phenobarbital 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
hypnotics, barbituric acid derivatives 2134 50-06-6

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • phenobarbitone
  • phenobarbital
  • adonal
  • dormiral
  • versomnal
  • neurobarb
  • phenaemal
  • sedophen
  • phenobarbital sodium
A barbituric acid derivative that acts as a nonselective central nervous system depressant. It potentiates GAMMA-AMINOBUTYRIC ACID action on GABA-A RECEPTORS, and modulates chloride currents through receptor channels. It also inhibits glutamate induced depolarizations.
  • Molecular weight: 232.24
  • Formula: C12H12N2O3
  • CLOGP: 1.36
  • LIPINSKI: 0
  • HAC: 5
  • HDO: 2
  • TPSA: 75.27
  • ALOGS: -2.93
  • ROTB: 2
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.10 g O
0.10 g P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 1 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 24 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 9.30 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 95 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.54 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 0.06 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.49 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 99 hours Lombardo F, Berellini G, Obach RS

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 0.638 High 1
caco2-efflux Caco-2 efflux ratio (BA/AB) 1.671 High 1
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 37.584 10^-6 cm/s High 1
dh-clint Dog hepatocyte intrinsic clearance 3.981 uL/min/10^6 cells High 1
dppb Dog plasma protein binding (% unbound) 53.450 % High 1
fcs-ppb Fetal calf serum protein binding (% unbound) 41.280 % High 1
herg hERG pIC50 4.227 pIC50 High 1
hh-clint Human hepatocyte intrinsic clearance 1.294 uL/min/10^6 cells High 1
hlm-clint Human liver microsomal intrinsic clearance 2.999 uL/min/mg protein High 1
hppb Human plasma protein binding (% unbound) 44.890 % High 1
kinase-safety-class ACVR2A,ACVR2B,AXL,BRAF,CAMK2D,CDK5,CDK9,DYRK1B,EIF2AK3,ERBB2,GRK2,ITK,MAP3K21,MAPK7,PDK1,PDK4,PIK3CB,PRKDC,TEK 19
kinase-selectivity-class AXL,GRK2,PDK4 3
mdck-mdr1-bcrp-efflux MDCK-MDR1-BCRP efflux ratio 2.291 Moderate 0.68
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 3.388 High 1
mh-clint Mouse hepatocyte intrinsic clearance 1.919 High 1
mppb Mouse plasma protein binding (% unbound) 57.880 High 1
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 1.531 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pppb Pig plasma protein binding (% unbound) 57.930 % High 1
rat-kpuu-brain Rat brain Kpuu 0.155 % Moderate 0.68
rh-clint Rat hepatocyte intrinsic clearance 2.099 uL/min/10^6 cells High 1
rh-fuinc Rat hepatocyte fraction unbound in incubation 91.390 % High 1
rppb Rat plasma protein binding (% unbound) 40.840 % High 1
solubility-dd Solubility at pH 7.4 in DMSO 874.984 uM High 1

Approvals:

