clobazam 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | 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

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 1494.10 19.19 735 17448 131899 63338940
Status epilepticus 601.31 19.19 208 17975 15025 63455814
Multiple-drug resistance 568.03 19.19 155 18028 5015 63465824
Epilepsy 491.72 19.19 210 17973 26855 63443984
Drug withdrawal convulsions 407.10 19.19 92 18091 1333 63469506
Psychogenic seizure 349.72 19.19 84 18099 1608 63469231
Drug resistance 277.11 19.19 134 18049 22799 63448040
Somnolence 274.58 19.19 295 17888 178390 63292449
Drug interaction 232.36 19.19 306 17877 228825 63242014
Partial seizures 231.23 19.19 80 18103 5762 63465077
Generalised tonic-clonic seizure 230.73 19.19 128 18055 28888 63441951
Drug ineffective 216.43 19.19 720 17463 1044045 62426794
Abortion spontaneous 208.31 19.19 143 18040 47052 63423787
Exposure during pregnancy 181.59 19.19 223 17960 155324 63315515
Aggression 163.44 19.19 95 18088 23403 63447436
Foetal exposure during pregnancy 138.98 19.19 96 18087 31866 63438973
Paradoxical drug reaction 134.46 19.19 49 18134 4103 63466736
Propofol infusion syndrome 129.31 19.19 34 18149 949 63469890
Drug reaction with eosinophilia and systemic symptoms 127.20 19.19 93 18090 33743 63437096
Abnormal behaviour 124.05 19.19 77 18106 21349 63449490
Petit mal epilepsy 123.70 19.19 45 18138 3749 63467090
Mitochondrial DNA mutation 108.44 19.19 25 18158 397 63470442
Irritability 103.32 19.19 80 18103 31614 63439225
Pain 101.28 19.19 43 18140 740585 62730254
Off label use 100.82 19.19 420 17763 674042 62796797
Ataxia 86.41 19.19 54 18129 15141 63455698
Respiratory disorder neonatal 85.90 19.19 26 18157 1219 63469620
Arthralgia 82.85 19.19 30 18153 569680 62901159
Hyperammonaemia 76.81 19.19 35 18148 5197 63465642
Abdominal discomfort 75.58 19.19 4 18179 320881 63149958
Bradycardia neonatal 74.88 19.19 22 18161 930 63469909
Gene mutation 70.54 19.19 24 18159 1641 63469198
Psychomotor skills impaired 69.50 19.19 26 18157 2342 63468497
Anticonvulsant drug level increased 68.74 19.19 23 18160 1494 63469345
Fanconi syndrome 66.65 19.19 22 18161 1370 63469469
Drug level decreased 65.83 19.19 36 18147 7883 63462956
Blood gases abnormal 65.25 19.19 19 18164 778 63470061
Tonic convulsion 64.12 19.19 21 18162 1276 63469563
Joint swelling 63.94 19.19 9 18174 327657 63143182
Systolic dysfunction 63.66 19.19 22 18161 1577 63469262
CSF oligoclonal band present 63.15 19.19 16 18167 384 63470455
Weight gain poor 62.64 19.19 19 18164 897 63469942
Atonic seizures 60.23 19.19 17 18166 622 63470217
Nausea 57.63 19.19 98 18085 854373 62616466
Change in seizure presentation 57.41 19.19 15 18168 408 63470431
Focal dyscognitive seizures 57.41 19.19 24 18159 2897 63467942
Rheumatoid arthritis 57.22 19.19 4 18179 253815 63217024
Pleocytosis 55.53 19.19 17 18166 828 63470011
Drug ineffective for unapproved indication 55.21 19.19 58 18125 34005 63436834
Seizure cluster 54.80 19.19 13 18170 235 63470604
Selective eating disorder 54.50 19.19 21 18162 2051 63468788
Dyspnoea 53.19 19.19 67 18116 661246 62809593
Overdose 50.94 19.19 106 18077 114972 63355867
Cognitive disorder 50.93 19.19 71 18112 55744 63415095
Premature baby 50.10 19.19 44 18139 20691 63450148
Developmental delay 49.87 19.19 18 18165 1465 63469374
Macroglossia 49.83 19.19 15 18168 690 63470149
Infusion related reaction 49.66 19.19 6 18177 245515 63225324
Sedation 49.00 19.19 58 18125 38751 63432088
Drug level increased 48.54 19.19 45 18138 22691 63448148
Disturbance in attention 48.10 19.19 57 18126 38132 63432707
Drug dependence 47.58 19.19 46 18137 24437 63446402
Contraindicated product administered 47.44 19.19 4 18179 217644 63253195
Coma 47.37 19.19 74 18109 64290 63406549
Lymphangioleiomyomatosis 47.34 19.19 11 18172 181 63470658
Angiofibroma 46.69 19.19 10 18173 111 63470728
Sudden unexplained death in epilepsy 46.48 19.19 12 18171 311 63470528
Oropharyngeal oedema 45.56 19.19 12 18171 337 63470502
Product substitution issue 44.90 19.19 37 18146 15959 63454880
Low birth weight baby 44.77 19.19 27 18156 7102 63463737
Diarrhoea 44.62 19.19 86 18097 715280 62755559
Aura 43.63 19.19 15 18168 1058 63469781
Temporal lobe epilepsy 43.62 19.19 12 18171 399 63470440
Suicidal behaviour 43.03 19.19 19 18164 2620 63468219
Electroencephalogram abnormal 42.94 19.19 21 18162 3651 63467188
Apnoea 41.84 19.19 27 18156 7995 63462844
Epilepsy with myoclonic-atonic seizures 41.69 19.19 9 18174 104 63470735
