{
 "query": "zonisamide",
 "ingredient": "zonisamide",
 "slug": "zonisamide",
 "rxcui": "39998",
 "brands": [
  "Zonegran",
  "Zonisade"
 ],
 "names": [
  "zonisamide"
 ],
 "classes": [],
 "alternatives": [],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 30
  },
  "boxed_warning": "",
  "indications_and_usage": "INDICATIONS AND USAGE Zonisamide capsules are indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy.",
  "contraindications": "CONTRAINDICATIONS Zonisamide capsules are contraindicated in patients who have demonstrated hypersensitivity to sulfonamides or zonisamide.",
  "warnings_and_cautions": "",
  "warnings": "WARNINGS Potentially Fatal Reactions to Sulfonamides: Fatalities have occurred, although rarely, as a result of severe reactions to sulfonamides (zonisamide is a sulfonamide) including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias. Such reactions may occur when a sulfonamide is readministered irrespective of the route of administration. If signs of hypersensitivity or other serious reactions occur, discontinue zonisamide immediately. Specific experience with sulfonamide-type adverse reaction to zonisamide is described below. Serious Skin Reactions: Consideration should be given to discontinuing zonisamide in patients who develop an otherwise unexplained rash. If the drug is not discontinued, patients should be observed frequently. Seven deaths from severe rash [i.e. Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN)] were reported in the first 11 years of marketing in Japan. All of the patients were receiving other drugs in addition to zonisamide. In post-marketing experience from Japan, a total of 49 cases of SJS or TEN have been reported, a reporting rate of 46 per mi...",
  "adverse_reactions": "ADVERSE REACTIONS The most common adverse reactions with zonisamide (an incidence at least 4% greater than placebo) in controlled clinical trials and shown in descending order of frequency were somnolence, anorexia, dizziness, ataxia, agitation/irritability, and difficulty with memory and/or concentration. In controlled clinical trials, 12% of patients receiving zonisamide as adjunctive therapy discontinued due to an adverse reaction compared to 6% receiving placebo. Approximately 21% of the 1,336 patients with epilepsy who received zonisamide in clinical studies discontinued treatment because of an adverse reaction. The most common adverse reactions leading to discontinuation were somnolence, fatigue and/or ataxia (6%), anorexia (3%), difficulty concentrating (2%), difficulty with memory, mental slowing, nausea/vomiting (2%), and weight loss (1%). Many of these adverse reactions were dose-related (see WARNINGS and PRECAUTIONS ). Adverse Reaction Incidence in Controlled Clinical Trials: Table 4 lists adverse reactions that occurred in at least 2% of patients treated with zonisamide in controlled clinical trials that were numerically more common in the zonisamide group. In these stu...",
  "drug_abuse_and_dependence": "DRUG ABUSE AND DEPENDENCE The abuse and dependence potential of zonisamide has not been evaluated in human studies (see subsection). In a series of animal studies, zonisamide did not demonstrate abuse liability and dependence potential. Monkeys did not self-administer zonisamide in a standard reinforcing paradigm. Rats exposed to zonisamide did not exhibit signs of physical dependence of the CNS-depressant type. Rats did not generalize the effects of diazepam to zonisamide in a standard discrimination paradigm after training, suggesting that zonisamide does not have abuse potential of the benzodiazepine-CNS depressant type.",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Information for Patients: Inform patients of the availability of a Medication Guide, and instruct them to read the Medication Guide prior to taking zonisamide. Instruct patients to take zonisamide only as prescribed. Advise patients as follows: (See Medication Guide ) Zonisamide may produce drowsiness, especially at higher doses. Patients should be advised not to drive a car or operate other complex machinery until they have gained experience on zonisamide sufficient to determine whether it affects their performance. Because of the potential of zonisamide to cause CNS depression, as well as other cognitive and/or neuropsychiatric adverse events, zonisamide should be used with caution if used in combination with alcohol or other CNS depressants. Patients should contact their physicians immediately if a skin rash develops (see WARNINGS,Serious Skin Reactions subsection). Instruct patients to seek immediate medical attention if they experience blurred vision, visual disturbances, or periorbital pain (see WARNINGS, Acute Myopia and Secondary Angle Closure Glaucoma subsection). Patients should contact their physician immediately if they develop signs or symptoms, such as sudden back pai...",