DateAgencyCompanyOrphan
Jan. 1, 1912 YEAR INTRODUCED

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
Multiple-drug resistance 871.39 16.33 224 19670 7552 90601001
Seizure 689.51 16.33 424 19470 152205 90456348
Status epilepticus 553.41 16.33 193 19701 18681 90589872
Drug reaction with eosinophilia and systemic symptoms 400.77 16.33 193 19701 42565 90565988
Drug ineffective 375.83 16.33 887 19007 1383411 89225142
Drug interaction 259.48 16.33 311 19583 276142 90332411
Toxicity to various agents 254.22 16.33 314 19580 287532 90321021
Drug resistance 239.35 16.33 122 19772 30327 90578226
Anticonvulsant drug level increased 151.23 16.33 41 19853 1695 90606858
Epilepsy 143.09 16.33 129 19765 82077 90526476
Cognitive disorder 134.97 16.33 116 19778 69291 90539262
Intra-abdominal pressure increased 130.31 16.33 26 19868 265 90608288
Generalised tonic-clonic seizure 127.36 16.33 85 19809 34818 90573735
Drug ineffective for unapproved indication 126.78 16.33 110 19784 66534 90542019
Off label use 123.33 16.33 522 19372 1101730 89506823
Overdose 121.48 16.33 161 19733 157548 90451005
Myoclonic epilepsy 121.29 16.33 34 19860 1593 90606960
Drug withdrawal convulsions 119.40 16.33 33 19861 1467 90607086
Hyperammonaemia 105.08 16.33 43 19851 6432 90602121
Ataxia 104.41 16.33 59 19835 17983 90590570
Coma 101.58 16.33 101 19793 72531 90536022
Myocardial depression 99.79 16.33 24 19870 609 90607944
Necrosis ischaemic 98.50 16.33 26 19868 969 90607584
Pneumatosis 96.04 16.33 22 19872 449 90608104
Abortion spontaneous 88.50 16.33 82 19812 53974 90554579
Partial seizures 87.33 16.33 39 19855 7221 90601332
Kounis syndrome 82.10 16.33 28 19866 2525 90606028
Anticonvulsant drug level decreased 80.91 16.33 24 19870 1376 90607177
Angiofibroma 80.08 16.33 15 19879 106 90608447
Drug abuse 74.29 16.33 91 19803 82256 90526297
Abdominal discomfort 73.92 16.33 9 19885 477319 90131234
Hypotension 72.65 16.33 195 19699 325202 90283351
Cardiac arrest 70.00 16.33 100 19794 104835 90503718
Depressed level of consciousness 69.85 16.33 83 19811 72701 90535852
Infantile spasms 69.22 16.33 15 19879 235 90608318
Multiple organ dysfunction syndrome 69.02 16.33 80 19814 68256 90540297
Nystagmus 68.77 16.33 33 19861 7194 90601359
Foetal exposure during pregnancy 68.04 16.33 64 19830 42911 90565642
Intraventricular haemorrhage neonatal 68.02 16.33 15 19879 256 90608297
Joint swelling 67.79 16.33 14 19880 503286 90105267
Arthralgia 67.60 16.33 44 19850 778478 89830075
Infusion related reaction 66.68 16.33 7 19887 416773 90191780
Systemic inflammatory response syndrome 65.81 16.33 31 19863 6485 90602068
Fatigue 64.80 16.33 96 19798 1153927 89454626
Alopecia 64.19 16.33 15 19879 495056 90113497
Intestinal ischaemia 62.32 16.33 33 19861 8850 90599703
Haemophagocytic lymphohistiocytosis 62.11 16.33 40 19854 15419 90593134
Developmental glaucoma 61.81 16.33 11 19883 56 90608497
Systemic lupus erythematosus 60.75 16.33 5 19889 361891 90246662
Renal function test abnormal 59.94 16.33 30 19864 7161 90601392
Altered state of consciousness 59.84 16.33 52 19842 31480 90577073
Hypotonia 59.79 16.33 35 19859 11391 90597162
Breast hyperplasia 59.32 16.33 14 19880 327 90608226
Aggression 58.90 16.33 48 19846 26620 90581933
Sedation complication 58.77 16.33 40 19854 16904 90591649
Rheumatoid arthritis 58.22 16.33 6 19888 362608 90245945
Hyperammonaemic encephalopathy 58.12 16.33 22 19872 2677 90605876
Contraindicated product administered 57.93 16.33 3 19891 320136 90288417
Creatinine renal clearance increased 57.40 16.33 23 19871 3258 90605295
Creatinine renal clearance decreased 57.11 16.33 41 19853 18858 90589695
Arthropathy 56.44 16.33 7 19887 366235 90242318
Metabolic acidosis 54.25 16.33 64 19830 55612 90552941
Respiratory failure 54.24 16.33 95 19799 118323 90490230
Systolic dysfunction 53.95 16.33 19 19875 1885 90606668
Oropharyngeal oedema 53.14 16.33 13 19881 355 90608198
Angiomyolipoma 52.43 16.33 12 19882 244 90608309
Cytomegalovirus hepatitis 51.77 16.33 13 19881 396 90608157
Focal dyscognitive seizures 51.42 16.33 21 19873 3123 90605430
Petit mal epilepsy 51.34 16.33 24 19870 4934 90603619
Macroglossia 50.50 16.33 15 19879 864 90607689
Musculoskeletal stiffness 50.03 16.33 4 19890 296528 90312025
Sedation 49.65 16.33 57 19837 48114 90560439
Tachycardia 48.51 16.33 107 19787 157566 90450987
Swelling 48.15 16.33 16 19878 419042 90189511
Anticonvulsant drug level above therapeutic 47.52 16.33 13 19881 556 90607997
Cerebellar atrophy 47.36 16.33 14 19880 793 90607760
Atonic seizures 47.21 16.33 14 19880 802 90607751
Irritability 46.92 16.33 48 19846 35614 90572939
Blood calcium decreased 45.97 16.33 44 19850 30138 90578415
Discomfort 45.45 16.33 4 19890 274331 90334222
Ultrasound ovary abnormal 45.44 16.33 9 19885 88 90608465
Foetal anticonvulsant syndrome 45.28 16.33 13 19881 664 90607889
Stillbirth 44.85 16.33 25 19869 7418 90601135
Mitral valve disease 44.82 16.33 18 19876 2564 90605989
Apnoea 44.47 16.33 27 19867 9387 90599166
Tonic convulsion 44.17 16.33 16 19878 1722 90606831
Ventricular hypokinesia 43.69 16.33 22 19872 5319 90603234
Sinusitis 43.26 16.33 11 19883 343077 90265476
Seizure cluster 42.53 16.33 11 19883 378 90608175
Peripheral swelling 42.12 16.33 19 19875 413087 90195466
Intentional overdose 41.31 16.33 74 19820 93760 90514793
Lymphangioleiomyomatosis 40.84 16.33 10 19884 274 90608279
Behaviour disorder 40.60 16.33 20 19874 4615 90603938
Cardio-respiratory arrest 40.38 16.33 59 19835 63081 90545472
Impaired healing 39.95 16.33 3 19891 234196 90374357
Electroencephalogram abnormal 39.87 16.33 19 19875 4077 90604476
Stevens-Johnson syndrome 39.48 16.33 40 19854 29336 90579217
Unmasking of previously unidentified disease 39.05 16.33 14 19880 1462 90607091
Atrioventricular block 38.38 16.33 24 19870 8791 90599762
Multiple drug therapy 38.07 16.33 22 19872 6987 90601566
Nasopharyngitis 38.07 16.33 21 19873 407083 90201470
Wound 37.64 16.33 10 19884 302970 90305583
Neonatal seizure 37.51 16.33 11 19883 606 90607947
Orthostatic hypotension 37.34 16.33 46 19848 41781 90566772
Electrocardiogram ST segment elevation 37.19 16.33 18 19876 3998 90604555
Myoclonus 37.15 16.33 32 19862 19136 90589417
Developmental delay 37.13 16.33 14 19880 1686 90606867
Laryngeal stenosis 36.56 16.33 13 19881 1326 90607227
Completed suicide 36.49 16.33 91 19803 144967 90463586
Asthma 36.40 16.33 5 19889 242155 90366398
Hypertonia 35.74 16.33 19 19875 5136 90603417
Malabsorption 35.66 16.33 19 19875 5159 90603394
