Quick answers
- What is Tiagabine hydrochloride used for?
- The FDA-approved label (Tiagabine Hydrochloride, Teva Pharmaceuticals USA, Inc., September 30, 2021) says: “Tiagabine HCl is indicated as adjunctive therapy in adults and children 12 years and older in the treatment of partial seizures.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the side effects of Tiagabine hydrochloride?
- The “Adverse Reactions” section of the FDA label (Tiagabine Hydrochloride, Teva Pharmaceuticals USA, Inc., September 30, 2021) begins: “The most commonly observed adverse events in placebo-controlled, parallel-group, add-on epilepsy trials associated with the use of tiagabine HCl in combination with other antiepilepsy drugs not seen at an equivalent frequency among placebo-treated patients were dizziness/light-headedness, asthenia/lack of energy, somnolence, nausea, nervousness/irritability, tremor, abdominal pain, and thinking abnormal/difficulty with concentration or attention.” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the drug interactions of Tiagabine hydrochloride?
- The “Drug Interactions” section of the FDA label (Tiagabine Hydrochloride, Teva Pharmaceuticals USA, Inc., September 30, 2021) begins: “In evaluating the potential for interactions among co-administered antiepilepsy drugs (AEDs), whether or not an AED induces or does not induce metabolic enzymes is an important consideration. Carbamazepine, phenytoin, primidone, and phenobarbital are generally classified as enzyme inducers; valproate and gabapentin are not. Tiagabine HCl is considered to be a non-enzyme inducing AED (see PRECAUTIONS, General, Use in Non-Induced Patients).” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Tiagabine hydrochloride have a boxed warning?
- No. None of the 3 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Tiagabine hydrochloride?
- The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated April 15, 2026). Ask your pharmacist about alternatives.
- Has Tiagabine hydrochloride been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started July 10, 2023 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Tiagabine hydrochloride?
- 3 companies list prescription products of Tiagabine hydrochloride in the FDA NDC Directory, including Novadoz Pharmaceuticals LLC, Teva Pharmaceuticals USA, Inc. and Sun Pharmaceutical Industries, Inc.
What Tiagabine hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Tiagabine HCl is indicated as adjunctive therapy in adults and children 12 years and older in the treatment of partial seizures.
— FDA label: Tiagabine Hydrochloride, Teva Pharmaceuticals USA, Inc., effective September 30, 2021. Read the full label on DailyMed →
Label quoted: the one for the most common form (tablet, film coated, oral), Tiagabine Hydrochloride, Teva Pharmaceuticals USA, Inc.; it covers 4 products in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.
The FDA has 3 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 3 FDA labels for this medicine have a boxed warning.
Tiagabine hydrochloride side effects
Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.
The most commonly observed adverse events in placebo-controlled, parallel-group, add-on epilepsy trials associated with the use of tiagabine HCl in combination with other antiepilepsy drugs not seen at an equivalent frequency among placebo-treated patients were dizziness/light-headedness, asthenia/lack of energy, somnolence, nausea, nervousness/irritability, tremor, abdominal pain, and thinking abnormal/difficulty with concentration or attention.
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Approximately 21% of the 2531 patients who received tiagabine HCl in clinical trials of epilepsy discontinued treatment because of an adverse event. The adverse events most commonly associated with discontinuation were dizziness (1.7%), somnolence (1.6%), depression (1.3%), confusion (1.1%), and asthenia (1.1%). In Studies 1 and 2 (U.S. studies), the double-blind, placebo-controlled, parallel-group, add-on studies, the proportion of patients who discontinued treatment because of adverse events was 11% for the group treated with tiagabine HCl and 6% for the placebo group. The most common adverse events considered the primary reason for discontinuation were confusion (1.2%), somnolence (1.0%), and ataxia (1.0%). Adverse Event Incidence in Controlled Clinical Trials: Table 5 lists treatment-emergent signs and symptoms that occurred in at least 1% of patients treated with tiagabine HCl for epilepsy participating in parallel-group, placebo-controlled trials and were numerically more common in the tiagabine HCl group. In these studies, either tiagabine HCl or placebo was added to the patient’s current antiepilepsy drug therapy. Adverse events were usually mild or moderate in intensity. The prescriber should be aware that these figures, obtained when tiagabine HCl was added to concurrent antiepilepsy drug therapy, cannot be used to predict the frequency of adverse events in the course of usual medical practice when patient characteristics and other factors may differ from those prevailing during clinical studies. Similarly, the cited frequencies cannot be directly compared with figures obtained from other clinical investigations involving different treatments, uses, or investigators. An inspection of these frequencies, however, does provide the prescribing physician with one basis to estimate the relative contribution of drug and non-drug factors to the adverse event incidences in the population studied.