Myoclonic epilepsy 41.35 19.19 15 18168 1239 63469600
Exposure via breast milk 40.76 19.19 17 18166 2040 63468799
Angiomyolipoma 40.65 19.19 10 18173 212 63470627
Gingival hypertrophy 40.64 19.19 16 18167 1655 63469184
Pregnancy 39.96 19.19 51 18132 36785 63434054
Stevens-Johnson syndrome 39.57 19.19 42 18141 24908 63445931
Behaviour disorder 39.53 19.19 19 18164 3180 63467659
Coma blister 38.57 19.19 9 18174 151 63470688
Psychotic disorder 38.52 19.19 42 18141 25670 63445169
Hypotonia 38.26 19.19 27 18156 9258 63461581
Sinusitis 38.22 19.19 9 18174 226644 63244195
Hepatocellular injury 38.05 19.19 43 18140 27338 63443501
Hyperammonaemic encephalopathy 38.00 19.19 17 18166 2417 63468422
Unmasking of previously unidentified disease 37.20 19.19 13 18170 963 63469876
Depressed level of consciousness 37.11 19.19 65 18118 62013 63408826
Peripheral swelling 36.90 19.19 15 18168 265927 63204912
Pain in extremity 36.71 19.19 25 18158 331461 63139378
Depressed mood 36.47 19.19 51 18132 40140 63430699
Infantile spasms 35.93 19.19 9 18174 206 63470633
Toxicity to various agents 35.87 19.19 153 18030 247097 63223742
Wound 35.57 19.19 3 18180 163260 63307579
Intentional product misuse 35.40 19.19 63 18120 60854 63409985
Myoclonus 35.02 19.19 32 18151 15836 63455003
Swelling 34.38 19.19 18 18165 275360 63195479
Cholestasis of pregnancy 34.32 19.19 13 18170 1212 63469627
Drop attacks 33.54 19.19 11 18172 671 63470168
Electrocardiogram repolarisation abnormality 33.40 19.19 13 18170 1304 63469535
Hallucination, visual 33.32 19.19 34 18149 19264 63451575
Drooling 33.30 19.19 18 18165 3850 63466989
Product administered to patient of inappropriate age 33.23 19.19 17 18166 3251 63467588
Congenital central nervous system anomaly 31.73 19.19 9 18174 335 63470504
Epileptic psychosis 31.29 19.19 6 18177 36 63470803
Hypothermia 31.18 19.19 28 18155 13553 63457286
Mood altered 31.12 19.19 29 18154 14714 63456125
Maternal exposure during pregnancy 31.00 19.19 135 18048 219927 63250912
Nystagmus 30.16 19.19 20 18163 6200 63464639
Therapeutic product effect decreased 30.04 19.19 9 18174 193178 63277661
Hypersomnia 29.71 19.19 31 18152 18024 63452815
Brown tumour 29.56 19.19 6 18177 50 63470789
Encephalopathy 29.24 19.19 45 18138 38575 63432264
Pneumonia necrotising 29.21 19.19 9 18174 448 63470391
Metapneumovirus infection 28.80 19.19 11 18172 1049 63469790
Pneumonia aspiration 28.65 19.19 42 18141 34498 63436341
Blood lactic acid increased 27.80 19.19 20 18163 7066 63463773
Cholestasis 27.68 19.19 38 18145 29396 63441443
Severe myoclonic epilepsy of infancy 27.66 19.19 6 18177 71 63470768
Electrocardiogram ST segment elevation 27.61 19.19 16 18167 3911 63466928
Pregnancy on contraceptive 27.54 19.19 11 18172 1181 63469658
Poisoning deliberate 27.49 19.19 24 18159 11194 63459645
Lower respiratory tract infection 27.32 19.19 3 18180 132304 63338535
Spina bifida 27.30 19.19 10 18173 849 63469990
Infection 27.12 19.19 16 18167 229157 63241682
Systemic lupus erythematosus 27.05 19.19 13 18170 208905 63261934
Benzodiazepine drug level increased 26.98 19.19 7 18176 185 63470654
Blood creatine phosphokinase increased 26.70 19.19 38 18145 30392 63440447
Brain operation 26.67 19.19 9 18174 600 63470239
High-pitched crying 26.52 19.19 5 18178 27 63470812
Developmental regression 26.52 19.19 5 18178 27 63470812
Herpangina 26.37 19.19 5 18178 28 63470811
Cough 26.34 19.19 27 18156 292716 63178123
Therapeutic product effective for unapproved indication 25.98 19.19 6 18177 96 63470743
Therapeutic product ineffective for unapproved indication 25.85 19.19 7 18176 219 63470620
Balance disorder 25.52 19.19 67 18116 84355 63386484
Hyponatraemia 25.30 19.19 80 18103 111820 63359019
Congenital tracheomalacia 25.28 19.19 5 18178 36 63470803
Alopecia 25.21 19.19 36 18147 337500 63133339
Speech disorder 24.87 19.19 43 18140 40586 63430253
Drug hypersensitivity 24.34 19.19 32 18151 310655 63160184
Stillbirth 24.10 19.19 18 18165 6732 63464107
Agitation 24.06 19.19 53 18130 59704 63411135
Cerebral atrophy 23.86 19.19 16 18167 5050 63465789
Bruxism 23.83 19.19 14 18169 3511 63467328
Encephalitis 23.80 19.19 20 18163 8860 63461979
Anticonvulsant drug level decreased 23.64 19.19 10 18173 1242 63469597
Abdominal pain upper 23.60 19.19 15 18168 206429 63264410
Dysmorphism 23.51 19.19 12 18171 2284 63468555
Fatigue 23.35 19.19 154 18029 887874 62582965
Polychromasia 23.30 19.19 6 18177 154 63470685