Suicide attempt 35.17 16.33 61 19833 75338 90533215
Perforation 34.96 16.33 14 19880 1980 90606573
Product administered to patient of inappropriate age 34.67 16.33 18 19876 4635 90603918
Hypothermia 34.32 16.33 28 19866 15547 90593006
Stomatitis 34.25 16.33 9 19885 274689 90333864
Sopor 33.93 16.33 34 19860 24610 90583943
Urine delta aminolevulinate increased 33.66 16.33 5 19889 5 90608548
Gingival hypertrophy 33.63 16.33 14 19880 2186 90606367
Choreoathetosis 33.56 16.33 10 19884 582 90607971
Type 2 diabetes mellitus 33.56 16.33 3 19891 203241 90405312
Balance disorder 33.44 16.33 69 19825 97011 90511542
Wheezing 33.33 16.33 6 19888 238074 90370479
Cross sensitivity reaction 33.25 16.33 15 19879 2842 90605711
Necrotising colitis 32.82 16.33 12 19882 1326 90607227
Diarrhoea 32.66 16.33 102 19792 939088 89669465
Left ventricular hypertrophy 32.62 16.33 19 19875 6125 90602428
Electrocardiogram repolarisation abnormality 32.49 16.33 12 19882 1364 90607189
Haemodynamic instability 32.14 16.33 24 19870 11715 90596838
Electrocardiogram QRS complex prolonged 31.98 16.33 20 19874 7328 90601225
Anticonvulsant drug level below therapeutic 31.97 16.33 10 19884 686 90607867
Irritable bowel syndrome 31.85 16.33 4 19890 207444 90401109
Pneumonia aspiration 31.78 16.33 42 19852 40898 90567655
Nausea 31.72 16.33 131 19763 1110185 89498368
Fibromyalgia 31.62 16.33 4 19890 206265 90402288
Magnetic resonance imaging head abnormal 31.60 16.33 14 19880 2542 90606011
Coma blister 30.41 16.33 7 19887 146 90608407
Rhabdomyolysis 30.06 16.33 46 19848 51210 90557343
Eosinophilia 29.80 16.33 34 19860 28499 90580054
Somnolence 29.56 16.33 107 19787 208977 90399576
Drug intolerance 29.36 16.33 33 19861 447558 90160995
Blindness cortical 29.23 16.33 9 19885 586 90607967
Propofol infusion syndrome 29.14 16.33 11 19883 1328 90607225
Headache 29.07 16.33 95 19799 862651 89745902
Euthyroid sick syndrome 28.45 16.33 6 19888 82 90608471
Intensive care unit acquired weakness 28.30 16.33 10 19884 1001 90607552
Respiratory depression 28.17 16.33 25 19869 15550 90593003
Pain in extremity 27.64 16.33 35 19859 450494 90158059
Labelled drug-drug interaction medication error 27.56 16.33 24 19870 14558 90593995
Abortion induced 27.52 16.33 22 19872 11866 90596687
Porphyrins stool increased 27.40 16.33 5 19889 30 90608523
Eye movement disorder 27.30 16.33 17 19877 6181 90602372
Drug level increased 27.18 16.33 32 19862 27730 90580823
Necrotising enterocolitis neonatal 27.11 16.33 7 19887 239 90608314
Hypertrophic cardiomyopathy 26.89 16.33 12 19882 2216 90606337
Rhesus incompatibility 26.70 16.33 6 19888 112 90608441
Maternal exposure during pregnancy 26.57 16.33 152 19742 359911 90248642
Bradyphrenia 26.46 16.33 18 19876 7594 90600959
Urine copper increased 26.46 16.33 4 19890 5 90608548
Exposure during pregnancy 26.41 16.33 113 19781 238297 90370256
Pain 26.33 16.33 121 19773 996220 89612333
Postictal paralysis 25.99 16.33 7 19887 282 90608271
Cardiomegaly 25.85 16.33 26 19868 18899 90589654
Enterocolitis 25.54 16.33 20 19874 10470 90598083
Abnormal behaviour 25.40 16.33 28 19866 22600 90585953
Rebound effect 25.28 16.33 19 19875 9365 90599188
Lactic acidosis 25.08 16.33 42 19852 50421 90558132
Calcinosis 24.71 16.33 12 19882 2683 90605870
Atrioventricular block first degree 24.65 16.33 18 19876 8493 90600060
Encephalitis autoimmune 24.57 16.33 11 19883 2047 90606506
Premature delivery 24.46 16.33 36 19858 38726 90569827
Intensive care unit delirium 24.39 16.33 5 19889 59 90608494
Cardiac dysfunction 24.21 16.33 13 19881 3584 90604969
Urine amphetamine positive 23.94 16.33 5 19889 65 90608488
Acute hepatic failure 23.76 16.33 27 19867 22534 90586019
Cerebral atrophy 23.65 16.33 15 19879 5631 90602922
Severe myoclonic epilepsy of infancy 23.47 16.33 5 19889 72 90608481
Hepatic enzyme increased 23.20 16.33 27 19867 360709 90247844
Hypoaesthesia 23.06 16.33 21 19873 314189 90294364
Acquired macroglossia 22.88 16.33 6 19888 218 90608335
Febrile infection-related epilepsy syndrome 22.54 16.33 4 19890 20 90608533
Intellectual disability 22.44 16.33 9 19885 1277 90607276
Hypersensitivity 22.42 16.33 41 19853 454636 90153917
Blood cholesterol increased 22.08 16.33 9 19885 208003 90400550
Cardiotoxicity 22.04 16.33 19 19875 11370 90597183
Paraesthesia 21.85 16.33 14 19880 250312 90358241
Circulatory collapse 21.60 16.33 27 19867 24877 90583676
Speech disorder developmental 21.44 16.33 8 19886 935 90607618
Cardiac arrest neonatal 21.34 16.33 5 19889 113 90608440
Febrile convulsion 21.32 16.33 7 19887 561 90607992
Respiratory acidosis 20.90 16.33 16 19878 8103 90600450
Peritoneal perforation 20.78 16.33 5 19889 127 90608426
Malaise 20.77 16.33 63 19831 585923 90022630
Cholestasis 20.47 16.33 32 19862 36267 90572286
Ovarian cancer stage III 20.38 16.33 6 19888 335 90608218
Ammonia increased 20.27 16.33 13 19881 4973 90603580
Inflammation 20.17 16.33 7 19887 178585 90429968
Cortical dysplasia 20.03 16.33 4 19890 41 90608512
Impulsive behaviour 19.87 16.33 9 19885 1721 90606832
Immobile 19.60 16.33 14 19880 6384 90602169
Bradycardia 19.41 16.33 51 19843 83796 90524757
General physical health deterioration 19.36 16.33 30 19864 355085 90253468
Sudden unexplained death in epilepsy 19.32 16.33 6 19888 402 90608151
C-reactive protein increased 19.00 16.33 8 19886 181381 90427172
Resuscitation 18.98 16.33 8 19886 1288 90607265
Abscess 18.87 16.33 22 19872 18869 90589684
Cachexia 18.69 16.33 14 19880 6864 90601689
Hyponatraemia 18.57 16.33 68 19826 133470 90475083
Hypoxic-ischaemic encephalopathy 18.55 16.33 12 19882 4656 90603897
Night sweats 18.55 16.33 3 19891 128763 90479790
Hepatic function abnormal 18.47 16.33 35 19859 46253 90562300
Urticaria 18.44 16.33 25 19869 312709 90295844
Agitation 17.82 16.33 43 19851 67055 90541498
Blood lactic acid increased 17.71 16.33 15 19879 8763 90599790
Therapy non-responder 17.67 16.33 68 19826 136636 90471917
Methaemoglobinaemia 17.65 16.33 11 19883 4004 90604549
Poor feeding infant 17.58 16.33 6 19888 542 90608011
Congenital eyelid malformation 17.45 16.33 3 19891 12 90608541
Crystalluria 17.43 16.33 6 19888 556 90607997
Dyspepsia 17.40 16.33 11 19883 198149 90410404
Sinus bradycardia 17.36 16.33 20 19874 16932 90591621
Conjunctival hyperaemia 17.35 16.33 10 19884 3159 90605394
Pruritus 17.26 16.33 61 19833 541464 90067089
Primitive reflex test positive 17.25 16.33 3 19891 13 90608540
Back pain 17.09 16.33 27 19867 317148 90291405
Hepatitis 16.35 16.33 43 19851 70696 90537857

