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

Stem definitionDrug idCAS RN
diazepam derivatives 682 22316-47-8

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • clobazam
  • clobazepam
  • frisium
  • frizium
  • urbadan
A benzodiazepine derivative that is a long-acting GABA-A RECEPTOR agonist. It is used as an antiepileptic in the treatment of SEIZURES, including seizures associated with LENNOX-GASTAUT SYNDROME. It is also used as an anxiolytic, for the short-term treatment of acute ANXIETY.
  • Molecular weight: 300.74
  • Formula: C16H13ClN2O2
  • CLOGP: 2.44
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 0
  • TPSA: 40.62
  • ALOGS: -3.26
  • ROTB: 1
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
20 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.08 mg/mL Bocci G, Oprea TI, Benet LZ
BA (Bioavailability) 90 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 1.768 High 1
caco2-efflux Caco-2 efflux ratio (BA/AB) 0.380 High 1
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 86.298 10^-6 cm/s High 1
dh-clint Dog hepatocyte intrinsic clearance 14.689 uL/min/10^6 cells High 1
dppb Dog plasma protein binding (% unbound) 20.220 % High 1
fcs-ppb Fetal calf serum protein binding (% unbound) 36.850 % High 1
herg hERG pIC50 4.384 pIC50 High 1
hh-clint Human hepatocyte intrinsic clearance 2.729 uL/min/10^6 cells High 1
hlm-clint Human liver microsomal intrinsic clearance 5 uL/min/mg protein High 1
hppb Human plasma protein binding (% unbound) 20.600 % High 1
kinase-safety-class ACVR2B,AXL,BRAF,BTK,CAMK2D,CDK5,CDK9,DDR1,DYRK1B,EIF2AK3,EPHB4,ERBB2,GRK2,ITK,MAPK7,NTRK2,PDK1,PDK2,PDK4,PDPK1,PIK3CB,PIK3CD,PRKDC,STK33,TEK,TTK 26
kinase-selectivity-class ACVR2B,AXL,GRK2 3
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 0.624 High 1
mh-clint Mouse hepatocyte intrinsic clearance 34.754 High 1
mppb Mouse plasma protein binding (% unbound) 23.570 High 1
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 1.306 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pppb Pig plasma protein binding (% unbound) 27.780 % High 1
rh-clint Rat hepatocyte intrinsic clearance 14.421 uL/min/10^6 cells High 1
rh-fuinc Rat hepatocyte fraction unbound in incubation 84.660 % High 1
rppb Rat plasma protein binding (% unbound) 25.310 % High 1
solubility-dd Solubility at pH 7.4 in DMSO 454.988 uM High 1

Approvals:

DateAgencyCompanyOrphan
Oct. 21, 2011 FDA LUNDBECK LLC

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Seizure 2161.24 20.09 969 23206 151660 90452612
Multiple-drug resistance 1004.38 20.09 261 23914 7515 90596757
Status epilepticus 732.56 20.09 250 23925 18624 90585648
Drug ineffective 517.73 20.09 1132 23043 1383166 89221106
Epilepsy 477.05 20.09 288 23887 81918 90522354
Generalised tonic-clonic seizure 445.15 20.09 207 23968 34696 90569576
Somnolence 428.56 20.09 391 23784 208693 90395579
Drug withdrawal convulsions 425.22 20.09 95 24080 1405 90602867
Drug resistance 414.61 20.09 189 23986 30260 90574012
Partial seizures 389.84 20.09 123 24052 7137 90597135
Psychogenic seizure 366.40 20.09 89 24086 1927 90602345
Drug interaction 325.37 20.09 384 23791 276069 90328203
Petit mal epilepsy 316.85 20.09 96 24079 4862 90599410
Off label use 243.11 20.09 742 23433 1101510 89502762
Aggression 226.44 20.09 120 24055 26548 90577724
Abortion spontaneous 218.46 20.09 151 24024 53905 90550367
Drug reaction with eosinophilia and systemic symptoms 174.06 20.09 120 24055 42638 90561634
Paradoxical drug reaction 172.51 20.09 63 24112 5703 90598569
Foetal exposure during pregnancy 161.85 20.09 115 24060 42860 90561412
Exposure during pregnancy 155.17 20.09 249 23926 238161 90366111
Ataxia 152.61 20.09 81 24094 17961 90586311
Tonic convulsion 143.27 20.09 41 24134 1697 90602575
Abnormal behaviour 140.71 20.09 83 24092 22545 90581727
Behaviour disorder 136.28 20.09 50 24125 4585 90599687
Irritability 130.98 20.09 94 24081 35568 90568704
Propofol infusion syndrome 130.45 20.09 36 24139 1303 90602969
Pain 121.93 20.09 57 24118 996284 89607988
Mitochondrial DNA mutation 118.89 20.09 27 24148 431 90603841
Arthralgia 116.47 20.09 32 24143 778490 89825782
Hyperammonaemia 113.36 20.09 48 24127 6427 90597845
Drug ineffective for unapproved indication 112.11 20.09 112 24063 66532 90537740
Seizure cluster 106.76 20.09 24 24151 365 90603907
Joint swelling 98.60 20.09 10 24165 503290 90100982
Abdominal discomfort 97.48 20.09 8 24167 477320 90126952
Myoclonic epilepsy 93.31 20.09 29 24146 1598 90602674
Change in seizure presentation 86.78 20.09 22 24153 570 90603702
Drug level decreased 86.01 20.09 45 24130 9685 90594587
Respiratory disorder neonatal 84.69 20.09 26 24149 1375 90602897
Atonic seizures 84.42 20.09 23 24152 793 90603479
Macroglossia 82.72 20.09 23 24152 856 90603416
Systolic dysfunction 80.80 20.09 27 24148 1877 90602395
Cognitive disorder 80.64 20.09 96 24079 69311 90534961
Rheumatoid arthritis 80.16 20.09 4 24171 362610 90241662
Developmental delay 79.74 20.09 26 24149 1674 90602598
Product preparation issue 79.07 20.09 28 24147 2318 90601954
Gene mutation 77.83 20.09 27 24148 2103 90602169
Dyspnoea 76.03 20.09 74 24101 880881 89723391
Overdose 75.48 20.09 144 24031 157565 90446707
Anticonvulsant drug level increased 75.19 20.09 25 24150 1711 90602561
Infusion related reaction 74.94 20.09 11 24164 416769 90187503
Bradycardia neonatal 73.42 20.09 22 24153 1071 90603201
Blood gases abnormal 72.67 20.09 21 24154 900 90603372
CSF oligoclonal band present 72.27 20.09 18 24157 433 90603839
Weight gain poor 71.91 20.09 22 24153 1150 90603122
Drug level increased 70.90 20.09 59 24116 27703 90576569
Psychomotor skills impaired 69.96 20.09 27 24148 2845 90601427
Wound 68.06 20.09 3 24172 302977 90301295
Coma 67.71 20.09 90 24085 72542 90531730
Focal dyscognitive seizures 67.59 20.09 27 24148 3117 90601155
Contraindicated product administered 66.34 20.09 5 24170 320134 90284138
Premature baby 65.51 20.09 54 24121 25023 90579249
Toxicity to various agents 64.76 20.09 196 23979 287650 90316622
Altered state of consciousness 64.40 20.09 59 24116 31473 90572799
Peripheral swelling 63.51 20.09 16 24159 413090 90191182
Pleocytosis 62.18 20.09 19 24156 989 90603283
Sinusitis 61.79 20.09 9 24166 343079 90261193
Sedation 61.58 20.09 70 24105 48101 90556171
Fanconi syndrome 60.99 20.09 22 24153 1921 90602351
Hypotonia 60.95 20.09 38 24137 11388 90592884
Maternal exposure during pregnancy 60.38 20.09 222 23953 359841 90244431
Hemianopia 59.51 20.09 22 24153 2060 90602212
Automatism epileptic 57.72 20.09 10 24165 33 90604239
Hypersomnia 57.58 20.09 47 24128 21484 90582788
Pneumonia aspiration 56.64 20.09 62 24113 40878 90563394
Selective eating disorder 56.14 20.09 21 24154 2032 90602240
Myoclonus 55.85 20.09 44 24131 19124 90585148
Systemic lupus erythematosus 55.65 20.09 14 24161 361882 90242390
Anorectal malformation 55.56 20.09 13 24162 238 90604034
Lower respiratory tract infection 54.64 20.09 3 24172 250656 90353616
Low birth weight baby 54.36 20.09 33 24142 9434 90594838
Depressed level of consciousness 54.19 20.09 81 24094 72703 90531569
Febrile convulsion 54.08 20.09 15 24160 553 90603719
Psychotic disorder 53.44 20.09 53 24122 31177 90573095
Agitation 53.32 20.09 77 24098 67021 90537251
Swelling 52.58 20.09 23 24152 419035 90185237
Drooling 51.88 20.09 25 24150 4521 90599751
Product substitution issue 51.74 20.09 41 24134 17967 90586305
Disturbance in attention 51.18 20.09 63 24112 47046 90557226
Pain in extremity 50.12 20.09 29 24146 450500 90153772
Hyponatraemia 49.77 20.09 110 24065 133428 90470844
Intellectual disability 49.70 20.09 17 24158 1269 90603003
Sudden unexplained death in epilepsy 49.29 20.09 13 24162 395 90603877
Hallucination, visual 48.70 20.09 44 24131 23048 90581224
Angiofibroma 47.39 20.09 10 24165 111 90604161
Drug dependence 46.94 20.09 48 24127 29279 90574993
Oropharyngeal oedema 45.77 20.09 12 24163 356 90603916
Alopecia 45.67 20.09 39 24136 495032 90109240
Premature delivery 45.64 20.09 54 24121 38708 90565564
Metapneumovirus infection 45.24 20.09 16 24159 1319 90602953
Electroencephalogram abnormal 45.16 20.09 22 24153 4074 90600198
Stevens-Johnson syndrome 45.06 20.09 47 24128 29329 90574943
Depressed mood 44.91 20.09 61 24114 50161 90554111
Diarrhoea 44.82 20.09 117 24058 939073 89665199
Temporal lobe epilepsy 44.06 20.09 12 24163 413 90603859
Cerebral atrophy 43.96 20.09 24 24151 5622 90598650
Nausea 43.89 20.09 151 24024 1110165 89494107
Lymphangioleiomyomatosis 43.84 20.09 11 24164 273 90603999
Infection 43.66 20.09 21 24154 362073 90242199
Postictal paralysis 43.65 20.09 11 24164 278 90603994
Intentional product misuse 43.06 20.09 82 24093 89522 90514750
Suicidal behaviour 42.96 20.09 19 24156 2825 90601447
Aura 42.83 20.09 15 24160 1202 90603070
Product administered to patient of inappropriate age 42.50 20.09 22 24153 4631 90599641
Epilepsy with myoclonic-atonic seizures 42.32 20.09 9 24166 104 90604168
Blood oestrogen increased 41.22 20.09 10 24165 215 90604057
