{
 "query": "topiramate",
 "ingredient": "topiramate",
 "slug": "topiramate",
 "rxcui": "38404",
 "brands": [
  "Topamax",
  "Eprontia",
  "Qudexy",
  "Trokendi"
 ],
 "names": [
  "topiramate"
 ],
 "classes": [],
 "alternatives": [],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 147
  },
  "boxed_warning": "",
  "indications_and_usage": "Topiramate is an antiepileptic (AED) agent indicated for: Monotherapy epilepsy: Initial monotherapy in patients \u2265 2 years of age with partial onset or primary generalized tonic-clonic seizures ( 1.1 ) Adjunctive therapy epilepsy: Adjunctive therapy for adults and pediatric patients (2 to 16 years of age) with partial onset seizures or primary generalized tonic-clonic seizures, and in patients \u22652 years of age with seizures associated with Lennox-Gastaut syndrome (LGS) ( 1.2 ) 1.1 Monotherapy Epilepsy Topiramate tablets, USP are indicated as initial monotherapy in patients 2 years of age and older with partial onset or primary generalized tonic-clonic seizures. Safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials [see Clinical Studies ( 14.1 )] . 1.2 Adjunctive Therapy Epilepsy Topiramate tablets, USP are indicated as adjunctive therapy for adults and pediatric patients ages 2 to 16 years with partial onset seizures or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with Lennox-Gastaut syndrome [see Clinica...",
  "contraindications": "None. None (4)",
  "warnings_and_cautions": "Acute myopia and secondary angle closure glaucoma: Untreated elevated intraocular pressure can lead to permanent visual loss. The primary treatment to reverse symptoms is discontinuation of topiramate as rapidly as possible ( 5.1 ) Visual field defects: These have been reported independent of elevated intraocular pressure. Consider discontinuation of topiramate ( 5.2 ) Oligohidrosis and hyperthermia: Monitor decreased sweating and increased body temperature, especially in pediatric patients ( 5.3 ) Metabolic acidosis: Baseline and periodic measurement of serum bicarbonate is recommended. Consider dose reduction or discontinuation of topiramate if clinically appropriate ( 5.4 ) Suicidal behavior and ideation: Antiepileptic drugs increase the risk of suicidal behavior or ideation ( 5.5 ) Cognitive/neuropsychiatric: Topiramate may cause cognitive dysfunction. Patients should use caution when operating machinery including automobiles. Depression and mood problems may occur in epilepsy population ( 5.6 ) Fetal Toxicity: Topiramate use during pregnancy can cause cleft lip and/or palate ( 5.7 ) Withdrawal of AEDs: Withdrawal of topiramate should be done gradually ( 5.8 ) Hyperammonemia an...",
  "warnings": "",
  "adverse_reactions": "The following adverse reactions are discussed in more detail in other sections of the labeling: Acute Myopia and Secondary Angle Closure [see Warnings and Precautions ( 5.1 )] Visual Field Defects [see Warnings and Precautions ( 5.2 )] Oligohidrosis and Hyperthermia [see Warnings and Precautions ( 5.3 )] Metabolic Acidosis [see Warnings and Precautions ( 5.4 )] Suicidal Behavior and Ideation [see Warnings and Precautions ( 5.5 )] Cognitive/Neuropsychiatric Adverse Reactions [see Warnings and Precautions ( 5.6 )] Fetal Toxicity [see Warnings and Precautions ( 5.7 ) and Use in Specific Populations ( 8.1 )] Withdrawal of Antiepileptic Drugs (AEDs) [see Warnings and Precautions ( 5.8 )] Sudden Unexplained Death in Epilepsy (SUDEP) [see Warnings and Precautions ( 5.9 )] Hyperammonemia and Encephalopathy (Without and With Concomitant Valproic Acid [VPA] Use [see Warnings and Precautions ( 5.10 )] Kidney Stones [see Warnings and Precautions ( 5.11 )] Hypothermia with Concomitant Valproic Acid (VPA) Use [see Warnings and Precautions ( 5.12 )] Paresthesia [see Warnings and Precautions ( 5.13 )] The data described in the following sections were obtained using topiramate tablets. The most com...",
  "drug_abuse_and_dependence": "9.1 Controlled Substance Topiramate is not a controlled substance. 9.2 Abuse The abuse and dependence potential of topiramate has not been evaluated in human studies. 9.3 Dependence Topiramate has not been systematically studied in animals or humans for its potential for tolerance or physical dependence.",
  "controlled_substance": "9.1 Controlled Substance Topiramate is not a controlled substance.",
  "recent_major_changes": "Warnings and Precautions, Visual Field Defects ( 5.2 ) 01/2014",
  "information_for_patients": "See FDA-approved Medication Guide. Inform patients and their caregivers of the availability of a Medication Guide, and instruct them to read this prior to taking topiramate Instruct patients to take topiramate only as prescribed. Eye Disorders Instruct patients taking topiramate tablets to seek immediate medical attention if they experience blurred vision, visual disturbances, or periorbital pain [see Warnings and Precautions ( 5.1 ), ( 5.2 )] . Oligohidrosis and Hyperthermia Closely monitor topiramate-treated patients, especially pediatric patients, for evidence of decreased sweating and increased body temperature, especially in hot weather. Counsel patients to contact their healthcare professionals immediately if they develop a high or persistent fever, or decreased sweating [see Warnings and Precautions ( 5.3 )] . Metabolic Acidosis Warn patients about the potential significant risk for metabolic acidosis that may be asymptomatic and may be associated with adverse effects on kidneys (e.g., kidney stones, nephrocalcinosis), bones (e.g., osteoporosis, osteomalacia, and/or rickets in children), and growth (e.g., growth delay/retardation) in pediatric patients, and on the fetus [see...",