— FDA label: Tiagabine Hydrochloride, Teva Pharmaceuticals USA, Inc., effective September 30, 2021. This is part of the section. Read the full label on DailyMed →
Tiagabine hydrochloride drug interactions
Quoted from the “Drug Interactions” section of the FDA-approved label. Tell your pharmacist about every medicine, vitamin and herbal product you take.
In evaluating the potential for interactions among co-administered antiepilepsy drugs (AEDs), whether or not an AED induces or does not induce metabolic enzymes is an important consideration. Carbamazepine, phenytoin, primidone, and phenobarbital are generally classified as enzyme inducers; valproate and gabapentin are not. Tiagabine HCl is considered to be a non-enzyme inducing AED (see PRECAUTIONS, General, Use in Non-Induced Patients).
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The drug interaction data described in this section were obtained from studies involving either healthy subjects or patients with epilepsy. Effects of Tiagabine HCl on other Antiepilepsy Drugs (AEDs): Phenytoin: Tiagabine had no effect on the steady-state plasma concentrations of phenytoin in patients with epilepsy. Carbamazepine: Tiagabine had no effect on the steady-state plasma concentrations of carbamazepine or its epoxide metabolite in patients with epilepsy. Valproate: Tiagabine causes a slight decrease (about 10%) in steady-state valproate concentrations. Phenobarbital or Primidone: No formal pharmacokinetic studies have been performed examining the addition of tiagabine to regimens containing phenobarbital or primidone. The addition of tiagabine in a limited number of patients in three well-controlled studies caused no systematic changes in phenobarbital or primidone concentrations when compared to placebo. Effects of other Antiepilepsy Drugs (AEDs) on Tiagabine HCl: Carbamazepine: Population pharmacokinetic analyses indicate that tiagabine clearance is 60% greater in patients taking carbamazepine with or without other enzyme-inducing AEDs. Phenytoin: Population pharmacokinetic analyses indicate that tiagabine clearance is 60% greater in patients taking phenytoin with or without other enzyme-inducing AEDs. Phenobarbital (Primidone): Population pharmacokinetic analyses indicate that tiagabine clearance is 60% greater in patients taking phenobarbital (primidone) with or without other enzyme-inducing AEDs. Valproate: The addition of tiagabine to patients taking valproate chronically had no effect on tiagabine pharmacokinetics, but valproate significantly decreased tiagabine binding in vitro from 96.3 to 94.8%, which resulted in an increase of approximately 40% in the free tiagabine concentration. The clinical relevance of this in vitro finding is unknown. Interaction of Tiagabine HCl with Other Drugs: Cimetidine: Co-administration of cimetidine (800 mg/day) to patients taking tiagabine chronically had no effect on tiagabine pharmacokinetics. Theophylline: A single 10 mg dose of tiagabine did not affect the pharmacokinetics of theophylline at steady state. Warfarin: No significant differences were observed in the steady-state pharmacokinetics of R-warfarin or S-warfarin with the addition of tiagabine given as a single dose. Prothrombin times were not affected by tiagabine. Digoxin: Concomitant administration of tiagabine did not affect the steady-state pharmacokinetics of digoxin or the mean daily trough serum level of digoxin. 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.
— FDA label: Tiagabine Hydrochloride, Teva Pharmaceuticals USA, Inc., effective September 30, 2021. This is part of the section. Read the full label on DailyMed →
Tiagabine hydrochloride dosage
Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.
General: The blood level of tiagabine obtained after a given dose depends on whether the patient also is receiving a drug that induces the metabolism of tiagabine. The presence of an inducer means that the attained blood level will be substantially reduced. Dosing should take the presence of concomitant medications into account. Tiagabine HCl is recommended as adjunctive therapy for the treatment of partial seizures in patients 12 years and older.
