Prescription medicine
Topiramate Brand names: Topamax, Qudexy, Trokendi, Eprontia
Topiramate (Topamax) is a prescription medicine with an FDA approval on record since 1996. FDA's NDC Directory lists it from 47 generic labelers, and pharmacies paid $0.0567 per topiramate 100 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the topiramate FDA label on DailyMed (effective June 1, 2026, Sun Pharmaceutical Industries, Inc.); the NDA 20505 record on Drugs@FDA; every topiramate label on DailyMed.
Highlights of the record
FDA label of June 1, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageTopiramate is indicated for: Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1);
Forms and strengths
- 15 mg
- 25 mg
- 50 mg
- 100 mg
- 150 mg
- 200 mg
- 25 mg/ml
Film-coated tablet; extended-release capsule; tablet; capsule (coated pellets); capsule.
On the market
- Earliest approval on file
- December 24, 1996 Topamax, Janssen Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 51 first December 17, 2003; 33 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 50 of which 47 under generic applications, 4 under brand applications, repackagers included
- Last listed patent
- August 21, 2040 Eprontia oral solution; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.0567 per tablet Topiramate 100 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 10 since 2012 0 Class I among all firms' recalls; latest August 31, 2026
- FAERS reports
- 91,067 through July 30, 2026
What is topiramate used for?
From the label: indications and usageTopiramate is indicated for: Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox- Gastaut syndrome in patients 2 years of age and older (1.2) Preventive treatment of migraine in patients 12 years of age and older (1.3) 1.1 Monotherapy Epilepsy Topiramate tablets are indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older. 1.2 Adjunctive Therapy Epilepsy […]
Conditions named in the indications of topiramate's FDA labels, with every medicine labeled for each:
Source: FDA drug label (Topiramate), Sun Pharmaceutical Industries, Inc., effective June 1, 2026 (SPL set 3c909a53-ae66-4b28-a741-b60bb25a69cf), via openFDA; the full label on DailyMed
What does the patient leaflet for topiramate say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about topiramate tablet?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 tablet 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 this condition. If a high fever, a fever that does not go away, or decreased sweating develops, call your healthcare provider right away. Topiramate tablet can increase the level of acid in your blood (metabolic acidosis). If left untreated, metabolic acidosis can cause brittle or soft bones (osteoporosis, osteomalacia, osteopenia), kidney stones, can slow the rate of growth in children, and may possibly harm your baby if you are pregnant. Metabolic acidosis can happen with or without symptoms. Sometimes people with metabolic acidosis will: feel tired not feel hungry (loss of appetite) feel changes in heartbeat have trouble thinking clearly Your healthcare provider should do a blood test to measure the level of acid in your blood before and during your treatment with topiramate tablets. If you are pregnant, you should talk to your healthcare provider about whether you have metabolic acidosis. Like other antiepileptic drugs, topiramate tablet may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. […]
From the patient leaflet: What should I avoid while taking topiramate tablets?You should not drink alcohol while taking topiramate tablets. Topiramate tablets and alcohol can affect each other causing side effects such as sleepiness and dizziness. • Do not drive a car or operate machinery until you know how topiramate tablets affect you. Topiramate tablets can slow your thinking and motor skills, and may affect vision.
From the patient leaflet: How should I store topiramate tablets?Store topiramate tablets at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). • Keep topiramate tablets in a tightly closed container. • Keep topiramate tablets dry and away from moisture. • Topiramate tablets comes in a child-resistant package. Keep topiramate tablets and all medicines out of the reach of children.
Source: FDA drug label (Topiramate), Sun Pharmaceutical Industries, Inc., effective June 1, 2026 (SPL set 3c909a53-ae66-4b28-a741-b60bb25a69cf), via openFDA; the full label on DailyMed
Is there a generic for topiramate (Topamax)?
