phenobarbital ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | 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 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 99 % 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

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 537.14 16.06 145 16199 5025 63467653
Seizure 520.66 16.06 358 15986 132276 63340402
Status epilepticus 430.64 16.06 158 16186 15075 63457603
Drug reaction with eosinophilia and systemic symptoms 329.80 16.06 165 16179 33671 63439007
Drug ineffective 202.55 16.06 656 15688 1044109 62428569
Epilepsy 189.82 16.06 106 16238 26959 63445719
Toxicity to various agents 176.44 16.06 264 16080 246986 63225692
Drug resistance 164.04 16.06 91 16253 22842 63449836
Drug interaction 163.92 16.06 245 16099 228886 63243792
Anticonvulsant drug level increased 109.41 16.06 32 16312 1485 63471193
Intra-abdominal pressure increased 106.52 16.06 22 16322 227 63472451
Generalised tonic-clonic seizure 94.23 16.06 70 16274 28946 63443732
Hyperammonaemia 93.66 16.06 39 16305 5193 63467485
Myoclonic epilepsy 92.86 16.06 27 16317 1227 63471451
Coma 91.18 16.06 97 16247 64267 63408411
Ataxia 86.52 16.06 52 16292 15143 63457535
Drug withdrawal convulsions 85.17 16.06 26 16318 1399 63471279
Abortion spontaneous 84.97 16.06 81 16263 47114 63425564
Pneumatosis 83.83 16.06 20 16324 415 63472263
Kounis syndrome 80.21 16.06 26 16318 1704 63470974
Anticonvulsant drug level decreased 79.79 16.06 24 16320 1228 63471450
Necrosis ischaemic 79.41 16.06 22 16322 838 63471840
Overdose 77.74 16.06 120 16224 114958 63357720
Angiofibroma 77.69 16.06 15 16329 106 63472572
Drug ineffective for unapproved indication 74.07 16.06 65 16279 33998 63438680
Infantile spasms 69.10 16.06 15 16329 200 63472478
Multiple organ dysfunction syndrome 69.07 16.06 79 16265 56673 63416005
Haemophagocytic lymphohistiocytosis 67.41 16.06 39 16305 10588 63462090
Cognitive disorder 66.75 16.06 77 16267 55738 63416940
Nystagmus 65.47 16.06 32 16312 6188 63466490
Partial seizures 64.33 16.06 31 16313 5811 63466867
Fatigue 62.17 16.06 83 16261 887945 62584733
Developmental glaucoma 60.74 16.06 11 16333 52 63472626
Abdominal discomfort 58.50 16.06 7 16337 320878 63151800
Breast hyperplasia 58.34 16.06 14 16330 298 63472380
Arthralgia 57.70 16.06 38 16306 569672 62903006
Intestinal ischaemia 57.14 16.06 31 16313 7437 63465241
Hyperammonaemic encephalopathy 56.93 16.06 22 16322 2412 63470266
Tachycardia 55.68 16.06 105 16239 118051 63354627
Systemic inflammatory response syndrome 53.48 16.06 27 16317 5594 63467084
Angiomyolipoma 52.23 16.06 12 16332 210 63472468
Oropharyngeal oedema 51.77 16.06 13 16331 336 63472342
Cytomegalovirus hepatitis 51.15 16.06 13 16331 353 63472325
Joint swelling 51.11 16.06 11 16333 327655 63145023
Foetal exposure during pregnancy 50.32 16.06 51 16293 31911 63440767
Alopecia 49.36 16.06 13 16331 337523 63135155
Petit mal epilepsy 47.51 16.06 22 16322 3772 63468906
Hypotension 47.38 16.06 166 16178 272438 63200240
Focal dyscognitive seizures 46.38 16.06 20 16324 2901 63469777
Cerebellar atrophy 46.21 16.06 14 16330 734 63471944
Hypotonia 45.79 16.06 29 16315 9256 63463422
Infusion related reaction 45.62 16.06 5 16339 245516 63227162
Rheumatoid arthritis 45.12 16.06 6 16338 253813 63218865
Off label use 45.08 16.06 312 16032 674150 62798528
Foetal anticonvulsant syndrome 44.68 16.06 13 16331 592 63472086
Contraindicated product administered 44.33 16.06 3 16341 217645 63255033
Ultrasound ovary abnormal 44.01 16.06 9 16335 88 63472590
Lymphangioleiomyomatosis 43.15 16.06 10 16334 182 63472496
Mitral valve disease 42.75 16.06 18 16326 2462 63470216
Unmasking of previously unidentified disease 42.54 16.06 14 16330 962 63471716
Metabolic acidosis 42.25 16.06 55 16289 45014 63427664
Anticonvulsant drug level above therapeutic 41.82 16.06 12 16332 520 63472158
Stillbirth 40.77 16.06 24 16320 6726 63465952
Necrotising colitis 40.33 16.06 12 16332 591 63472087
Systolic dysfunction 39.35 16.06 15 16329 1584 63471094
Macroglossia 38.48 16.06 12 16332 693 63471985
Arthropathy 38.44 16.06 7 16337 234785 63237893
Depressed level of consciousness 38.10 16.06 62 16282 62016 63410662
Product administered to patient of inappropriate age 37.99 16.06 18 16326 3250 63469428