Wheezing 41.14 20.09 7 24168 238073 90366199
Encephalopathy 40.91 20.09 56 24119 46388 90557884
Gingival hypertrophy 40.82 20.09 17 24158 2183 90602089
Fibromyalgia 40.59 20.09 4 24171 206265 90398007
Intentional overdose 40.40 20.09 82 24093 93752 90510520
Therapeutic product effect decreased 40.29 20.09 12 24163 277559 90326713
Infantile spasms 40.17 20.09 10 24165 240 90604032
Exposure via breast milk 39.98 20.09 17 24158 2298 90601974
Asthma 39.95 20.09 8 24167 242152 90362120
Angiomyolipoma 39.94 20.09 10 24165 246 90604026
Drug hypersensitivity 39.81 20.09 39 24136 463570 90140702
Apnoea 39.65 20.09 27 24148 9387 90594885
Blood lactic acid increased 38.94 20.09 26 24149 8752 90595520
Hepatocellular injury 38.57 20.09 43 24132 28915 90575357
Drop attacks 38.25 20.09 12 24163 682 90603590
Hypertension 37.57 20.09 40 24135 457492 90146780
Hyperammonaemic encephalopathy 37.48 20.09 17 24158 2682 90601590
Anticonvulsant drug level decreased 37.11 20.09 14 24161 1386 90602886
Blood cholesterol increased 36.19 20.09 6 24169 208006 90396266
Clonic convulsion 35.72 20.09 12 24163 848 90603424
Hypothermia 35.47 20.09 31 24144 15544 90588728
Ill-defined disorder 35.31 20.09 4 24171 184887 90419385
Therapeutic product effective for unapproved indication 35.09 20.09 8 24167 130 90604142
Suicide attempt 35.00 20.09 68 24107 75331 90528941
Brain operation 34.68 20.09 11 24164 648 90603624
Autism spectrum disorder 34.53 20.09 13 24162 1280 90602992
Right ventricular dilatation 34.48 20.09 14 24161 1685 90602587
Coma blister 34.27 20.09 8 24167 145 90604127
Anticonvulsant drug level below therapeutic 34.09 20.09 11 24164 685 90603587
Electrocardiogram repolarisation abnormality 33.74 20.09 13 24162 1363 90602909
Injury 33.66 20.09 6 24169 197343 90406929
Malaise 33.58 20.09 66 24109 585920 90018352
Therapeutic product ineffective for unapproved indication 33.56 20.09 9 24166 292 90603980
Abdominal pain upper 33.44 20.09 24 24151 332650 90271622
Mood altered 32.92 20.09 31 24144 17113 90587159
Unmasking of previously unidentified disease 32.86 20.09 13 24162 1463 90602809
Bruxism 32.47 20.09 18 24157 4345 90599927
Gastrointestinal disorder 32.31 20.09 14 24161 256673 90347599
Cholestasis of pregnancy 32.03 20.09 13 24162 1564 90602708
Dysmorphism 31.99 20.09 15 24160 2553 90601719
Herpangina 31.71 20.09 6 24169 36 90604236
Febrile neutropenia 31.34 20.09 3 24172 158346 90445926
Epileptic psychosis 31.30 20.09 6 24169 39 90604233
Toxic skin eruption 31.20 20.09 29 24146 15745 90588527
Osteoarthritis 31.19 20.09 7 24168 195723 90408549
Nystagmus 31.09 20.09 21 24154 7206 90597066
Thrombocytopenia 31.06 20.09 124 24051 208601 90395671
Mobility decreased 31.05 20.09 14 24161 250720 90353552
Balance disorder 30.70 20.09 75 24100 97005 90507267
Hyperthermia 30.70 20.09 24 24151 10311 90593961
Lethargy 30.60 20.09 58 24117 63081 90541191
Hepatic enzyme increased 30.20 20.09 31 24144 360705 90243567
Psychomotor hyperactivity 30.19 20.09 26 24149 12787 90591485
Stomatitis 30.07 20.09 18 24157 274680 90329592
Brown tumour 29.68 20.09 6 24169 53 90604219
Chest pain 29.67 20.09 25 24150 319620 90284652
Drug intolerance 29.63 20.09 46 24129 447545 90156727
Congenital central nervous system anomaly 29.52 20.09 9 24166 465 90603807
Speech disorder 28.73 20.09 47 24128 45538 90558734
Hypoaesthesia 28.64 20.09 25 24150 314185 90290087
Electrocardiogram ST segment elevation 28.34 20.09 16 24159 4000 90600272
Muscle spasms 28.29 20.09 16 24159 251867 90352405
Severe myoclonic epilepsy of infancy 28.08 20.09 6 24169 71 90604201
Spina bifida 27.76 20.09 10 24165 870 90603402
Nasopharyngitis 27.75 20.09 41 24134 407063 90197209
Pregnancy on contraceptive 27.42 20.09 11 24164 1284 90602988
Cough 27.32 20.09 35 24140 368927 90235345
Discomfort 27.29 20.09 20 24155 274315 90329957
Neurosurgery 27.15 20.09 6 24169 84 90604188
Benzodiazepine drug level increased 27.09 20.09 7 24168 196 90604076
Encephalitis 27.06 20.09 23 24152 11111 90593161
Automatism 27.02 20.09 6 24169 86 90604186
Pneumonia necrotising 26.76 20.09 9 24166 638 90603634
Arthritis 26.62 20.09 6 24169 167309 90436963
Suicidal ideation 26.56 20.09 60 24115 73795 90530477
Pulse abnormal 26.53 20.09 14 24161 3065 90601207
Cholestasis 26.44 20.09 40 24135 36259 90568013
Developmental regression 26.43 20.09 5 24170 30 90604242
High-pitched crying 26.29 20.09 5 24170 31 90604241
Pruritus 26.10 20.09 67 24108 541458 90062814
Stillbirth 25.91 20.09 19 24156 7424 90596848
Withdrawal syndrome 25.89 20.09 31 24144 22493 90581779
Mitral valve prolapse 25.84 20.09 13 24162 2578 90601694
Clumsiness 25.77 20.09 13 24162 2594 90601678
Type 2 diabetes mellitus 25.71 20.09 11 24164 203233 90401039
Congenital tracheomalacia 25.64 20.09 5 24170 36 90604236
Blood creatine phosphokinase increased 25.51 20.09 38 24137 33985 90570287
Hypersensitivity 25.35 20.09 52 24123 454625 90149647
Ammonia increased 25.13 20.09 16 24159 4970 90599302
Affective disorder 25.13 20.09 19 24156 7774 90596498
Electrocardiogram QT prolonged 25.10 20.09 58 24117 72398 90531874
Cardiac arrest 25.01 20.09 73 24102 104862 90499410
Back pain 24.62 20.09 29 24146 317146 90287126
Eye movement disorder 24.28 20.09 17 24158 6181 90598091
Aphasia 24.14 20.09 42 24133 42770 90561502
Night sweats 24.06 20.09 3 24172 128763 90475509
Loose tooth 23.97 20.09 14 24161 3729 90600543
Bradypnoea 23.61 20.09 15 24160 4643 90599629
Coma scale abnormal 23.37 20.09 16 24159 5610 90598662
Hypotonia neonatal 23.05 20.09 10 24165 1420 90602852
Pregnancy 22.97 20.09 51 24124 61996 90542276
Contusion 22.88 20.09 20 24155 251196 90353076
Shock 22.82 20.09 33 24142 28745 90575527
Toxic epidermal necrolysis 22.51 20.09 35 24140 32493 90571779
Foetal growth restriction 22.03 20.09 19 24156 9361 90594911
Hypopnoea 21.79 20.09 14 24161 4417 90599855
Acute pulmonary oedema 21.68 20.09 19 24156 9561 90594711
Paraesthesia 21.53 20.09 21 24154 250305 90353967
Loss of personal independence in daily activities 21.41 20.09 5 24170 136100 90468172
Mood swings 21.38 20.09 27 24148 20675 90583597
Screaming 21.34 20.09 13 24162 3737 90600535
Polychromasia 21.16 20.09 6 24169 240 90604032
Poisoning deliberate 21.13 20.09 24 24151 16462 90587810
Anger 21.13 20.09 22 24153 13698 90590574
Maternal exposure before pregnancy 21.00 20.09 20 24155 11193 90593079
Oedema 20.71 20.09 14 24161 200281 90403991
Caesarean section 20.42 20.09 25 24150 18552 90585720
Psoriasis 20.34 20.09 7 24168 147747 90456525
Antinuclear antibody positive 20.26 20.09 18 24157 9223 90595049
Excessive eye blinking 20.19 20.09 9 24166 1363 90602909