The FDA approved the first generic topiramate on December 17, 2003. 51 generic applications are approved; 33 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists topiramate from 47 labelers under a generic (ANDA) application and from 4 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Topamax tablets; a patent listed only for Eprontia oral solution runs to August 21, 2040. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1996 earliest approval on file
- 2003 first generic approved
- 2040 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for topiramate (Topamax)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0567 per Topiramate 100 mg tablet, down 10% from $0.0628 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Topiramate 25 mg tablet (generic)
- Eprontia 25 mg/mL solution (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Topiramate 100 mg tablet | Generic | $0.0567 per tablet | $1.70 | -10% |
| Topiramate 15 mg sprinkle capsule | Generic | $0.229 per capsule | $6.88 | -29% |
| Topiramate 200 mg tablet | Generic | $0.110 per tablet | $3.30 | +9% |
| Topiramate 25 mg sprinkle capsule | Generic | $0.246 per capsule | $7.38 | -34% |
| Topiramate 25 mg tablet | Generic | $0.0268 per tablet | $0.805 | +1% |
| Topiramate 25 mg/mL solution | Generic | $1.58 per mL | n/a | n/a |
| Topiramate 50 mg sprinkle capsule | Generic | $4.32 per capsule many times the lowest per-tablet cost; NADAC records the price, not why | $129.72 | n/a |
| Topiramate 50 mg tablet | Generic | $0.037 per tablet | $1.11 | -5% |
| Topiramate ER 100 mg capsule | Generic | $10.68 per capsule many times the lowest per-tablet cost; NADAC records the price, not why | $320.26 | -17% |
| Topiramate ER 100 mg sprink capsule | Generic | $5.49 per capsule many times the lowest per-tablet cost; NADAC records the price, not why | $164.76 | -37% |
| Topiramate ER 150 mg sprink capsule | Generic | $7.36 per capsule many times the lowest per-tablet cost; NADAC records the price, not why | $220.71 | -39% |
| Topiramate ER 200 mg capsule | Generic | $20.37 per capsule many times the lowest per-tablet cost; NADAC records the price, not why | $611.21 | -21% |
| Topiramate ER 200 mg sprink capsule | Generic | $9.54 per capsule many times the lowest per-tablet cost; NADAC records the price, not why | $286.26 | -27% |
| Topiramate ER 25 mg capsule | Generic | $4.14 per capsule many times the lowest per-tablet cost; NADAC records the price, not why | $124.20 | -6% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has topiramate been recalled?
The FDA's Enforcement Report lists 10 recalls naming topiramate since 2012: 0 Class I (the most serious), 4 Class II, 6 Class III; 2 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| August 31, 2026 | Class III | Supernus Pharmaceuticals, Inc. | Failed dissolution specifications. |
| July 6, 2026 | Class III | Supernus Pharmaceuticals, Inc. | Failed Dissolution Specifications |
| December 8, 2023 | Class III | Azurity Pharmaceuticals, Inc. | Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylidene topiramate) result observed during routine stability … |
| October 25, 2021 | Class III | UNICHEM PHARMACEUTICALS USA INC | Discoloration |
| March 15, 2021 | Class II | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. |
| July 27, 2020 | Class II | Calvin Scott & Company, Inc. | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches. |
| July 12, 2016 | Class II | Supernus Pharmaceuticals, Inc. | Superpotent Drug: Failure of assay specifications in the capsule. |
| September 15, 2014 | Class II | Zydus Pharmaceuticals USA Inc | Presence of Foreign Tablets: Presence of topiramate 100 mg tablets comingled with 200 mg tablets. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the topiramate label say about other medicines?