Laryngeal stenosis 37.29 16.06 13 16331 1065 63471613
Malabsorption 37.11 16.06 19 16325 4053 63468625
Systemic lupus erythematosus 36.98 16.06 5 16339 208913 63263765
Irritability 36.67 16.06 43 16301 31651 63441027
Perforation 36.11 16.06 13 16331 1170 63471508
Seizure cluster 35.60 16.06 9 16335 239 63472439
Atonic seizures 35.40 16.06 11 16333 628 63472050
Electrocardiogram ST segment elevation 34.85 16.06 18 16326 3909 63468769
Ventricular hypokinesia 34.76 16.06 19 16325 4625 63468053
Stevens-Johnson syndrome 34.24 16.06 37 16307 24913 63447765
Altered state of consciousness 33.90 16.06 37 16307 25193 63447485
Exposure during pregnancy 33.53 16.06 102 16242 155445 63317233
Urine delta aminolevulinate increased 32.86 16.06 5 16339 5 63472673
Swelling 32.69 16.06 15 16329 275363 63197315
Sinusitis 32.60 16.06 9 16335 226644 63246034
Sopor 32.42 16.06 34 16310 22130 63450548
Hypertonia 32.04 16.06 18 16326 4619 63468059
Electrocardiogram repolarisation abnormality 31.14 16.06 12 16332 1305 63471373
Electrocardiogram QRS complex prolonged 30.42 16.06 19 16325 5919 63466759
Electroencephalogram abnormal 30.21 16.06 16 16328 3656 63469022
Eosinophilia 29.93 16.06 33 16311 22723 63449955
Hypothermia 29.68 16.06 26 16318 13555 63459123
Cardio-respiratory arrest 29.11 16.06 54 16290 59905 63412773
Coma blister 28.99 16.06 7 16337 153 63472525
Choreoathetosis 28.86 16.06 9 16335 520 63472158
Intensive care unit acquired weakness 28.78 16.06 10 16334 811 63471867
Cardiac arrest 28.26 16.06 69 16275 92476 63380202
Peripheral swelling 27.86 16.06 17 16327 265925 63206753
Enterocolitis 27.86 16.06 20 16324 7838 63464840
Euthyroid sick syndrome 27.71 16.06 6 16338 79 63472599
Nausea 27.56 16.06 120 16224 854351 62618327
Hepatitis 27.54 16.06 42 16302 39746 63432932
Left ventricular hypertrophy 27.21 16.06 17 16327 5298 63467380
Diarrhoea 27.19 16.06 94 16250 715272 62757406
Anticonvulsant drug level below therapeutic 27.19 16.06 9 16335 630 63472048
Pain 27.04 16.06 99 16245 740529 62732149
Necrotising enterocolitis neonatal 26.94 16.06 7 16337 208 63472470
Rhesus incompatibility 26.74 16.06 6 16338 94 63472584
Intentional overdose 26.72 16.06 59 16285 74093 63398585
Porphyrins stool increased 26.60 16.06 5 16339 30 63472648
Labelled drug-drug interaction medication error 26.02 16.06 24 16320 13375 63459303
Respiratory failure 26.01 16.06 71 16273 101787 63370891
Urine copper increased 25.82 16.06 4 16340 5 63472673
Calcinosis 25.36 16.06 12 16332 2160 63470518
Maternal exposure during pregnancy 25.35 16.06 118 16226 219944 63252734
Bradyphrenia 25.28 16.06 18 16326 6962 63465716
Haemodynamic instability 25.07 16.06 20 16324 9170 63463508
Eye movement disorder 24.96 16.06 16 16328 5212 63467466
Acute hepatic failure 24.83 16.06 27 16317 18300 63454378
Neonatal seizure 24.83 16.06 8 16336 514 63472164
Pneumonia aspiration 24.67 16.06 37 16307 34503 63438175
Atrioventricular block first degree 24.62 16.06 18 16326 7255 63465423
Myoclonus 24.39 16.06 25 16319 15843 63456835
Cardiotoxicity 24.39 16.06 19 16325 8419 63464259
Intensive care unit delirium 24.26 16.06 5 16339 51 63472627
Sedation complication 23.49 16.06 23 16321 13799 63458879
Developmental delay 23.04 16.06 10 16334 1473 63471205
Nasopharyngitis 23.02 16.06 19 16325 254238 63218440
Severe myoclonic epilepsy of infancy 22.67 16.06 5 16339 72 63472606
Wound 22.52 16.06 7 16337 163256 63309422
Cardiomegaly 22.23 16.06 25 16319 17589 63455089
Somnolence 22.20 16.06 98 16246 178587 63294091
Drug abuse 22.06 16.06 54 16290 72464 63400214
Gingival hypertrophy 21.90 16.06 10 16334 1661 63471017
Respiratory depression 21.79 16.06 22 16322 13693 63458985
Sedation 21.46 16.06 37 16307 38772 63433906
Suicide attempt 21.41 16.06 48 16296 60870 63411808
Pain in extremity 21.07 16.06 33 16311 331453 63141225
Aggression 20.97 16.06 28 16316 23470 63449208
Apnoea 20.91 16.06 17 16327 8005 63464673
Cerebral atrophy 20.54 16.06 14 16330 5052 63467626
Lactic acidosis 20.51 16.06 36 16308 38251 63434427
Asthma 20.44 16.06 4 16340 127557 63345121
Creatinine renal clearance decreased 20.33 16.06 23 16321 16285 63456393
Drug intolerance 20.31 16.06 30 16314 308631 63164047
Peritoneal perforation 20.22 16.06 5 16339 121 63472557
Ovarian cancer stage III 20.14 16.06 6 16338 297 63472381
