zonisamide 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| 2872 | 68291-97-4 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
an antiseizure drug chemically classified as a sulfonamide and unrelated to other antiseizure agents, blocks sodium channels and reduces voltage-dependent, transient inward currents (T-type Ca2+ currents), consequently stabilizing neuronal membranes and suppressing neuronal hypersynchronization
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 0.20 | g | O |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 1 | Benet LZ, Broccatelli F, Oprea TI |
| S (Water solubility) | 0.80 mg/mL | Benet LZ, Broccatelli F, Oprea TI |
| EoM (Fraction excreted unchanged in urine) | 22 % | Benet LZ, Broccatelli F, Oprea TI |
| MRTD (Maximum Recommended Therapeutic Daily Dose) | 40.39 µM/kg/day | Contrera JF, Matthews EJ, Kruhlak NL, Benz RD |
| BA (Bioavailability) | 99 % | Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| March 27, 2000 | FDA | EISAI INC | |
| March 10, 2005 | EMA | ||
| Dec. 4, 2008 | PMDA | Dainippon Sumitomo Pharma Co., Ltd. |
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 | 750.14 | 14.60 | 419 | 11571 | 117455 | 50475679 |
| Multiple-drug resistance | 192.45 | 14.60 | 58 | 11932 | 3256 | 50589878 |
| Drug reaction with eosinophilia and systemic symptoms | 155.58 | 14.60 | 92 | 11898 | 28332 | 50564802 |
| Epilepsy | 142.66 | 14.60 | 79 | 11911 | 21488 | 50571646 |
| Status epilepticus | 125.55 | 14.60 | 62 | 11928 | 13344 | 50579790 |
| Generalised tonic-clonic seizure | 123.01 | 14.60 | 77 | 11913 | 26233 | 50566901 |
| Atonic seizures | 119.55 | 14.60 | 28 | 11962 | 584 | 50592550 |
| Stevens-Johnson syndrome | 82.86 | 14.60 | 56 | 11934 | 21696 | 50571438 |
| Irritability | 73.73 | 14.60 | 58 | 11932 | 28368 | 50564766 |
| Focal dyscognitive seizures | 70.69 | 14.60 | 26 | 11964 | 2706 | 50590428 |
| Aggression | 70.19 | 14.60 | 50 | 11940 | 21066 | 50572068 |
| Cognitive disorder | 68.05 | 14.60 | 67 | 11923 | 44056 | 50549078 |
| Product substitution issue | 65.32 | 14.60 | 41 | 11949 | 14016 | 50579118 |
| Drug eruption | 65.20 | 14.60 | 50 | 11940 | 23556 | 50569578 |
| Psychotic disorder | 62.00 | 14.60 | 47 | 11943 | 21765 | 50571369 |
| Ataxia | 61.04 | 14.60 | 39 | 11951 | 13747 | 50579387 |
| Suicidal behaviour | 59.61 | 14.60 | 22 | 11968 | 2312 | 50590822 |
| Drug ineffective | 58.27 | 14.60 | 361 | 11629 | 818972 | 49774162 |
| Somnolence | 57.92 | 14.60 | 119 | 11871 | 154866 | 50438268 |
| Partial seizures | 56.20 | 14.60 | 26 | 11964 | 4839 | 50588295 |
| Petit mal epilepsy | 55.65 | 14.60 | 23 | 11967 | 3266 | 50589868 |
| Drug withdrawal convulsions | 54.84 | 14.60 | 18 | 11972 | 1335 | 50591799 |
| Choroidal effusion | 54.28 | 14.60 | 14 | 11976 | 440 | 50592694 |
| Dyskinesia | 53.90 | 14.60 | 48 | 11942 | 27813 | 50565321 |
| Therapeutic response unexpected | 53.61 | 14.60 | 38 | 11952 | 15877 | 50577257 |
| Vestibular migraine | 53.49 | 14.60 | 12 | 11978 | 205 | 50592929 |
| Hyperammonaemic encephalopathy | 44.35 | 14.60 | 17 | 11973 | 1982 | 50591152 |
| Infantile spasms | 42.99 | 14.60 | 10 | 11980 | 202 | 50592932 |
| Ovarian granulosa-theca cell tumour | 40.38 | 14.60 | 7 | 11983 | 27 | 50593107 |
| Depression | 38.84 | 14.60 | 106 | 11884 | 165317 | 50427817 |
| Drug interaction | 38.31 | 14.60 | 119 | 11871 | 199502 | 50393632 |
| Tonic convulsion | 37.65 | 14.60 | 13 | 11977 | 1126 | 50592008 |
| Drug resistance | 35.31 | 14.60 | 32 | 11958 | 18957 | 50574177 |
| Toxic epidermal necrolysis | 34.45 | 14.60 | 33 | 11957 | 20959 | 50572175 |
| Diplopia | 32.99 | 14.60 | 31 | 11959 | 19229 | 50573905 |
| Epileptic psychosis | 32.42 | 14.60 | 6 | 11984 | 36 | 50593098 |
| Abortion spontaneous | 31.59 | 14.60 | 44 | 11946 | 41728 | 50551406 |
| Brown tumour | 31.50 | 14.60 | 6 | 11984 | 43 | 50593091 |
| Oculomucocutaneous syndrome | 31.40 | 14.60 | 7 | 11983 | 116 | 50593018 |
| Joint swelling | 30.62 | 14.60 | 10 | 11980 | 245276 | 50347858 |
| Placental infarction | 30.27 | 14.60 | 8 | 11982 | 277 | 50592857 |
| Diarrhoea | 29.96 | 14.60 | 59 | 11931 | 588417 | 50004717 |