  "spl_medguide": "MEDICATION GUIDE Topiramate Tablets, USP (toe-PEER-uh-mate) Read this Medication Guide before you start taking topiramate tablets and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. If you have any questions about topiramate tablets, talk to your healthcare provider or pharmacist. What is the most important information I should know about topiramate tablets? Topiramate tablets may cause eye problems. Serious eye problems include: any sudden decrease in vision with or without eye pain and redness, a blockage of fluid in the eye causing increased pressure in the eye (secondary angle closure glaucoma). These eye problems can lead to permanent loss of vision if not treated. You should call your healthcare provider right away if you have any new eye symptoms, including any new problems with your vision. Topiramate tablets may cause decreased sweating and increased body temperature (fever). People, especially children, should be watched for signs of decreased sweating and fever, especially in hot temperatures. Some people may need to be hospitalized for thi...",
  "clinical_studies": "The studies described in the following sections were conducted using topiramate tablets. 14.1 Monotherapy Epilepsy Controlled Trial Patients with Partial Onset or Primary Generalized Tonic-Clonic Seizures Adults and Pediatric Patients 10 Years of Age and Older The effectiveness of topiramate as initial monotherapy in adults and children 10 years of age and older with partial onset or primary generalized tonic-clonic seizures was established in a multicenter, randomized, double-blind, parallel-group trial. The trial was conducted in 487 patients diagnosed with epilepsy (6 to 83 years of age) who had 1 or 2 well-documented seizures during the 3-month retrospective baseline phase who then entered the study and received topiramate 25 mg/day for 7 days in an open-label fashion. Forty-nine percent of patients had no prior AED treatment and 17% had a diagnosis of epilepsy for greater than 24 months. Any AED therapy used for temporary or emergency purposes was discontinued prior to randomization. In the double-blind phase, 470 patients were randomized to titrate up to 50 mg/day or 400 mg/day. If the target dose could not be achieved, patients were maintained on the maximum tolerated dose. ...",
  "brand_name": "Topiramate",
  "manufacturer": "Sun Pharmaceutical Industries, Inc.",
  "application_number": "ANDA090278",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20181101",
  "set_id": "2d9513e0-2fb8-46c9-bbd6-b03efd31c3ef",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 72260,
  "serious": 48026,
  "death": 5390,
  "hospitalization": 18038,
  "primary_suspect": 71997,
  "top_reactions": [
   [
    "Drug Ineffective",
    9299
   ],
   [
    "Off Label Use",
    7422
   ],
   [
    "Headache",
    5492
   ],
   [
    "Nausea",
    4889
   ],
   [
    "Fatigue",
    4598
   ],
   [
    "Seizure",
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   ],
   [
    "Migraine",
    3924
   ],
   [
    "Pain",
    3689
   ],
   [
    "Dizziness",
    3441
   ],
   [
    "Product Use In Unapproved Indication",
    3354
   ],
   [
    "Diarrhoea",
    3225
   ],
   [
    "Vomiting",
    3017
   ],
   [
    "Depression",
    2784
   ],
   [
    "Condition Aggravated",
    2585
   ],
   [
    "Paraesthesia",
    2447
   ]
  ],
  "by_year": {
   "2019": 7386,
   "2020": 6407,
   "2021": 5787,
   "2022": 5162,
   "2023": 5180,
   "2024": 5783,
   "2025": 5599,
   "2026": 2382
  },
  "by_year_primary": {
   "2019": 7378,
   "2020": 6400,
   "2021": 5770,
   "2022": 5126,
   "2023": 5126,
   "2024": 5722,
   "2025": 5545,
   "2026": 2362
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class III",
   "date": "20231208",
   "reason": "Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylidene topiramate) result observed during routine stability testing at 18 months.",
   "firm": "Azurity Pharmaceuticals, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20211025",
   "reason": "Discoloration",
   "firm": "UNICHEM PHARMACEUTICALS USA INC",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20140915",
   "reason": "Presence of Foreign Tablets: Presence of topiramate 100 mg tablets comingled with 200 mg tablets.",
   "firm": "Zydus Pharmaceuticals USA Inc",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20130405",
   "reason": "Chemical Contamination: Topiramate Tablets is being recalled due to complaints related to an off - odor. described as moldy, musty or fishy in nature.",
   "firm": "Glenmark Generics Inc., USA",
   "status": "Terminated"
  }
 ],
 "recall_total": 4,
 "drugsfda": {