Magnetic resonance imaging head abnormal 20.12 16.06 10 16334 2003 63470675
Headache 19.72 16.06 90 16254 633151 62839527
Febrile infection-related epilepsy syndrome 19.72 16.06 3 16341 3 63472675
Cross sensitivity reaction 19.45 16.06 10 16334 2152 63470526
Rhabdomyolysis 19.37 16.06 38 16306 43913 63428765
Impulsive behaviour 19.26 16.06 9 16335 1574 63471104
Ammonia increased 19.19 16.06 13 16331 4643 63468035
Respiratory acidosis 19.15 16.06 15 16329 6700 63465978
Intellectual disability 19.11 16.06 8 16336 1078 63471600
Back pain 19.06 16.06 24 16320 264121 63208557
Cachexia 18.99 16.06 14 16330 5712 63466966
Cardiac dysfunction 18.80 16.06 10 16334 2305 63470373
Resuscitation 18.71 16.06 8 16336 1136 63471542
Drug level increased 18.64 16.06 26 16318 22710 63449968
Immobile 18.53 16.06 14 16330 5929 63466749
Urine amphetamine positive 18.24 16.06 4 16340 56 63472622
Acquired macroglossia 18.24 16.06 5 16339 183 63472495
Crystalluria 18.17 16.06 6 16338 417 63472261
Circulatory collapse 17.85 16.06 25 16319 21913 63450765
Hypoxic-ischaemic encephalopathy 17.74 16.06 12 16332 4275 63468403
Stomatitis 17.33 16.06 7 16337 138718 63333960
Sinus bradycardia 17.26 16.06 20 16324 14531 63458147
Congenital megaureter 17.10 16.06 4 16340 76 63472602
Blood calcium decreased 17.02 16.06 27 16317 26424 63446254
Pulmonary venous thrombosis 16.97 16.06 3 16341 12 63472666
Ventricular dysfunction 16.93 16.06 10 16334 2818 63469860
Impaired healing 16.89 16.06 3 16341 102539 63370139
Hypersensitivity 16.88 16.06 31 16313 292654 63180024
Primitive reflex test positive 16.78 16.06 3 16341 13 63472665
Congenital eyelid malformation 16.78 16.06 3 16341 13 63472665
Encephalitis autoimmune 16.71 16.06 8 16336 1478 63471200
Completed suicide 16.67 16.06 78 16266 145595 63327083
Abscess 16.65 16.06 21 16323 16647 63456031
Propofol infusion syndrome 16.50 16.06 7 16337 976 63471702
Lip erosion 16.43 16.06 7 16337 986 63471692
Hypertrophic cardiomyopathy 16.21 16.06 8 16336 1579 63471099
Cholestasis 16.19 16.06 28 16316 29406 63443272

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 467.93 17.64 722 13151 456029 34487029
Seizure 457.72 17.64 358 13515 104499 34838559
Status epilepticus 379.46 17.64 154 13719 12460 34930598
Multiple-drug resistance 369.25 17.64 120 13753 5119 34937939
Epilepsy 198.32 17.64 117 13756 21378 34921680
Respiratory depression 143.48 17.64 86 13787 16159 34926899
Hyperammonaemia 139.07 17.64 62 13811 6305 34936753
Drug reaction with eosinophilia and systemic symptoms 129.03 17.64 106 13767 32906 34910152
Victim of child abuse 111.31 17.64 32 13841 895 34942163
Infantile spasms 106.37 17.64 23 13850 187 34942871
Partial seizures 106.02 17.64 47 13826 4713 34938345
Drug resistance 104.97 17.64 85 13788 25842 34917216
Anticonvulsant drug level above therapeutic 97.57 17.64 27 13846 655 34942403
Epidural lipomatosis 90.15 17.64 28 13845 1026 34942032
Toxicity to various agents 86.19 17.64 222 13651 200140 34742918
Drug dependence 82.74 17.64 72 13801 24145 34918913
Coma 82.37 17.64 96 13777 45582 34897476
Off label use 77.77 17.64 350 13523 419174 34523884
Intellectual disability 75.72 17.64 26 13847 1312 34941746
Generalised tonic-clonic seizure 74.45 17.64 64 13809 21110 34921948
Juvenile idiopathic arthritis 74.03 17.64 28 13845 1869 34941189
Product prescribing error 72.02 17.64 65 13808 22862 34920196
Sedation 70.84 17.64 62 13811 20944 34922114
Product use issue 69.20 17.64 104 13769 63112 34879946
Necrosis ischaemic 67.93 17.64 17 13856 275 34942783
Electroencephalogram abnormal 66.78 17.64 28 13845 2450 34940608
Autism spectrum disorder 65.43 17.64 27 13846 2269 34940789
Dyspnoea 62.74 17.64 36 13837 376746 34566312
Nausea 61.72 17.64 29 13844 339879 34603179
Excessive eye blinking 61.36 17.64 18 13855 541 34942517
Petit mal epilepsy 57.83 17.64 27 13846 3051 34940007
Dysmorphism 57.19 17.64 27 13846 3129 34939929
Drug ineffective for unapproved indication 56.97 17.64 58 13815 23657 34919401
Urine copper increased 55.26 17.64 9 13864 9 34943049
Gaze palsy 55.20 17.64 22 13851 1690 34941368
Anticonvulsant drug level increased 52.92 17.64 21 13852 1595 34941463
Drug withdrawal convulsions 51.89 17.64 19 13854 1158 34941900
Developmental delay 51.08 17.64 24 13849 2751 34940307
Sudden unexplained death in epilepsy 50.75 17.64 15 13858 463 34942595