| Bipolar disorder | 29.62 | 14.60 | 19 | 11971 | 6738 | 50586396 |
| Dyspnoea | 29.54 | 14.60 | 53 | 11937 | 547555 | 50045579 |
| Migraine | 29.49 | 14.60 | 59 | 11931 | 75221 | 50517913 |
| Therapeutic response changed | 29.45 | 14.60 | 10 | 11980 | 823 | 50592311 |
| Intentional overdose | 29.45 | 14.60 | 53 | 11937 | 62451 | 50530683 |
| Hallucination, visual | 28.99 | 14.60 | 27 | 11963 | 16555 | 50576579 |
| Mood altered | 28.74 | 14.60 | 24 | 11966 | 12749 | 50580385 |
| Suicidal ideation | 28.73 | 14.60 | 49 | 11941 | 55336 | 50537798 |
| Calculus urinary | 28.19 | 14.60 | 10 | 11980 | 938 | 50592196 |
| Myoclonic epilepsy | 27.91 | 14.60 | 10 | 11980 | 965 | 50592169 |
| Therapeutic product effective for unapproved indication | 27.60 | 14.60 | 6 | 11984 | 88 | 50593046 |
| Rheumatoid arthritis | 27.59 | 14.60 | 7 | 11983 | 202543 | 50390591 |
| Lichen planus | 27.38 | 14.60 | 12 | 11978 | 1967 | 50591167 |
| Arthralgia | 26.89 | 14.60 | 39 | 11951 | 438663 | 50154471 |
| Depressed mood | 25.97 | 14.60 | 36 | 11954 | 33987 | 50559147 |
| Disturbance in attention | 25.32 | 14.60 | 34 | 11956 | 31152 | 50561982 |
| Suicide attempt | 24.54 | 14.60 | 44 | 11946 | 51688 | 50541446 |
| Anticonvulsant drug level increased | 24.51 | 14.60 | 10 | 11980 | 1374 | 50591760 |
| Encapsulating peritoneal sclerosis | 24.38 | 14.60 | 7 | 11983 | 331 | 50592803 |
| Hallucination, auditory | 23.81 | 14.60 | 20 | 11970 | 10708 | 50582426 |
| Systemic lupus erythematosus | 23.13 | 14.60 | 3 | 11987 | 140619 | 50452515 |
| Endometrial cancer | 23.08 | 14.60 | 12 | 11978 | 2871 | 50590263 |
| Exposure during pregnancy | 23.04 | 14.60 | 72 | 11918 | 120943 | 50472191 |
| Therapeutic product ineffective for unapproved indication | 22.75 | 14.60 | 6 | 11984 | 206 | 50592928 |
| Hepatic function abnormal | 22.61 | 14.60 | 33 | 11957 | 32648 | 50560486 |
| Arthropathy | 22.39 | 14.60 | 5 | 11985 | 157901 | 50435233 |
| Swelling | 22.05 | 14.60 | 10 | 11980 | 200862 | 50392272 |
| Delusion | 22.02 | 14.60 | 19 | 11971 | 10550 | 50582584 |
| Microcephaly | 21.98 | 14.60 | 8 | 11982 | 808 | 50592326 |
| Altered state of consciousness | 21.10 | 14.60 | 26 | 11964 | 21884 | 50571250 |
| Anger | 20.87 | 14.60 | 19 | 11971 | 11314 | 50581820 |
| Depressed level of consciousness | 20.68 | 14.60 | 41 | 11949 | 51912 | 50541222 |
| Myoclonus | 20.50 | 14.60 | 21 | 11969 | 14449 | 50578685 |
| Withdrawal syndrome | 20.47 | 14.60 | 23 | 11967 | 17567 | 50575567 |
| Hallucination | 20.01 | 14.60 | 38 | 11952 | 46619 | 50546515 |
| Retinogram abnormal | 19.94 | 14.60 | 5 | 11985 | 140 | 50592994 |
| Agitation | 19.90 | 14.60 | 41 | 11949 | 53343 | 50539791 |
| Upper respiratory tract inflammation | 19.29 | 14.60 | 10 | 11980 | 2379 | 50590755 |
| Coma | 19.25 | 14.60 | 42 | 11948 | 56837 | 50536297 |
| Anticonvulsant drug level decreased | 19.17 | 14.60 | 8 | 11982 | 1163 | 50591971 |
| Insomnia | 19.06 | 14.60 | 87 | 11903 | 174778 | 50418356 |
| Magnetic resonance imaging head abnormal | 18.99 | 14.60 | 9 | 11981 | 1768 | 50591366 |
| Restless legs syndrome | 18.87 | 14.60 | 21 | 11969 | 15876 | 50577258 |
| Dysmetria | 18.85 | 14.60 | 6 | 11984 | 403 | 50592731 |
| Drug level increased | 18.77 | 14.60 | 23 | 11967 | 19245 | 50573889 |
| Product complaint | 18.76 | 14.60 | 18 | 11972 | 11448 | 50581686 |
| Aphasia | 18.60 | 14.60 | 28 | 11962 | 28466 | 50564668 |
| Developmental delay | 18.40 | 14.60 | 8 | 11982 | 1286 | 50591848 |
| Abnormal behaviour | 18.40 | 14.60 | 23 | 11967 | 19635 | 50573499 |
| Sinus arrhythmia | 17.97 | 14.60 | 8 | 11982 | 1361 | 50591773 |
| Infusion related reaction | 17.75 | 14.60 | 9 | 11981 | 169548 | 50423586 |
| Placental disorder | 17.64 | 14.60 | 8 | 11982 | 1422 | 50591712 |
| Neuroleptic malignant syndrome | 17.33 | 14.60 | 17 | 11973 | 11113 | 50582021 |
| Myopia | 17.20 | 14.60 | 8 | 11982 | 1505 | 50591629 |
| Sudden unexplained death in epilepsy | 16.46 | 14.60 | 5 | 11985 | 288 | 50592846 |
| Pain | 16.45 | 14.60 | 76 | 11914 | 578827 | 50014307 |
| Human herpes virus 6 serology positive | 16.35 | 14.60 | 4 | 11986 | 101 | 50593033 |
| Ureterolithiasis | 16.34 | 14.60 | 8 | 11982 | 1687 | 50591447 |