The topiramate label names 10 other medicines in its interaction, contraindication or warning sections. The labels of 35 other medicines name topiramate. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Acetazolamide | drug interactions | Concomitant use of topiramate, a carbonic anhydrase inhibitor, with any other carbonic anhydrase inhibitor (e.g., zonisamide or acetazolamide) may increase the severity of metabolic acidosis and may also increase the risk of kidney stone formation. |
| Amitriptyline | drug interactions | Some patients may experience a large increase in amitriptyline concentration in the presence of topiramate and any adjustments in amitriptyline dose should be made according to the patient's clinical response and not on the basis of plasma levels [see Clinical Pharmacology (12.3) ]. |
| Carbamazepine | drug interactions | Concomitant administration of phenytoin or carbamazepine with topiramate resulted in a clinically significant decrease in plasma concentrations of topiramate when compared to topiramate given alone. |
| Divalproex | drug interactions | Concomitant administration of valproic acid and topiramate has been associated with hypothermia and hyperammonemia with and without encephalopathy. |
| Hydrochlorothiazide | drug interactions | Hydrochlorothiazide (HCTZ) Topiramate Cmax and AUC increased when HCTZ was added to topiramate. |
| Lithium | drug interactions | Monitor lithium levels if lithium is used with high-dose topiramate |
| Phenytoin | drug interactions | Concomitant administration of phenytoin or carbamazepine with topiramate resulted in a clinically significant decrease in plasma concentrations of topiramate when compared to topiramate given alone. |
| Pioglitazone | drug interactions | Pioglitazone A decrease in the exposure of pioglitazone and its active metabolites were noted with the concurrent use of pioglitazone and topiramatein a clinical trial. |
| Valproic acid | drug interactions | Concomitant administration of valproic acid and topiramate has been associated with hypothermia and hyperammonemia with and without encephalopathy. |
| Zonisamide | drug interactions | Concomitant use of topiramate, a carbonic anhydrase inhibitor, with any other carbonic anhydrase inhibitor (e.g., zonisamide or acetazolamide) may increase the severity of metabolic acidosis and may also increase the risk of kidney stone formation. |
Other labels that name topiramate
- Atogepant
- Dienogest and estradiol
- Drospirenone and ethinyl estradiol
- Drospirenone and ethinyl estradiol and levomefolate
- Ethinyl estradiol and ferrous bisglycinate and levonorgestrel
- Ethinyl estradiol and ferrous fumarate and levonorgestrel
- Ethinyl estradiol and ferrous fumarate and norethindrone
- Ethinyl estradiol and levonorgestrel
- Ethinyl estradiol and norelgestromin
- Ethinyl estradiol and norethindrone
- Ethinyl estradiol and norgestimate
- Etonogestrel
- Medroxyprogesterone
- Metformin
- Risperidone
Source: FDA drug label (Topiramate), Sun Pharmaceutical Industries, Inc., effective June 1, 2026 (SPL set 3c909a53-ae66-4b28-a741-b60bb25a69cf), via openFDA; the full label on DailyMed
What do FAERS reports show for topiramate?
The FDA Adverse Event Reporting System holds 91,067 reports that list topiramate among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 6,839 are coded as a death and 23,609 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as topiramate?
18 other medicines are given the same way (oral) and in the same FDA class as topiramate or labeled mainly for the same use (seizures and epilepsy), the same class first. Seizures and epilepsy lists all 27 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Lamotrigine | Seizures and epilepsy | 50 labelers | $0.0268 per tablet 25 mg tablet | A presentation being discontinued |
| Levetiracetam | Seizures and epilepsy | 63 labelers | $0.0736 per tablet 500 mg tablet | No current entry |
| Phenobarbital | Seizures and epilepsy | none listed | $0.213 per tablet 100 mg tablet | A presentation being discontinued |
| Clonazepam | Seizures and epilepsy | 31 labelers | $0.0244 per tablet 1 mg tablet | In shortage |
| Lacosamide | Seizures and epilepsy | 43 labelers | $0.174 per tablet 100 mg tablet | No current entry |
| Oxcarbazepine | Seizures and epilepsy | 43 labelers | $0.167 per tablet 300 mg tablet | No current entry |
| Brivaracetam | Seizures and epilepsy | 14 labelers | $0.259 per tablet 100 mg tablet | No current entry |
| Zonisamide | Seizures and epilepsy | 20 labelers | $0.106 per capsule 100 mg capsule | No current entry |
Every medicine labeled for the same conditions as topiramate
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does topiramate compare with medicines for the same use?
10 side-by-side pages set topiramate beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to topiramate
- 18 medicines for the same use
- Topiramate side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other