Intensive care unit acquired weakness 50.60 17.64 18 13855 1009 34942049
Nystagmus 49.65 17.64 28 13845 4687 34938371
Intestinal ischaemia 48.25 17.64 33 13840 7761 34935297
Foetal anticonvulsant syndrome 48.06 17.64 18 13855 1169 34941889
Tonic convulsion 47.85 17.64 18 13855 1183 34941875
Mucosal ulceration 47.37 17.64 17 13856 978 34942080
Superinfection 47.03 17.64 22 13851 2497 34940561
Hypotonia 45.68 17.64 32 13841 7821 34935237
Hyperammonaemic encephalopathy 45.57 17.64 21 13852 2303 34940755
Pneumonia aspiration 44.49 17.64 68 13805 41835 34901223
Drug abuse 43.69 17.64 111 13762 98985 34844073
Child abuse 43.60 17.64 13 13860 414 34942644
Language disorder 43.04 17.64 20 13853 2236 34940822
Porphyrins stool increased 42.98 17.64 7 13866 7 34943051
Ataxia 42.95 17.64 39 13834 13814 34929244
Somnolence 42.44 17.64 118 13755 110998 34832060
Anticonvulsant drug level decreased 42.18 17.64 16 13857 1076 34941982
Porphyria acute 41.75 17.64 12 13861 335 34942723
Behaviour disorder 40.76 17.64 25 13848 4885 34938173
Fatigue 40.32 17.64 53 13820 370600 34572458
Posture abnormal 40.09 17.64 19 13854 2220 34940838
Psychomotor retardation 39.31 17.64 22 13851 3628 34939430
Partial seizures with secondary generalisation 37.68 17.64 11 13862 325 34942733
Hypertelorism 35.64 17.64 12 13861 570 34942488
Cognitive disorder 35.42 17.64 50 13823 28643 34914415
Benzodiazepine drug level decreased 35.30 17.64 7 13866 35 34943023
Ehlers-Danlos syndrome 35.30 17.64 7 13866 35 34943023
Myoclonic epilepsy 34.31 17.64 14 13859 1143 34941915
Foetal exposure during pregnancy 33.82 17.64 57 13816 38044 34905014
Systemic inflammatory response syndrome 33.67 17.64 25 13848 6684 34936374
Arthralgia 33.18 17.64 13 13860 170028 34773030
Misleading laboratory test result 32.69 17.64 6 13867 18 34943040
Cerebellar atrophy 32.26 17.64 11 13862 543 34942515
Necrotising enterocolitis neonatal 31.71 17.64 9 13864 240 34942818
Coma neonatal 31.55 17.64 6 13867 23 34943035
Testicular atrophy 31.55 17.64 11 13862 581 34942477
Hepatitis fulminant 31.42 17.64 20 13853 4170 34938888
Muscle mass 31.19 17.64 9 13864 255 34942803
Obesity 30.02 17.64 31 13842 12847 34930211
Diarrhoea 29.47 17.64 70 13803 389842 34553216
Pain 29.33 17.64 23 13850 204652 34738406
Blood lactic acid increased 29.21 17.64 23 13850 6705 34936353
Laryngomalacia 29.15 17.64 9 13864 323 34942735
Malaise 29.09 17.64 19 13854 185806 34757252
Poor feeding infant 28.70 17.64 10 13863 527 34942531
Hepatic adenoma 27.72 17.64 6 13867 49 34943009
Posthaemorrhagic hydrocephalus 27.64 17.64 7 13866 119 34942939
Cerebral atrophy 27.53 17.64 19 13854 4533 34938525
Atonic seizures 26.56 17.64 8 13865 264 34942794
Sopor 26.12 17.64 28 13845 12108 34930950
Irritability 26.10 17.64 40 13833 24650 34918408
Fanconi syndrome 26.00 17.64 13 13860 1707 34941351
Mental disability 25.95 17.64 6 13867 68 34942990
Strabismus 25.92 17.64 13 13860 1718 34941340
Respiratory acidosis 25.75 17.64 19 13854 5031 34938027
Hyperchloraemia 25.43 17.64 9 13864 497 34942561
Hyperlipasaemia 25.41 17.64 9 13864 498 34942560
Drug monitoring procedure not performed 25.10 17.64 8 13865 319 34942739
Dizziness 24.99 17.64 30 13843 218491 34724567
Overdose 24.79 17.64 86 13787 90973 34852085
Therapeutic product effect incomplete 24.77 17.64 59 13814 50482 34892576
Urine delta aminolevulinate increased 24.56 17.64 4 13869 4 34943054
Abdominal pain 23.92 17.64 18 13855 163600 34779458
Asterixis 23.73 17.64 11 13862 1222 34941836
Anticonvulsant drug level below therapeutic 23.27 17.64 9 13864 638 34942420
Propofol infusion syndrome 23 17.64 10 13863 956 34942102
Completed suicide 22.75 17.64 88 13785 98080 34844978
Acute hepatic failure 22.74 17.64 28 13845 14046 34929012
Chest pain 22.64 17.64 11 13862 126751 34816307
Idiopathic generalised epilepsy 22.57 17.64 5 13868 46 34943012
Drug interaction 22.50 17.64 160 13713 225786 34717272
Malignant neoplasm progression 22.31 17.64 4 13869 88042 34855016
Condition aggravated 22.06 17.64 141 13732 192055 34751003
Drug withdrawal syndrome neonatal 21.63 17.64 15 13858 3604 34939454
Purple glove syndrome 21.29 17.64 5 13868 61 34942997
Change in seizure presentation 21.21 17.64 6 13867 158 34942900
Autonomic nervous system imbalance 21.20 17.64 13 13860 2538 34940520