  "applications": 59,
  "nda": 5,
  "anda": 51,
  "first_approval": "19961224",
  "rems": false,
  "rems_last": "20130520",
  "labeling_supplements": 87,
  "labeling_recent": 25,
  "sponsors": [
   "ACCORD HLTHCARE",
   "ACTAVIS LABS FL",
   "ACTAVIS TOTOWA",
   "AIPING PHARM INC",
   "AJANTA PHARMA LTD",
   "ALKEM LABS LTD",
   "AMTA",
   "ASCENT PHARMS INC"
  ],
  "unapproved": false,
  "first_approval_fmt": "12/24/1996"
 },
 "trials": {
  "total": 340,
  "completed": 226,
  "terminated": 52,
  "with_results": 107,
  "industry": 160,
  "phase3": 82,
  "results_share": 0.47345132743362833,
  "terminated_share": 0.15294117647058825
 },
 "pubmed": {
  "rct": 350,
  "meta": 67,
  "recent_rct": 50,
  "cochrane": [
   {
    "pmid": "34817852",
    "title": "Topiramate for juvenile myoclonic epilepsy",
    "year": "2021"
   },
   {
    "pmid": "31642054",
    "title": "Topiramate add-on therapy for drug-resistant focal epilepsy",
    "year": "2019"
   },
   {
    "pmid": "31233229",
    "title": "Topiramate versus carbamazepine monotherapy for epilepsy: an individual participant data review",
    "year": "2019"
   },
   {
    "pmid": "30687937",
    "title": "Topiramate for juvenile myoclonic epilepsy",
    "year": "2019"
   },
   {
    "pmid": "28434203",
    "title": "Topiramate monotherapy for juvenile myoclonic epilepsy",
    "year": "2017"
   },
   {
    "pmid": "28409827",
    "title": "Topiramate for essential tremor",
    "year": "2017"
   },
   {
    "pmid": "27922722",
    "title": "Topiramate versus carbamazepine monotherapy for epilepsy: an individual participant data review",
    "year": "2016"
   },
   {
    "pmid": "27591453",
    "title": "Topiramate for acute affective episodes in bipolar disorder in adults",
    "year": "2016"
   },
   {
    "pmid": "26695884",
    "title": "Topiramate monotherapy for juvenile myoclonic epilepsy",
    "year": "2015"
   },
   {
    "pmid": "24570033",
    "title": "Topiramate add-on for drug-resistant partial epilepsy",
    "year": "2014"
   },
   {
    "pmid": "23996081",
    "title": "Topiramate for neuropathic pain and fibromyalgia in adults",
    "year": "2013"
   },
   {
    "pmid": "23797676",
    "title": "Topiramate for the prophylaxis of episodic migraine in adults",
    "year": "2013"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "topiramate",
   "Topamax",
   "Eprontia",
   "Qudexy",
   "Trokendi"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 3373229,
  "beneficiaries": 703117,
  "spend": 130071322.16,
  "by_brand": [
   {
    "brand": "Topiramate",
    "claims": 3304484,
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   {
    "brand": "Topiramate ER",
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   {
    "brand": "Topamax",
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    "brand": "Trokendi XR",
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   {
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   },
   {
    "brand": "Qudexy XR",
    "claims": 653,
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   }
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  "per_claim": 38.559884952963465
 },
 "mdl": [],
 "dsc": [
  {
   "date": "20110304",
   "title": "Topamax - Risk of oral clefts in children born to mothers taking Topamax (topiramate)",
   "url": "https://www.fda.gov/Drugs/DrugSafety/ucm245085.htm",
   "kind": "drug",
   "matched": "topiramate"
  }
 ],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 13629,
  "fills": 3373229,
  "per_million": 4040.3423544621487,
  "ratio": 1.459160589292488,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 84,
   "letter": "B",
   "why": [
    "FDA issued 1 Drug Safety Communication(s) naming this drug since 2010, most recently 2011 (-8)",
    "4,040 FDA reports naming it as the suspect drug per million Medicare fills, 1.5x the median drug on this site (-3)",
    "Death share in reports is near or below the FAERS average (0.8x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 68,
   "letter": "C",
   "why": [
    "350 randomized trials and 67 systematic reviews/meta-analyses indexed in PubMed",
    "12 independent Cochrane review(s) exist",
    "Only 47% of completed registered trials posted results (-8)",
    "'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 86,
   "letter": "B",
   "why": [
    "Recalls since 2016: 0 Class I, 0 Class II, 2 Class III across 51 generic makers (-1)",
    "25 label changes approved since 2021: the safety story is still moving (-8)",
    "Label lists recent major changes to warnings or indications (-5)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $0 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 (51 applications)",
    "No same-class alternatives found: little leverage to switch (-30)"
   ],
   "weight": 0.1
  }
 },
 "total": 81,
 "grade": "B",
 "questions": [
  "In 2011 the FDA issued a safety communication about this drug (Topamax - Risk of oral clefts in children born to mothers taking Topamax (topiramate)). Does that risk apply to me?",
  "The most-reported problems in FDA's adverse event data are headache, nausea. 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.)"
 ]
}