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The following dosing recommendations apply to all patients taking tiagabine HCl: Tiagabine HCl is given orally and should be taken with food. Do not use a loading dose of tiagabine HCl. Dose titration: Rapid escalation and/or large dose increments of tiagabine HCl should not be used. Missed dose(s): If the patient forgets to take the prescribed dose of tiagabine HCl at the scheduled time, the patient should not attempt to make up for the missed dose by increasing the next dose. If a patient has missed multiple doses, patient should refer back to his or her physician for possible re-titration as clinically indicated. Dosage adjustment of tiagabine HCl should be considered whenever a change in patient’s enzyme-inducing status occurs as a result of the addition, discontinuation, or dose change of the enzyme-inducing agent. Induced Adults and Adolescents 12 Years or Older: The following dosing recommendations apply to patients who are already taking enzyme-inducing antiepilepsy drugs (AEDs) (e.g., carbamazepine, phenytoin, primidone, and phenobarbital). Such patients are considered induced patients when administering tiagabine HCl. In adolescents 12 to 18 years old, tiagabine HCl should be initiated at 4 mg once daily. Modification of concomitant antiepilepsy drugs is not necessary, unless clinically indicated. The total daily dose of tiagabine HCl may be increased by 4 mg at the beginning of Week 2. Thereafter, the total daily dose may be increased by 4 to 8 mg at weekly intervals until clinical response is achieved or up to 32 mg/day. The total daily dose should be given in divided doses two to four times daily. Doses above 32 mg/day have been tolerated in a small number of adolescent patients for a relatively short duration. In adults, tiagabine HCl should be initiated at 4 mg once daily. Modification of concomitant antiepilepsy drugs is not necessary, unless clinically indicated. The total daily dose of tiagabine HCl may be increased by 4 to 8 mg at weekly intervals until clinical response is achieved or, up to 56 mg/day. The total daily dose should be given in divided doses two to four times daily. Doses above 56 mg/day have not been systematically evaluated in adequate and well-controlled clinical trials. Experience is limited in patients taking total daily doses above 32 mg/day using twice daily dosing. A typical dosing titration regimen for patients taking enzyme-inducing AEDs (induced patients) is provided in Table 7.
Table from the label
| Initiation and Titration Schedule | Total Daily Dose | |
|---|---|---|
| Week 1 | Initiate at 4 mg once daily | 4 mg/day |
| Week 2 | Increase total daily dose by 4 mg | 8 mg/day (in two divided doses) |
| Week 3 | Increase total daily dose by 4 mg | 12 mg/day(in three divided doses) |
| Week 4 | Increase total daily dose by 4 mg | 16 mg/day(in two to four divided doses) |
| Week 5 | Increase total daily dose by 4 to 8 mg | 20 to 24 mg/day(in two to four divided doses) |
| Week 6 | Increase total daily dose by 4 to 8 mg | 24 to 32 mg/day(in two to four divided doses) |
| Usual Adult Maintenance Dose in Induced Patients: | 32 to 56 mg/day in two to four divided doses |
— FDA label: Tiagabine Hydrochloride, Teva Pharmaceuticals USA, Inc., effective September 30, 2021. This is part of the section. Read the full label on DailyMed →
Tiagabine hydrochloride in pregnancy
Quoted from the pregnancy part of the FDA-approved label. Ask your doctor before you take any medicine while pregnant or planning a pregnancy.
Tiagabine has been shown to have adverse effects on embryo-fetal development, including teratogenic effects, when administered to pregnant rats and rabbits at doses greater than the human therapeutic dose. An increased incidence of malformed fetuses (various craniofacial, appendicular, and visceral defects) and decreased fetal weights were observed following oral administration of 100 mg/kg/day to pregnant rats during the period of organogenesis.
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This dose is approximately 16 times the maximum recommended human dose (MRHD) of 56 mg/day, based on body surface area (mg/m 2). Maternal toxicity (transient weight loss/reduced maternal weight gain during gestation) was associated with this dose, but there is no evidence to suggest that the teratogenic effects were secondary to the maternal effects. No adverse maternal or embryo-fetal effects were seen at a dose of 20 mg/kg/day (3 times the MRHD on a mg/m 2 basis). Decreased maternal weight gain, increased resorption of embryos and increased incidences of fetal variations, but not malformations, were observed when pregnant rabbits were given 25 mg/kg/day (8 times the MRHD on a mg/m 2 basis) during organogenesis. The no effect level for maternal and embryo-fetal toxicity in rabbits was 5 mg/kg/day (equivalent to the MRHD on a mg/m 2 basis). When female rats were given tiagabine 100 mg/kg/day during late gestation and throughout parturition and lactation, decreased maternal weight gain during gestation, an increase in stillbirths, and decreased postnatal offspring viability and growth were found. There are no adequate and well-controlled studies in pregnant women. Tiagabine should be used during pregnancy only if clearly needed. To provide additional information regarding the effects of in utero exposure to tiagabine HCl, physicians are advised to recommend that pregnant patients taking tiagabine HCl enroll in the NAAED Pregnancy Registry. This can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves. Information on the registry can also be found at the website http://www.aedpregnancyregistry.org/.