Pain in extremity 21.09 17.64 12 13861 126501 34816557
Myocardial fibrosis 20.95 17.64 10 13863 1187 34941871
Psychomotor skills impaired 20.60 17.64 15 13858 3891 34939167
Product administered to patient of inappropriate age 20.52 17.64 14 13859 3277 34939781
Abnormal labour affecting foetus 20.52 17.64 4 13869 18 34943040
Drug level decreased 20.32 17.64 20 13853 7826 34935232
Haematuria traumatic 20.06 17.64 6 13867 193 34942865
Cerebral ataxia 19.70 17.64 4 13869 23 34943035
Clonic convulsion 19.69 17.64 8 13865 646 34942412
Back pain 19.66 17.64 12 13861 121777 34821281
Focal dyscognitive seizures 19.59 17.64 10 13863 1371 34941687
Abdominal wall haematoma 19.59 17.64 11 13862 1826 34941232
Growth retardation 19.53 17.64 11 13862 1837 34941221
Cross sensitivity reaction 19.48 17.64 10 13863 1387 34941671
Talipes 19.12 17.64 11 13862 1912 34941146
Pancytopenia 19 17.64 7 13866 95150 34847908
Social avoidant behaviour 18.83 17.64 13 13860 3101 34939957
Necrotising colitis 18.77 17.64 9 13864 1079 34941979
Myoclonus 18.67 17.64 26 13847 14699 34928359
Psychomotor hyperactivity 18.63 17.64 21 13852 9601 34933457
Blood pressure increased 18.42 17.64 6 13867 88096 34854962
Prognathism 18.08 17.64 5 13868 121 34942937
Camptodactyly congenital 17.88 17.64 5 13868 126 34942932
Chills 17.88 17.64 5 13868 81038 34862020
Scoliosis 17.70 17.64 12 13861 2781 34940277

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
Status epilepticus 687.62 15.13 268 24707 24773 79694640
Seizure 669.48 15.13 518 24457 188316 79531097
Multiple-drug resistance 630.35 15.13 193 24782 8615 79710798
Drug ineffective 465.55 15.13 1031 23944 1079882 78639531
Drug reaction with eosinophilia and systemic symptoms 436.91 15.13 264 24711 63980 79655433
Epilepsy 311.89 15.13 181 24794 40679 79678734
Hyperammonaemia 226.27 15.13 96 24879 10997 79708416
Toxicity to various agents 223.62 15.13 440 24535 421100 79298313
Drug resistance 167.04 15.13 124 24851 42089 79677324
Drug interaction 159.89 15.13 381 24594 414802 79304611
Coma 155.19 15.13 174 24801 100475 79618938
Partial seizures 154.72 15.13 69 24906 8909 79710504
Generalised tonic-clonic seizure 147.46 15.13 117 24858 43793 79675620
Respiratory depression 146.24 15.13 97 24878 27533 79691880
Necrosis ischaemic 146.17 15.13 39 24936 1051 79718362
Anticonvulsant drug level above therapeutic 138.74 15.13 38 24937 1133 79718280
Anticonvulsant drug level increased 127.56 15.13 43 24932 2610 79716803
Ataxia 125.53 15.13 85 24890 24954 79694459
Intestinal ischaemia 123.50 15.13 67 24908 13203 79706210
Drug withdrawal convulsions 122.82 15.13 40 24935 2180 79717233
Victim of child abuse 117.91 15.13 32 24943 921 79718492
Anticonvulsant drug level decreased 115.79 15.13 37 24938 1897 79717516
Nystagmus 109.19 15.13 56 24919 9848 79709565
Drug ineffective for unapproved indication 104.70 15.13 103 24872 51135 79668278
Intra-abdominal pressure increased 99.65 15.13 22 24953 258 79719155
Infantile spasms 99.03 15.13 22 24953 266 79719147
Drug dependence 98.64 15.13 90 24885 40679 79678734
Hyperammonaemic encephalopathy 92.93 15.13 40 24935 4742 79714671
Epidural lipomatosis 92.46 15.13 28 24947 1200 79718213
Systemic inflammatory response syndrome 90.63 15.13 52 24923 11413 79708000
Overdose 89.76 15.13 186 24789 184020 79535393
Off label use 85.15 15.13 529 24446 906686 78812727
Urine copper increased 82.40 15.13 13 24962 14 79719399
Intensive care unit acquired weakness 79.98 15.13 28 24947 1905 79717508
Drug abuse 78.92 15.13 164 24811 162527 79556886
Arthralgia 78.02 15.13 41 24934 571762 79147651
Pneumonia aspiration 77.29 15.13 100 24875 66867 79652546
Cerebellar atrophy 76.93 15.13 24 24951 1137 79718276
Petit mal epilepsy 76.81 15.13 37 24938 5690 79713723
Fatigue 76.74 15.13 108 24867 929619 78789794
Nausea 75.29 15.13 115 24860 957081 78762332
Product prescribing error 75.11 15.13 81 24894 44732 79674681
Pneumatosis 74.42 15.13 22 24953 867 79718546
Angiofibroma 73.01 15.13 15 24960 121 79719292
Porphyrins stool increased 67.96 15.13 12 24963 37 79719376
Cognitive disorder 67.89 15.13 96 24879 69830 79649583
Breast hyperplasia 65.44 15.13 14 24961 140 79719273
Myoclonic epilepsy 64.49 15.13 24 24951 1946 79717467
Electroencephalogram abnormal 63.61 15.13 32 24943 5402 79714011