| Hypothermia | 16.23 | 14.60 | 17 | 11973 | 11999 | 50581135 |
| Electrocardiogram PR prolongation | 16.02 | 14.60 | 6 | 11984 | 657 | 50592477 |
| Nystagmus | 15.83 | 14.60 | 12 | 11978 | 5549 | 50587585 |
| Encephalocele | 15.65 | 14.60 | 4 | 11986 | 121 | 50593013 |
| Pneumonia aspiration | 15.51 | 14.60 | 27 | 11963 | 30977 | 50562157 |
| Illiteracy | 15.46 | 14.60 | 3 | 11987 | 24 | 50593110 |
| Pregnancy | 15.11 | 14.60 | 26 | 11964 | 29551 | 50563583 |
| Developmental regression | 15.05 | 14.60 | 3 | 11987 | 28 | 50593106 |
| Angle closure glaucoma | 14.96 | 14.60 | 8 | 11982 | 2026 | 50591108 |
| High-pitched crying | 14.95 | 14.60 | 3 | 11987 | 29 | 50593105 |
| Renal hypoplasia | 14.86 | 14.60 | 3 | 11987 | 30 | 50593104 |
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 | 496.64 | 17.30 | 311 | 7810 | 92812 | 29473594 |
| Status epilepticus | 248.37 | 17.30 | 98 | 8023 | 10696 | 29555710 |
| Generalised tonic-clonic seizure | 119.37 | 17.30 | 71 | 8050 | 19068 | 29547338 |
| Multiple-drug resistance | 105.98 | 17.30 | 40 | 8081 | 3860 | 29562546 |
| Somnolence | 103.46 | 17.30 | 128 | 7993 | 93827 | 29472579 |
| Drug ineffective | 94.43 | 17.30 | 264 | 7857 | 362906 | 29203500 |
| Aggression | 90.02 | 17.30 | 76 | 8045 | 35465 | 29530941 |
| Partial seizures | 84.68 | 17.30 | 34 | 8087 | 3869 | 29562537 |
| Neonatal pneumonia | 63.23 | 17.30 | 13 | 8108 | 122 | 29566284 |
| Choroidal effusion | 61.60 | 17.30 | 13 | 8108 | 140 | 29566266 |
| Neonatal hypotension | 61.35 | 17.30 | 13 | 8108 | 143 | 29566263 |
| Stevens-Johnson syndrome | 60.66 | 17.30 | 44 | 8077 | 16453 | 29549953 |
| Postictal psychosis | 59.86 | 17.30 | 13 | 8108 | 162 | 29566244 |
| Nystagmus | 58.67 | 17.30 | 27 | 8094 | 4282 | 29562124 |
| Epilepsy | 58.49 | 17.30 | 45 | 8076 | 18387 | 29548019 |
| Ataxia | 57.99 | 17.30 | 38 | 8083 | 12065 | 29554341 |
| Focal dyscognitive seizures | 53.69 | 17.30 | 18 | 8103 | 1228 | 29565178 |
| Drug reaction with eosinophilia and systemic symptoms | 53.31 | 17.30 | 51 | 8070 | 27941 | 29538465 |
| Irritability | 49.24 | 17.30 | 44 | 8077 | 22108 | 29544298 |
| Psychotic disorder | 48.38 | 17.30 | 42 | 8079 | 20312 | 29546094 |
| Dyspnoea | 48.24 | 17.30 | 15 | 8106 | 326717 | 29239689 |
| Calculus urinary | 47.12 | 17.30 | 16 | 8105 | 1135 | 29565271 |
| Pneumonia aspiration | 46.80 | 17.30 | 54 | 8067 | 36683 | 29529723 |
| Vitamin D deficiency | 43.80 | 17.30 | 24 | 8097 | 5505 | 29560901 |
| Product substitution issue | 42.00 | 17.30 | 28 | 8093 | 9144 | 29557262 |
| Toxic epidermal necrolysis | 40.22 | 17.30 | 36 | 8085 | 18117 | 29548289 |
| Hyperammonaemic encephalopathy | 38.59 | 17.30 | 16 | 8105 | 1974 | 29564432 |
| Nephrolithiasis | 36.99 | 17.30 | 40 | 8081 | 25294 | 29541112 |
| Respiratory disorder neonatal | 36.49 | 17.30 | 14 | 8107 | 1411 | 29564995 |
| Salivary hypersecretion | 34.84 | 17.30 | 23 | 8098 | 7386 | 29559020 |
| Delusion | 32.58 | 17.30 | 26 | 8095 | 11190 | 29555216 |
| Drug withdrawal convulsions | 31.86 | 17.30 | 12 | 8109 | 1149 | 29565257 |
| Developmental delay | 31.86 | 17.30 | 15 | 8106 | 2503 | 29563903 |
| Abnormal behaviour | 31.14 | 17.30 | 35 | 8086 | 23092 | 29543314 |
| Petit mal epilepsy | 30.75 | 17.30 | 15 | 8106 | 2707 | 29563699 |
| Sudden unexplained death in epilepsy | 29.61 | 17.30 | 9 | 8112 | 447 | 29565959 |
| Encephalopathy | 28.89 | 17.30 | 39 | 8082 | 31004 | 29535402 |
| Myoclonus | 28.70 | 17.30 | 26 | 8095 | 13283 | 29553123 |
| Drug interaction | 28.26 | 17.30 | 118 | 8003 | 197267 | 29369139 |
| Dyskinesia | 28.11 | 17.30 | 31 | 8090 | 20030 | 29546376 |
| Cytotoxic oedema | 28.08 | 17.30 | 7 | 8114 | 164 | 29566242 |
| Condition aggravated | 28.00 | 17.30 | 96 | 8025 | 146199 | 29420207 |
| Temporal lobe epilepsy | 27.80 | 17.30 | 7 | 8114 | 171 | 29566235 |
| Atonic seizures | 27.42 | 17.30 | 7 | 8114 | 181 | 29566225 |
| Altered state of consciousness | 26.60 | 17.30 | 30 | 8091 | 19859 | 29546547 |
| Parkinsonism | 25.81 | 17.30 | 19 | 8102 | 7259 | 29559147 |
| Lymphocyte stimulation test positive | 25.80 | 17.30 | 9 | 8112 | 692 | 29565714 |
| Anticonvulsant drug level increased | 25.80 | 17.30 | 11 | 8110 | 1455 | 29564951 |