Chest pain 22.95 19.19 17 18166 215942 63254897
Hypopnoea 22.84 19.19 14 18169 3792 63467047
Ammonia increased 22.64 19.19 15 18168 4641 63466198
Premature delivery 22.52 19.19 35 18148 30246 63440593
Foetal growth restriction 22.31 19.19 18 18165 7535 63463304
Neurosurgery 22.14 19.19 5 18178 72 63470767
Shock 21.62 19.19 30 18153 23433 63447406
Aphasia 21.62 19.19 36 18147 32964 63437875
Intellectual disability 21.60 19.19 9 18174 1077 63469762
Suicidal ideation 21.43 19.19 52 18131 62369 63408470
Acute pulmonary oedema 21.10 19.19 18 18165 8140 63462699
Affective disorder 21.08 19.19 16 18167 6130 63464709
Eye movement disorder 21.07 19.19 15 18168 5213 63465626
Glioblastoma multiforme 20.63 19.19 8 18175 795 63470044
Parainfluenzae virus infection 20.51 19.19 11 18172 2316 63468523
Altered state of consciousness 19.95 19.19 30 18153 25200 63445639
Back pain 19.88 19.19 28 18155 264117 63206722
Rash maculo-papular 19.84 19.19 34 18149 31862 63438977
Hypertension 19.67 19.19 31 18152 279272 63191567
Intentional overdose 19.57 19.19 56 18127 74096 63396743
Right ventricular dilatation 19.55 19.19 9 18174 1367 63469472
Microcephaly 19.40 19.19 8 18175 932 63469907
Electrocardiogram QRS complex prolonged 19.36 19.19 15 18168 5923 63464916
Hyperthermia 19.30 19.19 18 18165 9138 63461701
Obsessive thoughts 19.23 19.19 7 18176 584 63470255

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 1185.74 19.29 700 16595 104157 34835479
Status epilepticus 574.90 19.29 221 17074 12393 34927243
Multiple-drug resistance 366.40 19.29 126 17169 5113 34934523
Somnolence 335.01 19.29 339 16956 110777 34828859
Drug ineffective 310.27 19.29 688 16607 456063 34483573
Drug withdrawal convulsions 280.41 19.29 73 17222 1104 34938532
Epilepsy 263.50 19.29 152 17143 21343 34918293
Generalised tonic-clonic seizure 257.61 19.29 149 17146 21025 34918611
Aggression 196.33 19.29 159 17136 38805 34900831
Petit mal epilepsy 191.98 19.29 68 17227 3010 34936626
Partial seizures 143.23 19.29 62 17233 4698 34934938
Foetal exposure during pregnancy 134.46 19.29 127 17168 37974 34901662
Abnormal behaviour 132.31 19.29 105 17190 24864 34914772
Respiratory depression 130.83 19.29 88 17207 16157 34923479
Drug resistance 122.54 19.29 102 17193 25825 34913811
Sudden unexplained death in epilepsy 120.42 19.29 31 17264 447 34939189
Atonic seizures 111.01 19.29 26 17269 246 34939390
Victim of child abuse 104.34 19.29 32 17263 895 34938741
Tonic convulsion 104.22 19.29 34 17261 1167 34938469
Drug dependence 103.64 19.29 90 17205 24127 34915509
Developmental delay 103.09 19.29 42 17253 2733 34936903
Ataxia 101.96 19.29 71 17224 13782 34925854
Sedation 97.92 19.29 82 17213 20924 34918712
Drug reaction with eosinophilia and systemic symptoms 97.74 19.29 100 17195 32912 34906724
Anticonvulsant drug level above therapeutic 91.68 19.29 27 17268 655 34938981
Myoclonic epilepsy 89.37 19.29 30 17265 1127 34938509
Encephalopathy 88.64 19.29 98 17197 35221 34904415
Hypotonia 84.26 19.29 51 17244 7802 34931834
Focal dyscognitive seizures 84.17 19.29 30 17265 1351 34938285
Epidural lipomatosis 84.08 19.29 28 17267 1026 34938610
Anticonvulsant drug level increased 83.22 19.29 31 17264 1585 34938051
Behaviour disorder 83.04 19.29 43 17252 4867 34934769
Cognitive disorder 81.47 19.29 85 17210 28608 34911028
Psychogenic seizure 78.90 19.29 21 17274 347 34939289
Product use issue 78.33 19.29 124 17171 63092 34876544
Fanconi syndrome 77.75 19.29 30 17265 1690 34937946
Dyspnoea 76.62 19.29 46 17249 376736 34562900
Intellectual disability 73.81 19.29 27 17268 1311 34938325
Hyperammonaemic encephalopathy 72.30 19.29 31 17264 2293 34937343
Gaze palsy 70.82 19.29 28 17267 1684 34937952
Excessive eye blinking 70.22 19.29 21 17274 538 34939098
Product prescribing error 68.83 19.29 70 17225 22857 34916779
Brain scan abnormal 68.69 19.29 23 17272 857 34938779
Juvenile idiopathic arthritis 68.04 19.29 28 17267 1869 34937767
Cerebral artery thrombosis 67.35 19.29 22 17273 758 34938878
Hamartoma 67.00 19.29 13 17282 43 34939593
Child abuse 66.71 19.29 19 17276 408 34939228
Dysmorphism 66.23 19.29 32 17263 3124 34936512
Postictal psychosis 65.09 19.29 16 17279 189 34939447
Nystagmus 64.88 19.29 36 17259 4679 34934957
Drug interaction 63.56 19.29 250 17045 225696 34713940
Hyperammonaemia 59.81 19.29 38 17257 6329 34933307
Autism spectrum disorder 59.70 19.29 27 17268 2269 34937367
Sedation complication 59.59 19.29 25 17270 1752 34937884
Motor developmental delay 58.32 19.29 19 17276 649 34938987