Atonic seizures 59.72 15.13 18 24957 759 79718654
Anticonvulsant drug level below therapeutic 57.87 15.13 19 24956 1062 79718351
Urine delta aminolevulinate increased 57.39 15.13 9 24966 9 79719404
Dyspnoea 56.41 15.13 115 24860 856910 78862503
Sopor 55.90 15.13 60 24915 32950 79686463
Juvenile idiopathic arthritis 55.61 15.13 28 24947 4735 79714678
Joint swelling 54.29 15.13 12 24963 288634 79430779
Malabsorption 54.16 15.13 28 24947 5004 79714409
Sudden unexplained death in epilepsy 53.61 15.13 16 24959 652 79718761
Kounis syndrome 52.43 15.13 26 24949 4256 79715157
Multiple organ dysfunction syndrome 52.28 15.13 116 24859 120130 79599283
Gaze palsy 51.46 15.13 23 24952 2982 79716431
Acute hepatic failure 51.46 15.13 55 24920 30058 79689355
Angiomyolipoma 51.01 15.13 12 24963 190 79719223
Partial seizures with secondary generalisation 49.91 15.13 15 24960 626 79718787
Cerebral atrophy 49.24 15.13 31 24944 8044 79711369
Stevens-Johnson syndrome 49.16 15.13 61 24914 39105 79680308
Somnolence 48.68 15.13 175 24800 238806 79480607
Rheumatoid arthritis 47.52 15.13 5 24970 208465 79510948
Intellectual disability 46.60 15.13 17 24958 1303 79718110
Infusion related reaction 46.60 15.13 8 24967 230229 79489184
Child abuse 46.58 15.13 13 24962 416 79718997
Oropharyngeal oedema 46.08 15.13 13 24962 433 79718980
Abdominal discomfort 46.00 15.13 11 24964 250716 79468697
Excessive eye blinking 45.90 15.13 18 24957 1683 79717730
Cardiotoxicity 44.06 15.13 34 24941 12205 79707208
Irritability 43.69 15.13 59 24916 41085 79678328
Electrocardiogram QRS complex prolonged 43.22 15.13 32 24943 10801 79708612
Hypotonia 42.55 15.13 34 24941 12836 79706577
Ultrasound ovary abnormal 42.25 15.13 9 24966 88 79719325
Lymphangioleiomyomatosis 42.24 15.13 10 24965 163 79719250
Metabolic acidosis 42.11 15.13 85 24890 82444 79636969
Focal dyscognitive seizures 42.04 15.13 21 24954 3491 79715922
Peripheral swelling 41.92 15.13 16 24959 269601 79449812
Mucosal ulceration 40.83 15.13 17 24958 1856 79717557
Alopecia 40.80 15.13 11 24964 231344 79488069
Blood lactic acid increased 40.72 15.13 33 24942 12711 79706702
Pain 40.11 15.13 102 24873 703700 79015713
Respiratory acidosis 40.07 15.13 31 24944 11169 79708244
Propofol infusion syndrome 39.89 15.13 17 24958 1966 79717447
Completed suicide 39.49 15.13 167 24808 245600 79473813
Haemophagocytic lymphohistiocytosis 39.29 15.13 41 24934 21796 79697617
Malaise 39.19 15.13 58 24917 489811 79229602
Cytomegalovirus hepatitis 38.85 15.13 13 24962 771 79718642
Diarrhoea 38.55 15.13 144 24831 880345 78839068
Superinfection 38.12 15.13 22 24953 4880 79714533
Tonic convulsion 38.04 15.13 17 24958 2203 79717210
Contraindicated product administered 37.98 15.13 3 24972 157535 79561878
Mitral valve disease 37.93 15.13 19 24956 3178 79716235
Depressed level of consciousness 37.32 15.13 89 24886 96563 79622850
Posture abnormal 37.31 15.13 20 24955 3846 79715567
Porphyria acute 37.09 15.13 15 24960 1520 79717893
Benzodiazepine drug level decreased 36.95 15.13 7 24968 35 79719378
Tachycardia 36.88 15.13 131 24844 177637 79541776
Choreoathetosis 36.77 15.13 15 24960 1555 79717858
Myoclonus 36.20 15.13 44 24931 27616 79691797
Pain in extremity 35.60 15.13 37 24938 364501 79354912
Hepatic adenoma 35.53 15.13 10 24965 330 79719083
Altered state of consciousness 35.11 15.13 55 24920 43767 79675646
Headache 34.77 15.13 98 24877 653674 79065739
Laryngeal stenosis 34.68 15.13 13 24962 1075 79718338
Testicular atrophy 34.67 15.13 10 24965 361 79719052
Ammonia increased 33.75 15.13 24 24951 7611 79711802
Eosinophilia 33.70 15.13 55 24920 45290 79674123
Macroglossia 33.65 15.13 13 24962 1168 79718245
Cardiac arrest 33.31 15.13 124 24851 171972 79547441
Hypothermia 32.76 15.13 38 24937 22708 79696705
Cross sensitivity reaction 32.48 15.13 18 24957 3694 79715719
Therapeutic product effect decreased 32.48 15.13 6 24969 163857 79555556
Gingival hypertrophy 32.43 15.13 17 24958 3125 79716288
Arthropathy 32.02 15.13 8 24967 177103 79542310
Back pain 31.86 15.13 29 24946 304151 79415262
Left ventricular hypertrophy 31.64 15.13 27 24948 11164 79708249
Drug level decreased 31.37 15.13 30 24945 14372 79705041
Perforation 31.27 15.13 13 24962 1413 79718000
Hypotension 31.10 15.13 240 24735 440077 79279336
Hypertonia 30.29 15.13 22 24953 7210 79712203