| Drug eruption | 25.43 | 17.30 | 27 | 8094 | 16714 | 29549692 |
| Aminoaciduria | 24.60 | 17.30 | 6 | 8115 | 128 | 29566278 |
| Small for dates baby | 24.18 | 17.30 | 14 | 8107 | 3565 | 29562841 |
| Tachyarrhythmia | 23.82 | 17.30 | 13 | 8108 | 2956 | 29563450 |
| Wrong schedule | 23.81 | 17.30 | 6 | 8115 | 147 | 29566259 |
| Congenital inguinal hernia | 23.44 | 17.30 | 6 | 8115 | 157 | 29566249 |
| Hallucination | 23.23 | 17.30 | 43 | 8078 | 44669 | 29521737 |
| Myoclonic epilepsy | 22.91 | 17.30 | 9 | 8112 | 966 | 29565440 |
| Infantile spasms | 22.56 | 17.30 | 6 | 8115 | 183 | 29566223 |
| Congenital cutis laxa | 22.35 | 17.30 | 5 | 8116 | 72 | 29566334 |
| Foetal exposure during pregnancy | 22.07 | 17.30 | 36 | 8085 | 33831 | 29532575 |
| Death | 21.74 | 17.30 | 38 | 8083 | 342046 | 29224360 |
| Fanconi syndrome | 21.71 | 17.30 | 10 | 8111 | 1588 | 29564818 |
| Premature baby | 21.32 | 17.30 | 25 | 8096 | 17255 | 29549151 |
| Arthralgia | 21.28 | 17.30 | 6 | 8115 | 139611 | 29426795 |
| Angle closure glaucoma | 20.74 | 17.30 | 8 | 8113 | 817 | 29565589 |
| Retinogram abnormal | 20.27 | 17.30 | 5 | 8116 | 112 | 29566294 |
| Product lot number issue | 20.25 | 17.30 | 4 | 8117 | 30 | 29566376 |
| Language disorder | 19.77 | 17.30 | 10 | 8111 | 1949 | 29564457 |
| Implant site pruritus | 19.52 | 17.30 | 3 | 8118 | 3 | 29566403 |
| Hepatic function abnormal | 19.45 | 17.30 | 37 | 8084 | 39222 | 29527184 |
| Aura | 19.36 | 17.30 | 6 | 8115 | 318 | 29566088 |
| Hallucination, visual | 18.98 | 17.30 | 22 | 8099 | 14993 | 29551413 |
| Persecutory delusion | 18.93 | 17.30 | 10 | 8111 | 2131 | 29564275 |
| Idiopathic generalised epilepsy | 18.79 | 17.30 | 4 | 8117 | 45 | 29566361 |
| Febrile neutropenia | 18.70 | 17.30 | 4 | 8117 | 112236 | 29454170 |
| Oculomucocutaneous syndrome | 18.33 | 17.30 | 5 | 8116 | 168 | 29566238 |
| Assisted delivery | 18.31 | 17.30 | 3 | 8118 | 6 | 29566400 |
| Implant site rash | 18.31 | 17.30 | 3 | 8118 | 6 | 29566400 |
| Electroencephalogram abnormal | 18.12 | 17.30 | 10 | 8111 | 2325 | 29564081 |
| Depressive symptom | 18.02 | 17.30 | 9 | 8112 | 1708 | 29564698 |
| Macrocephaly | 17.79 | 17.30 | 6 | 8115 | 417 | 29565989 |
| Haemoglobin decreased | 17.77 | 17.30 | 4 | 8117 | 108371 | 29458035 |
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 | 687.98 | 15.14 | 457 | 15517 | 166435 | 64316323 |
| Status epilepticus | 306.32 | 15.14 | 135 | 15839 | 21528 | 64461230 |
| Multiple-drug resistance | 199.59 | 15.14 | 71 | 15903 | 6431 | 64476327 |
| Drug reaction with eosinophilia and systemic symptoms | 192.79 | 15.14 | 136 | 15838 | 54081 | 64428677 |
| Generalised tonic-clonic seizure | 177.58 | 15.14 | 115 | 15859 | 39742 | 64443016 |
| Epilepsy | 162.42 | 15.14 | 102 | 15872 | 33429 | 64449329 |
| Aggression | 143.86 | 15.14 | 107 | 15867 | 46125 | 64436633 |
| Somnolence | 125.28 | 15.14 | 199 | 15775 | 203446 | 64279312 |
| Stevens-Johnson syndrome | 124.21 | 15.14 | 87 | 15887 | 34162 | 64448596 |
| Drug ineffective | 119.90 | 15.14 | 466 | 15508 | 839781 | 63642977 |
| Choroidal effusion | 113.10 | 15.14 | 27 | 15947 | 585 | 64482173 |
| Partial seizures | 107.95 | 15.14 | 47 | 15927 | 7260 | 64475498 |
| Irritability | 107.53 | 15.14 | 82 | 15892 | 36664 | 64446094 |
| Psychotic disorder | 98.63 | 15.14 | 76 | 15898 | 34502 | 64448256 |
| Focal dyscognitive seizures | 97.46 | 15.14 | 35 | 15939 | 3255 | 64479503 |
| Ataxia | 91.68 | 15.14 | 61 | 15913 | 22023 | 64460735 |
| Atonic seizures | 90.78 | 15.14 | 23 | 15951 | 642 | 64482116 |
| Hyperammonaemic encephalopathy | 79.78 | 15.14 | 32 | 15942 | 4026 | 64478732 |
| Petit mal epilepsy | 79.69 | 15.14 | 34 | 15940 | 4998 | 64477760 |
| Dyskinesia | 77.82 | 15.14 | 70 | 15904 | 39318 | 64443440 |
| Drug eruption | 68.99 | 15.14 | 63 | 15911 | 36073 | 64446685 |
| Nystagmus | 66.16 | 15.14 | 36 | 15938 | 9032 | 64473726 |
| Drug interaction | 65.85 | 15.14 | 218 | 15756 | 361865 | 64120893 |
| Toxic epidermal necrolysis | 63.65 | 15.14 | 61 | 15913 | 37105 | 64445653 |
| Calculus urinary | 63.57 | 15.14 | 22 | 15952 | 1835 | 64480923 |