Language disorder 56.99 19.29 26 17269 2230 34937406
Hypospadias 56.92 19.29 29 17266 3172 34936464
Psychomotor hyperactivity 56.44 19.29 43 17252 9579 34930057
Disturbance in attention 50.13 19.29 63 17232 25882 34913754
Areflexia 49.69 19.29 26 17269 3005 34936631
Depressed level of consciousness 48.89 19.29 81 17214 42760 34896876
Psychomotor retardation 47.85 19.29 27 17268 3623 34936013
Salivary hypersecretion 47.14 19.29 37 17258 8607 34931029
Irritability 46.19 19.29 59 17236 24631 34915005
Cerebellar atrophy 45.32 19.29 15 17280 539 34939097
Death 45.27 19.29 80 17215 397969 34541667
Chest pain 45.17 19.29 5 17290 126757 34812879
Pneumonia aspiration 44.86 19.29 77 17218 41826 34897810
Psychomotor skills impaired 43.53 19.29 26 17269 3880 34935756
Anaemia 41.32 19.29 33 17262 233302 34706334
Foetal anticonvulsant syndrome 40.81 19.29 17 17278 1170 34938466
Developmental regression 39.65 19.29 8 17287 34 34939602
Partial seizures with secondary generalisation 39.52 19.29 12 17283 324 34939312
Speech disorder developmental 39.32 19.29 20 17275 2180 34937456
Seizure cluster 39.31 19.29 10 17285 137 34939499
Posture abnormal 38.99 19.29 20 17275 2219 34937417
Learning disorder 38.77 19.29 16 17279 1075 34938561
Hypoventilation 38.76 19.29 23 17272 3391 34936245
Diarrhoea 38.59 19.29 85 17210 389827 34549809
Arthralgia 38.50 19.29 18 17277 170023 34769613
Myocardial infarction 37.96 19.29 7 17288 121078 34818558
Hypertelorism 36.82 19.29 13 17282 569 34939067
Atrial septal defect 36.81 19.29 30 17265 7362 34932274
Drop attacks 36.80 19.29 13 17282 570 34939066
Agitation 36.68 19.29 85 17210 57314 34882322
Nausea 36.22 19.29 71 17224 339837 34599799
Respiratory distress 36.17 19.29 64 17231 35601 34904035
Pain 36.15 19.29 29 17266 204646 34734990
Condition aggravated 35.49 19.29 188 17107 192008 34747628
Ehlers-Danlos syndrome 33.76 19.29 7 17288 35 34939601
Benzodiazepine drug level decreased 33.76 19.29 7 17288 35 34939601
Akinesia 33.72 19.29 18 17277 2166 34937470
Febrile neutropenia 33.34 19.29 13 17282 136836 34802800
Neonatal respiratory depression 32.74 19.29 11 17284 414 34939222
Acidosis hyperchloraemic 32.30 19.29 11 17284 432 34939204
Haemoglobin decreased 31.95 19.29 10 17285 120762 34818874
Circadian rhythm sleep disorder 31.91 19.29 11 17284 448 34939188
Product administered to patient of inappropriate age 31.80 19.29 20 17275 3271 34936365
Acute kidney injury 31.37 19.29 65 17230 304923 34634713
Infantile spasms 31.26 19.29 9 17286 201 34939435
Extrapyramidal disorder 31.01 19.29 35 17260 12845 34926791
Stevens-Johnson syndrome 30.93 19.29 42 17253 18597 34921039
Hepatocellular injury 30.89 19.29 46 17249 22165 34917471
Product substitution issue 30.61 19.29 31 17264 10064 34929572
Off label use 30.54 19.29 329 16966 419195 34520441
Intensive care unit acquired weakness 29.66 19.29 13 17282 1014 34938622
Hypotonia neonatal 29.32 19.29 14 17281 1331 34938305
Cardiac failure 29.19 19.29 5 17290 91243 34848393
Haemophagocytic lymphohistiocytosis 29.13 19.29 34 17261 12939 34926697
Back pain 28.96 19.29 12 17283 121777 34817859
Electroencephalogram abnormal 28.93 19.29 17 17278 2461 34937175
Psychotic disorder 28.92 19.29 47 17248 24405 34915231
Change in seizure presentation 28.81 19.29 8 17287 156 34939480
Retrognathia 28.55 19.29 9 17286 276 34939360
Drug level increased 28.23 19.29 44 17251 22052 34917584
Oedema peripheral 28.17 19.29 12 17283 119800 34819836
Therapeutic product effect incomplete 28.16 19.29 71 17224 50470 34889166
Atrial fibrillation 27.62 19.29 13 17282 122380 34817256
Dysgraphia 27.52 19.29 16 17279 2271 34937365
Intentional product misuse 27.45 19.29 66 17229 45545 34894091
Renal tubular acidosis 27.32 19.29 16 17279 2303 34937333
Hyperchloraemia 27.13 19.29 10 17285 496 34939140
Maternal exposure during pregnancy 26.71 19.29 21 17274 4897 34934739
Anger 26.44 19.29 31 17264 11853 34927783
Pain in extremity 26.23 19.29 15 17280 126498 34813138
Metabolic acidosis 26.07 19.29 63 17232 43617 34896019
Blood pressure increased 25.73 19.29 6 17289 88096 34851540
Hypothermia 25.53 19.29 29 17266 10719 34928917
Irregular sleep phase 25.23 19.29 6 17289 61 34939575
Pruritus 25.19 19.29 20 17275 141961 34797675
Screaming 25.10 19.29 13 17282 1471 34938165
Memory impairment 24.28 19.29 61 17234 43257 34896379
Sepsis 24.27 19.29 28 17267 166533 34773103
Hypernatraemia 23.81 19.29 25 17270 8465 34931171