Hepatitis fulminant 30.21 15.13 22 24953 7240 79712173
Paraesthesia 29.94 15.13 9 24966 176314 79543099
Stomatitis 29.90 15.13 5 24970 146752 79572661
Cardio-respiratory arrest 29.77 15.13 88 24887 108422 79610991
Unmasking of previously unidentified disease 29.75 15.13 14 24961 2043 79717370
Seizure cluster 29.55 15.13 9 24966 393 79719020
Febrile infection-related epilepsy syndrome 29.03 15.13 6 24969 50 79719363
Blood pressure increased 28.98 15.13 15 24960 211345 79508068
Swelling 28.81 15.13 16 24959 216695 79502718
Product use issue 28.73 15.13 136 24839 209686 79509727
Abdominal pain 28.41 15.13 49 24926 389520 79329893
Encephalitis autoimmune 28.30 15.13 14 24961 2280 79717133
Muscle mass 28.28 15.13 9 24966 455 79718958
Fanconi syndrome 28.19 15.13 15 24960 2841 79716572
Rhesus incompatibility 28.18 15.13 5 24970 16 79719397
Product administered to patient of inappropriate age 28.18 15.13 19 24956 5534 79713879
Ehlers-Danlos syndrome 28.08 15.13 7 24968 143 79719270
Febrile neutropenia 28 15.13 19 24956 230980 79488433
Anticonvulsant drug level therapeutic 27.51 15.13 5 24970 19 79719394
Ventricular hypokinesia 27.49 15.13 23 24952 9256 79710157
Intentional overdose 27.25 15.13 84 24891 105876 79613537
Hyperchloraemia 27.24 15.13 11 24964 1110 79718303
Malignant neoplasm progression 26.91 15.13 5 24970 135985 79583428
Rhabdomyolysis 26.75 15.13 82 24893 103049 79616364
Asthma 26.66 15.13 5 24970 135090 79584323
Sinusitis 26.62 15.13 14 24961 195487 79523926
Discomfort 26.22 15.13 4 24971 125613 79593800
Cerebral ataxia 26.07 15.13 5 24970 27 79719386
Product use in unapproved indication 25.82 15.13 150 24825 250209 79469204
Euthyroid sick syndrome 25.81 15.13 6 24969 90 79719323
Blood zinc increased 25.51 15.13 4 24971 4 79719409
Suicide attempt 25.41 15.13 70 24905 82862 79636551
Chest pain 24.99 15.13 31 24944 282273 79437140
Intentional product misuse 24.99 15.13 76 24899 95089 79624324
Systemic lupus erythematosus 24.97 15.13 4 24971 121145 79598268
Coma blister 24.79 15.13 7 24968 234 79719179
Temporal lobe epilepsy 24.52 15.13 8 24967 438 79718975
Nasopharyngitis 24.51 15.13 26 24949 253855 79465558
Systolic dysfunction 24.22 15.13 15 24960 3780 79715633
Behaviour disorder 23.74 15.13 18 24957 6295 79713118
Hepatic function abnormal 23.70 15.13 63 24912 73044 79646369
Withdrawal syndrome 23.33 15.13 35 24940 26819 79692594
Haemodynamic instability 23.31 15.13 28 24947 17354 79702059
Coagulopathy 23.22 15.13 41 24934 35965 79683448
Electrocardiogram ST segment elevation 23.21 15.13 20 24955 8377 79711036
Developmental delay 22.94 15.13 10 24965 1221 79718192
Intensive care unit delirium 22.86 15.13 5 24970 56 79719357
Hypoaesthesia 22.76 15.13 14 24961 179338 79540075
Idiopathic generalised epilepsy 22.70 15.13 5 24970 58 79719355
Electrocardiogram repolarisation abnormality 22.64 15.13 12 24963 2255 79717158
Hepatitis 22.25 15.13 52 24923 55675 79663738
Calcinosis 22.16 15.13 12 24963 2353 79717060
Poor feeding infant 22.03 15.13 6 24969 175 79719238
Eye movement disorder 21.98 15.13 19 24956 7992 79711421
Haematuria traumatic 21.53 15.13 6 24969 191 79719222
Hyponatraemia 21.30 15.13 111 24864 177737 79541676
Dermatitis exfoliative 20.69 15.13 21 24954 10808 79708605
Foetal anticonvulsant syndrome 20.31 15.13 6 24969 236 79719177
Neurodegenerative disorder 19.80 15.13 7 24968 490 79718923
Myocardial fibrosis 19.76 15.13 10 24965 1708 79717705
Aggression 19.74 15.13 47 24928 50911 79668502
Ovarian cancer stage III 19.72 15.13 6 24969 261 79719152
Injection site pain 19.68 15.13 8 24967 129830 79589583
Hyperplasia 19.66 15.13 9 24966 1234 79718179
Wound 19.59 15.13 6 24969 116173 79603240
Hyperlipasaemia 19.58 15.13 9 24966 1245 79718168
Acidosis hyperchloraemic 19.56 15.13 8 24967 834 79718579
Cough 19.44 15.13 55 24920 366734 79352679
Drug level increased 19.22 15.13 40 24935 39611 79679802
Ileus paralytic 19.01 15.13 19 24956 9601 79709812
Selective eating disorder 18.84 15.13 6 24969 304 79719109
Dysmorphism 18.73 15.13 7 24968 574 79718839
Dizziness 18.73 15.13 93 24882 526348 79193065
Drug monitoring procedure not performed 18.15 15.13 8 24967 1003 79718410
Asterixis 18.04 15.13 11 24964 2696 79716717
Anaemia 17.98 15.13 75 24900 444940 79274473
Brain oedema 17.91 15.13 30 24945 25233 79694180