| Postictal psychosis | 62.69 | 15.14 | 13 | 15961 | 143 | 64482615 |
| Dyspnoea | 62.51 | 15.14 | 52 | 15922 | 718622 | 63764136 |
| Cognitive disorder | 61.52 | 15.14 | 72 | 15902 | 55015 | 64427743 |
| Pneumonia aspiration | 57.28 | 15.14 | 72 | 15902 | 59199 | 64423559 |
| Delusion | 54.45 | 15.14 | 41 | 15933 | 17973 | 64464785 |
| Drug withdrawal convulsions | 53.26 | 15.14 | 20 | 15954 | 2108 | 64480650 |
| Tonic convulsion | 51.94 | 15.14 | 19 | 15955 | 1862 | 64480896 |
| Suicidal behaviour | 50.71 | 15.14 | 21 | 15953 | 2866 | 64479892 |
| Drug resistance | 47.98 | 15.14 | 51 | 15923 | 35051 | 64447707 |
| Altered state of consciousness | 43.07 | 15.14 | 50 | 15924 | 37852 | 64444906 |
| Hallucination, visual | 42.65 | 15.14 | 43 | 15931 | 27791 | 64454967 |
| Myoclonus | 42.57 | 15.14 | 41 | 15933 | 25077 | 64457681 |
| Hepatic function abnormal | 42.41 | 15.14 | 65 | 15909 | 64248 | 64418510 |
| Lymphocyte stimulation test positive | 41.36 | 15.14 | 14 | 15960 | 1092 | 64481666 |
| Ovarian granulosa-theca cell tumour | 40.72 | 15.14 | 7 | 15967 | 24 | 64482734 |
| Myoclonic epilepsy | 39.84 | 15.14 | 15 | 15959 | 1593 | 64481165 |
| Neonatal pneumonia | 39.29 | 15.14 | 7 | 15967 | 31 | 64482727 |
| Neonatal hypotension | 39.29 | 15.14 | 7 | 15967 | 31 | 64482727 |
| Retinogram abnormal | 38.52 | 15.14 | 10 | 15964 | 308 | 64482450 |
| Vitamin D deficiency | 38.45 | 15.14 | 28 | 15946 | 11664 | 64471094 |
| Arthralgia | 38.35 | 15.14 | 32 | 15942 | 442228 | 64040530 |
| Abnormal behaviour | 37.61 | 15.14 | 44 | 15930 | 33578 | 64449180 |
| Anticonvulsant drug level increased | 37.44 | 15.14 | 16 | 15958 | 2361 | 64480397 |
| Nephrolithiasis | 37.40 | 15.14 | 50 | 15924 | 43633 | 64439125 |
| Placental infarction | 36.86 | 15.14 | 8 | 15966 | 111 | 64482647 |
| Salivary hypersecretion | 35.34 | 15.14 | 27 | 15947 | 12086 | 64470672 |
| Respiratory disorder neonatal | 35.33 | 15.14 | 7 | 15967 | 60 | 64482698 |
| Hallucination | 35.18 | 15.14 | 64 | 15910 | 72724 | 64410034 |
| Infantile spasms | 34.77 | 15.14 | 9 | 15965 | 274 | 64482484 |
| Oculomucocutaneous syndrome | 33.65 | 15.14 | 9 | 15965 | 312 | 64482446 |
| Angle closure glaucoma | 32.56 | 15.14 | 15 | 15959 | 2642 | 64480116 |
| Product substitution issue | 31.87 | 15.14 | 30 | 15944 | 17831 | 64464927 |
| Sudden unexplained death in epilepsy | 31.84 | 15.14 | 10 | 15964 | 615 | 64482143 |
| Diplopia | 31.57 | 15.14 | 36 | 15938 | 26729 | 64456029 |
| Brown tumour | 30.88 | 15.14 | 6 | 15968 | 46 | 64482712 |
| Febrile neutropenia | 30.38 | 15.14 | 5 | 15969 | 187652 | 64295106 |
| Upper respiratory tract inflammation | 30.35 | 15.14 | 16 | 15958 | 3766 | 64478992 |
| Fanconi syndrome | 30.28 | 15.14 | 14 | 15960 | 2487 | 64480271 |
| Joint swelling | 30.23 | 15.14 | 8 | 15966 | 215374 | 64267384 |
| Vestibular migraine | 29.90 | 15.14 | 7 | 15967 | 139 | 64482619 |
| Hallucination, auditory | 27.48 | 15.14 | 27 | 15947 | 16912 | 64465846 |
| Bronchial hyperreactivity | 27.14 | 15.14 | 13 | 15961 | 2499 | 64480259 |
| Neuroleptic malignant syndrome | 26.78 | 15.14 | 32 | 15942 | 24964 | 64457794 |
| Disturbance in attention | 26.35 | 15.14 | 41 | 15933 | 41033 | 64441725 |
| Therapeutic product effective for unapproved indication | 26.29 | 15.14 | 6 | 15968 | 106 | 64482652 |
| Therapeutic response unexpected | 25.56 | 15.14 | 26 | 15948 | 16975 | 64465783 |
| Therapeutic product ineffective for unapproved indication | 25.49 | 15.14 | 6 | 15968 | 122 | 64482636 |
| Suicidal ideation | 25.43 | 15.14 | 53 | 15921 | 66489 | 64416269 |
| Breast disorder | 25.42 | 15.14 | 11 | 15963 | 1673 | 64481085 |
| Parkinsonism | 25.37 | 15.14 | 24 | 15950 | 14349 | 64468409 |
| Magnetic resonance imaging head abnormal | 24.60 | 15.14 | 12 | 15962 | 2400 | 64480358 |
| Depression | 24.47 | 15.14 | 100 | 15874 | 183191 | 64299567 |
| Hyperammonaemia | 24.43 | 15.14 | 20 | 15954 | 9884 | 64472874 |
| Cytotoxic oedema | 24.41 | 15.14 | 7 | 15967 | 315 | 64482443 |
| Encephalopathy | 23.84 | 15.14 | 48 | 15926 | 58771 | 64423987 |
| Swelling | 22.38 | 15.14 | 6 | 15968 | 160212 | 64322546 |
| Human herpes virus 6 serology positive | 22.35 | 15.14 | 6 | 15968 | 211 | 64482547 |