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
Drug ineffective 721.18 16.88 1054 16081 629143 41975057
Multiple-drug resistance 568.38 16.88 181 16954 7141 42597059
Seizure 537.28 16.88 419 16716 120142 42484058
Status epilepticus 438.39 16.88 182 16953 15396 42588804
Epilepsy 233.36 16.88 140 16995 26031 42578169
Respiratory depression 208.30 16.88 116 17019 18752 42585448
Off label use 148.53 16.88 575 16560 637760 41966440
Hyperammonaemia 147.00 16.88 69 17066 7797 42596403
Epidural lipomatosis 137.51 16.88 44 17091 1756 42602444
Drug dependence 135.20 16.88 104 17031 28990 42575210
Drug resistance 134.72 16.88 111 17024 34137 42570063
Drug reaction with eosinophilia and systemic symptoms 134.31 16.88 121 17014 41954 42562246
Victim of child abuse 133.19 16.88 39 17096 1150 42603050
Partial seizures 123.88 16.88 56 17079 5803 42598397
Juvenile idiopathic arthritis 121.02 16.88 44 17091 2595 42601605
Product prescribing error 111.91 16.88 89 17046 26023 42578177
Drug ineffective for unapproved indication 108.14 16.88 112 17023 46051 42558149
Intellectual disability 103.01 16.88 36 17099 1891 42602309
Infantile spasms 99.65 16.88 23 17112 255 42603945
Child abuse 98.77 16.88 29 17106 863 42603337
Coma 97.79 16.88 114 17021 53440 42550760
Generalised tonic-clonic seizure 96.48 16.88 82 17053 26297 42577903
Anticonvulsant drug level above therapeutic 96.03 16.88 27 17108 686 42603514
Product use issue 95.43 16.88 135 17000 76616 42527584
Sedation 90.11 16.88 84 17051 30391 42573809
Tonic convulsion 88.70 16.88 31 17104 1628 42602572
Toxicity to various agents 86.48 16.88 244 16891 228892 42375308
Ataxia 82.32 16.88 61 17074 16064 42588136
Petit mal epilepsy 77.52 16.88 35 17100 3615 42600585
Nausea 76.60 16.88 32 17103 396767 42207433
Dyspnoea 74.41 16.88 43 17092 442578 42161622
Drug abuse 74.21 16.88 143 16992 104628 42499572
Necrosis ischaemic 67.50 16.88 18 17117 373 42603827
Pneumonia aspiration 66.55 16.88 91 17044 49987 42554213
Developmental delay 65.95 16.88 30 17105 3152 42601048
Intensive care unit acquired weakness 64.96 16.88 23 17112 1255 42602945
Electroencephalogram abnormal 64.52 16.88 29 17106 2963 42601237
Dysmorphism 61.67 16.88 29 17106 3287 42600913
Somnolence 60.87 16.88 158 16977 140947 42463253
Drug withdrawal convulsions 60.20 16.88 22 17113 1316 42602884
Excessive eye blinking 58.65 16.88 18 17117 625 42603575
Autism spectrum disorder 58.26 16.88 27 17108 2961 42601239
Anticonvulsant drug level increased 55.80 16.88 22 17113 1621 42602579
Urine copper increased 55.14 16.88 9 17126 9 42604191
Anticonvulsant drug level decreased 54.58 16.88 20 17115 1205 42602995
Fatigue 53.45 16.88 58 17077 435583 42168617
Gaze palsy 52.65 16.88 22 17113 1883 42602317
Obesity 51.81 16.88 47 17088 16412 42587788
Sudden unexplained death in epilepsy 49.06 16.88 15 17120 514 42603686
Anticonvulsant drug level below therapeutic 48.56 16.88 16 17119 701 42603499
Nystagmus 48.38 16.88 29 17106 5367 42598833
Cognitive disorder 48.29 16.88 64 17071 34108 42570092
Foetal anticonvulsant syndrome 47.61 16.88 18 17117 1184 42603016
Superinfection 46.39 16.88 23 17112 2928 42601272
Mucosal ulceration 45.53 16.88 18 17117 1336 42602864
Hyperammonaemic encephalopathy 44.85 16.88 22 17113 2736 42601464
Diarrhoea 44.66 16.88 73 17062 460776 42143424
Intestinal ischaemia 44.54 16.88 34 17101 9354 42594846
Hypotonia 44.18 16.88 34 17101 9465 42594735
Porphyria acute 43.76 16.88 13 17122 403 42603797
Partial seizures with secondary generalisation 43.49 16.88 13 17122 412 42603788
Porphyrins stool increased 42.89 16.88 7 17128 7 42604193
Testicular atrophy 42.39 16.88 14 17121 618 42603582
Arthralgia 42.07 16.88 15 17120 205223 42398977
Drug interaction 41.33 16.88 214 16921 266785 42337415
Behaviour disorder 41.28 16.88 29 17106 7025 42597175
Language disorder 41.02 16.88 20 17115 2455 42601745
Muscle mass 40.37 16.88 11 17124 248 42603952
Posture abnormal 37.71 16.88 19 17116 2502 42601698
Malaise 36.41 16.88 20 17115 212136 42392064
Systemic inflammatory response syndrome 35.58 16.88 27 17108 7363 42596837
Pain 35.38 16.88 28 17107 244820 42359380
Tenderness 35.33 16.88 29 17106 8854 42595346
Psychomotor retardation 35.24 16.88 22 17113 4377 42599823
Benzodiazepine drug level decreased 35.21 16.88 7 17128 35 42604165
Hypertelorism 34.76 16.88 12 17123 607 42603593
Cerebral atrophy 34.75 16.88 23 17112 5056 42599144
Ehlers-Danlos syndrome 34.73 16.88 7 17128 38 42604162
Myoclonic epilepsy 32.24 16.88 15 17120 1659 42602541
Misleading laboratory test result 31.90 16.88 6 17129 21 42604179
Psychomotor skills impaired 31.87 16.88 22 17113 5182 42599018
Coma neonatal 31.47 16.88 6 17129 23 42604177
Thrombotic microangiopathy 31.27 16.88 34 17101 14748 42589452
Malignant neoplasm progression 30.07 16.88 4 17131 108396 42495804
Magnetic resonance imaging head abnormal 30.05 16.88 14 17121 1553 42602647
Myocardial fibrosis 29.55 16.88 13 17122 1262 42602938
Blood lactic acid increased 29.39 16.88 25 17110 8014 42596186
Change in seizure presentation 29.33 16.88 9 17126 312 42603888
Pain in extremity 29.19 16.88 12 17123 150592 42453608
Necrotising enterocolitis neonatal 29.06 16.88 9 17126 322 42603878
Wrong patient received product 28.91 16.88 18 17117 3565 42600635
Laryngomalacia 28.88 16.88 9 17126 329 42603871
Cerebellar atrophy 28.76 16.88 11 17124 747 42603453
Haematuria traumatic 28.70 16.88 9 17126 336 42603864
Hepatitis fulminant 28.12 16.88 20 17115 4939 42599261
Foetal exposure during pregnancy 28.00 16.88 60 17075 47251 42556949
Hyperchloraemia 27.75 16.88 10 17125 574 42603626
Posthaemorrhagic hydrocephalus 27.55 16.88 7 17128 119 42604081
Overdose 27.55 16.88 99 17036 105165 42499035
Completed suicide 27.21 16.88 93 17042 96372 42507828
Therapeutic product effect incomplete 27.08 16.88 76 17059 70863 42533337
Pancytopenia 27.00 16.88 7 17128 117736 42486464
Propofol infusion syndrome 26.97 16.88 12 17123 1197 42603003
Product use in unapproved indication 26.53 16.88 145 16990 184311 42419889
Inappropriate antidiuretic hormone secretion 26.53 16.88 33 17102 16508 42587692
COVID-19 26.39 16.88 7 17128 115941 42488259
Condition aggravated 26.26 16.88 187 16948 260567 42343633
Hepatic adenoma 26.20 16.88 6 17129 64 42604136
Mental disability 25.87 16.88 6 17129 68 42604132
Pruritus 25.52 16.88 23 17112 188748 42415452
Fanconi syndrome 25.32 16.88 13 17122 1781 42602419
Therapy non-responder 25.30 16.88 62 17073 53297 42550903
Urine delta aminolevulinate increased 24.51 16.88 4 17131 4 42604196
Irritability 24.45 16.88 42 17093 28086 42576114
Poor feeding infant 24.20 16.88 10 17125 832 42603368
Encephalopathy 23.98 16.88 52 17083 41281 42562919
Sopor 23.89 16.88 28 17107 13174 42591026
Hyperlipasaemia 23.86 16.88 9 17126 588 42603612
Clonic convulsion 23.83 16.88 10 17125 865 42603335
Respiratory acidosis 23.78 16.88 20 17115 6311 42597889
Blood pressure increased 23.49 16.88 6 17129 101922 42502278
Back pain 23.40 16.88 14 17121 141762 42462438
Atonic seizures 23.11 16.88 8 17127 408 42603792
Talipes 22.63 16.88 13 17122 2223 42601977
Acute hepatic failure 22.62 16.88 31 17104 17042 42587158
Asterixis 22.44 16.88 11 17124 1366 42602834
Idiopathic generalised epilepsy 22.13 16.88 5 17130 50 42604150
Strabismus 22.04 16.88 13 17122 2335 42601865
Drug monitoring procedure not performed 22.02 16.88 8 17127 470 42603730
Low set ears 21.53 16.88 8 17127 501 42603699
Cardiac death 21.19 16.88 10 17125 1142 42603058
Drug withdrawal syndrome neonatal 20.82 16.88 16 17119 4445 42599755
Chills 20.80 16.88 6 17129 94060 42510140
Asthenia 20.69 16.88 52 17083 280741 42323459
Abnormal labour affecting foetus 20.47 16.88 4 17131 18 42604182
Purple glove syndrome 20.39 16.88 5 17130 73 42604127
Headache 20.34 16.88 41 17094 239328 42364872
Ammonia increased 20.20 16.88 16 17119 4643 42599557
Dizziness 20.09 16.88 44 17091 249210 42354990
Haemodynamic instability 20.06 16.88 25 17110 12532 42591668
Hyperthermia 20.03 16.88 25 17110 12549 42591651
Poor sucking reflex 19.98 16.88 7 17128 370 42603830
Necrotising colitis 19.96 16.88 10 17125 1301 42602899
Neuropathy peripheral 19.92 16.88 8 17127 101845 42502355
Paraesthesia 19.69 16.88 3 17132 73456 42530744
Cerebral ataxia 19.65 16.88 4 17131 23 42604177
Abdominal pain 19.48 16.88 29 17106 190442 42413758
Drug level decreased 19.46 16.88 22 17113 9955 42594245
Muscle contracture 19.11 16.88 10 17125 1425 42602775
Temporal lobe epilepsy 19.05 16.88 6 17129 227 42603973
Focal dyscognitive seizures 18.90 16.88 10 17125 1457 42602743
Autonomic nervous system imbalance 18.67 16.88 13 17122 3103 42601097
Scoliosis 18.63 16.88 13 17122 3113 42601087
Myoclonus 18.25 16.88 28 17107 17037 42587163
Thrombophlebitis 18.14 16.88 14 17121 3912 42600288
Pulmonary embolism 18.12 16.88 13 17122 119599 42484601
Prognathism 18.01 16.88 5 17130 121 42604079
Camptodactyly congenital 17.93 16.88 5 17130 123 42604077
Oedema peripheral 17.88 16.88 17 17118 136059 42468141
Product administered to patient of inappropriate age 17.80 16.88 15 17120 4746 42599454
Psychomotor hyperactivity 17.80 16.88 22 17113 10936 42593264
Social avoidant behaviour 17.78 16.88 13 17122 3351 42600849
Chest pain 17.68 16.88 18 17117 139512 42464688
Cross sensitivity reaction 17.66 16.88 10 17125 1665 42602535
Stress cardiomyopathy 17.59 16.88 12 17123 2773 42601427
Hyponatraemia 17.52 16.88 84 17051 101378 42502822
Aggression 17.52 16.88 48 17087 44115 42560085
Pneumonia 17.50 16.88 99 17036 422050 42182150
Seizure cluster 17.49 16.88 6 17129 298 42603902
Abdominal wall haematoma 17.07 16.88 11 17124 2311 42601889
Depression 17.00 16.88 12 17123 111351 42492849
Quadriparesis 16.95 16.88 11 17124 2339 42601861
Withdrawal syndrome 16.88 16.88 25 17110 14750 42589450