Sexually inappropriate behaviour 23.39 19.29 9 17286 503 34939133
Pleural effusion 22.95 19.29 6 17289 81540 34858096
Developmental coordination disorder 22.88 19.29 7 17288 194 34939442
Bronchiolitis 22.71 19.29 16 17279 3160 34936476
Educational problem 22.58 19.29 9 17286 553 34939083
Dyskinesia 22.43 19.29 40 17255 22373 34917263
Cholestasis 21.90 19.29 44 17251 26904 34912732
Drooling 21.80 19.29 16 17279 3366 34936270
Cerebellar syndrome 21.80 19.29 14 17281 2374 34937262
Cerebral atrophy 21.67 19.29 18 17277 4534 34935102
Ear infection 21.62 19.29 26 17269 10205 34929431
Logorrhoea 21.60 19.29 14 17281 2412 34937224
Myoclonus 21.19 19.29 31 17264 14694 34924942
Clinodactyly 21.19 19.29 7 17288 250 34939386
Body dysmorphic disorder 20.97 19.29 6 17289 131 34939505
Fine motor delay 20.90 19.29 7 17288 261 34939375
Asthenia 20.64 19.29 58 17237 245193 34694443
Low set ears 20.56 19.29 8 17287 461 34939175
Dystonia 20.41 19.29 26 17269 10819 34928817
Hemiplegia 20.39 19.29 21 17274 6951 34932685
Abdominal pain 20.27 19.29 31 17264 163587 34776049
White blood cell count decreased 20.23 19.29 11 17284 95434 34844202
Cough 20.02 19.29 27 17268 150113 34789523
Aphasia 19.84 19.29 37 17258 21417 34918219
Obesity 19.84 19.29 28 17267 12850 34926786
Reaction to excipient 19.83 19.29 8 17287 507 34939129
Joint swelling 19.78 19.29 3 17292 59887 34879749

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 1676.29 17.43 962 27523 187872 79528031
Status epilepticus 999.90 17.43 365 28120 24676 79691227
Multiple-drug resistance 787.06 17.43 236 28249 8572 79707331
Epilepsy 644.27 17.43 307 28178 40553 79675350
Somnolence 528.46 17.43 531 27954 238450 79477453
Drug withdrawal convulsions 503.54 17.43 124 28361 2096 79713807
Psychogenic seizure 418.52 17.43 104 28381 1827 79714076
Drug ineffective 401.66 17.43 1057 27428 1079856 78636047
Generalised tonic-clonic seizure 385.39 17.43 223 28262 43687 79672216
Partial seizures 343.69 17.43 127 28358 8851 79707052
Drug resistance 309.57 17.43 191 28294 42022 79673881
Drug interaction 290.77 17.43 526 27959 414657 79301246
Petit mal epilepsy 275.67 17.43 96 28389 5631 79710272
Aggression 260.35 17.43 184 28301 50774 79665129
Drug reaction with eosinophilia and systemic symptoms 220.35 17.43 183 28302 64061 79651842
Ataxia 177.69 17.43 111 28374 24928 79690975
Drug dependence 169.38 17.43 130 28355 40639 79675264
Fanconi syndrome 153.49 17.43 52 28433 2804 79713099
Abnormal behaviour 153.19 17.43 117 28368 36304 79679599
Tonic convulsion 141.62 17.43 46 28439 2174 79713729
Hyperammonaemia 140.83 17.43 72 28413 11021 79704882
Anticonvulsant drug level increased 137.47 17.43 47 28438 2606 79713297
Sudden unexplained death in epilepsy 134.87 17.43 34 28451 634 79715269
Respiratory depression 132.39 17.43 96 28389 27534 79688369
Paradoxical drug reaction 122.35 17.43 57 28428 7128 79708775
Focal dyscognitive seizures 117.39 17.43 45 28440 3467 79712436
Victim of child abuse 113.74 17.43 32 28453 921 79714982
Encephalopathy 111.82 17.43 129 28356 67268 79648635
Irritability 106.58 17.43 100 28385 41044 79674859
Propofol infusion syndrome 106.15 17.43 36 28449 1947 79713956
Atonic seizures 106.12 17.43 29 28456 748 79715155
Dyspnoea 104.34 17.43 92 28393 856933 78858970
Pain 103.24 17.43 62 28423 703740 79012163
Anticonvulsant drug level above therapeutic 102.91 17.43 31 28454 1140 79714763
Arthralgia 102.83 17.43 38 28447 571765 79144138
Mitochondrial DNA mutation 102.30 17.43 25 28460 408 79715495
Hyperammonaemic encephalopathy 100.69 17.43 44 28441 4738 79711165
Psychomotor skills impaired 96.85 17.43 44 28441 5193 79710710
Cognitive disorder 95.05 17.43 121 28364 69805 79646098
Epidural lipomatosis 88.83 17.43 28 28457 1200 79714703
Off label use 83.44 17.43 581 27904 906634 78809269
Nystagmus 83.36 17.43 49 28436 9855 79706048
Depressed level of consciousness 81.07 17.43 133 28352 96519 79619384
Developmental delay 80.52 17.43 26 28459 1205 79714698
Pneumonia aspiration 80.36 17.43 109 28376 66858 79649045
Myoclonic epilepsy 79.56 17.43 29 28456 1941 79713962
Disturbance in attention 78.86 17.43 94 28391 50707 79665196
Postictal psychosis 78.56 17.43 17 28468 156 79715747
Behaviour disorder 77.31 17.43 40 28445 6273 79709630
Product substitution issue 76.33 17.43 61 28424 20195 79695708
Psychotic disorder 75.04 17.43 83 28402 41319 79674584
Child abuse 72.74 17.43 19 28466 410 79715493
Intentional product misuse 71.91 17.43 125 28360 95040 79620863
