clobazam 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| diazepam derivatives | 682 | 22316-47-8 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
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.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 20 | mg | O |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| 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:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Oct. 21, 2011 | FDA | LUNDBECK LLC |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients 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 |
| Developmental regression | 26.52 | 19.19 | 5 | 18178 | 27 | 63470812 |
| High-pitched crying | 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 term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients 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 term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients 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 term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Weight gain poor | 27.56 | 27.02 | 10 | 257 | 72 | 89453 |
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| 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|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Lennox-Gastaut syndrome | indication | 230418006 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 8.14 | acidic |
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent 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:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| GABA-A receptor alpha-1/beta-2/gamma-2 | Ion channel | POSITIVE ALLOSTERIC MODULATOR | WOMBAT-PK | CHEMBL |
External reference:
| ID | Source |
|---|---|
| 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:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| 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 |