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Seizure 1549.38 18.83 912 22832 119649 42477942
Status epilepticus 723.92 18.83 286 23458 15292 42582299
Multiple-drug resistance 579.48 18.83 199 23545 7123 42590468
Somnolence 509.32 18.83 501 23243 140604 42456987
Drug ineffective 430.81 18.83 1022 22722 629175 41968416
Epilepsy 333.80 18.83 198 23546 25973 42571618
Generalised tonic-clonic seizure 309.08 18.83 189 23555 26190 42571401
Petit mal epilepsy 303.53 18.83 103 23641 3547 42594044
Drug withdrawal convulsions 267.10 18.83 74 23670 1264 42596327
Aggression 227.68 18.83 192 23552 43971 42553620
Ataxia 213.39 18.83 125 23619 16000 42581591
Respiratory depression 212.83 18.83 132 23612 18736 42578855
Partial seizures 192.22 18.83 84 23660 5775 42591816
Atonic seizures 176.66 18.83 42 23702 374 42597217
Tonic convulsion 174.82 18.83 56 23688 1603 42595988
Sudden unexplained death in epilepsy 161.68 18.83 41 23703 488 42597103
Drug interaction 153.86 18.83 408 23336 266591 42331000
Product use issue 151.84 18.83 200 23544 76551 42521040
Drug resistance 150.48 18.83 136 23608 34112 42563479
Behaviour disorder 144.33 18.83 73 23671 6981 42590610
Drug dependence 142.73 18.83 123 23621 28971 42568620
Off label use 139.93 18.83 711 23033 637624 41959967
Encephalopathy 139.65 18.83 142 23602 41191 42556400
Developmental delay 128.91 18.83 53 23691 3129 42594462
Abnormal behaviour 128.07 18.83 111 23633 26340 42571251
Epidural lipomatosis 123.43 18.83 44 23700 1756 42595835
Victim of child abuse 120.64 18.83 39 23705 1150 42596441
Myoclonic epilepsy 115.09 18.83 41 23703 1633 42595958
Intellectual disability 113.11 18.83 42 23702 1885 42595706
Child abuse 110.19 18.83 34 23710 858 42596733
Foetal exposure during pregnancy 108.88 18.83 133 23611 47178 42550413
Dyspnoea 108.34 18.83 56 23688 442565 42155026
Juvenile idiopathic arthritis 107.06 18.83 44 23700 2595 42594996
Brain scan abnormal 103.13 18.83 35 23709 1204 42596387
Sedation 99.83 18.83 103 23641 30372 42567219
Cerebral artery thrombosis 98.95 18.83 34 23710 1215 42596376
Hyperammonaemia 98.85 18.83 59 23685 7807 42589784
Product prescribing error 96.08 18.83 94 23650 26018 42571573
Drug reaction with eosinophilia and systemic symptoms 93.12 18.83 116 23628 41959 42555632
Product preparation issue 91.97 18.83 31 23713 1044 42596547
Cognitive disorder 90.09 18.83 103 23641 34069 42563522
Anticonvulsant drug level increased 89.84 18.83 34 23710 1609 42595982
Hypotonia 88.62 18.83 59 23685 9440 42588151
Anticonvulsant drug level above therapeutic 87.33 18.83 27 23717 686 42596905
Focal dyscognitive seizures 86.20 18.83 32 23712 1435 42596156
Change in seizure presentation 84.06 18.83 22 23722 299 42597292
Nystagmus 79.82 18.83 45 23699 5351 42592240
Psychogenic seizure 75.53 18.83 22 23722 453 42597138
Areflexia 74.42 18.83 38 23706 3705 42593886
Fanconi syndrome 73.07 18.83 30 23714 1764 42595827
Seizure cluster 70.86 18.83 19 23725 285 42597306
Treatment failure 69.58 18.83 125 23619 62499 42535092
Irritability 69.47 18.83 82 23662 28046 42569545
Postictal psychosis 66.90 18.83 17 23727 204 42597387
Hyperammonaemic encephalopathy 66.72 18.83 32 23712 2726 42594865
Hamartoma 65.46 18.83 13 23731 43 42597548
Excessive eye blinking 64.86 18.83 21 23723 622 42596969
Gaze palsy 64.71 18.83 28 23716 1877 42595714
Disturbance in attention 63.93 18.83 81 23663 29785 42567806
Cerebellar atrophy 61.47 18.83 21 23723 737 42596854
Autism spectrum disorder 61.34 18.83 31 23713 2957 42594634
Dysmorphism 61.13 18.83 32 23712 3284 42594307
Anaemia 56.68 18.83 44 23700 280234 42317357
Chest pain 56.47 18.83 6 23738 139524 42458067
Respiratory distress 56.38 18.83 91 23653 41729 42555862
Pneumonia aspiration 54.39 18.83 99 23645 49979 42547612
Diarrhoea 53.96 18.83 110 23634 460739 42136852
Arthralgia 53.04 18.83 24 23720 205214 42392377
Language disorder 51.75 18.83 26 23718 2449 42595142
Pain 51.34 18.83 37 23707 244811 42352780
Motor developmental delay 51.10 18.83 18 23726 693 42596898
Hypospadias 50.74 18.83 29 23715 3538 42594053
Febrile neutropenia 50.73 18.83 20 23724 185683 42411908
Psychomotor retardation 50.14 18.83 31 23713 4368 42593223
Depressed level of consciousness 49.79 18.83 93 23651 47877 42549714
Death 49.79 18.83 119 23625 471066 42126525
Drug level increased 49.76 18.83 67 23677 26133 42571458
Renal tubular acidosis 49.16 18.83 26 23718 2724 42594867
Developmental regression 48.28 18.83 10 23734 43 42597548
Acute kidney injury 47.97 18.83 82 23662 367255 42230336
Nausea 47.88 18.83 93 23651 396706 42200885
Psychomotor skills impaired 47.76 18.83 32 23712 5172 42592419
Partial seizures with secondary generalisation 47.47 18.83 15 23729 410 42597181
Psychomotor hyperactivity 47.08 18.83 43 23701 10915 42586676
Salivary hypersecretion 45.18 18.83 42 23702 10901 42586690
Sedation complication 44.95 18.83 25 23719 2894 42594697
Pruritus 44.38 18.83 25 23719 188746 42408845
Electroencephalogram abnormal 44.38 18.83 25 23719 2967 42594624
Haemoglobin decreased 41.94 18.83 11 23733 132460 42465131
Intensive care unit acquired weakness 40.86 18.83 18 23726 1260 42596331
Atrial fibrillation 39.85 18.83 14 23730 139579 42458012
Cardiac failure 39.82 18.83 6 23738 106850 42490741
Agitation 39.59 18.83 101 23643 64213 42533378
Speech disorder developmental 39.15 18.83 21 23723 2264 42595327
Obesity 39.01 18.83 47 23697 16412 42581179
Foetal anticonvulsant syndrome 38.66 18.83 17 23727 1185 42596406
Altered state of consciousness 38.52 18.83 63 23681 29196 42568395
Hemiplegia 37.98 18.83 33 23711 7846 42589745
Sepsis 36.93 18.83 34 23710 199300 42398291
Pain in extremity 36.77 18.83 19 23725 150585 42447006
Learning disorder 36.63 18.83 16 23728 1097 42596494
Oedema peripheral 36.58 18.83 15 23729 136061 42461530
Blood pressure increased 35.18 18.83 7 23737 101921 42495670
Drop attacks 35.12 18.83 13 23731 578 42597013
Posture abnormal 34.53 18.83 20 23724 2501 42595090
Hypertelorism 34.53 18.83 13 23731 606 42596985
Back pain 34.44 18.83 18 23726 141758 42455833
Hypoventilation 33.98 18.83 23 23721 3779 42593812
Benzodiazepine drug level decreased 32.93 18.83 7 23737 35 42597556
Ehlers-Danlos syndrome 32.45 18.83 7 23737 38 42597553
Circadian rhythm sleep disorder 32.41 18.83 12 23732 534 42597057
Atrial septal defect 31.93 18.83 30 23714 7889 42589702
Infantile spasms 31.83 18.83 10 23734 268 42597323
Coma 31.82 18.83 83 23661 53471 42544120
Headache 31.59 18.83 53 23691 239316 42358275
Hypertension 31.58 18.83 28 23716 167176 42430415
Maternal exposure during pregnancy 31.19 18.83 28 23716 6950 42590641
Epileptic encephalopathy 31.18 18.83 10 23734 287 42597304
Neonatal respiratory depression 30.47 18.83 11 23733 455 42597136
Dysarthria 30.41 18.83 68 23676 39739 42557852
Abdominal pain 30.23 18.83 37 23707 190434 42407157
Logorrhoea 30.02 18.83 19 23725 2788 42594803
White blood cell count decreased 29.94 18.83 12 23732 110384 42487207
Muscle contracture 29.78 18.83 15 23729 1420 42596171
Haematuria traumatic 29.71 18.83 10 23734 335 42597256
Akinesia 29.65 18.83 18 23726 2454 42595137
Stevens-Johnson syndrome 29.52 18.83 48 23696 22130 42575461
Product administered to patient of inappropriate age 29.34 18.83 23 23721 4738 42592853
Drooling 29.19 18.83 22 23722 4277 42593314
Pleural effusion 29.03 18.83 9 23735 97157 42500434
Tenderness 29.02 18.83 30 23714 8853 42588738
Anger 28.95 18.83 36 23708 12982 42584609
Platelet count decreased 28.93 18.83 21 23723 138560 42459031
Condition aggravated 28.54 18.83 245 23499 260509 42337082
Myocardial infarction 28.31 18.83 17 23727 123992 42473599
Extrapyramidal disorder 28.20 18.83 40 23704 16372 42581219
Screaming 28.15 18.83 16 23728 1931 42595660
Product substitution issue 28.01 18.83 33 23711 11257 42586334
Cough 27.84 18.83 35 23709 178068 42419523
Disease recurrence 27.67 18.83 55 23689 29623 42567968
Cryptorchism 27.55 18.83 16 23728 2011 42595580
Retrognathia 27.47 18.83 9 23735 277 42597314
Joint swelling 27.31 18.83 3 23741 68019 42529572
Facial paralysis 26.76 18.83 34 23710 12529 42585062
Reaction to excipient 26.72 18.83 11 23733 651 42596940
Drug screen false positive 26.58 18.83 12 23732 890 42596701
Hypotonia neonatal 26.44 18.83 14 23730 1470 42596121
Acidosis hyperchloraemic 26.44 18.83 11 23733 669 42596922
Chills 25.88 18.83 10 23734 94056 42503535
Therapeutic product effect incomplete 25.32 18.83 92 23652 70847 42526744
Hypothermia 25.29 18.83 33 23711 12482 42585109
Chest discomfort 25.05 18.83 3 23741 63613 42533978
Psychotic disorder 24.71 18.83 52 23692 29156 42568435
Hepatocellular injury 24.67 18.83 46 23698 23632 42573959
Hyperchloraemia 24.58 18.83 10 23734 574 42597017
Hypersomnia 24.19 18.83 35 23709 14583 42583008
Cerebral atrophy 23.93 18.83 21 23723 5058 42592533
Neutropenia 23.75 18.83 47 23697 199384 42398207
Myalgia 23.62 18.83 12 23732 96068 42501523
Blood glucose increased 23.54 18.83 6 23738 73693 42523898
Ammonia increased 23.44 18.83 20 23724 4639 42592952
Malignant neoplasm progression 23.18 18.83 16 23728 108384 42489207
Paradoxical drug reaction 23.15 18.83 20 23724 4718 42592873
Premature baby 22.91 18.83 44 23700 23109 42574482
Hypernatraemia 22.72 18.83 28 23716 10004 42587587
Hyperhidrosis 22.71 18.83 11 23733 90501 42507090
Pulmonary embolism 22.61 18.83 20 23724 119592 42477999
Impulsive behaviour 22.46 18.83 15 23729 2410 42595181
Bradypnoea 22.39 18.83 19 23725 4374 42593217
Vagal nerve stimulator implantation 22.31 18.83 6 23738 91 42597500
Acute myocardial infarction 22.28 18.83 3 23741 58162 42539429
Injection site pain 22.10 18.83 3 23741 57795 42539796
Malaise 21.98 18.83 54 23690 212102 42385489
Drug ineffective for unapproved indication 21.96 18.83 66 23678 46097 42551494
Dysgraphia 21.90 18.83 15 23729 2513 42595078
Gait disturbance 21.72 18.83 110 23634 97890 42499701
Aphasia 21.70 18.83 44 23700 24039 42573552
Ascites 21.53 18.83 3 23741 56675 42540916
Educational problem 21.30 18.83 9 23735 569 42597022
Self-destructive behaviour 21.17 18.83 8 23736 377 42597214
Peripheral swelling 21.13 18.83 12 23732 90258 42507333
Learning disability 21.05 18.83 8 23736 383 42597208
Haemophagocytic lymphohistiocytosis 21.02 18.83 37 23707 18185 42579406
Developmental coordination disorder 21.02 18.83 7 23737 227 42597364
Intentional product misuse 21.01 18.83 79 23665 61821 42535770
Sexually inappropriate behaviour 20.65 18.83 9 23735 614 42596977
Irregular sleep phase 20.44 18.83 6 23738 127 42597464
Memory impairment 20.40 18.83 68 23676 50154 42547437
Anticonvulsant drug level decreased 20.26 18.83 11 23733 1214 42596377
Myoclonus 20.14 18.83 35 23709 17030 42580561
Bronchiolitis 20.13 18.83 17 23727 3889 42593702
Drug abuse 20.08 18.83 113 23631 104658 42492933
Coronary artery disease 20.04 18.83 3 23741 53717 42543874
Metabolic acidosis 20.00 18.83 69 23675 51789 42545802
Clinodactyly 19.98 18.83 7 23737 265 42597326
Fine motor delay 19.96 18.83 7 23737 266 42597325
Otitis media acute 19.62 18.83 9 23735 693 42596898
Febrile convulsion 19.53 18.83 9 23735 700 42596891
Neuroprosthesis implantation 19.48 18.83 3 23741 0 42597591
Abdominal pain upper 19.30 18.83 11 23733 82598 42514993
Neuropathy peripheral 19.29 18.83 17 23727 101836 42495755
Low set ears 19.00 18.83 8 23736 501 42597090
Labelled drug-drug interaction issue 18.97 18.83 12 23732 1759 42595832