Gaze palsy 71.00 17.43 30 28455 2975 79712928
Seizure cluster 69.11 17.43 18 28467 384 79715519
Nausea 68.98 17.43 150 28335 957046 78758857
Hepatocellular injury 68.88 17.43 85 28400 47508 79668395
Joint swelling 67.64 17.43 11 28474 288635 79427268
Excessive eye blinking 64.85 17.43 24 28461 1677 79714226
Brain scan abnormal 64.67 17.43 22 28463 1201 79714702
Hypotonia 64.57 17.43 46 28439 12824 79703079
Stevens-Johnson syndrome 63.32 17.43 74 28411 39092 79676811
Drug level increased 62.58 17.43 74 28411 39577 79676326
Product use issue 61.92 17.43 190 28295 209632 79506271
Coma 60.71 17.43 120 28365 100529 79615374
Intellectual disability 59.20 17.43 21 28464 1299 79714604
Rheumatoid arthritis 58.86 17.43 4 28481 208466 79507437
CSF oligoclonal band present 58.83 17.43 16 28469 405 79715498
Cerebral artery thrombosis 58.80 17.43 20 28465 1091 79714812
Diarrhoea 57.75 17.43 145 28340 880344 78835559
Electroencephalogram abnormal 56.85 17.43 31 28454 5403 79710500
Cholestasis 56.80 17.43 81 28404 52028 79663875
Change in seizure presentation 55.43 17.43 16 28469 506 79715397
Juvenile idiopathic arthritis 54.96 17.43 29 28456 4734 79711169
Gene mutation 54.24 17.43 24 28461 2662 79713241
Product prescribing error 53.84 17.43 73 28412 44740 79671163
Blood gases abnormal 53.79 17.43 19 28466 1161 79714742
Abdominal discomfort 53.55 17.43 12 28473 250715 79465188
Temporal lobe epilepsy 53.34 17.43 15 28470 431 79715472
Coma blister 52.32 17.43 13 28472 228 79715675
Drug level decreased 51.36 17.43 42 28443 14360 79701543
Pain in extremity 50.72 17.43 34 28451 364504 79351399
Agitation 49.75 17.43 110 28375 99605 79616298
Infusion related reaction 49.20 17.43 11 28474 230226 79485677
Drug ineffective for unapproved indication 49.14 17.43 75 28410 51163 79664740
Angiofibroma 48.70 17.43 11 28474 125 79715778
Areflexia 48.21 17.43 28 28457 5506 79710397
Product administered to patient of inappropriate age 48.12 17.43 28 28457 5525 79710378
Peripheral swelling 46.57 17.43 19 28466 269598 79446305
Lymphangioleiomyomatosis 46.06 17.43 11 28474 162 79715741
Cerebellar syndrome 45.82 17.43 27 28458 5453 79710450
Salivary hypersecretion 45.59 17.43 39 28446 14185 79701718
Myocardial infarction 45.47 17.43 6 28479 184123 79531780
Chest pain 45.46 17.43 22 28463 282282 79433621
Gingival hypertrophy 44.59 17.43 22 28463 3120 79712783
Metabolic acidosis 44.56 17.43 94 28391 82435 79633468
Hypoventilation 43.75 17.43 29 28456 7195 79708708
Pleocytosis 43.00 17.43 17 28468 1422 79714481
Cerebellar atrophy 42.86 17.43 16 28469 1145 79714758
Macroglossia 42.60 17.43 16 28469 1165 79714738
Aura 42.30 17.43 15 28470 927 79714976
Febrile neutropenia 42.02 17.43 15 28470 230984 79484919
Hypothermia 41.90 17.43 46 28439 22700 79693203
Foetal exposure during pregnancy 41.90 17.43 26 28459 5764 79710139
Contraindicated product administered 41.75 17.43 4 28481 157534 79558369
Blood lactic acid increased 40.96 17.43 35 28450 12709 79703194
Cerebral atrophy 40.83 17.43 29 28456 8046 79707857
Infantile spasms 40.50 17.43 11 28474 277 79715626
Oropharyngeal oedema 40.02 17.43 12 28473 434 79715469
Partial seizures with secondary generalisation 39.74 17.43 13 28472 628 79715275
Epilepsy with myoclonic-atonic seizures 39.47 17.43 9 28476 107 79715796
Angiomyolipoma 39.39 17.43 10 28475 192 79715711
Myoclonus 39.37 17.43 49 28436 27611 79688292
Cough 39.14 17.43 44 28441 366745 79349158
Anticonvulsant drug level decreased 38.15 17.43 17 28468 1917 79713986
Suicidal behaviour 38.12 17.43 20 28465 3227 79712676
Systolic dysfunction 37.91 17.43 21 28464 3774 79712129
Ammonia increased 37.64 17.43 27 28458 7608 79708295
Anger 37.47 17.43 38 28447 17124 79698779
Intentional overdose 37.04 17.43 102 28383 105858 79610045
Learning disorder 36.94 17.43 12 28473 567 79715336
Sedation complication 36.62 17.43 36 28449 15633 79700270
Malaise 36.62 17.43 75 28410 489794 79226109
Hypersomnia 36.28 17.43 43 28442 23043 79692860
Benzodiazepine drug level decreased 36.03 17.43 7 28478 35 79715868
Developmental regression 35.40 17.43 7 28478 39 79715864
Anaemia 35.10 17.43 66 28419 444949 79270954
Aphasia 34.78 17.43 61 28424 46671 79669232
Dystonia 33.86 17.43 40 28445 21359 79694544
Abdominal pain upper 33.71 17.43 19 28466 223800 79492103
Condition aggravated 33.66 17.43 299 28186 500825 79215078
Suicidal ideation 33.42 17.43 80 28405 76260 79639643
Sinusitis 33.39 17.43 14 28471 195487 79520416
Swelling 33.22 17.43 18 28467 216693 79499210