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
Multiple-drug resistance 1003.39 15.90 295 30452 12940 110545612
Status epilepticus 866.44 15.90 327 30420 31244 110527308
Seizure 846.83 15.90 606 30141 220579 110337973
Drug ineffective 787.68 15.90 1458 29289 1519082 109039470
Drug reaction with eosinophilia and systemic symptoms 507.23 15.90 304 30443 81791 110476761
Toxicity to various agents 301.00 15.90 504 30243 480051 110078501
Epilepsy 277.69 15.90 227 30520 99982 110458570
Drug interaction 269.49 15.90 491 30256 499692 110058860
Hyperammonaemia 256.98 15.90 108 30639 13624 110544928
Drug resistance 234.74 15.90 163 30584 56211 110502341
Respiratory depression 217.09 15.90 126 30621 31875 110526677
Drug ineffective for unapproved indication 208.42 15.90 195 30552 102643 110455909
Generalised tonic-clonic seizure 197.49 15.90 145 30602 54535 110504017
Ataxia 194.88 15.90 115 30632 29993 110528559
Coma 191.36 15.90 198 30549 117671 110440881
Partial seizures 185.13 15.90 81 30666 11268 110547284
Off label use 178.98 15.90 855 29892 1499330 109059222
Anticonvulsant drug level increased 174.66 15.90 54 30693 2804 110555748
Drug abuse 173.98 15.90 230 30517 177181 110381371
Necrosis ischaemic 165.74 15.90 44 30703 1315 110557237
Drug dependence 161.40 15.90 124 30623 49896 110508656
Epidural lipomatosis 147.48 15.90 44 30703 2023 110556529
Victim of child abuse 146.70 15.90 39 30708 1172 110557380
Anticonvulsant drug level above therapeutic 145.10 15.90 39 30708 1223 110557329
Overdose 137.69 15.90 239 30508 233555 110324997
Cognitive disorder 133.06 15.90 142 30605 87369 110471183
Drug withdrawal convulsions 131.83 15.90 42 30705 2407 110556145
Anticonvulsant drug level decreased 129.02 15.90 40 30707 2096 110556456
Intestinal ischaemia 126.71 15.90 70 30677 16109 110542443
Intra-abdominal pressure increased 117.13 15.90 26 30721 356 110558196
Product prescribing error 116.96 15.90 104 30643 51227 110507325
Pneumonia aspiration 115.08 15.90 127 30620 81106 110477446
Nystagmus 112.97 15.90 58 30689 11519 110547033
Child abuse 109.45 15.90 29 30718 860 110557692
Systemic inflammatory response syndrome 103.70 15.90 57 30690 12986 110545566
Juvenile idiopathic arthritis 101.64 15.90 44 30703 5963 110552589
Intensive care unit acquired weakness 100.91 15.90 34 30713 2325 110556227
Infantile spasms 100.27 15.90 23 30724 368 110558184
Fatigue 96.66 15.90 118 30629 1215840 109342712
Arthralgia 95.36 15.90 49 30698 779583 109778969
Petit mal epilepsy 95.08 15.90 45 30702 7502 110551050
Hyperammonaemic encephalopathy 92.58 15.90 40 30707 5394 110553158
Nausea 88.95 15.90 129 30618 1235561 109322991
Tonic convulsion 88.44 15.90 33 30714 3041 110555511
Somnolence 86.27 15.90 228 30519 297221 110261331
Myocardial depression 85.94 15.90 23 30724 709 110557843
Anticonvulsant drug level below therapeutic 84.05 15.90 25 30722 1137 110557415
Urine copper increased 83.95 15.90 13 30734 14 110558538
Myoclonic epilepsy 81.50 15.90 30 30717 2661 110555891
Joint swelling 78.88 15.90 14 30733 442831 110115721
Pneumatosis 78.82 15.90 23 30724 978 110557574
Angiofibroma 74.68 15.90 15 30732 122 110558430
Cerebellar atrophy 74.44 15.90 24 30723 1429 110557123
Infusion related reaction 72.52 15.90 10 30737 381152 110177400
Electroencephalogram abnormal 72.27 15.90 35 30712 6138 110552414
Depressed level of consciousness 70.25 15.90 118 30629 112160 110446392
Completed suicide 69.44 15.90 185 30562 242196 110316356
Porphyrins stool increased 69.39 15.90 12 30735 37 110558515
Abdominal discomfort 68.95 15.90 13 30734 393845 110164707
Atonic seizures 67.14 15.90 21 30726 1133 110557419
Cardiac arrest 65.53 15.90 159 30588 196594 110361958
Breast hyperplasia 64.40 15.90 14 30733 173 110558379
Rheumatoid arthritis 64.34 15.90 5 30742 299608 110258944
Malaise 60.06 15.90 59 30688 671760 109886792
Cerebral atrophy 59.55 15.90 35 30712 9050 110549502
Urine delta aminolevulinate increased 58.46 15.90 9 30738 9 110558543
Peripheral swelling 57.96 15.90 20 30727 404014 110154538
Alopecia 57.87 15.90 15 30732 364738 110193814
Multiple organ dysfunction syndrome 57.51 15.90 129 30618 151581 110406971
Metabolic acidosis 57.37 15.90 101 30646 99643 110458909
Sopor 56.75 15.90 60 30687 36486 110522066
Intellectual disability 56.04 15.90 21 30726 1958 110556594
Partial seizures with secondary generalisation 55.75 15.90 17 30730 842 110557710
Systemic lupus erythematosus 55.30 15.90 4 30743 254334 110304218
Hypotonia 55.12 15.90 41 30706 15704 110542848
Gaze palsy 54.53 15.90 24 30723 3383 110555169
Propofol infusion syndrome 53.96 15.90 22 30725 2567 110555985
Altered state of consciousness 53.78 15.90 73 30674 57553 110500999
Arthropathy 53.61 15.90 8 30739 287514 110271038
Acute hepatic failure 53.33 15.90 58 30689 36410 110522142
Dyspnoea 53.31 15.90 146 30601 1106726 109451826
Testicular atrophy 53.27 15.90 14 30733 402 110558150
Irritability 53.10 15.90 66 30681 47743 110510809
Kounis syndrome 52.98 15.90 28 30719 5897 110552655
Stevens-Johnson syndrome 52.50 15.90 65 30682 46836 110511716
Sudden unexplained death in epilepsy 52.19 15.90 16 30731 807 110557745
Headache 51.54 15.90 105 30642 882272 109676280
Swelling 51.00 15.90 17 30730 351024 110207528
Contraindicated product administered 50.97 15.90 5 30742 248262 110310290
Malabsorption 50.86 15.90 28 30719 6397 110552155
Developmental delay 50.61 15.90 18 30729 1447 110557105
Behaviour disorder 50.03 15.90 32 30715 9615 110548937
Creatinine renal clearance increased 49.95 15.90 23 30724 3602 110554950
Asthma 48.95 15.90 6 30741 250285 110308267
Sedation 48.68 15.90 77 30670 69606 110488946
Hyponatraemia 48.64 15.90 152 30595 217501 110341051
Focal dyscognitive seizures 48.64 15.90 23 30724 3826 110554726
Blood lactic acid increased 48.36 15.90 38 30709 15783 110542769
Electrocardiogram QRS complex prolonged 48.05 15.90 35 30712 12986 110545566
Pain in extremity 48.03 15.90 39 30708 487079 110071473
Diarrhoea 47.92 15.90 160 30587 1139345 109419207
Hypotension 47.64 15.90 278 30469 523571 110034981
Stomatitis 47.11 15.90 9 30738 270233 110288319
Oropharyngeal oedema 47.07 15.90 13 30734 452 110558100
Angiomyolipoma 46.87 15.90 12 30735 310 110558242
Sedation complication 46.75 15.90 41 30706 19814 110538738
Pain 46.66 15.90 125 30622 954830 109603722
Paraesthesia 46.56 15.90 10 30737 276511 110282041
Excessive eye blinking 46.33 15.90 18 30729 1852 110556700
Product use issue 45.99 15.90 190 30557 311505 110247047
Aggression 44.96 15.90 68 30679 59142 110499410
Renal function test abnormal 44.73 15.90 29 30718 8917 110549635
Myoclonus 43.98 15.90 50 30697 32948 110525604
Seizure cluster 43.66 15.90 14 30733 819 110557733
Creatinine renal clearance decreased 43.44 15.90 41 30706 21774 110536778
Ultrasound ovary abnormal 43.32 15.90 9 30738 88 110558464
Macroglossia 43.19 15.90 16 30731 1445 110557107
Gingival hypertrophy 43.13 15.90 22 30725 4309 110554243
Left ventricular hypertrophy 43.07 15.90 33 30714 13211 110545341
Impaired healing 43.03 15.90 3 30744 196714 110361838
Product use in unapproved indication 43.01 15.90 241 30506 447136 110111416
Hypoaesthesia 42.62 15.90 17 30730 314206 110244346
Mucosal ulceration 42.13 15.90 18 30729 2361 110556191
Muscle mass 42.05 15.90 12 30735 471 110558081
Ammonia increased 41.88 15.90 27 30720 8223 110550329
Choreoathetosis 40.85 15.90 16 30731 1682 110556870
Cross sensitivity reaction 40.63 15.90 23 30724 5544 110553008
Wound 40.45 15.90 8 30739 234429 110324123
Lymphangioleiomyomatosis 40.38 15.90 10 30737 225 110558327
Sinusitis 40.32 15.90 16 30731 296672 110261880
Cardiotoxicity 40.03 15.90 35 30712 16846 110541706
Superinfection 39.88 15.90 23 30724 5740 110552812
Respiratory acidosis 39.67 15.90 32 30715 13794 110544758
Nasopharyngitis 39.58 15.90 31 30716 394330 110164222
Haemophagocytic lymphohistiocytosis 39.01 15.90 46 30701 31513 110527039
Cardio-respiratory arrest 38.96 15.90 94 30653 115742 110442810
Mitral valve disease 38.83 15.90 19 30728 3406 110555146
Therapeutic product effect decreased 38.82 15.90 10 30737 244306 110314246
Hypothermia 38.75 15.90 42 30705 26260 110532292
Cytomegalovirus hepatitis 38.52 15.90 13 30734 893 110557659
Encephalitis autoimmune 38.30 15.90 19 30728 3509 110555043
Suicide attempt 38.15 15.90 87 30660 103307 110455245
Benzodiazepine drug level decreased 37.79 15.90 7 30740 35 110558517
Discomfort 37.74 15.90 7 30740 214700 110343852