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Seizure 2480.49 17.07 1327 39284 219858 110328830
Multiple-drug resistance 1393.08 17.07 405 40206 12830 110535858
Status epilepticus 1332.72 17.07 483 40128 31088 110517600
Somnolence 930.25 17.07 811 39800 296638 110252050
Drug ineffective 751.56 17.07 1686 38925 1518854 109029834
Epilepsy 708.08 17.07 447 40164 99762 110448926
Generalised tonic-clonic seizure 631.96 17.07 336 40275 54344 110494344
Petit mal epilepsy 549.44 17.07 174 40437 7373 110541315
Partial seizures 525.08 17.07 186 40425 11163 110537525
Drug withdrawal convulsions 507.74 17.07 128 40483 2321 110546367
Drug interaction 494.25 17.07 751 39860 499432 110049256
Drug resistance 450.04 17.07 272 40339 56102 110492586
Psychogenic seizure 418.79 17.07 109 40502 2255 110546433
Aggression 402.64 17.07 258 40353 58952 110489736
Ataxia 393.46 17.07 201 40410 29907 110518781
Off label use 288.82 17.07 1198 39413 1498987 109049701
Tonic convulsion 279.22 17.07 84 40527 2990 110545698
Behaviour disorder 264.74 17.07 108 40503 9539 110539149
Drug reaction with eosinophilia and systemic symptoms 255.86 17.07 224 40387 81871 110466817
Atonic seizures 237.64 17.07 60 40551 1094 110547594
Respiratory depression 223.80 17.07 142 40469 31859 110516829
Hyperammonaemia 215.91 17.07 104 40507 13628 110535060
Drug dependence 215.86 17.07 165 40446 49855 110498833
Encephalopathy 186.73 17.07 187 40424 80868 110467820
Myoclonic epilepsy 183.31 17.07 59 40552 2632 110546056
Sudden unexplained death in epilepsy 180.47 17.07 45 40566 778 110547910
Paradoxical drug reaction 177.88 17.07 82 40529 9735 110538953
Abnormal behaviour 175.55 17.07 132 40479 38907 110509781
Seizure cluster 169.99 17.07 43 40568 790 110547898
Anticonvulsant drug level increased 163.83 17.07 55 40556 2803 110545885
Arthralgia 156.91 17.07 46 40565 779586 109769102
Irritability 156.07 17.07 134 40477 47675 110501013
Dyspnoea 155.11 17.07 109 40502 1106763 109441925
Pain 150.42 17.07 82 40529 954873 109593815
Fanconi syndrome 141.46 17.07 52 40559 3467 110545221
Change in seizure presentation 140.71 17.07 37 40574 797 110547891
Focal dyscognitive seizures 140.53 17.07 53 40558 3796 110544892
Cognitive disorder 138.93 17.07 166 40445 87345 110461343
Developmental delay 137.23 17.07 41 40570 1424 110547264
Victim of child abuse 135.95 17.07 39 40572 1172 110547516
Epidural lipomatosis 135.42 17.07 44 40567 2023 110546665
Child abuse 124.30 17.07 34 40577 855 110547833
Drug ineffective for unapproved indication 120.73 17.07 168 40443 102670 110446018
Joint swelling 119.63 17.07 12 40599 442833 110105855
Pneumonia aspiration 117.45 17.07 147 40464 81086 110467602
Product preparation issue 115.17 17.07 42 40569 2737 110545951
Mitochondrial DNA mutation 109.26 17.07 27 40584 449 110548239
Drug level increased 107.86 17.07 109 40502 47610 110501078
Propofol infusion syndrome 106.82 17.07 39 40572 2550 110546138
Intellectual disability 105.24 17.07 36 40575 1943 110546745
Brain scan abnormal 105.19 17.07 34 40577 1537 110547151
Anticonvulsant drug level above therapeutic 103.99 17.07 32 40579 1230 110547458
Disturbance in attention 102.35 17.07 120 40491 61875 110486813
Coma 101.96 17.07 167 40444 117702 110430986
Depressed level of consciousness 101.09 17.07 162 40449 112116 110436572
Nystagmus 100.48 17.07 59 40552 11518 110537170
Altered state of consciousness 99.25 17.07 114 40497 57512 110491176
Psychomotor skills impaired 97.65 17.07 49 40562 7009 110541679
Cerebral artery thrombosis 95.21 17.07 32 40579 1636 110547052
Agitation 94.86 17.07 158 40453 112893 110435795
Hyperammonaemic encephalopathy 94.12 17.07 44 40567 5390 110543298
Hypotonia 93.29 17.07 63 40548 15682 110533006
Juvenile idiopathic arthritis 92.93 17.07 45 40566 5962 110542726
Rheumatoid arthritis 92.91 17.07 4 40607 299609 110249079
Abdominal discomfort 89.32 17.07 18 40593 393840 110154848
Peripheral swelling 86.51 17.07 21 40590 404013 110144675
Hypersomnia 86.22 17.07 76 40535 27985 110520703
Product use issue 86.18 17.07 281 40330 311414 110237274
Infusion related reaction 85.24 17.07 18 40593 381144 110167544
Psychotic disorder 84.75 17.07 99 40512 50838 110497850
Product prescribing error 84.13 17.07 99 40512 51232 110497456
Product substitution issue 80.09 17.07 67 40544 22994 110525694
Vagal nerve stimulator implantation 77.11 17.07 18 40593 232 110548456
Pain in extremity 76.25 17.07 42 40569 487076 110061612
Cerebellar atrophy 75.58 17.07 26 40585 1427 110547261
Postictal psychosis 75.27 17.07 18 40593 259 110548429
Synovitis 75.10 17.07 7 40604 274085 110274603
Intentional product misuse 74.22 17.07 156 40455 132748 110415940
Areflexia 73.64 17.07 40 40571 6729 110541959
Nausea 73.01 17.07 223 40388 1235467 109313221
Gaze palsy 73.00 17.07 32 40579 3375 110545313
Overdose 72.15 17.07 219 40392 233575 110315113
Partial seizures with secondary generalisation 71.71 17.07 22 40589 837 110547851
Macroglossia 71.58 17.07 25 40586 1436 110547252
Wound 69.90 17.07 4 40607 234433 110314255
Excessive eye blinking 69.18 17.07 26 40585 1844 110546844
Contraindicated product administered 68.93 17.07 6 40605 248261 110300427
Drug level decreased 68.82 17.07 56 40555 18492 110530196
Toxicity to various agents 68.60 17.07 353 40258 480202 110068486
Swelling 68.15 17.07 22 40589 351019 110197669
Pericarditis 67.67 17.07 3 40608 219111 110329577
Stevens-Johnson syndrome 66.38 17.07 84 40527 46817 110501871
Drooling 66.24 17.07 38 40573 7101 110541587
CSF oligoclonal band present 65.75 17.07 18 40593 454 110548234
Myoclonus 63.18 17.07 69 40542 32929 110515759
Hepatocellular injury 62.82 17.07 85 40526 50557 110498131
Chest pain 62.53 17.07 30 40581 376345 110172343
Sinusitis 62.36 17.07 16 40595 296672 110252016
Malaise 62.30 17.07 94 40517 671725 109876963
Febrile convulsion 62.19 17.07 21 40590 1089 110547599
Systemic lupus erythematosus 61.14 17.07 10 40601 254328 110294360
Electroencephalogram abnormal 60.35 17.07 34 40577 6139 110542549
Cerebral atrophy 60.24 17.07 39 40572 9046 110539642
Diarrhoea 60.12 17.07 216 40395 1139289 109409399
Hypertension 58.08 17.07 61 40550 510023 110038665
Blood gases abnormal 58.05 17.07 21 40590 1337 110547351
Abdominal pain upper 57.73 17.07 28 40583 349083 110199605
Gene mutation 57.03 17.07 27 40584 3402 110545286
Foetal exposure during pregnancy 56.72 17.07 35 40576 7470 110541218
Febrile neutropenia 56.15 17.07 23 40588 316744 110231944
Automatism epileptic 55.25 17.07 10 40601 30 110548658
