Prescription medicine
Tiagabine First approved as Gabitril
Tiagabine (Gabitril) is a prescription medicine with an FDA approval on record since 1997. FDA's NDC Directory lists it from 2 generic labelers, and pharmacies paid $2.62 per tiagabine HCl 2 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- A presentation discontinued
Check it at the source: the tiagabine FDA label on DailyMed (effective September 30, 2021, Teva Pharmaceuticals USA, Inc.); the NDA 20646 record on Drugs@FDA; every tiagabine label on DailyMed.
Highlights of the record
FDA label of September 30, 2021; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageTiagabine HCl is indicated as adjunctive therapy in adults and children 12 years and older in the treatment of partial seizures.
Forms and strengths
- 2 mg
- 4 mg
- 12 mg
- 16 mg
Film-coated tablet; tablet.
On the market
- Earliest approval on file
- September 30, 1997 Gabitril, Cephalon; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 4 first November 4, 2011; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 3 of which 2 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $2.62 per tablet Tiagabine HCl 2 mg tablet
- Shortage (FDA)
- None current 4 past records
- Recalls by its makers (FDA)
- 1 since 2023 0 Class I among all firms' recalls; latest July 10, 2023
- FAERS reports
- 84 through July 30, 2026
What is tiagabine used for?
From the label: indications and usageTiagabine HCl is indicated as adjunctive therapy in adults and children 12 years and older in the treatment of partial seizures.
Conditions named in the indications of tiagabine's FDA labels, with every medicine labeled for each:
From other tiagabine labelsSeizures and epilepsy: INDICATIONS AND USAGE Tiagabine HCl is indicated as adjunctive therapy in adults and children 12 years and older in the treatment of partial seizures.
FDA pharmacologic class: Anti-epileptic Agent.
Source: FDA drug label (Tiagabine Hydrochloride), NDA020646 (Cephalon), as published by Teva Pharmaceuticals USA, Inc., effective September 30, 2021 (SPL set 953ef3cc-e3cb-480f-b9ea-256520fd62b8), via openFDA; the full label on DailyMed
What does the patient leaflet for tiagabine 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 tiagabine hydrochloride?Do not stop taking tiagabine hydrochloride without first talking to your healthcare provider. Stopping tiagabine hydrochloride suddenly can cause serious problems. Tiagabine hydrochloride can cause serious side effects, including: 1. Tiagabine HCl may cause seizures in people who do not have epilepsy. If you do not have a seizure disorder and you take tiagabine hydrochloride, you may have a seizure or seizures that do not stop (status epilepticus). Call your healthcare provider right away if you have a seizure and you are not taking tiagabine hydrochloride for epilepsy. 2. Like other antiepileptic drugs, tiagabine hydrochloride may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying attempts to commit suicide new or worse depression new or worse anxiety feeling agitated or restless panic attacks trouble sleeping (insomnia) new or worse irritability acting aggressive, being angry, or violent acting on dangerous impulses an extreme increase in activity and talking (mania) other unusual changes in behavior or mood Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes. How can I watch for early symptoms of suicidal thoughts and actions? Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you are worried about symptoms. […]
From the patient leaflet: What should I avoid while taking tiagabine hydrochloride?Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking tiagabine hydrochloride without first talking to your healthcare provider. Taking tiagabine hydrochloride with alcohol or drugs that cause sleepiness or dizziness may make your sleepiness or dizziness worse. Do not drive, operate heavy machinery, or do other dangerous activities until you know how tiagabine hydrochloride affects you. Tiagabine hydrochloride can slow your thinking and motor skills.
From the patient leaflet: How should I store tiagabine hydrochloride?Store tiagabine hydrochloride between 68°F to 77°F (20°C to 25°C) Keep tiagabine hydrochloride out of light Keep tiagabine hydrochloride dry Keep tiagabine hydrochloride and all medicines out of the reach of children. General Information about tiagabine hydrochloride Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use tiagabine hydrochloride for a condition for which it was not prescribed. Do not give tiagabine hydrochloride to other people, even if they have the same symptoms that you have. It may harm them. This Medication Guide summarizes the most important information about tiagabine hydrochloride. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about tiagabine hydrochloride that is written for health professionals.
Source: FDA drug label (Tiagabine Hydrochloride), NDA020646 (Cephalon), as published by Teva Pharmaceuticals USA, Inc., effective September 30, 2021 (SPL set 953ef3cc-e3cb-480f-b9ea-256520fd62b8), via openFDA; the full label on DailyMed
Is there a generic for tiagabine (Gabitril)?
The FDA approved the first generic tiagabine on November 4, 2011. 4 generic applications are approved; 1 of them carries a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists tiagabine from 2 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1997 earliest approval on file
- 2011 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for tiagabine (Gabitril)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $2.62 per Tiagabine HCl 2 mg tablet, up 25% from $2.10 on October 8, 2025. 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.