Wheezing 37.69 15.90 12 30735 255218 110303334
Tachycardia 37.31 15.90 143 30604 226502 110332050
Posture abnormal 36.95 15.90 20 30727 4418 110554134
Intentional overdose 36.77 15.90 100 30647 132401 110426151
Haematuria traumatic 35.74 15.90 10 30737 365 110558187
Rhabdomyolysis 35.56 15.90 93 30654 120308 110438244
Myocardial fibrosis 35.02 15.90 15 30732 1980 110556572
Blood calcium decreased 34.34 15.90 46 30701 35799 110522753
Systolic dysfunction 34.28 15.90 19 30728 4396 110554156
Hypertonia 34.24 15.90 24 30723 8382 110550170
Fibromyalgia 33.65 15.90 4 30743 170905 110387647
Hepatic adenoma 33.57 15.90 10 30737 457 110558095
Urticaria 33.36 15.90 24 30723 318833 110239719
Perforation 33.07 15.90 14 30733 1796 110556756
Laryngeal stenosis 33.02 15.90 13 30734 1385 110557167
Type 2 diabetes mellitus 32.87 15.90 5 30742 177227 110381325
Back pain 32.62 15.90 33 30714 370963 110187589
Pruritus 32.39 15.90 71 30676 581489 109977063
Drug level increased 32.32 15.90 52 30695 47667 110510885
Ventricular hypokinesia 32.27 15.90 26 30721 11188 110547364
Malignant neoplasm progression 32.20 15.90 5 30742 174562 110383990
Irritable bowel syndrome 31.95 15.90 4 30743 164211 110394341
Wrong patient received product 31.82 15.90 21 30726 6653 110551899
Intentional product misuse 31.71 15.90 95 30652 132809 110425743
Febrile infection-related epilepsy syndrome 31.59 15.90 7 30740 95 110558457
Drug level decreased 31.58 15.90 32 30715 18516 110540036
Multiple drug therapy 30.61 15.90 22 30725 7992 110550560
Hyperchloraemia 30.34 15.90 12 30735 1294 110557258
Eosinophilia 29.91 15.90 56 30691 57880 110500672
General physical health deterioration 29.86 15.90 45 30702 425250 110133302
Fanconi syndrome 29.69 15.90 16 30731 3503 110555049
Withdrawal syndrome 29.65 15.90 40 30707 31340 110527212
Drug intolerance 29.53 15.90 42 30705 406470 110152082
Haemodynamic instability 29.35 15.90 34 30713 22854 110535698
Hepatitis fulminant 29.31 15.90 22 30725 8538 110550014
Febrile neutropenia 29.21 15.90 27 30720 316740 110241812
Abdominal pain 29.08 15.90 62 30685 512927 110045625
Blood pressure increased 28.97 15.90 18 30729 258355 110300197
Temporal lobe epilepsy 28.71 15.90 9 30738 489 110558063
Musculoskeletal pain 28.11 15.90 8 30739 183015 110375537
Rhesus incompatibility 28.10 15.90 5 30742 19 110558533
Anticonvulsant drug level therapeutic 28.10 15.90 5 30742 19 110558533
Rebound effect 27.91 15.90 27 30720 14779 110543773
Inappropriate antidiuretic hormone secretion 27.30 15.90 40 30707 33811 110524741
Unmasking of previously unidentified disease 26.92 15.90 14 30733 2854 110555698
Magnetic resonance imaging head abnormal 26.87 15.90 15 30732 3520 110555032
Poor feeding infant 26.80 15.90 7 30740 196 110558356
Cerebral ataxia 26.67 15.90 5 30742 27 110558525
Contusion 26.52 15.90 16 30731 233345 110325207
Encephalopathy 26.42 15.90 65 30682 80990 110477562
Chest pain 26.24 15.90 40 30707 376335 110182217
Dysmorphism 26.17 15.90 9 30738 655 110557897
Weight increased 26.12 15.90 48 30699 419596 110138956
Euthyroid sick syndrome 26.10 15.90 6 30741 97 110558455
Coma blister 25.87 15.90 7 30740 225 110558327
Thrombotic microangiopathy 25.80 15.90 36 30711 29113 110529439
Agitation 25.28 15.90 79 30668 112972 110445580
Injection site pain 25.16 15.90 9 30738 177913 110380639
Febrile convulsion 25.09 15.90 10 30737 1100 110557452
Atrioventricular block 24.95 15.90 27 30720 16850 110541702
Eye movement disorder 24.75 15.90 21 30726 9707 110548845
Blood zinc increased 24.71 15.90 4 30743 7 110558545
Musculoskeletal stiffness 24.46 15.90 25 30722 279797 110278755
Gastrointestinal disorder 24.29 15.90 19 30728 241933 110316619
Cardiac death 24.12 15.90 11 30736 1685 110556867
Product administered to patient of inappropriate age 23.91 15.90 19 30728 8017 110550535
Electrocardiogram ST segment elevation 23.77 15.90 20 30727 9140 110549412
COVID-19 23.66 15.90 20 30727 245040 110313512
Electrocardiogram repolarisation abnormality 23.65 15.90 12 30735 2323 110556229
Joint range of motion decreased 23.62 15.90 3 30744 121829 110436723
Ehlers-Danlos syndrome 23.41 15.90 7 30740 324 110558228
Hypertension 23.19 15.90 69 30678 510015 110048537
Coagulopathy 22.96 15.90 41 30706 40870 110517682
Idiopathic generalised epilepsy 22.84 15.90 5 30742 64 110558488
Cough 22.80 15.90 60 30687 461581 110096971
Hypersensitivity 22.74 15.90 49 30698 403949 110154603
Intensive care unit delirium 22.62 15.90 5 30742 67 110558485
Inflammation 22.31 15.90 13 30734 193225 110365327
Dermatitis exfoliative 21.97 15.90 21 30726 11326 110547226
Psoriasis 21.72 15.90 6 30741 139987 110418565
Clonic convulsion 21.69 15.90 10 30737 1570 110556982
Blindness cortical 21.47 15.90 9 30738 1126 110557426
Hyperthermia 21.46 15.90 28 30719 21244 110537308
Calcinosis 21.40 15.90 12 30735 2840 110555712
Ileus paralytic 21.37 15.90 21 30726 11716 110546836
Toxic epidermal necrolysis 21.21 15.90 48 30699 56679 110501873
Asthenia 21.21 15.90 109 30638 688890 109869662
Salivary hypersecretion 20.88 15.90 25 30722 17396 110541156
Vagal nerve stimulator implantation 20.82 15.90 6 30741 244 110558308
Change in seizure presentation 20.56 15.90 8 30739 826 110557726
Hepatic function abnormal 20.52 15.90 63 30684 89232 110469320
Foetal anticonvulsant syndrome 20.41 15.90 6 30741 262 110558290
Acquired macroglossia 20.41 15.90 6 30741 262 110558290
Balance disorder 20.37 15.90 75 30672 116485 110442067
Respiratory arrest 20.34 15.90 48 30699 58251 110500301
Night sweats 20.31 15.90 6 30741 133977 110424575
Circulatory collapse 20.28 15.90 40 30707 42953 110515599
Hypertrophic cardiomyopathy 20.24 15.90 12 30735 3151 110555401
Osteoarthritis 20.09 15.90 13 30734 182610 110375942
Brain oedema 19.86 15.90 33 30714 31065 110527487
Ovarian cancer stage III 19.82 15.90 6 30741 290 110558262
Arthritis 19.74 15.90 11 30736 167575 110390977
Autism spectrum disorder 19.70 15.90 10 30737 1938 110556614
Selective eating disorder 19.68 15.90 6 30741 297 110558255
Rash maculo-papular 19.57 15.90 55 30692 74167 110484385
Respiratory failure 19.34 15.90 114 30633 215218 110343334
Stupor 19.32 15.90 17 30730 8248 110550304
Abnormal behaviour 19.24 15.90 37 30710 39002 110519550
Blood cholesterol increased 19.20 15.90 14 30733 184771 110373781
Dyspepsia 19.16 15.90 15 30732 190950 110367602
Pancytopenia 19.16 15.90 18 30729 209595 110348957
Dyspnoea exertional 19.14 15.90 3 30744 104057 110454495
Hyperlipasaemia 19.13 15.90 9 30738 1480 110557072
Urine amphetamine positive 19.11 15.90 5 30742 141 110558411
Postictal paralysis 19.09 15.90 7 30740 614 110557938
Hyperplasia 18.96 15.90 9 30738 1509 110557043
Hypospadias 18.91 15.90 5 30742 147 110558405
Muscle contracture 18.88 15.90 11 30736 2797 110555755
Pancreatitis 18.77 15.90 63 30684 93470 110465082
Pulmonary fibrosis 18.64 15.90 3 30744 102039 110456513
Unresponsive to stimuli 18.55 15.90 49 30698 63741 110494811
Epileptic encephalopathy 18.42 15.90 7 30740 678 110557874
Thrombophlebitis 18.36 15.90 16 30731 7663 110550889
Abdominal pain upper 18.30 15.90 44 30703 349067 110209485
Peritoneal perforation 18.04 15.90 5 30742 176 110558376
Chills 17.85 15.90 16 30731 190564 110367988
Drug level below therapeutic 17.83 15.90 19 30728 11654 110546898
Asterixis 17.69 15.90 11 30736 3147 110555405
Premature delivery 17.58 15.90 31 30716 30601 110527951
Neurodegenerative disorder 17.48 15.90 7 30740 780 110557772
Drug eruption 17.45 15.90 43 30704 53616 110504936
Microcephaly 17.40 15.90 5 30742 201 110558351
Labelled drug-drug interaction medication error 17.26 15.90 30 30717 29272 110529280
Impulsive behaviour 17.20 15.90 11 30736 3304 110555248
Tenderness 17.16 15.90 30 30717 29407 110529145
Myalgia 17.12 15.90 22 30725 222359 110336193
Drug monitoring procedure not performed 16.97 15.90 8 30739 1322 110557230
Cellulitis 16.78 15.90 7 30740 126009 110432543
Foetal exposure during pregnancy 16.68 15.90 15 30732 7490 110551062
Bradycardia 16.40 15.90 86 30661 155431 110403121
Product preparation issue 16.38 15.90 10 30737 2769 110555783
Diabetes insipidus 16.34 15.90 14 30733 6556 110551996
C-reactive protein increased 16.33 15.90 22 30725 217897 110340655
Sciatica 16.26 15.90 3 30744 92396 110466156
Stress cardiomyopathy 16.25 15.90 21 30726 15785 110542767
Fever neonatal 16.19 15.90 3 30744 15 110558537
No adverse event 15.95 15.90 51 30696 73788 110484764
Therapy non-responder 15.92 15.90 86 30661 157221 110401331