Pruritus 53.29 17.07 82 40529 581478 109967210
Dysarthria 53.21 17.07 104 40507 84017 110464671
Injection site pain 53.14 17.07 3 40608 177919 110370769
Respiratory distress 52.15 17.07 92 40519 68782 110479906
Product administered to patient of inappropriate age 52.07 17.07 34 40577 8002 110540686
Drug hypersensitivity 52.02 17.07 54 40557 454036 110094652
Intentional overdose 51.51 17.07 135 40476 132366 110416322
Temporal lobe epilepsy 51.29 17.07 15 40596 483 110548205
Cholestasis 51.22 17.07 88 40523 64430 110484258
Tricuspid valve incompetence 51.16 17.07 53 40558 23820 110524868
Alopecia 50.76 17.07 36 40575 364717 110183971
Hypothermia 50.36 17.07 55 40556 26247 110522441
Infantile spasms 50.26 17.07 14 40597 377 110548311
Blood cholesterol increased 49.87 17.07 5 40606 184780 110363908
Anger 49.63 17.07 47 40564 18960 110529728
Wheezing 49.52 17.07 16 40595 255214 110293474
Lower respiratory tract infection 49.41 17.07 14 40597 243092 110305596
Learning disorder 49.23 17.07 16 40595 736 110547952
Osteoarthritis 49.13 17.07 5 40606 182618 110366070
Ammonia increased 48.85 17.07 33 40578 8217 110540471
Cough 48.40 17.07 59 40552 461582 110087106
Angiofibroma 48.31 17.07 11 40600 126 110548562
Asthma 48.01 17.07 16 40595 250275 110298413
Systolic dysfunction 47.78 17.07 26 40585 4389 110544299
Sedation 47.57 17.07 89 40522 69594 110479094
Coma blister 47.46 17.07 12 40599 220 110548468
Intensive care unit acquired weakness 46.82 17.07 21 40590 2338 110546350
Pleocytosis 46.27 17.07 19 40592 1705 110546983
Renal tubular acidosis 46.18 17.07 26 40585 4689 110543999
Anticonvulsant drug level decreased 45.56 17.07 20 40591 2116 110546572
Salivary hypersecretion 45.34 17.07 43 40568 17378 110531310
Screaming 45.34 17.07 26 40585 4855 110543833
Headache 45.32 17.07 169 40442 882208 109666480
Developmental regression 45.29 17.07 9 40602 50 110548638
Fibromyalgia 45.15 17.07 5 40606 170904 110377784
Bradypnoea 45.11 17.07 32 40579 8617 110540071
Blood lactic acid increased 44.94 17.07 41 40570 15780 110532908
Hypoventilation 44.71 17.07 31 40580 8050 110540638
Lethargy 44.49 17.07 103 40508 93473 110455215
Cerebellar syndrome 44.13 17.07 28 40583 6274 110542414
Autism spectrum disorder 44.03 17.07 19 40592 1929 110546759
Back pain 43.76 17.07 43 40568 370953 110177735
Hypoaesthesia 43.73 17.07 31 40580 314192 110234496
Metabolic acidosis 43.33 17.07 106 40505 99638 110449050
Suicide attempt 42.93 17.07 108 40503 103286 110445402
Hemianopia 42.91 17.07 21 40590 2847 110545841
Lymphangioleiomyomatosis 42.41 17.07 11 40600 224 110548464
Blood pressure increased 42.28 17.07 21 40590 258352 110290336
Gait disturbance 42.18 17.07 208 40403 278000 110270688
Therapeutic product effect decreased 41.29 17.07 19 40592 244297 110304391
Anaemia 41.25 17.07 87 40524 546999 110001689
Aphasia 41.08 17.07 76 40535 58921 110489767
Gingival hypertrophy 40.04 17.07 23 40588 4308 110544380
Arthritis 39.36 17.07 7 40604 167579 110381109
Aura 39.31 17.07 15 40596 1109 110547579
Epilepsy with myoclonic-atonic seizures 39.22 17.07 9 40602 107 110548581
Oropharyngeal oedema 39.20 17.07 12 40599 453 110548235
Suicidal ideation 38.87 17.07 98 40513 93839 110454849
Paraesthesia 38.85 17.07 27 40584 276494 110272194
Blood oestrogen increased 38.73 17.07 10 40601 200 110548488
Epileptic encephalopathy 38.54 17.07 13 40598 672 110548016
Stomatitis 38.48 17.07 26 40585 270216 110278472
Automatism 37.96 17.07 10 40601 217 110548471
Musculoskeletal stiffness 37.14 17.07 29 40582 279793 110268895
Depressed mood 37.02 17.07 74 40537 60735 110487953
Treatment failure 36.97 17.07 200 40411 277034 110271654
Myalgia 36.49 17.07 18 40593 222363 110326325
Injury 36.40 17.07 10 40601 177255 110371433
Type 2 diabetes mellitus 36.39 17.07 10 40601 177222 110371466
Suicidal behaviour 36.20 17.07 20 40591 3477 110545211
Disease recurrence 35.85 17.07 73 40538 60711 110487977
Benzodiazepine drug level decreased 35.84 17.07 7 40604 35 110548653
Postictal paralysis 35.79 17.07 12 40599 609 110548079
Pulmonary valve incompetence 35.26 17.07 18 40593 2668 110546020
Neurosurgery 35.03 17.07 8 40603 93 110548595
Psychomotor hyperactivity 34.71 17.07 40 40571 20237 110528451
Blood glucose increased 34.69 17.07 4 40607 132492 110416196
Gastrostomy 34.65 17.07 15 40596 1535 110547153
Angiomyolipoma 34.50 17.07 10 40601 312 110548376
Mitral valve prolapse 34.35 17.07 17 40594 2361 110546327
Acidosis hyperchloraemic 34.31 17.07 15 40596 1571 110547117
Right ventricular dilatation 34.28 17.07 17 40594 2370 110546318
Speech disorder 34.04 17.07 72 40539 61497 110487191
Thrombocytopenia 34.01 17.07 232 40379 348653 110200035
Metapneumovirus infection 33.90 17.07 17 40594 2427 110546261
Herpangina 33.83 17.07 7 40604 49 110548639
Loss of personal independence in daily activities 33.68 17.07 7 40604 150013 110398675
Chest discomfort 33.53 17.07 11 40600 173837 110374851
Prescribed underdose 33.50 17.07 74 40537 65100 110483588
Infection 33.20 17.07 51 40560 362149 110186539
Blood creatine phosphokinase increased 33.17 17.07 79 40532 72998 110475690
Haematuria traumatic 32.99 17.07 10 40601 365 110548323
Balance disorder 32.98 17.07 106 40505 116454 110432234
Rectal haemorrhage 32.97 17.07 3 40608 119830 110428858
Nasopharyngitis 32.93 17.07 59 40552 394302 110154386
Retinogram abnormal 32.71 17.07 10 40601 376 110548312
Drug abuse 32.31 17.07 140 40471 177271 110371417
Drop attacks 32.22 17.07 13 40598 1115 110547573
Ill-defined disorder 31.92 17.07 9 40602 156844 110391844
Language disorder 31.84 17.07 19 40592 3819 110544869
Posture abnormal 31.78 17.07 20 40591 4418 110544270
Dystonia 31.52 17.07 43 40568 25762 110522926
Hypersensitivity 31.49 17.07 63 40548 403935 110144753
Hallucination, visual 31.40 17.07 54 40557 39551 110509137
Therapeutic product effective for unapproved indication 31.22 17.07 8 40603 155 110548533
Speech disorder developmental 31.19 17.07 12 40599 907 110547781
Brain operation 31.18 17.07 12 40599 908 110547780
Cardiac failure 31.07 17.07 15 40596 187611 110361077
Mood swings 30.93 17.07 40 40571 22772 110525916
Myocardial infarction 30.84 17.07 16 40595 192067 110356621
Apnoea 30.53 17.07 31 40580 13608 110535080
Sedation complication 30.40 17.07 37 40574 19818 110528870
Therapeutic product ineffective for unapproved indication 30.33 17.07 9 40602 305 110548383
Urticaria 30.09 17.07 44 40567 318813 110229875
Hepatic cytolysis 29.99 17.07 64 40547 54989 110493699
Musculoskeletal pain 29.75 17.07 15 40596 183008 110365680