  "spl_medguide": "Medication Guide Zonisamide Capsules USP (zoe nis\u2019 a mide) What is the most important information I should know about zonisamide? Zonisamide may cause serious side effects, including: Serious skin rash that can cause death. Serious allergic reactions that may affect different parts of the body. Less sweating and increase in your body temperature (fever). Serious eye problems Suicidal thoughts or actions in some people. Increased level of acid in your blood (metabolic acidosis). Problems with your concentration, attention, memory, thinking, speech, or language. Blood cell changes such as reduced red and white blood cell counts. These serious side effects are described below. Zonisamide may cause a serious skin rash that can cause death. These serious skin reactions are more likely to happen when you begin taking zonisamide within the first 4 months of treatment but may occur at later times. Zonisamide can cause other types of allergic reactions or serious problems that may affect different parts of the body such as your liver, kidneys, heart, or blood cells. You may or may not have a rash with these types of reactions. These reactions can be very serious and can cause death. Call yo...",
  "clinical_studies": "Clinical Studies: The effectiveness of zonisamide as adjunctive therapy (added to other antiepilepsy drugs) has been established in three multicenter, placebo-controlled, double blind, 3-month clinical trials (two domestic, one European) in 499 patients with refractory partial onset seizures with or without secondary generalization. Each patient had a history of at least four partial onset seizures per month in spite of receiving one or two antiepilepsy drugs at therapeutic concentrations. The 499 patients (209 women, 290 men) ranged in age from 13 to 68 years with a mean age of about 35 years. In the two US studies, over 80% of patients were Caucasian; 100% of patients in the European study were Caucasian. Zonisamide or placebo was added to the existing therapy. The primary measure of effectiveness was median percent reduction from baseline in partial seizure frequency. The secondary measure was proportion of patients achieving a 50% or greater seizure reduction from baseline (responders). The results described below are for all partial seizures in the intent-to-treat populations. In the first study (n = 203), all patients had a 1-month baseline observation period, then received p...",
  "brand_name": "Zonisamide",
  "manufacturer": "BluePoint Laboratories",
  "application_number": "ANDA077651",
  "pharm_class_epc": [
   "Anti-epileptic Agent [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20260304",
  "set_id": "345efcc4-6a36-4ddf-8b6c-9c6c844dab0a",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 12182,
  "serious": 9152,
  "death": 719,
  "hospitalization": 3651,
  "primary_suspect": 12108,
  "top_reactions": [
   [
    "Seizure",
    1695
   ],
   [
    "Drug Ineffective",
    1500
   ],
   [
    "Off Label Use",
    928
   ],
   [
    "Fatigue",
    621
   ],
   [
    "Somnolence",
    602
   ],
   [
    "Dizziness",
    475
   ],
   [
    "Nausea",
    460
   ],
   [
    "Headache",
    452
   ],
   [
    "Fall",
    438
   ],
   [
    "Epilepsy",
    382
   ],
   [
    "Diarrhoea",
    355
   ],
   [
    "Vomiting",
    349
   ],
   [
    "Drug Interaction",
    343
   ],
   [
    "Condition Aggravated",
    338
   ],
   [
    "Product Use In Unapproved Indication",
    329
   ]
  ],
  "by_year": {
   "2019": 1152,
   "2020": 1014,
   "2021": 1180,
   "2022": 1095,
   "2023": 1037,
   "2024": 980,
   "2025": 956,
   "2026": 457
  },
  "by_year_primary": {
   "2019": 1152,
   "2020": 1013,
   "2021": 1179,
   "2022": 1089,
   "2023": 1016,
   "2024": 948,
   "2025": 949,
   "2026": 451
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20220425",
   "reason": "cGMP deviations",
   "firm": "Glenmark Pharmaceuticals Inc., USA",
   "status": "Completed"
  },
  {
   "class": "Class II",
   "date": "20220425",
   "reason": "cGMP deviations",