Impaired healing 17.82 15.13 3 24972 87652 79631761
Dyspnoea exertional 17.66 15.13 3 24972 87070 79632343
Peritoneal perforation 17.59 15.13 5 24970 171 79719242
Sedation complication 17.44 15.13 23 24952 15646 79703767
Impulsive behaviour 17.35 15.13 11 24964 2889 79716524
Microcephaly 17.32 15.13 5 24970 181 79719232
Autism spectrum disorder 17.15 15.13 8 24967 1144 79718269
Toxic epidermal necrolysis 17.14 15.13 41 24934 44540 79674873
Circulatory collapse 17.10 15.13 37 24938 37631 79681782
Chills 17.09 15.13 15 24960 160219 79559194
Contusion 17.02 15.13 13 24962 148763 79570650
Rash maculo-papular 16.85 15.13 47 24928 56031 79663382
Myalgia 16.83 15.13 20 24955 185621 79533792
Drug intolerance 16.81 15.13 36 24939 264083 79455330
Weight increased 16.69 15.13 39 24936 277347 79442066
Stress cardiomyopathy 16.66 15.13 19 24956 11147 79708266
Hypertension 16.54 15.13 51 24924 330941 79388472
COVID-19 16.53 15.13 15 24960 157659 79561754
Foetal exposure during pregnancy 16.43 15.13 14 24961 5776 79713637
Acquired macroglossia 16.38 15.13 5 24970 220 79719193
Pancreatitis 16.37 15.13 53 24922 68522 79650891
No adverse event 16.28 15.13 36 24939 37156 79682257
Pruritus 16.26 15.13 66 24909 394582 79324831
Cellulitis 16.08 15.13 7 24968 109053 79610360
Salivary hypersecretion 16.02 15.13 21 24954 14203 79705210
Unresponsive to stimuli 16.02 15.13 46 24929 55742 79663671
Arthritis 15.97 15.13 8 24967 114872 79604541
Labelled drug-drug interaction medication error 15.94 15.13 30 24945 27620 79691793
Fever neonatal 15.84 15.13 3 24972 15 79719398
Inappropriate antidiuretic hormone secretion 15.74 15.13 29 24946 26284 79693129
Urticaria 15.70 15.13 21 24954 185180 79534233
Diabetes insipidus 15.56 15.13 13 24962 5224 79714189
General physical health deterioration 15.53 15.13 40 24935 275198 79444215
Conjunctival hyperaemia 15.32 15.13 12 24963 4401 79715012
Urine amphetamine positive 15.28 15.13 4 24971 100 79719313
Inhibitory drug interaction 15.22 15.13 12 24963 4441 79714972
Respiratory arrest 15.14 15.13 46 24929 57504 79661909

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 124.35 34.47 62 244 990 88496
Off label use 38.82 34.47 25 281 621 88865

Pharmacologic Action:

SourceCodeDescription
ATC N03AA02 NERVOUS SYSTEM
ANTIEPILEPTICS
ANTIEPILEPTICS
Barbiturates and derivatives
MeSH PA D018757 GABA Modulators
MeSH PA D000927 Anticonvulsants
MeSH PA D002491 Central Nervous System Agents
MeSH PA D002492 Central Nervous System Depressants
MeSH PA D065695 Cytochrome P-450 CYP2B6 Inducers
MeSH PA D065701 Cytochrome P-450 CYP3A Inducers
MeSH PA D018691 Excitatory Amino Acid Antagonists
MeSH PA D018682 GABA Agents
MeSH PA D006993 Hypnotics and Sedatives
MeSH PA D065606 Metabolic Side Effects of Drugs and Substances
MeSH PA D018377 Neurotransmitter Agents
CHEBI has role CHEBI:35623 anticonvulsants
CHEBI has role CHEBI:35717 hypnotics
CHEBI has role CHEBI:60798 EAA receptor antagonists
CHEBI has role CHEBI:88188 allergenic drug

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




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

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

Orange Book patent data (new drug applications)

None

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 0121-0942 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 0121-1884 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 Oral Solution HUMAN PRESCRIPTION DRUG LABEL 1 0121-2826 SOLUTION 60 mg ORAL unapproved drug other 14 sections
Phenobarbital HUMAN PRESCRIPTION DRUG LABEL 1 0143-1445 TABLET 15 mg ORAL UNAPPROVED DRUG OTHER 17 sections
Phenobarbital HUMAN PRESCRIPTION DRUG LABEL 1 0143-1450 TABLET 30 mg ORAL UNAPPROVED DRUG OTHER 17 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 0603-1508 ELIXIR 20 mg ORAL UNAPPROVED DRUG OTHER 22 sections
Phenobarbital HUMAN PRESCRIPTION DRUG LABEL 1 0603-1508 ELIXIR 20 mg ORAL UNAPPROVED DRUG OTHER 22 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 0603-5165 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 0603-5166 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 0603-5167 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 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 0641-0476 INJECTION 65 mg INTRAMUSCULAR UNAPPROVED DRUG OTHER 19 sections