
Toxic encephalopathy 39.87 11.13 49 67928 11391 79665020
Dystonia 39.74 11.13 68 67909 21331 79655080
Intention tremor 39.50 11.13 17 67960 729 79675682
Angiofibroma 39.20 11.13 11 67966 125 79676286
Atonic seizures 38.83 11.13 17 67960 760 79675651
Aura 38.78 11.13 18 67959 924 79675487
Psoriasis 38.65 11.13 14 67963 89573 79586838
Hemiparesis 38.10 11.13 87 67890 33646 79642765
Liver function test abnormal 37.79 11.13 131 67846 64344 79612067
Acidosis hyperchloraemic 37.52 11.13 17 67960 825 79675586
Product dose omission issue 37.18 11.13 99 67878 247438 79428973
Osteoarthritis 37.06 11.13 14 67963 87295 79589116
Tremor 36.94 11.13 260 67717 169823 79506588
Rash morbilliform 36.70 11.13 35 67942 6115 79670296
Myalgia 36.38 11.13 64 67913 185577 79490834
Irritable bowel syndrome 36.26 11.13 5 67972 62236 79614175
Blood albumin decreased 36.09 11.13 70 67907 24173 79652238
Inhibitory drug interaction 35.82 11.13 30 67947 4423 79671988
Fibromyalgia 35.59 11.13 6 67971 64334 79612077
Lymphadenopathy 35.49 11.13 113 67864 53134 79623277
Loss of consciousness 34.89 11.13 254 67723 167689 79508722
Fall 34.68 11.13 596 67381 487033 79189378
Porphyria 34.58 11.13 11 67966 197 79676214
Chest discomfort 34.56 11.13 40 67937 138004 79538407
Chorea 34.55 11.13 23 67954 2394 79674017
Dehydration 34.51 11.13 103 67874 248084 79428327
Cognitive disorder 34.20 11.13 134 67843 69792 79606619
Excessive eye blinking 33.94 11.13 20 67957 1681 79674730
Completed suicide 33.78 11.13 339 67638 245428 79430983
Wheezing 33.53 11.13 30 67947 116634 79559777
Ultrasound ovary abnormal 33.29 11.13 9 67968 88 79676323
Anti-erythropoietin antibody negative 33.29 11.13 12 67965 319 79676092
Hypothermia 33.03 11.13 65 67912 22681 79653730
Intentional product use issue 33.03 11.13 49 67928 152063 79524348
Hypertension 32.65 11.13 158 67819 330834 79345577
Blood pH decreased 32.36 11.13 29 67948 4682 79671729
Lymphangioleiomyomatosis 32.32 11.13 10 67967 163 79676248
Foetal death 32.23 11.13 37 67940 8007 79668404
Cardiac arrest neonatal 31.65 11.13 7 67970 26 79676385
C-reactive protein increased 31.64 11.13 38 67939 128989 79547422
Treatment noncompliance 31.33 11.13 107 67870 52161 79624250
Arthritis 31.30 11.13 31 67946 114849 79561562
Constipation 30.98 11.13 130 67847 282920 79393491
Angiomyolipoma 30.79 11.13 10 67967 192 79676219
Dysmetria 30.73 11.13 16 67961 1055 79675356
Simple partial seizures 30.70 11.13 14 67963 690 79675721
CSF oligoclonal band present 30.48 11.13 12 67965 409 79676002
Blood homocysteine increased 30.07 11.13 12 67965 424 79675987
Hyperchloraemia 30.05 11.13 16 67961 1105 79675306
Blood bicarbonate decreased 29.95 11.13 29 67948 5162 79671249
Aplasia pure red cell 29.75 11.13 35 67942 7775 79668636
Leukocytosis 29.68 11.13 93 67884 43362 79633049
Inflammation 29.56 11.13 22 67955 93731 79582680
Dyspnoea exertional 29.36 11.13 19 67958 87054 79589357
Aphasia 29.18 11.13 97 67880 46635 79629776
Past-pointing 28.95 11.13 9 67968 149 79676262
Pleocytosis 28.92 11.13 17 67960 1422 79674989
Gliosis 28.53 11.13 12 67965 486 79675925
Incoherent 28.52 11.13 34 67943 7658 79668753
Impaired healing 28.38 11.13 20 67957 87635 79588776
Stomatitis 28.38 11.13 51 67926 146706 79529705