   "firm": "Glenmark Pharmaceuticals Inc., USA",
   "status": "Completed"
  },
  {
   "class": "Class II",
   "date": "20220425",
   "reason": "cGMP deviations",
   "firm": "Glenmark Pharmaceuticals Inc., USA",
   "status": "Completed"
  },
  {
   "class": "Class II",
   "date": "20210827",
   "reason": "CGMP Deviations",
   "firm": "Glenmark Pharmaceuticals Inc., USA",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20210827",
   "reason": "CGMP Deviations",
   "firm": "Glenmark Pharmaceuticals Inc., USA",
   "status": "Terminated"
  }
 ],
 "recall_total": 5,
 "drugsfda": {
  "applications": 21,
  "nda": 2,
  "anda": 19,
  "first_approval": "20000327",
  "rems": false,
  "rems_last": "20110927",
  "labeling_supplements": 10,
  "labeling_recent": 0,
  "sponsors": [
   "ADVANZ PHARMA",
   "ANI PHARMS",
   "APOTEX",
   "AUROBINDO PHARMA LTD",
   "AZURITY",
   "BIONPHARMA",
   "CHARTWELL RX",
   "EPIC PHARMA LLC"
  ],
  "unapproved": false,
  "first_approval_fmt": "03/27/2000"
 },
 "trials": {
  "total": 87,
  "completed": 58,
  "terminated": 21,
  "with_results": 38,
  "industry": 49,
  "phase3": 22,
  "results_share": 0.6551724137931034,
  "terminated_share": 0.2413793103448276
 },
 "pubmed": {
  "rct": 57,
  "meta": 17,
  "recent_rct": 9,
  "cochrane": [
   {
    "pmid": "32715463",
    "title": "Zonisamide add-on therapy for focal epilepsy",
    "year": "2020"
   },
   {
    "pmid": "30335200",
    "title": "Zonisamide add-on therapy for focal epilepsy",
    "year": "2018"
   },
   {
    "pmid": "28836659",
    "title": "Zonisamide for essential tremor",
    "year": "2017"
   },
   {
    "pmid": "25879104",
    "title": "Zonisamide for neuropathic pain in adults",
    "year": "2015"
   },
   {
    "pmid": "24353187",
    "title": "Zonisamide add-on for drug-resistant partial epilepsy",
    "year": "2013"
   },
   {
    "pmid": "16235282",
    "title": "Zonisamide add-on for drug-resistant partial epilepsy",
    "year": "2005"
   },
   {
    "pmid": "12076409",
    "title": "Zonisamide add-on for drug-resistant partial epilepsy",
    "year": "2002"
   },
   {
    "pmid": "10796786",
    "title": "Zonisamide for drug-resistant partial epilepsy",
    "year": "2000"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 24489.8,
  "records": 355,
  "by_name": [
   [
    "Zonisade",
    24489.8
   ]
  ],
  "names_checked": [
   "zonisamide",
   "Zonegran",
   "Zonisade"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 421239,
  "beneficiaries": 74311,
  "spend": 38863414.989999995,
  "by_brand": [
   {
    "brand": "Zonisamide",
    "claims": 412533,
    "per_claim": 32.883072263,
    "is_generic": true
   },
   {
    "brand": "Zonegran",
    "claims": 4783,
    "per_claim": 4366.3276333,
    "is_generic": false
   },
   {
    "brand": "Zonisade",
    "claims": 3923,
    "per_claim": 1125.1382794,
    "is_generic": false
   }
  ],
  "per_claim": 92.25977411873069
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 2348,
  "fills": 421239,
  "per_million": 5574.032793734673,
  "ratio": 2.013049455341083,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 89,
   "letter": "A",
   "why": [
    "5,574 FDA reports naming it as the suspect drug per million Medicare fills, 2.0x the median drug on this site (-6)",
    "Death share in reports is near or below the FAERS average (0.6x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 51,
   "letter": "D",
   "why": [
    "57 randomized trials and 17 systematic reviews/meta-analyses indexed in PubMed",
    "8 independent Cochrane review(s) exist",
    "24% of registered trials were terminated, withdrawn, or suspended (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 94,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 5 Class II, 0 Class III across 19 generic makers (-6)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $24,490 tied to this drug last year: negligible",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 70,
   "letter": "C",
   "why": [
    "Generic versions approved (19 applications)",
    "No same-class alternatives found: little leverage to switch (-30)"
   ],
   "weight": 0.1
  }
 },
 "total": 80,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are seizure, fatigue. How would we recognize and handle those?",
  "Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?",
  "What result are we expecting, by when, and what is the plan if it does not happen?",
  "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)"
 ]
}