Mitral valve thickening 29.57 17.07 11 40600 758 110547930
Condition aggravated 29.52 17.07 405 40206 734431 109814257
Hyponatraemia 29.00 17.07 157 40454 217496 110331192
Wrong patient received product 28.74 17.07 22 40589 6652 110542036
Glioblastoma multiforme 28.73 17.07 13 40598 1477 110547211
Personality change 28.33 17.07 27 40584 10975 110537713
Hyperhidrosis 28.05 17.07 17 40594 187281 110361407
Magnetic resonance imaging head abnormal 28.03 17.07 17 40594 3518 110545170
Benzodiazepine drug level increased 27.90 17.07 8 40603 240 110548448
Cholestasis of pregnancy 27.49 17.07 12 40599 1253 110547435
Mobility decreased 27.43 17.07 28 40583 237394 110311294
Dysmorphism 27.38 17.07 10 40601 654 110548034
Premature delivery 27.28 17.07 44 40567 30588 110518100
Intentional self-injury 27.05 17.07 49 40562 37380 110511308
Echocardiogram abnormal 26.88 17.07 15 40596 2659 110546029
Hyperthermia 26.83 17.07 36 40575 21236 110527452
Psoriasis 26.75 17.07 9 40602 139984 110408704
Drug screen false positive 26.58 17.07 12 40599 1357 110547331
Abdominal pain 26.44 17.07 98 40513 512891 110035797
Hallucination, auditory 26.40 17.07 40 40571 26357 110522331
Epileptic psychosis 26.33 17.07 6 40605 69 110548619
Electrocardiogram QRS complex prolonged 26.28 17.07 28 40583 12993 110535695
Lung disorder 26.06 17.07 17 40594 180030 110368658
Gastrooesophageal reflux disease 26.04 17.07 17 40594 179959 110368729
Oedema peripheral 25.82 17.07 51 40560 328609 110220079
Psychomotor retardation 25.74 17.07 22 40589 7770 110540918
Acute kidney injury 25.70 17.07 133 40478 635297 109913391
Bronchiolitis 25.63 17.07 19 40592 5474 110543214
Atrial fibrillation 25.50 17.07 28 40583 229614 110319074
Hypernatraemia 25.32 17.07 32 40579 17801 110530887
Mood altered 25.18 17.07 35 40576 21340 110527348
Neck pain 25.18 17.07 7 40604 123123 110425565
Discomfort 25.17 17.07 25 40586 214682 110334006
Oedema 25.13 17.07 24 40587 209952 110338736
Chills 24.97 17.07 20 40591 190560 110358128
Self-destructive behaviour 24.93 17.07 10 40601 845 110547843
Hemiplegia 24.91 17.07 36 40575 22746 110525942
Poor feeding infant 24.87 17.07 7 40604 196 110548492
Gastrointestinal haemorrhage 24.82 17.07 15 40596 165503 110383185
Learning disability 24.74 17.07 7 40604 200 110548488
Diplopia 24.33 17.07 50 40561 41844 110506844
Fluid retention 24.31 17.07 3 40608 94304 110454384
Pleural effusion 24.10 17.07 18 40593 177691 110370997
Hyperchloraemia 23.94 17.07 11 40600 1295 110547393
Muscle spasms 23.77 17.07 41 40570 278116 110270572
Dry mouth 23.76 17.07 23 40588 199925 110348763
Therapy partial responder 23.64 17.07 46 40565 37015 110511673
Muscle contracture 23.55 17.07 14 40597 2794 110545894
Coma scale abnormal 23.41 17.07 23 40588 9703 110538985
Mitral valve incompetence 23.28 17.07 43 40568 33286 110515402
Electrocardiogram repolarisation abnormality 23.20 17.07 13 40598 2322 110546366
Brown tumour 23.19 17.07 6 40605 121 110548567
Simple partial seizures 23.07 17.07 10 40601 1026 110547662
Motor developmental delay 22.87 17.07 7 40604 264 110548424
Haematochezia 22.83 17.07 7 40604 115517 110433171
Circadian rhythm sleep disorder 22.74 17.07 10 40601 1062 110547626
Bruxism 22.69 17.07 17 40594 4977 110543711
Mucosal inflammation 22.61 17.07 4 40607 96137 110452551
Migraine 22.50 17.07 18 40593 171634 110377054
Pulmonary fibrosis 22.41 17.07 5 40606 102037 110446651
Haemophagocytic lymphohistiocytosis 22.40 17.07 41 40570 31518 110517170
Contusion 22.21 17.07 32 40579 233329 110315359
Asterixis 22.03 17.07 14 40597 3144 110545544
Malignant neoplasm progression 22.03 17.07 19 40592 174548 110374140
Anticonvulsant drug level below therapeutic 21.97 17.07 10 40601 1152 110547536
Injection site erythema 21.97 17.07 4 40607 94172 110454516
Haemoglobin decreased 21.86 17.07 36 40575 248691 110299997
High-pitched crying 21.86 17.07 4 40607 13 110548675
Loose tooth 21.65 17.07 14 40597 3239 110545449
Diabetes mellitus 21.57 17.07 5 40606 99376 110449312
Bradyphrenia 21.54 17.07 24 40587 11704 110536984
Ehlers-Danlos syndrome 21.50 17.07 7 40604 324 110548364
Liver disorder 21.17 17.07 13 40598 142230 110406458
Fatigue 21.13 17.07 317 40294 1215641 109333047
Extrapyramidal disorder 21.12 17.07 38 40573 28829 110519859
Encephalitis 20.94 17.07 30 40581 18809 110529879
Neuropathy peripheral 20.86 17.07 21 40590 179256 110369432
Unmasking of previously unidentified disease 20.73 17.07 13 40598 2855 110545833
Palpitations 20.49 17.07 17 40594 159195 110389493
Fanconi syndrome acquired 20.06 17.07 13 40598 3021 110545667
Intentional product use issue 19.87 17.07 38 40573 247868 110300820
Rhinovirus infection 19.75 17.07 23 40588 11766 110536922
Aortic valve thickening 19.59 17.07 6 40605 227 110548461
Rash morbilliform 19.51 17.07 19 40592 7932 110540756
Febrile infection-related epilepsy syndrome 19.51 17.07 5 40606 97 110548591
Dermatitis exfoliative generalised 19.38 17.07 22 40589 10950 110537738
Urinary retention 19.37 17.07 63 40548 69620 110479068
Dyspnoea exertional 19.34 17.07 7 40604 104053 110444635
Death 19.31 17.07 164 40447 698705 109849983
Reaction to excipient 19.21 17.07 11 40600 2048 110546640
Facial paralysis 19.17 17.07 33 40578 24181 110524507
Neuroprosthesis implantation 18.98 17.07 4 40607 31 110548657
Hypercholesterolaemia 18.88 17.07 5 40606 90832 110457856
Catatonia 18.85 17.07 22 40589 11278 110537410
Drug intolerance 18.82 17.07 81 40530 406431 110142257
Acute myocardial infarction 18.61 17.07 4 40607 83773 110464915
Mydriasis 18.61 17.07 31 40580 22126 110526562
Pulse abnormal 18.58 17.07 14 40597 4135 110544553
Pancreas infection 18.55 17.07 7 40604 502 110548186
Myelosuppression 18.13 17.07 6 40605 94334 110454354
Tenderness 18.13 17.07 36 40575 29401 110519287
Blister 18.10 17.07 35 40576 227341 110321347
Neutrophil count decreased 18.07 17.07 11 40600 120930 110427758
Akinesia 17.82 17.07 13 40598 3654 110545034
C-reactive protein increased 17.82 17.07 33 40578 217886 110330802
Essential tremor 17.53 17.07 10 40601 1848 110546840
Fall 17.49 17.07 315 40296 603167 109945521
Toxic skin eruption 17.37 17.07 34 40577 27481 110521207
Bundle branch block right 17.36 17.07 22 40589 12269 110536419
Accidental poisoning 17.29 17.07 11 40600 2476 110546212
Antinuclear antibody positive 17.25 17.07 19 40592 9149 110539539
Colitis 17.21 17.07 8 40603 102315 110446373
Abdominal compartment syndrome 17.19 17.07 10 40601 1917 110546771
Irregular sleep phase 17.10 17.07 5 40606 161 110548527