Hypersensitivity 28.35 11.13 121 67856 262118 79414293
Weight decreased 28.25 11.13 182 67795 355016 79321395
Postictal paralysis 28.10 11.13 11 67966 369 79676042
Muscle injury 28.06 11.13 4 67973 48557 79627854
Herpes zoster 27.89 11.13 23 67954 93060 79583351
Interstitial lung disease 27.78 11.13 33 67944 112567 79563844
Intellectual disability 27.60 11.13 16 67961 1304 79675107
Bronchitis 27.48 11.13 43 67934 130601 79545810
Metabolic acidosis 27.42 11.13 141 67836 82388 79594023
Dry mouth 27.31 11.13 21 67956 87998 79588413
Disorientation 27.29 11.13 116 67861 62660 79613751
Idiosyncratic drug reaction 27.19 11.13 16 67961 1341 79675070
Pneumonia 27.11 11.13 398 67579 659848 79016563
Muscle twitching 27.01 11.13 63 67914 24701 79651710
Posture abnormal 26.95 11.13 24 67953 3842 79672569
Respiratory acidosis 26.86 11.13 40 67937 11160 79665251
Fluid retention 26.75 11.13 13 67964 69796 79606615
Tonic convulsion 26.72 11.13 19 67958 2201 79674210
Sleep disorder due to general medical condition, insomnia type 26.59 11.13 3 67974 43553 79632858
Cytomegalovirus hepatitis 26.25 11.13 13 67964 771 79675640
Medication error 26.19 11.13 122 67855 68520 79607891
Influenza 26.01 11.13 44 67933 129562 79546849
Abnormal behaviour 25.85 11.13 79 67898 36342 79640069
Blood alkaline phosphatase increased 25.66 11.13 115 67862 63549 79612862
Palpitations 25.39 11.13 43 67934 126567 79549844
Muscle spasms 25.39 11.13 71 67906 174659 79501752
Oxygen saturation abnormal 25.32 11.13 25 67952 4557 79671854
Blood pressure fluctuation 24.98 11.13 13 67964 67132 79609279
Clonus 24.98 11.13 30 67947 6810 79669601
Laryngeal stenosis 24.93 11.13 14 67963 1074 79675337
Areflexia 24.83 11.13 27 67950 5507 79670904
Mucosal ulceration 24.81 11.13 17 67960 1856 79674555
Cardiac failure 24.73 11.13 60 67917 154782 79521629
Posterior reversible encephalopathy syndrome 24.55 11.13 63 67914 26218 79650193
Product use issue 24.44 11.13 94 67883 209728 79466683
Cerebellar cognitive affective syndrome 24.27 11.13 4 67973 0 79676411
Euthyroid sick syndrome 24.23 11.13 7 67970 89 79676322
Gastrooesophageal reflux disease 24.20 11.13 32 67945 104214 79572197
Musculoskeletal pain 24.20 11.13 31 67946 102323 79574088
Psychotic disorder 24.15 11.13 84 67893 41318 79635093
Atrial fibrillation 24.13 11.13 87 67890 197799 79478612
Postictal psychosis 24.10 11.13 8 67969 165 79676246
Seizure cluster 24.08 11.13 10 67967 392 79676019
Oedema peripheral 23.96 11.13 122 67855 252166 79424245
Injection site erythema 23.83 11.13 19 67958 78178 79598233
Influenza like illness 23.70 11.13 16 67961 71691 79604720
Intracranial pressure increased 23.31 11.13 32 67945 8290 79668121
Encephalomalacia 23.22 11.13 14 67963 1227 79675184
Decreased appetite 22.61 11.13 185 67792 342233 79334178
Pulmonary fibrosis 22.52 11.13 5 67972 44107 79632304
Conjunctival hyperaemia 22.41 11.13 23 67954 4390 79672021
Creutzfeldt-Jakob disease 22.39 11.13 8 67969 207 79676204
Haematochezia 22.36 11.13 25 67952 87620 79588791
Ammonia increased 22.36 11.13 30 67947 7605 79668806
Postictal state 22.35 11.13 16 67961 1873 79674538
Drug eruption 22.13 11.13 85 67892 43850 79632561
Vitamin B6 deficiency 22.06 11.13 9 67968 337 79676074