Language disorder 32.70 17.43 18 28467 3196 79712707
Acidosis hyperchloraemic 32.54 17.43 12 28473 830 79715073
Overdose 32.36 17.43 141 28344 184065 79531838
Altered state of consciousness 32.35 17.43 57 28428 43765 79672138
Posture abnormal 32.20 17.43 19 28466 3847 79712056
Depressed mood 31.91 17.43 60 28425 48420 79667483
Screaming 31.90 17.43 19 28466 3914 79711989
Back pain 31.89 17.43 37 28448 304143 79411760
Blood pressure increased 31.75 17.43 18 28467 211342 79504561
Haemophagocytic lymphohistiocytosis 31.58 17.43 39 28446 21798 79694105
Glioblastoma multiforme 31.50 17.43 13 28472 1215 79714688
Apnoea 31.36 17.43 29 28456 11675 79704228
Bronchiolitis 30.79 17.43 19 28466 4169 79711734
Cholestasis of pregnancy 30.61 17.43 12 28473 981 79714922
Neurosurgery 30.27 17.43 7 28478 89 79715814
Blood glucose increased 30.25 17.43 3 28482 114972 79600931
Lethargy 30.16 17.43 80 28405 81212 79634691
Retinogram abnormal 29.54 17.43 9 28476 344 79715559
Headache 29.37 17.43 127 28358 653645 79062258
Drooling 29.29 17.43 21 28464 5913 79709990
Dysmorphism 28.96 17.43 10 28475 571 79715332
Respiratory distress 28.68 17.43 64 28421 58275 79657628
Blood creatine phosphokinase increased 28.65 17.43 69 28416 66021 79649882
Toxicity to various agents 28.53 17.43 252 28233 421288 79294615
Benzodiazepine drug level increased 28.51 17.43 8 28477 228 79715675
Wound 28.17 17.43 4 28481 116175 79599728
Brown tumour 27.93 17.43 6 28479 53 79715850
Balance disorder 27.72 17.43 88 28397 98769 79617134
Brain operation 27.64 17.43 10 28475 655 79715248
Epileptic psychosis 27.54 17.43 6 28479 57 79715846
Psychomotor hyperactivity 27.50 17.43 32 28453 16817 79699086
Ehlers-Danlos syndrome 27.16 17.43 7 28478 143 79715760
Abdominal pain 27.14 17.43 62 28423 389507 79326396
Circadian rhythm sleep disorder 27.11 17.43 10 28475 692 79715211
Sedation 26.72 17.43 58 28427 51837 79664066
Drop attacks 26.49 17.43 11 28474 1044 79714859
Loss of personal independence in daily activities 26.15 17.43 3 28482 102577 79613326
Intensive care unit acquired weakness 25.85 17.43 13 28472 1920 79713983
Hyperchloraemia 25.85 17.43 11 28474 1110 79714793
Fatigue 25.66 17.43 211 28274 929516 78786387
Renal tubular acidosis 25.57 17.43 16 28469 3598 79712305
Diplopia 25.31 17.43 44 28441 33422 79682481
Hypertension 25.28 17.43 50 28435 330942 79384961
Therapeutic product ineffective for unapproved indication 25.13 17.43 7 28478 194 79715709
Herpangina 25.11 17.43 5 28480 29 79715874
Unmasking of previously unidentified disease 25.09 17.43 13 28472 2044 79713859
Chest discomfort 25.03 17.43 9 28476 138035 79577868
Cardiac failure 25.01 17.43 12 28473 154830 79561073
Myalgia 24.88 17.43 18 28467 185623 79530280
Therapeutic product effect decreased 24.54 17.43 14 28471 163849 79552054
Gait disturbance 24.52 17.43 142 28343 207364 79508539
Hypernatraemia 24.52 17.43 28 28457 14423 79701480
Alopecia 24.39 17.43 28 28457 231327 79484576
Motor developmental delay 23.99 17.43 7 28478 230 79715673
Memory impairment 23.96 17.43 91 28394 111643 79604260
Electrocardiogram repolarisation abnormality 23.90 17.43 13 28472 2254 79713649
Therapeutic product effective for unapproved indication 23.89 17.43 6 28479 110 79715793
Metapneumovirus infection 23.87 17.43 12 28473 1772 79714131
Intentional self-injury 23.71 17.43 42 28443 32377 79683526
High-pitched crying 23.04 17.43 4 28481 9 79715894
Speech disorder 22.70 17.43 56 28429 54389 79661514
Rash maculo-papular 22.66 17.43 57 28428 56021 79659882
Drug hypersensitivity 22.10 17.43 46 28439 298870 79417033
Pruritus 22.06 17.43 70 28415 394578 79321325
Fanconi syndrome acquired 21.81 17.43 13 28472 2681 79713222
Arthritis 21.68 17.43 7 28478 114873 79601030
Gastrointestinal haemorrhage 21.58 17.43 13 28472 147706 79568197
Exposure during pregnancy 21.38 17.43 82 28403 101050 79614853
Paraesthesia 21.25 17.43 19 28466 176304 79539599
Hyperhidrosis 21.21 17.43 14 28471 151478 79564425
Hepatic cytolysis 20.93 17.43 36 28449 27115 79688788
Pleural effusion 20.92 17.43 13 28472 145249 79570654
Chills 20.87 17.43 16 28469 160218 79555685
Hallucination, auditory 20.84 17.43 31 28454 20662 79695241
Haematuria traumatic 20.75 17.43 6 28479 191 79715712
Dysarthria 20.62 17.43 62 28423 67560 79648343
Bradyphrenia 20.44 17.43 22 28463 10618 79705285
Systemic lupus erythematosus 20.16 17.43 9 28476 121140 79594763
Extrapyramidal disorder 20.07 17.43 32 28453 22647 79693256
Pregnancy 19.91 17.43 35 28450 26816 79689087