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 164.38 47.78 87 313 1546 112007
Off label use 75.80 47.78 51 349 1356 112197
Multiple-drug resistance 56.49 47.78 18 382 67 113486

Pharmacologic Action:

SourceCodeDescription
ATC N03AA02 NERVOUS SYSTEM
ANTIEPILEPTICS
ANTIEPILEPTICS
Barbiturates and derivatives
MeSH PA D000927 Anticonvulsants
MeSH PA D002492 Central Nervous System Depressants
MeSH PA D006993 Hypnotics and Sedatives
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D018682 GABA Agents
MeSH PA D018691 Excitatory Amino Acid Antagonists
MeSH PA D018757 GABA Modulators
MeSH PA D065695 Cytochrome P-450 CYP2B6 Inducers
MeSH PA D065701 Cytochrome P-450 CYP3A 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:35717 sedative
CHEBI has role CHEBI:60798 excitatory amino acid antagonist
CHEBI has role CHEBI:88188 drug allergen

Related Drugs by ATC class:

N03AA Barbiturates and derivatives 4 drugs
barbexaclonemetharbitalmethylphenobarbitalprimidone

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

DiseaseRelationSNOMED_IDDOID
Migraine indication 37796009 DOID:6364
Tonic-clonic seizure indication 54200006
Epilepsy indication 84757009 DOID:1826
Bipolar disorder in remission indication 85248005
Vascular headache indication 128187005
Cluster headache syndrome indication 193031009
Lennox-Gastaut syndrome indication 230418006
Tonic-clonic epilepsy indication 352818000 DOID:7725
Epilepsy characterized by intractable complex partial seizures indication 442481002
Simple partial seizure indication 117891000119100
Cluster Headache Prevention indication
Hyperbilirubinemia off-label use 14783006 DOID:2741
Postmenopausal osteoporosis off-label use 102447009
Seizure disorder off-label use 128613002
Alcohol withdrawal syndrome off-label use 191480000
Bipolar affective disorder, current episode depression off-label use 191627008 DOID:3312
Status epilepticus off-label use 230456007 DOID:1824
Neuropathic pain off-label use 247398009
Rapid Cycling Bipolar Affective Disorder off-label use
Brain damage contraindication 2470005
Necrotizing enterocolitis in fetus OR newborn contraindication 2707005
Goiter contraindication 3716002 DOID:12176
Gastritis contraindication 4556007 DOID:4029
Osteomalacia contraindication 4598005 DOID:10573
Tachyarrhythmia contraindication 6285003
Suicidal thoughts contraindication 6471006
Urinary tract obstruction contraindication 7163005 DOID:5200
Alcoholism contraindication 7200002
Hyperammonemia contraindication 9360008
Peptic ulcer contraindication 13200003 DOID:750
Chronic obstructive lung disease contraindication 13645005 DOID:3083
Hepatic encephalopathy contraindication 13920009 DOID:13413
Hyperkalemia contraindication 14140009
Disorder of thyroid gland contraindication 14304000 DOID:50
Severe chronic ulcerative colitis contraindication 14311001
Disorder of autonomic nervous system contraindication 15241006
Agranulocytosis contraindication 17182001 DOID:12987
Pulmonary edema contraindication 19242006 DOID:11396
Hashimoto thyroiditis contraindication 21983002
Myocardial infarction contraindication 22298006 DOID:5844
Glaucoma contraindication 23986001 DOID:1686
Acute tuberculosis contraindication 25629007
Alcohol intoxication contraindication 25702006
Shock contraindication 27942005
Toxic megacolon contraindication 28536002 DOID:1770
Atony of colon contraindication 29479008
Lymphadenopathy contraindication 30746006
Sarcoidosis contraindication 31541009 DOID:11335
Bronchitis contraindication 32398004 DOID:6132
Dehydration contraindication 34095006
Hyperthyroidism contraindication 34486009 DOID:7998
Depressive disorder contraindication 35489007
Acute hepatitis contraindication 37871000
Hypertensive disorder contraindication 38341003 DOID:10763
Hypovolemic shock contraindication 39419009
Gastrointestinal ulcer contraindication 40845000
Hypothyroidism contraindication 40930008 DOID:1459
Complete trisomy 21 syndrome contraindication 41040004 DOID:14250
Third trimester pregnancy contraindication 41587001
Hyperactive behavior contraindication 44548000
Conduction disorder of the heart contraindication 44808001
Low blood pressure contraindication 45007003
Achalasia of esophagus contraindication 45564002 DOID:9164
Chronic heart failure contraindication 48447003
Retroperitoneal fibrosis contraindication 49120005
Disorder of cardiovascular system contraindication 49601007 DOID:1287
Fibrosis of lung contraindication 51615001 DOID:3770
Vitamin K deficiency contraindication 52675005 DOID:11249
Nasal polyp contraindication 52756005
Megaloblastic anemia contraindication 53165003 DOID:13382
Systemic lupus erythematosus contraindication 55464009 DOID:9074
Paralytic ileus contraindication 55525008 DOID:8442
Heart disease contraindication 56265001 DOID:114
Peptic reflux disease contraindication 57643001
Multiple organ failure contraindication 57653000
Acute nephropathy contraindication 58574008
Hepatic failure contraindication 59927004
Diarrhea contraindication 62315008
Thrombophlebitis contraindication 64156001 DOID:3875
Ulcerative colitis contraindication 64766004 DOID:8577
Poisoning by phenobarbital contraindication 64921004
Drug AND/OR toxin-induced diarrhea contraindication 65979008
Substance abuse contraindication 66214007
Hypercalcemia contraindication 66931009 DOID:12678
Hyperparathyroidism contraindication 66999008 DOID:13543
Psychotic disorder contraindication 69322001
Poisoning by acetaminophen contraindication 70273001
Agoraphobia contraindication 70691001 DOID:593
Incontinence of feces contraindication 72042002
Hepatic coma contraindication 72836002 DOID:12550
Diabetes mellitus contraindication 73211009 DOID:9351
Sleep apnea contraindication 73430006 DOID:0050847
Factor II deficiency contraindication 73975000
Reye's syndrome contraindication 74351001 DOID:14525
Appendicitis contraindication 74400008 DOID:8337
Gastrointestinal hemorrhage contraindication 74474003
Thrombotic thrombocytopenic purpura contraindication 78129009 DOID:10772
Spastic paralysis contraindication 78403003
Disturbance of salivary secretion contraindication 78948009
Hyperglycemia contraindication 80394007 DOID:4195
Cor pulmonale contraindication 83291003 DOID:8515
Hiatal hernia contraindication 84089009 DOID:12642
Leukopenia contraindication 84828003 DOID:615
Gout contraindication 90560007 DOID:13189
Kidney disease contraindication 90708001 DOID:557
Hemophilia contraindication 90935002
Myasthenia gravis contraindication 91637004 DOID:437
Kidney stone contraindication 95570007
Dermatitis herpetiformis contraindication 111196000 DOID:8505
Anemia due to enzyme deficiency contraindication 111577008
Gastrointestinal obstruction contraindication 126765001
Pancytopenia contraindication 127034005 DOID:12450
von Willebrand disorder contraindication 128105004 DOID:12531
Autonomic dysreflexia contraindication 129618003
Bleeding contraindication 131148009
Cystic fibrosis contraindication 190905008 DOID:1485
Obsessive-compulsive disorder contraindication 191736004 DOID:10933
Insomnia contraindication 193462001
Angina pectoris contraindication 194828000
Impaired renal function disorder contraindication 197663003
Osteolysis contraindication 203522001
Non-infective meningitis contraindication 230155003
Myocardial dysfunction contraindication 233928007
Peripheral ischemia contraindication 233958001
Gastroesophageal reflux disease contraindication 235595009 DOID:8534
Disease of liver contraindication 235856003 DOID:409
Bladder outflow obstruction contraindication 236645006
Sepsis syndrome contraindication 238150007
Hypocomplementemic urticarial vasculitis contraindication 239945009
Pyloric obstruction contraindication 244815007
Sleep automatism contraindication 247962006
Raynaud's phenomenon contraindication 266261006
Benign prostatic hyperplasia contraindication 266569009
Dyspnea contraindication 267036007
Retention of urine contraindication 267064002
Anemia contraindication 271737000 DOID:2355
Continuous fever contraindication 271751000
Drowsy contraindication 271782001
Cerebral ischemia contraindication 287731003
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
Panic disorder contraindication 371631005 DOID:594
Smoking cessation assistance contraindication 384742004
Angle-closure glaucoma contraindication 392291006 DOID:13550
Gastric ulcer contraindication 397825006 DOID:10808
Peripheral vascular disease contraindication 400047006
Respiratory insufficiency contraindication 409623005
Breastfeeding (mother) contraindication 413712001
Chronic lung disease contraindication 413839001
Chronic myocardial ischemia contraindication 413844008 DOID:3393
Disorder of coronary artery contraindication 414024009
Myocardial ischemia contraindication 414795007 DOID:3393
Granulocytopenic disorder contraindication 417672002
Myocardial infarction in recovery phase contraindication 418044006
Porphyria contraindication 418470004
Fever greater than 100.4 Fahrenheit contraindication 426000000
Hyperplasia of gingiva contraindication 441798003
Fibrosis of pleura contraindication 442110002
Acute erosive gastritis contraindication 444926003
Smokes tobacco daily contraindication 449868002
Acute exacerbation of asthma contraindication 708038006
Ergot Alkaloid Toxicity contraindication
Severe Pruritus contraindication
HLA-B 1502 Positive Status contraindication
Theophylline Toxicity contraindication
Severe Hypoxemia contraindication