Brain injury 21.91 11.13 37 67940 11480 79664931
Knee arthroplasty 21.88 11.13 5 67972 43243 79633168
Potentiating drug interaction 21.87 11.13 32 67945 8787 79667624
Gastric disorder 21.82 11.13 3 67974 37430 79638981
Myocardial infarction 21.76 11.13 82 67895 184047 79492364
Blood zinc increased 21.50 11.13 4 67973 4 79676407
Autonomic nervous system imbalance 21.49 11.13 23 67954 4607 79671804
Altered state of consciousness 21.44 11.13 84 67893 43738 79632673
Ill-defined disorder 21.37 11.13 15 67962 65860 79610551
Type 2 diabetes mellitus 21.34 11.13 11 67966 57111 79619300
Cerebral ataxia 21.08 11.13 5 67972 27 79676384
Lymphocyte morphology abnormal 21.07 11.13 12 67965 946 79675465
Memory impairment 20.95 11.13 165 67812 111569 79564842
Blood pressure systolic increased 20.76 11.13 16 67961 66970 79609441
Neuroleptic malignant syndrome 20.71 11.13 61 67916 27498 79648913
Gingival atrophy 20.64 11.13 6 67971 78 79676333
Hypernatraemia 20.63 11.13 41 67936 14410 79662001
Hepatic failure 20.62 11.13 105 67872 61107 79615304
Learning disorder 20.58 11.13 10 67967 569 79675842
Chills 20.51 11.13 69 67908 160165 79516246
Bone pain 20.43 11.13 11 67966 55731 79620680
Chronic graft versus host disease 20.40 11.13 27 67950 6754 79669657
Disease recurrence 20.34 11.13 83 67894 44026 79632385
Gingival disorder 20.32 11.13 20 67957 3631 79672780
Mitochondrial DNA mutation 20.12 11.13 9 67968 424 79675987
Rash erythematous 20.10 11.13 100 67877 57669 79618742
Face oedema 19.94 11.13 61 67916 28075 79648336
Macule 19.91 11.13 18 67959 2939 79673472
Aspartate aminotransferase increased 19.88 11.13 193 67784 138448 79537963
Haemodynamic instability 19.81 11.13 45 67932 17337 79659074
Staring 19.60 11.13 17 67960 2628 79673783
Melaena 19.57 11.13 14 67963 60876 79615535
Nodal arrhythmia 19.47 11.13 15 67962 1963 79674448
Alanine aminotransferase increased 19.39 11.13 218 67759 162352 79514059
Product dispensing error 19.38 11.13 38 67939 13225 79663186
Haematuria traumatic 19.28 11.13 7 67970 190 79676221
Injection site swelling 19.27 11.13 8 67969 47124 79629287
Calcinosis 19.16 11.13 16 67961 2349 79674062
Perforation 19.02 11.13 13 67964 1413 79674998
Linear IgA disease 19.02 11.13 18 67959 3114 79673297
Autism spectrum disorder 19.02 11.13 12 67965 1140 79675271
Acute generalised exanthematous pustulosis 18.93 11.13 44 67933 17210 79659201
Hospitalisation 18.89 11.13 32 67945 94204 79582207
Musculoskeletal stiffness 18.75 11.13 81 67896 174927 79501484
Superinfection 18.72 11.13 22 67955 4880 79671531
Therapeutic product effect decreased 18.70 11.13 74 67903 163789 79512622
Head injury 18.58 11.13 72 67905 37297 79639114
Vitamin B6 decreased 18.50 11.13 4 67973 13 79676398
Blood ketone body increased 18.50 11.13 10 67967 712 79675699
Enzyme induction 18.48 11.13 6 67971 115 79676296
Hot flush 18.46 11.13 12 67965 54865 79621546
Cardiac failure congestive 18.44 11.13 61 67916 142341 79534070
Hip arthroplasty 18.36 11.13 4 67973 35752 79640659
Eye movement disorder 18.34 11.13 28 67949 7983 79668428
Nasal congestion 18.28 11.13 23 67954 76529 79599882
Cortical laminar necrosis 18.21 11.13 3 67974 0 79676411
Urine zinc 18.21 11.13 3 67974 0 79676411