| Small for dates baby | 22.26 | 15.14 | 7 | 15967 | 432 | 64482326 |
| Encephalocele | 21.89 | 15.14 | 4 | 15970 | 21 | 64482737 |
| Aminoaciduria | 21.82 | 15.14 | 6 | 15968 | 231 | 64482527 |
| Diarrhoea | 21.56 | 15.14 | 99 | 15875 | 722605 | 63760153 |
| Mood swings | 21.46 | 15.14 | 24 | 15950 | 17444 | 64465314 |
| Depressed level of consciousness | 21.40 | 15.14 | 56 | 15918 | 81380 | 64401378 |
| Anticonvulsant drug level decreased | 21.40 | 15.14 | 10 | 15964 | 1820 | 64480938 |
| Overdose | 21.24 | 15.14 | 87 | 15887 | 159479 | 64323279 |
| Placental disorder | 21.13 | 15.14 | 8 | 15966 | 862 | 64481896 |
| Condition aggravated | 21.07 | 15.14 | 161 | 15813 | 372265 | 64110493 |
| Illiteracy | 21.03 | 15.14 | 4 | 15970 | 27 | 64482731 |
| Dysmetria | 20.90 | 15.14 | 8 | 15966 | 888 | 64481870 |
| Low birth weight baby | 20.62 | 15.14 | 7 | 15967 | 551 | 64482207 |
| Wrong schedule | 20.01 | 15.14 | 6 | 15968 | 316 | 64482442 |
| Therapeutic response shortened | 19.93 | 15.14 | 18 | 15956 | 10152 | 64472606 |
| Infusion related reaction | 19.75 | 15.14 | 8 | 15966 | 164459 | 64318299 |
| Migraine | 19.52 | 15.14 | 46 | 15928 | 62631 | 64420127 |
| Developmental regression | 19.46 | 15.14 | 4 | 15970 | 42 | 64482716 |
| Lichen planus | 19.11 | 15.14 | 10 | 15964 | 2318 | 64480440 |
| Ureterolithiasis | 18.73 | 15.14 | 11 | 15963 | 3190 | 64479568 |
| Idiopathic generalised epilepsy | 18.60 | 15.14 | 4 | 15970 | 53 | 64482705 |
| Agitation | 18.54 | 15.14 | 56 | 15918 | 88311 | 64394447 |
| Persecutory delusion | 18.50 | 15.14 | 12 | 15962 | 4146 | 64478612 |
| Personality change | 18.41 | 15.14 | 16 | 15958 | 8577 | 64474181 |
| Cough | 18.41 | 15.14 | 29 | 15945 | 302119 | 64180639 |
| Dyscalculia | 18.40 | 15.14 | 4 | 15970 | 56 | 64482702 |
| Electroencephalogram abnormal | 18.34 | 15.14 | 13 | 15961 | 5190 | 64477568 |
| Haemoglobin decreased | 18.28 | 15.14 | 13 | 15961 | 195050 | 64287708 |
| Malaise | 18.14 | 15.14 | 45 | 15929 | 396202 | 64086556 |
| Mood altered | 18.01 | 15.14 | 21 | 15953 | 15958 | 64466800 |
| Atrial fibrillation | 17.97 | 15.14 | 10 | 15964 | 171079 | 64311679 |
| Encapsulating peritoneal sclerosis | 17.94 | 15.14 | 7 | 15967 | 818 | 64481940 |
| Arthropathy | 17.93 | 15.14 | 4 | 15970 | 120963 | 64361795 |
| Drug level increased | 17.71 | 15.14 | 31 | 15943 | 34165 | 64448593 |
| Depressive symptom | 17.65 | 15.14 | 12 | 15962 | 4484 | 64478274 |
| Osteomalacia | 17.51 | 15.14 | 8 | 15966 | 1383 | 64481375 |
| Jealous delusion | 17.50 | 15.14 | 5 | 15969 | 222 | 64482536 |
| Anaemia | 17.34 | 15.14 | 43 | 15931 | 378637 | 64104121 |
| Human herpesvirus 6 infection | 17.27 | 15.14 | 12 | 15962 | 4642 | 64478116 |
| Peripheral swelling | 17.04 | 15.14 | 16 | 15958 | 209137 | 64273621 |
| Torticollis | 16.88 | 15.14 | 9 | 15965 | 2168 | 64480590 |
| Suicide attempt | 16.82 | 15.14 | 47 | 15927 | 70960 | 64411798 |
| Brain neoplasm | 16.76 | 15.14 | 12 | 15962 | 4866 | 64477892 |
| Speech disorder | 16.69 | 15.14 | 37 | 15937 | 48404 | 64434354 |
| Insomnia | 16.31 | 15.14 | 94 | 15880 | 197742 | 64285016 |
| Cerebellar atrophy | 16.20 | 15.14 | 7 | 15967 | 1061 | 64481697 |
| Intentional overdose | 16.12 | 15.14 | 54 | 15920 | 89890 | 64392868 |
| Aphasia | 16.12 | 15.14 | 33 | 15941 | 40873 | 64441885 |
| Staring | 16.02 | 15.14 | 9 | 15965 | 2401 | 64480357 |
| Neutropenia | 15.56 | 15.14 | 22 | 15952 | 239602 | 64243156 |
| Abdominal pain | 15.47 | 15.14 | 34 | 15940 | 312341 | 64170417 |
| Gestational diabetes | 15.30 | 15.14 | 12 | 15962 | 5578 | 64477180 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | N03AX15 | NERVOUS SYSTEM ANTIEPILEPTICS ANTIEPILEPTICS Other antiepileptics |
| FDA CS | M0020790 | Sulfonamides |
| FDA MoA | N0000000235 | Carbonic Anhydrase Inhibitors |
| FDA PE | N0000008486 | Decreased Central Nervous System Disorganized Electrical Activity |
| MeSH PA | D000927 | Anticonvulsants |
| MeSH PA | D002121 | Calcium Channel Blockers |
| MeSH PA | D000077264 | Calcium-Regulating Hormones and Agents |
| MeSH PA | D002317 | Cardiovascular Agents |
| MeSH PA | D002491 | Central Nervous System Agents |