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
Weight gain poor 31.52 24.91 11 314 73 113555

Pharmacologic Action:

SourceCodeDescription
ATC N05BA09 NERVOUS SYSTEM
PSYCHOLEPTICS
ANXIOLYTICS
Benzodiazepine derivatives
FDA CS M0002356 Benzodiazepines
MeSH PA D000927 Anticonvulsants
MeSH PA D002492 Central Nervous System Depressants
MeSH PA D011619 Psychotropic Drugs
MeSH PA D014151 Anti-Anxiety Agents
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D018682 GABA Agents
MeSH PA D058785 GABA-A Receptor Agonists
FDA EPC N0000175694 Benzodiazepine
FDA MoA N0000182137 Cytochrome P450 2D6 Inhibitors
FDA MoA N0000185506 Cytochrome P450 3A4 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:35480 analgesic
CHEBI has role CHEBI:35623 anticonvulsant
CHEBI has role CHEBI:50268 GABA modulator

Related Drugs by ATC class:

N05BA Benzodiazepine derivatives 23 drugs
adinazolamalprazolambentazepambromazepamcamazepamchlordiazepoxideclorazepateclotiazepamcloxazolamdiazepamethyl loflazepateetizolam show all 23 →

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

DiseaseRelationSNOMED_IDDOID
Lennox-Gastaut syndrome indication 230418006




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 8.14 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
10MG SYMPAZAN COSETTE N210833 Nov. 1, 2018 RX FILM ORAL 12290597 Sept. 5, 2039 METHOD OF TREATING SEIZURES
10MG SYMPAZAN COSETTE N210833 Nov. 1, 2018 RX FILM ORAL 12403090 Sept. 5, 2039 METHOD OF TREATING SEIZURES
5MG SYMPAZAN COSETTE N210833 Nov. 1, 2018 RX FILM ORAL 12290597 Sept. 5, 2039 METHOD OF TREATING SEIZURES
5MG SYMPAZAN COSETTE N210833 Nov. 1, 2018 RX FILM ORAL 12403090 Sept. 5, 2039 METHOD OF TREATING SEIZURES
10MG SYMPAZAN COSETTE N210833 Nov. 1, 2018 RX FILM ORAL 11541002 Jan. 31, 2040 METHOD OF TREATING SEIZURES
20MG SYMPAZAN COSETTE N210833 Nov. 1, 2018 RX FILM ORAL 11541002 Jan. 31, 2040 METHOD OF TREATING SEIZURES
5MG SYMPAZAN COSETTE N210833 Nov. 1, 2018 RX FILM ORAL 11541002 Jan. 31, 2040 METHOD OF TREATING SEIZURES

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
GABA-A receptor alpha-1/beta-2/gamma-2 Ion channel POSITIVE ALLOSTERIC MODULATOR WOMBAT-PK CHEMBL

External reference:

IDSource
4025788 VUID
N0000179086 NUI
D01253 KEGG_DRUG
151794 RXNORM
C0055891 UMLSCUI
CHEBI:31413 CHEBI
CHEMBL70418 ChEMBL_ID
DB00349 DRUGBANK_ID
D000078306 MESH_DESCRIPTOR_UI
2789 PUBCHEM_CID
7149 IUPHAR_LIGAND_ID
3055 INN_ID
2MRO291B4U UNII
14923 MMSL
66309 MMSL
d04557 MMSL
003693 NDDF
387572002 SNOMEDCT_US
96236000 SNOMEDCT_US
4025788 VANDF

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Clobazam HUMAN PRESCRIPTION DRUG LABEL 1 0832-0580 TABLET 10 mg ORAL ANDA 39 sections
Clobazam HUMAN PRESCRIPTION DRUG LABEL 1 0832-0581 TABLET 20 mg ORAL ANDA 39 sections
SYMPAZAN HUMAN PRESCRIPTION DRUG LABEL 1 10094-205 FILM 5 mg ORAL NDA 36 sections
SYMPAZAN HUMAN PRESCRIPTION DRUG LABEL 1 10094-205 FILM 5 mg ORAL NDA 36 sections
SYMPAZAN HUMAN PRESCRIPTION DRUG LABEL 1 10094-210 FILM 10 mg ORAL NDA 36 sections
SYMPAZAN HUMAN PRESCRIPTION DRUG LABEL 1 10094-210 FILM 10 mg ORAL NDA 36 sections
SYMPAZAN HUMAN PRESCRIPTION DRUG LABEL 1 10094-220 FILM 20 mg ORAL NDA 36 sections
SYMPAZAN HUMAN PRESCRIPTION DRUG LABEL 1 10094-220 FILM 20 mg ORAL NDA 36 sections
Clobazam HUMAN PRESCRIPTION DRUG LABEL 1 16714-087 SUSPENSION 2.50 mg ORAL ANDA 35 sections
Clobazam HUMAN PRESCRIPTION DRUG LABEL 1 16714-887 TABLET 10 mg ORAL ANDA 32 sections
Clobazam HUMAN PRESCRIPTION DRUG LABEL 1 16714-888 TABLET 20 mg ORAL ANDA 32 sections
Clobazam HUMAN PRESCRIPTION DRUG LABEL 1 16729-572 SUSPENSION 2.50 mg ORAL ANDA 32 sections
Clobazam HUMAN PRESCRIPTION DRUG LABEL 1 31722-639 TABLET 10 mg ORAL ANDA 32 sections
Clobazam HUMAN PRESCRIPTION DRUG LABEL 1 31722-640 TABLET 20 mg ORAL ANDA 32 sections
Clobazam HUMAN PRESCRIPTION DRUG LABEL 1 31722-641 SUSPENSION 2.50 mg ORAL ANDA 35 sections
Clobazam HUMAN PRESCRIPTION DRUG LABEL 1 42571-315 TABLET 10 mg ORAL ANDA 32 sections
Clobazam HUMAN PRESCRIPTION DRUG LABEL 1 42571-316 TABLET 20 mg ORAL ANDA 32 sections
Clobazam HUMAN PRESCRIPTION DRUG LABEL 1 51407-585 TABLET 10 mg ORAL ANDA 39 sections
Clobazam HUMAN PRESCRIPTION DRUG LABEL 1 51407-586 TABLET 20 mg ORAL ANDA 39 sections
Clobazam HUMAN PRESCRIPTION DRUG LABEL 1 51672-4227 SUSPENSION 2.50 mg ORAL ANDA 40 sections
Clobazam Human Prescription Drug Label 1 59651-401 SUSPENSION 2.50 mg ORAL ANDA 34 sections
Clobazam HUMAN PRESCRIPTION DRUG LABEL 1 60687-423 TABLET 10 mg ORAL ANDA 29 sections
Clobazam HUMAN PRESCRIPTION DRUG LABEL 1 62135-527 SUSPENSION 2.50 mg ORAL ANDA 39 sections
Onfi HUMAN PRESCRIPTION DRUG LABEL 1 67386-313 SUSPENSION 2.50 mg ORAL NDA 32 sections
Onfi HUMAN PRESCRIPTION DRUG LABEL 1 67386-314 TABLET 10 mg ORAL NDA 32 sections
Onfi HUMAN PRESCRIPTION DRUG LABEL 1 67386-315 TABLET 20 mg ORAL NDA 32 sections
Clobazam Human Prescription Drug Label 1 67877-658 SUSPENSION 2.50 mg ORAL ANDA 34 sections
Clobazam Human Prescription Drug Label 1 67877-664 TABLET 5 mg ORAL ANDA 31 sections
Clobazam Human Prescription Drug Label 1 67877-665 TABLET 10 mg ORAL ANDA 31 sections
Clobazam Human Prescription Drug Label 1 67877-666 TABLET 20 mg ORAL ANDA 31 sections