Methylenetetrahydrofolate reductase deficiency 18.21 11.13 3 67974 0 79676411
Bradyarrhythmia 18.20 11.13 20 67957 4126 79672285
Ischaemic cerebral infarction 18.20 11.13 16 67961 2519 79673892
Inappropriate schedule of product administration 18.17 11.13 56 67921 133572 79542839
Mental impairment 18.16 11.13 46 67931 18990 79657421
Night sweats 18.07 11.13 11 67966 52084 79624327
Adverse drug reaction 17.99 11.13 18 67959 66374 79610037
Orthostatic hypotension 17.94 11.13 13 67964 56151 79620260
Intensive care unit delirium 17.88 11.13 5 67972 56 79676355
Wrong technique in product usage process 17.85 11.13 22 67955 73853 79602558
Brain neoplasm 17.79 11.13 23 67954 5623 79670788
Haemoglobin decreased 17.55 11.13 114 67863 222005 79454406
Hepatitis fulminant 17.51 11.13 26 67951 7236 79669175
Anxiety 17.45 11.13 132 67845 248380 79428031
Insomnia 17.32 11.13 130 67847 245040 79431371
Hyperkinesia 17.18 11.13 16 67961 2713 79673698
Hyporeflexia 17.05 11.13 18 67959 3550 79672861
Platelet aggregation inhibition 16.84 11.13 6 67971 154 79676257
Unmasking of previously unidentified disease 16.84 11.13 14 67963 2043 79674368
Sinus arrest 16.82 11.13 18 67959 3604 79672807
Temporal lobe epilepsy 16.75 11.13 8 67969 438 79675973
Oropharyngeal oedema 16.75 11.13 8 67969 438 79675973
Bacterial toxaemia 16.73 11.13 6 67971 157 79676254
Pyrexia 16.62 11.13 722 67255 677987 78998424
Paranoia 16.54 11.13 45 67932 19387 79657024
Angina pectoris 16.49 11.13 12 67965 51720 79624691
Malignant neoplasm progression 16.43 11.13 60 67917 135930 79540481
Death 16.41 11.13 363 67614 566151 79110260
Hypotension 16.33 11.13 491 67486 439826 79236585
Bradycardia 16.26 11.13 182 67795 135375 79541036
Barbiturates positive 16.13 11.13 3 67974 3 79676408
Pyroglutamate increased 16.03 11.13 9 67968 690 79675721
Pneumonitis 15.92 11.13 17 67960 60843 79615568
Frequent bowel movements 15.80 11.13 3 67974 29536 79646875
Behaviour disorder 15.79 11.13 23 67954 6290 79670121
Electrocardiogram QRS complex prolonged 15.78 11.13 31 67946 10802 79665609
Apallic syndrome 15.77 11.13 10 67967 958 79675453
Colitis ulcerative 15.73 11.13 5 67972 34737 79641674
Hepatic necrosis 15.70 11.13 28 67949 9072 79667339
Nephritis allergic 15.67 11.13 9 67968 721 79675690
Cataract 15.54 11.13 18 67959 62102 79614309
Pneumonia aspiration 15.49 11.13 104 67873 66863 79609548
Plasmodium falciparum infection 15.44 11.13 5 67972 95 79676316
Rhinorrhoea 15.10 11.13 26 67951 76048 79600363
Post-traumatic epilepsy 15.09 11.13 4 67973 36 79676375
Ischaemic hepatitis 14.93 11.13 17 67960 3647 79672764
Rasmussen encephalitis 14.91 11.13 3 67974 6 79676405
Upper respiratory tract infection 14.81 11.13 35 67942 91133 79585278
Hypoventilation 14.81 11.13 24 67953 7200 79669211
Hypoxic-ischaemic encephalopathy 14.72 11.13 25 67952 7795 79668616
Drug abuse 14.70 11.13 80 67897 162611 79513800
Periorbital oedema 14.69 11.13 26 67951 8376 79668035
Prostate cancer 14.69 11.13 5 67972 33263 79643148
Lung disorder 14.68 11.13 29 67948 80528 79595883
Injection site reaction 14.67 11.13 15 67962 54770 79621641
Illusion 14.57 11.13 12 67965 1729 79674682
Dyspepsia 14.46 11.13 46 67931 108641 79567770