| MeSH PA | D049990 | Membrane Transport Modulators |
| CHEBI has role | CHEBI:22586 | antioxidants |
| CHEBI has role | CHEBI:35470 | central nervous system agents |
| CHEBI has role | CHEBI:35623 | anticonvulsants |
| CHEBI has role | CHEBI:50267 | protective agents |
| FDA EPC | N0000175753 | Anti-epileptic Agent |
| FDA MoA | N0000185503 | P-Glycoprotein Inhibitors |
Drug Use (View source of the data)
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Diffuse Lewy body disease | indication | 80098002 | |
| Partial Epilepsy Treatment Adjunct | indication | ||
| Suicidal thoughts | contraindication | 6471006 | |
| Agranulocytosis | contraindication | 17182001 | DOID:12987 |
| Mood swings | contraindication | 18963009 | |
| Depressive disorder | contraindication | 35489007 | |
| Metabolic acidosis | contraindication | 59455009 | |
| Diarrhea | contraindication | 62315008 | |
| Psychotic disorder | contraindication | 69322001 | |
| Kidney disease | contraindication | 90708001 | DOID:557 |
| Kidney stone | contraindication | 95570007 | |
| Diminished sweating | contraindication | 111980002 | |
| Disease of liver | contraindication | 235856003 | DOID:409 |
| Aplastic anemia | contraindication | 306058006 | DOID:12449 |
| Severe chronic obstructive pulmonary disease | contraindication | 313299006 | |
| Fever | contraindication | 386661006 | |
| Surgical procedure | contraindication | 387713003 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 10.47 | acidic |
Orange Book patent data (new drug applications)
None
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 |
|---|---|---|---|---|---|---|---|---|---|
| Sodium channel protein type 1 subunit alpha | Ion channel | BLOCKER | WOMBAT-PK | CHEMBL | |||||
| Carbonic anhydrase 2 | Enzyme | Ki | 6.99 | WOMBAT-PK | |||||
| Voltage-dependent T-type calcium channel subunit alpha-1G | Ion channel | WOMBAT-PK | |||||||
| Carbonic anhydrase 1 | Enzyme | Ki | 7.25 | WOMBAT-PK | |||||
| Carbonic anhydrase 4 | Enzyme | Ki | 5.07 | CHEMBL | |||||
| Amine oxidase [flavin-containing] B | Enzyme | Ki | 5.51 | CHEMBL | |||||
| Carbonic anhydrase 9 | Enzyme | Ki | 8.30 | WOMBAT-PK | |||||
| Carbonic anhydrase 12 | Enzyme | INHIBITOR | Ki | 4.96 | IUPHAR | ||||
| Carbonic anhydrase 5A, mitochondrial | Enzyme | Ki | 7.70 | CHEMBL | |||||
| Carbonic anhydrase 5B, mitochondrial | Enzyme | Ki | 5.22 | CHEMBL | |||||
| Carbonic anhydrase 7 | Enzyme | Ki | 6.93 | CHEMBL | |||||
| Carbonic anhydrase 6 | Enzyme | Ki | 7.05 | CHEMBL | |||||
| Carbonic anhydrase 14 | Enzyme | Ki | 5.28 | CHEMBL | |||||
| Carbonic anhydrase 13 | Enzyme | Ki | 6.37 | CHEMBL | |||||
| Carbonic anhydrase V | Enzyme | Ki | 7.69 | CHEMBL | |||||
| Carbonic anhydrase | Enzyme | Ki | 6.66 | CHEMBL | |||||
| Amine oxidase [flavin-containing] B | Enzyme | Ki | 5.54 | CHEMBL | |||||
| Carbonic anhydrase 15 | Enzyme | Ki | 6.20 | CHEMBL | |||||
| Carbonic anhydrase | Enzyme | Ki | 6.97 | CHEMBL | |||||
| Carbonic anhydrase | Enzyme | Ki | 7.46 | CHEMBL | |||||
| Probable transmembrane carbonic anhydrase (Carbonate dehydratase) (Carbonic dehydratase); Transmembrane carbonic anhydrase | Enzyme | Ki | 6.68 | CHEMBL | |||||
| Carbonic anhydrase | Enzyme | Ki | 6.94 | CHEMBL | |||||
| Alpha carbonic anhydrase | Enzyme | Ki | 6.59 | CHEMBL | |||||
| Carbonic anhydrase | Enzyme | Ki | 6.19 | CHEMBL | |||||
| Carbonic anhydrase 2 | Enzyme | Ki | 6.01 | CHEMBL | |||||
| Astrosclerin-3 | Enzyme | Ki | 6.78 | CHEMBL | |||||
| Beta-carbonic anhydrase 1 | Enzyme | Ki | 4.54 | CHEMBL | |||||
| Delta carbonic anhydrase | Unclassified | Ki | 6.39 | CHEMBL | |||||
| Carbonic anhydrase 2 | Enzyme | Ki | 6.06 | CHEMBL | |||||
| Carbonic anhydrase 3 | Enzyme | Ki | 5.07 | CHEMBL | |||||
| Amine oxidase [flavin-containing] | Enzyme | Ki | 4.51 | CHEMBL | |||||
| Carbonic anhydrase | Enzyme | Ki | 6.58 | CHEMBL | |||||
| Carbonic anhydrase, alpha family | Unclassified | Ki | 6.39 | CHEMBL | |||||
| Carbonate dehydratase | Enzyme | Ki | 6.85 | CHEMBL | |||||
| Amine oxidase [flavin-containing] B | Enzyme | IC50 | 4.61 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| 4021224 | VUID |
| N0000148668 | NUI |