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 7.56 acidic
pKa2 9.25 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
100MG/VIAL SEZABY SUN PHARM INDS INC N215910 Nov. 17, 2022 RX POWDER INTRAVENOUS 11857683 April 7, 2042 METHOD OF TREATING NEONATAL SEIZURES
100MG/VIAL SEZABY SUN PHARM INDS INC N215910 Nov. 17, 2022 RX POWDER INTRAVENOUS 12636254 April 7, 2042 METHOD OF TREATING NEONATAL SEIZURES

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
100MG/VIAL SEZABY SUN PHARM INDS INC N215910 Nov. 17, 2022 RX POWDER INTRAVENOUS Nov. 17, 2029 TREATMENT OF NEONATAL SEIZURES IN TERM AND PRETERM INFANTS

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Nuclear receptor subfamily 1 group I member 3 Nuclear hormone receptor WOMBAT-PK
Nuclear receptor subfamily 1 group I member 2 Nuclear hormone receptor WOMBAT-PK
GABA-A receptor alpha-1/beta-2/gamma-2 Ion channel WOMBAT-PK
Sodium channel alpha subunits; brain (Types I, II, III) Ion channel IC50 5.60 CHEMBL

External reference:

IDSource
4017422 VUID
N0000145810 NUI
D00506 KEGG_DRUG
57-30-7 SECONDARY_CAS_RN
4017422 VANDF
4017423 VANDF
C0031412 UMLSCUI
CHEBI:8069 CHEBI
UQA PDB_CHEM_ID
CHEMBL40 ChEMBL_ID
DB01174 DRUGBANK_ID
CHEMBL149972 ChEMBL_ID
D010634 MESH_DESCRIPTOR_UI
4763 PUBCHEM_CID
2804 IUPHAR_LIGAND_ID
414 INN_ID
YQE403BP4D UNII
8134 RXNORM
2390 MMSL
33817 MMSL
4349 MMSL
5272 MMSL
5273 MMSL
d00340 MMSL
001406 NDDF
001407 NDDF
373505007 SNOMEDCT_US
51073002 SNOMEDCT_US
76898000 SNOMEDCT_US
4172 INN_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Phenobarbital HUMAN PRESCRIPTION DRUG LABEL 1 0121-0531 SOLUTION 20 mg ORAL unapproved drug other 29 sections
Phenobarbital Oral Solution HUMAN PRESCRIPTION DRUG LABEL 1 0121-0942 SOLUTION 20 mg ORAL unapproved drug other 14 sections
Phenobarbital Oral Solution HUMAN PRESCRIPTION DRUG LABEL 1 0121-1884 SOLUTION 30 mg ORAL unapproved drug other 14 sections
Phenobarbital Oral Solution HUMAN PRESCRIPTION DRUG LABEL 1 0121-2826 SOLUTION 60 mg ORAL unapproved drug other 14 sections
Phenobarbital HUMAN PRESCRIPTION DRUG LABEL 1 0143-1455 TABLET 60 mg ORAL unapproved drug other 17 sections
Phenobarbital HUMAN PRESCRIPTION DRUG LABEL 1 0143-1458 TABLET 100 mg ORAL unapproved drug other 17 sections
Phenobarbital HUMAN PRESCRIPTION DRUG LABEL 1 0143-1495 TABLET 15 mg ORAL unapproved drug other 17 sections
Phenobarbital HUMAN PRESCRIPTION DRUG LABEL 1 0143-1500 TABLET 30 mg ORAL unapproved drug other 17 sections
Belladonna Alkaloids with Phenobartbital HUMAN PRESCRIPTION DRUG LABEL 4 0440-7183 TABLET 16.20 mg ORAL UNAPPROVED DRUG OTHER 14 sections
Phenobarbital HUMAN PRESCRIPTION DRUG LABEL 1 0463-6145 TABLET 30 mg ORAL UNAPPROVED DRUG OTHER 17 sections
Phenobarbital HUMAN PRESCRIPTION DRUG LABEL 1 0463-6151 TABLET 60 mg ORAL UNAPPROVED DRUG OTHER 17 sections
Phenobarbital HUMAN PRESCRIPTION DRUG LABEL 1 0463-6160 TABLET 15 mg ORAL UNAPPROVED DRUG OTHER 17 sections
Phenobarbital HUMAN PRESCRIPTION DRUG LABEL 1 0463-6170 TABLET 100 mg ORAL UNAPPROVED DRUG OTHER 17 sections
Phenobarbital HUMAN PRESCRIPTION DRUG LABEL 1 0603-5165 TABLET 16.20 mg ORAL unapproved drug other 22 sections
Phenobarbital HUMAN PRESCRIPTION DRUG LABEL 1 0603-5166 TABLET 32.40 mg ORAL unapproved drug other 22 sections
Phenobarbital HUMAN PRESCRIPTION DRUG LABEL 1 0603-5167 TABLET 64.80 mg ORAL unapproved drug other 22 sections
Phenobarbital HUMAN PRESCRIPTION DRUG LABEL 1 0603-5168 TABLET 97.20 mg ORAL unapproved drug other 22 sections
Phenobarbital Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0641-0476 INJECTION 65 mg INTRAMUSCULAR unapproved drug other 19 sections
Phenobarbital Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0641-0477 INJECTION 130 mg INTRAMUSCULAR unapproved drug other 19 sections
Phenobarbital HUMAN PRESCRIPTION DRUG LABEL 1 0904-6575 TABLET 32.40 mg ORAL Unapproved drug other 22 sections
Phenobarbital HUMAN PRESCRIPTION DRUG LABEL 1 13517-625 TABLET 16.20 mg ORAL unapproved drug other 22 sections
Phenobarbital HUMAN PRESCRIPTION DRUG LABEL 1 13517-626 TABLET 32.40 mg ORAL unapproved drug other 22 sections
Phenobarbital HUMAN PRESCRIPTION DRUG LABEL 1 13517-627 TABLET 64.80 mg ORAL unapproved drug other 22 sections
Phenobarbital HUMAN PRESCRIPTION DRUG LABEL 1 13517-628 TABLET 97.20 mg ORAL unapproved drug other 22 sections
Phenobarbital HUMAN PRESCRIPTION DRUG LABEL 1 13517-691 TABLET 15 mg ORAL unapproved drug other 22 sections
Phenobarbital HUMAN PRESCRIPTION DRUG LABEL 1 13517-692 TABLET 30 mg ORAL unapproved drug other 22 sections
Phenobarbital HUMAN PRESCRIPTION DRUG LABEL 1 13517-693 TABLET 60 mg ORAL unapproved drug other 22 sections
Phenobarbital HUMAN PRESCRIPTION DRUG LABEL 1 13517-694 TABLET 100 mg ORAL unapproved drug other 22 sections
Phenobarbital HUMAN PRESCRIPTION DRUG LABEL 1 13811-299 ELIXIR 20 mg ORAL unapproved drug other 20 sections
Phenobarbital HUMAN PRESCRIPTION DRUG LABEL 1 13811-300 TABLET 15 mg ORAL unapproved drug other 17 sections