Tongue biting 14.45 11.13 13 67964 2108 79674303
Idiopathic interstitial pneumonia 14.43 11.13 6 67971 236 79676175
Hallucination, tactile 14.40 11.13 8 67969 601 79675810
Headache 14.39 11.13 436 67541 653336 79023075
Productive cough 14.28 11.13 34 67943 88297 79588114
Irritability 14.16 11.13 71 67906 41073 79635338
Pneumocystis jirovecii pneumonia 14.15 11.13 5 67972 32503 79643908
Apnoea 14.13 11.13 31 67946 11673 79664738
Contusion 14.08 11.13 72 67905 148704 79527707
Visual evoked potentials abnormal 14.05 11.13 4 67973 48 79676363
Vasogenic cerebral oedema 14.00 11.13 11 67966 1482 79674929
Device issue 13.99 11.13 3 67974 27105 79649306
Hypometabolism 13.87 11.13 5 67972 133 79676278
Osteonecrosis of jaw 13.81 11.13 10 67967 43216 79633195
Pseudolymphoma 13.79 11.13 10 67967 1195 79675216
Echopraxia 13.76 11.13 4 67973 52 79676359
Open angle glaucoma 13.76 11.13 7 67970 440 79675971
Injection site bruising 13.75 11.13 9 67968 40993 79635418
Blood cholesterol increased 13.71 11.13 32 67945 83688 79592723
Ovarian failure 13.62 11.13 8 67969 668 79675743
Pulmonary embolism 13.60 11.13 88 67889 171566 79504845
Developmental delay 13.59 11.13 10 67967 1221 79675190
Pulmonary mass 13.46 11.13 4 67973 29030 79647381
Grimacing 13.46 11.13 8 67969 683 79675728
Haemodialysis 13.45 11.13 40 67937 18128 79658283
Infantile spasms 13.42 11.13 6 67971 282 79676129
Respiratory tract infection 13.42 11.13 13 67964 48676 79627735
Therapy interrupted 13.34 11.13 5 67972 31336 79645075
COVID-19 pneumonia 13.33 11.13 4 67973 28845 79647566
Psychomotor retardation 13.30 11.13 21 67956 6163 79670248
Epileptic psychosis 13.30 11.13 4 67973 59 79676352
Bursitis 13.24 11.13 7 67970 35837 79640574
Mutism 13.21 11.13 13 67964 2359 79674052
Skin ulcer 13.21 11.13 16 67961 54134 79622277
Biopsy brain 13.19 11.13 3 67974 13 79676398
Factor VIII deficiency 13.18 11.13 5 67972 154 79676257
Torticollis 13.15 11.13 13 67964 2374 79674037
Migraine 13.11 11.13 35 67942 87458 79588953
Lymphocytosis 13.07 11.13 18 67959 4675 79671736
Oxygen saturation decreased 13.05 11.13 61 67916 128986 79547425
Diverticulitis 12.97 11.13 12 67965 45924 79630487
Localised infection 12.94 11.13 8 67969 37567 79638844
Obesity 12.77 11.13 7 67970 35118 79641293
Genital erythema 12.75 11.13 6 67971 318 79676093
Cytokine storm 12.70 11.13 9 67968 1037 79675374
International normalised ratio increased 12.67 11.13 119 67858 84602 79591809
Hepatic function abnormal 12.64 11.13 106 67871 73001 79603410
Hirsutism 12.57 11.13 10 67967 1372 79675039
Poor feeding infant 12.55 11.13 5 67972 176 79676235
Fibrous dysplasia of bone 12.53 11.13 3 67974 17 79676394
Dry eye 12.53 11.13 8 67969 36923 79639488
Respiratory arrest 12.49 11.13 88 67889 57462 79618949
Adverse event 12.49 11.13 20 67957 60194 79616217
Presyncope 12.47 11.13 10 67967 41044 79635367
Epileptic aura 12.46 11.13 4 67973 74 79676337
Blood glucose increased 12.44 11.13 53 67924 114922 79561489
Viral infection 12.43 11.13 11 67966 43005 79633406
Microcephaly 12.41 11.13 5 67972 181 79676230
Ejaculation delayed 12.41 11.13 5 67972 181 79676230
Mydriasis 12.27 11.13 38 67939 17605 79658806
Lactic acidosis 12.25 11.13 26 67951 70333 79606078
Rash macular 12.25 11.13 53 67924 28846 79647565