- Tiagabine HCl 4 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Tiagabine HCl 12 mg tablet | Generic | $6.62 per tablet | $198.57 | +35% |
| Tiagabine HCl 2 mg tablet | Generic | $2.62 per tablet | $78.65 | +25% |
| Tiagabine HCl 4 mg tablet | Generic | $2.52 per tablet | $75.74 | +37% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is tiagabine in shortage?
No tiagabine presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 4 records are all marked to be discontinued, the latest updated April 15, 2026. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Tiagabine Hydrochloride, Tablet, 12mg 30 count (NDC 0093-8072-56) | Teva Pharmaceuticals USA, Inc. | To Be Discontinued | April 15, 2026 |
| Tiagabine Hydrochloride, Tablet, 16mg 30 count (NDC 0093-8076-56) | Teva Pharmaceuticals USA, Inc. | To Be Discontinued | April 15, 2026 |
| Tiagabine Hydrochloride, Tablet, 2mg 30 count (NDC 0093-5030-56) | Teva Pharmaceuticals USA, Inc. | To Be Discontinued | April 15, 2026 |
| Tiagabine Hydrochloride, Tablet, 4mg 30 count (NDC 0093-5031-56) | Teva Pharmaceuticals USA, Inc. | To Be Discontinued | April 15, 2026 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has tiagabine been recalled?
The FDA's Enforcement Report lists 1 recall naming tiagabine since 2023: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| July 10, 2023 | Class II | SUN PHARMACEUTICAL INDUSTRIES INC | Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the tiagabine label say about other medicines?
The tiagabine label names 9 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name tiagabine. 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 |
|---|---|---|
| Carbamazepine | drug interactions | Carbamazepine, phenytoin, primidone, and phenobarbital are generally classified as enzyme inducers; valproate and gabapentin are not. |
| Cimetidine | drug interactions | Interaction of Tiagabine HCl with Other Drugs: Co-administration of cimetidine (800 mg/day) to patients taking tiagabine chronically had no effect on tiagabine pharmacokinetics. |
| Digoxin | drug interactions | Concomitant administration of tiagabine did not affect the steady-state pharmacokinetics of digoxin or the mean daily trough serum level of digoxin. |
| Gabapentin | drug interactions | Carbamazepine, phenytoin, primidone, and phenobarbital are generally classified as enzyme inducers; valproate and gabapentin are not. |
| Phenobarbital | drug interactions | Carbamazepine, phenytoin, primidone, and phenobarbital are generally classified as enzyme inducers; valproate and gabapentin are not. |
| Phenytoin | drug interactions | Carbamazepine, phenytoin, primidone, and phenobarbital are generally classified as enzyme inducers; valproate and gabapentin are not. |
| Primidone | drug interactions | Carbamazepine, phenytoin, primidone, and phenobarbital are generally classified as enzyme inducers; valproate and gabapentin are not. |
| Theophylline | drug interactions | Theophylline: A single 10 mg dose of tiagabine did not affect the pharmacokinetics of theophylline at steady state. |
| Triazolam | drug interactions | Ethanol or Triazolam: No significant differences were observed in the pharmacokinetics of triazolam (0.125 mg) and tiagabine (10 mg) when given together as a single dose. |
Source: FDA drug label (Tiagabine Hydrochloride), NDA020646 (Cephalon), as published by Teva Pharmaceuticals USA, Inc., effective September 30, 2021 (SPL set 953ef3cc-e3cb-480f-b9ea-256520fd62b8), via openFDA; the full label on DailyMed
What do FAERS reports show for tiagabine?
The FDA Adverse Event Reporting System holds 84 reports that list tiagabine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 7 are coded as a death and 33 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.
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 tiagabine?
20 other medicines are given the same way (oral) and in the same FDA class as tiagabine 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 |
|---|---|---|---|---|
| Gabapentin | Seizures and epilepsy | 87 labelers | $0.0218 per capsule 100 mg capsule | No current entry |
| Lamotrigine | Seizures and epilepsy | 50 labelers | $0.0268 per tablet 25 mg tablet | A presentation being discontinued |
| Divalproex | Seizures and epilepsy | 44 labelers | $0.194 per tablet 500 mg tablet | No current entry |
| Oxcarbazepine | Seizures and epilepsy | 43 labelers | $0.167 per tablet 300 mg tablet | No current entry |
| Zonisamide | Seizures and epilepsy | 20 labelers | $0.106 per capsule 100 mg capsule | No current entry |
| Valproic acid | Seizures and epilepsy | 19 labelers | $0.243 per capsule 250 mg capsule | Listed; available |
| Phenytoin | Seizures and epilepsy | 23 labelers | $0.145 per capsule 100 mg capsule | No current entry |
| Primidone | Seizures and epilepsy | 21 labelers | $0.0914 per tablet 50 mg tablet | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does tiagabine compare with medicines for the same use?
1 side-by-side page set tiagabine beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to tiagabine
- 20 medicines for the same use
- Other anti-seizure medicines
- the pharmacologic class, with prices and generics
- Tiagabine side effects
- the label's list beside FAERS reports
- Tiagabine shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other