Psychomotor retardation 19.91 17.43 17 28468 6167 79709736
Mood altered 19.82 17.43 28 28457 17819 79698084
Acute kidney injury 19.75 17.43 107 28378 519297 79196606
Anticonvulsant drug level below therapeutic 19.73 17.43 9 28476 1072 79714831
Irregular sleep phase 19.69 17.43 5 28480 96 79715807
Hyperthermia 19.59 17.43 28 28457 18009 79697894
Interstitial lung disease 19.32 17.43 8 28477 112592 79603311
Hyponatraemia 19.27 17.43 119 28366 177729 79538174
Death 19.25 17.43 121 28364 566393 79149510
Haemoglobin decreased 19.25 17.43 31 28454 222088 79493815
Asterixis 19.19 17.43 12 28473 2695 79713208
Encephalitis 19.19 17.43 25 28460 14735 79701168
Autism spectrum disorder 19.18 17.43 9 28476 1143 79714760
Haematochezia 19.09 17.43 4 28481 87641 79628262
Suicide attempt 18.99 17.43 69 28416 82863 79633040
Infection 18.89 17.43 36 28449 241676 79474227
Atrial fibrillation 18.72 17.43 26 28459 197860 79518043
Pneumonia necrotising 18.64 17.43 9 28476 1218 79714685
Renal failure 18.42 17.43 27 28458 200941 79514962
Sexually inappropriate behaviour 18.27 17.43 7 28478 538 79715365
Sopor 18.27 17.43 38 28447 32972 79682931
Hypertelorism 18.01 17.43 5 28480 137 79715766
Rash morbilliform 17.97 17.43 16 28469 6134 79709769
Rectal haemorrhage 17.65 17.43 3 28482 76297 79639606
Thrombocytopenia 17.61 17.43 158 28327 265101 79450802
Right ventricular dilatation 17.46 17.43 10 28475 1916 79713987

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 27.56 27.02 10 257 72 89453

Pharmacologic Action:

SourceCodeDescription
ATC N05BA09 NERVOUS SYSTEM
PSYCHOLEPTICS
ANXIOLYTICS
Benzodiazepine derivatives
FDA CS M0002356 Benzodiazepines
MeSH PA D014151 Anti-Anxiety Agents
MeSH PA D000927 Anticonvulsants
MeSH PA D002491 Central Nervous System Agents
MeSH PA D002492 Central Nervous System Depressants
MeSH PA D018682 GABA Agents
MeSH PA D018755 GABA Agonists
MeSH PA D058785 GABA-A Receptor Agonists
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D011619 Psychotropic Drugs
MeSH PA D014149 Tranquilizing Agents
FDA EPC N0000175694 Benzodiazepine
FDA MoA N0000182137 Cytochrome P450 2D6 Inhibitors
FDA MoA N0000185506 Cytochrome P450 3A4 Inducers
CHEBI has role CHEBI:35474 anti-anxiety agents
CHEBI has role CHEBI:35623 anticonvulsants
CHEBI has role CHEBI:50268 GABA modulators

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 OTTER PHARMS N210833 Nov. 1, 2018 RX FILM ORAL 11541002 Jan. 31, 2040 METHOD OF TREATING SEIZURES
20MG SYMPAZAN OTTER PHARMS N210833 Nov. 1, 2018 RX FILM ORAL 11541002 Jan. 31, 2040 METHOD OF TREATING SEIZURES
5MG SYMPAZAN OTTER PHARMS 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
4025788 VANDF
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

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Clobazam HUMAN PRESCRIPTION DRUG LABEL 1 0054-0526 TABLET 10 mg ORAL ANDA 31 sections
Clobazam HUMAN PRESCRIPTION DRUG LABEL 1 0054-0527 TABLET 20 mg ORAL ANDA 31 sections
clobazam HUMAN PRESCRIPTION DRUG LABEL 1 0054-0561 SOLUTION 2.50 mg ORAL ANDA 32 sections
clobazam HUMAN PRESCRIPTION DRUG LABEL 1 0054-0561 SOLUTION 2.50 mg ORAL ANDA 32 sections
Clobazam HUMAN PRESCRIPTION DRUG LABEL 1 0378-8043 SUSPENSION 2.50 mg ORAL ANDA 35 sections
Clobazam HUMAN PRESCRIPTION DRUG LABEL 1 0378-8043 SUSPENSION 2.50 mg ORAL ANDA 35 sections
Clobazam HUMAN PRESCRIPTION DRUG LABEL 1 0527-1681 TABLET 10 mg ORAL ANDA 32 sections
Clobazam HUMAN PRESCRIPTION DRUG LABEL 1 0527-1682 TABLET 20 mg ORAL ANDA 32 sections
Clobazam HUMAN PRESCRIPTION DRUG LABEL 1 0527-5301 SUSPENSION 2.50 mg ORAL ANDA 33 sections
Clobazam HUMAN PRESCRIPTION DRUG LABEL 1 0527-5301 SUSPENSION 2.50 mg ORAL ANDA 33 sections
Clobazam Human Prescription Drug Label 1 0781-8013 TABLET 10 mg ORAL ANDA 32 sections
Clobazam Human Prescription Drug Label 1 0781-8014 TABLET 20 mg ORAL ANDA 32 sections
Clobazam HUMAN PRESCRIPTION DRUG LABEL 1 0832-0580 TABLET 10 mg ORAL ANDA 39 sections
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
Clobazam HUMAN PRESCRIPTION DRUG LABEL 1 0832-0581 TABLET 20 mg ORAL ANDA 39 sections
Clobazam HUMAN PRESCRIPTION DRUG LABEL 1 0832-0585 SUSPENSION 2.50 mg ORAL ANDA 40 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 16714-087 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 16714-887 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 16714-888 TABLET 20 mg ORAL ANDA 32 sections
CLOBAZAM HUMAN PRESCRIPTION DRUG LABEL 1 16729-445 TABLET 10 mg ORAL ANDA 33 sections