Bone marrow transplant 12.16 11.13 10 67967 1438 79674973
Vomiting projectile 12.15 11.13 11 67966 1800 79674611
Urticaria papular 12.09 11.13 5 67972 194 79676217
Somatosensory evoked potentials abnormal 12.06 11.13 5 67972 195 79676216
Symblepharon 12.04 11.13 5 67972 196 79676215
Eosinophil count increased 12.04 11.13 37 67940 17068 79659343
Cerebral palsy 12.04 11.13 5 67972 196 79676215
Labelled drug-drug interaction medication error 11.94 11.13 51 67926 27599 79648812
Chemical burn 11.90 11.13 7 67970 586 79675825
Chronic kidney disease 11.90 11.13 24 67953 66130 79610281
Cerebral venous sinus thrombosis 11.74 11.13 12 67965 2279 79674132
Blood gases abnormal 11.73 11.13 9 67968 1171 79675240
Intentional overdose 11.70 11.13 140 67837 105820 79570591
Tumour lysis syndrome 11.66 11.13 3 67974 23936 79652475
Muscle contracture 11.63 11.13 12 67965 2305 79674106
Premature menopause 11.59 11.13 7 67970 615 79675796
Infection 11.59 11.13 141 67836 241571 79434840
Neutropenia 11.57 11.13 174 67803 287536 79388875
Movement disorder 11.56 11.13 50 67927 27209 79649202
Conjunctivitis 11.55 11.13 48 67929 25667 79650744
Hypertrophic cardiomyopathy 11.53 11.13 12 67965 2328 79674083
Lip erosion 11.51 11.13 10 67967 1550 79674861
Oropharyngeal pain 11.47 11.13 51 67926 109302 79567109
Acute myeloid leukaemia 11.46 11.13 6 67971 30879 79645532
Psychomotor hyperactivity 11.45 11.13 36 67941 16813 79659598
Acute myocardial infarction 11.41 11.13 31 67946 77005 79599406
Brugada syndrome 11.35 11.13 9 67968 1229 79675182
Blood lactic acid increased 11.34 11.13 30 67947 12714 79663697
Methylobacterium infection 11.32 11.13 3 67974 27 79676384
Ear pain 11.31 11.13 7 67970 32862 79643549
No adverse event 11.29 11.13 62 67915 37130 79639281
Rhabdomyolysis 11.27 11.13 136 67841 102995 79573416
Surgery 11.25 11.13 7 67970 32759 79643652
Haemoptysis 11.24 11.13 19 67958 55980 79620431
Soft tissue haemorrhage 11.23 11.13 6 67971 417 79675994
Head titubation 11.23 11.13 8 67969 930 79675481
Clonic convulsion 11.19 11.13 9 67968 1253 79675158
Febrile convulsion 11.16 11.13 8 67969 938 79675473
Brain operation 11.16 11.13 7 67970 658 79675753
Joint stiffness 11.14 11.13 11 67966 40819 79635592

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




🐶 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

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 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
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 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
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 0378-2670 CAPSULE, EXTENDED RELEASE 200 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
Phenytek HUMAN PRESCRIPTION DRUG LABEL 1 0378-3750 CAPSULE, EXTENDED RELEASE 300 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 0404-9932 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 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 35 sections
Phenytoin Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0615-8020 CAPSULE, EXTENDED RELEASE 100 mg ORAL ANDA 35 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 0615-8260 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