| D00538 | KEGG_DRUG |
| 4021224 | VANDF |
| C0078844 | UMLSCUI |
| CHEBI:10127 | CHEBI |
| ZON | PDB_CHEM_ID |
| CHEMBL750 | ChEMBL_ID |
| DB00909 | DRUGBANK_ID |
| D000078305 | MESH_DESCRIPTOR_UI |
| 5734 | PUBCHEM_CID |
| 5575 | INN_ID |
| 7047 | IUPHAR_LIGAND_ID |
| 459384H98V | UNII |
| 261708 | RXNORM |
| 31898 | MMSL |
| 73622 | MMSL |
| 8781 | MMSL |
| d04527 | MMSL |
| 008137 | NDDF |
| 125693002 | SNOMEDCT_US |
| 398762003 | SNOMEDCT_US |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| zonisamide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0615-8266 | CAPSULE | 100 mg | ORAL | ANDA | 23 sections |
| ZONISAMIDE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16590-539 | CAPSULE | 100 mg | ORAL | ANDA | 16 sections |
| ZONISAMIDE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16590-724 | CAPSULE | 25 mg | ORAL | ANDA | 13 sections |
| ZONISAMIDE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 21695-155 | CAPSULE | 100 mg | ORAL | ANDA | 28 sections |
| ZONISAMIDE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 21695-654 | CAPSULE | 50 mg | ORAL | ANDA | 28 sections |
| Zonisamide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 29300-428 | CAPSULE | 25 mg | ORAL | ANDA | 12 sections |
| Zonisamide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 29300-429 | CAPSULE | 50 mg | ORAL | ANDA | 12 sections |
| Zonisamide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 29300-430 | CAPSULE | 100 mg | ORAL | ANDA | 12 sections |
| Zonisamide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 31722-228 | CAPSULE | 100 mg | ORAL | ANDA | 25 sections |
| ZONISAMIDE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 33261-843 | CAPSULE | 100 mg | ORAL | ANDA | 13 sections |
| ZONISAMIDE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 35356-143 | CAPSULE | 100 mg | ORAL | ANDA | 16 sections |
| ZONISAMIDE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 35356-143 | CAPSULE | 100 mg | ORAL | ANDA | 16 sections |
| Zonisamide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43063-932 | CAPSULE | 25 mg | ORAL | ANDA | 22 sections |
| Zonisamide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50268-816 | CAPSULE | 100 mg | ORAL | ANDA | 26 sections |
| Zonisamide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 51407-137 | CAPSULE | 25 mg | ORAL | ANDA | 22 sections |
| Zonisamide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 51407-137 | CAPSULE | 25 mg | ORAL | ANDA | 22 sections |
| Zonisamide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 51407-138 | CAPSULE | 50 mg | ORAL | ANDA | 22 sections |
| Zonisamide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 51407-138 | CAPSULE | 50 mg | ORAL | ANDA | 22 sections |
| Zonisamide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 51407-139 | CAPSULE | 100 mg | ORAL | ANDA | 22 sections |
| Zonisamide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 51407-139 | CAPSULE | 100 mg | ORAL | ANDA | 22 sections |
| zonisamide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 53217-301 | CAPSULE | 100 mg | ORAL | ANDA | 24 sections |
| Zonisamide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 54868-5789 | CAPSULE | 100 mg | ORAL | ANDA | 14 sections |
| Zonisamide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 54868-6221 | CAPSULE | 50 mg | ORAL | ANDA | 14 sections |
| ZONISAMIDE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 55648-945 | CAPSULE | 25 mg | ORAL | ANDA | 13 sections |
| ZONISAMIDE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 55648-946 | CAPSULE | 50 mg | ORAL | ANDA | 13 sections |
| ZONISAMIDE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 55648-990 | CAPSULE | 100 mg | ORAL | ANDA | 13 sections |
| Zonegran | Human Prescription Drug Label | 1 | 59212-680 | CAPSULE | 100 mg | ORAL | NDA | 26 sections |
| Zonegran | Human Prescription Drug Label | 1 | 59212-681 | CAPSULE | 25 mg | ORAL | NDA | 26 sections |
| Zonisamide | Human Prescription Drug Label | 1 | 59651-378 | CAPSULE | 25 mg | ORAL | ANDA | 23 sections |
| Zonisamide | Human Prescription Drug Label | 1 | 59651-379 | CAPSULE | 50 mg | ORAL | ANDA | 23 sections |