— FDA label: Tiagabine Hydrochloride, Teva Pharmaceuticals USA, Inc., effective September 30, 2021. Read the full label on DailyMed →
Tiagabine hydrochloride and breastfeeding
Quoted from the nursing mothers / lactation part of the FDA-approved label.
Use in Nursing Mothers: Studies in rats have shown that tiagabine HCl and/or its metabolites are excreted in the milk of that species. Levels of excretion of tiagabine and/or its metabolites in human milk have not been determined and effects on the nursing infant are unknown. Tiagabine HCl should be used in women who are nursing only if the benefits clearly outweigh the risks.
— FDA label: Tiagabine Hydrochloride, Teva Pharmaceuticals USA, Inc., effective September 30, 2021. Read the full label on DailyMed →
When Tiagabine hydrochloride should not be used
Quoted from the “Contraindications” section of the FDA-approved label.
Tiagabine HCl is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients.
— FDA label: Tiagabine Hydrochloride, Teva Pharmaceuticals USA, Inc., effective September 30, 2021. Read the full label on DailyMed →
Tiagabine hydrochloride overdose
Quoted from the “Overdosage” section of the FDA-approved label. If someone may have taken too much, call Poison Help at 1-800-222-1222 (or 911 in an emergency).
Human Overdose Experience: Human experience of acute overdose with tiagabine HCl is limited. Eleven patients in clinical trials took single doses of tiagabine HCl up to 800 mg. All patients fully recovered, usually within one day. The most common symptoms reported after overdose included somnolence, impaired consciousness, agitation, confusion, speech difficulty, hostility, depression, weakness, and myoclonus.
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One patient who ingested a single dose of 400 mg experienced generalized tonic-clonic status epilepticus, which responded to intravenous phenobarbital. From post-marketing experience, reports of overdose involving tiagabine HCl alone have included cases in which patients required intubation and ventilatory support as part of the management of their status epilepticus. Overdoses involving multiple drugs, including tiagabine HCl, have resulted in fatal outcomes. Symptoms most often accompanying tiagabine HCl overdose, alone or in combination with other drugs, have included: seizures including status epilepticus in patients with and without underlying seizure disorders, nonconvulsive status epilepticus, respiratory arrest, coma, loss of consciousness, ataxia, dizziness, confusion, somnolence, drowsiness, impaired speech, aggression, agitation, lethargy, myoclonus, spike wave stupor, encephalopathy, amnesia, dyskinesia, tremors, disorientation, psychotic disorder, vomiting, hostility, and temporary paralysis. Respiratory depression was seen in a number of patients, including children, in the context of seizures. Management of Overdose: There is no specific antidote for overdose with tiagabine HCl. If indicated, elimination of unabsorbed drug should be achieved by emesis or gastric lavage; usual precautions should be observed to maintain the airway. General supportive care of the patient is indicated including monitoring of vital signs and observation of clinical status of the patient. Since tiagabine is mostly metabolized by the liver and is highly protein bound, dialysis is unlikely to be beneficial. A Certified Poison Control Center should be consulted for up to date information on the management of overdose with tiagabine HCl.
— FDA label: Tiagabine Hydrochloride, Teva Pharmaceuticals USA, Inc., effective September 30, 2021. Read the full label on DailyMed →
Forms and how it is given
| Dosage forms | Tablet, film coated · Tablet |
|---|---|
| Route | Oral |
| Prescription products | 10 in the FDA NDC Directory |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| tiagabine hydrochloride 12 mg tablet | Generic | $6.56 per tablet |
| tiagabine hydrochloride 2 mg tablet | Generic | $2.75 per tablet |
| tiagabine hydrochloride 4 mg tablet | Generic | $3.06 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Novadoz Pharmaceuticals LLC4 products
- Teva Pharmaceuticals USA, Inc.4 products
- Sun Pharmaceutical Industries, Inc.2 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA020646 GABITRIL | Cephalon | September 30, 1997 | 19, latest March 3, 2023 2023: Labeling · 2016: Labeling · 2015: Labeling |
Generic approvals (2)
- ANDA077555Sun Pharm Inds · November 4, 2011
- ANDA214816Msn · November 16, 2021
Shortage status
To be discontinued · updated April 15, 2026 · first posted April 15, 2026
| Product | Tiagabine Hydrochloride, Tablet, 12mg 30 count (NDC 0093-8072-56) |
|---|---|
| Company | Teva Pharmaceuticals USA, Inc. |
Ask your pharmacist whether your product is affected and what the options are.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
July 10, 2023 · Class II · Terminated · D-0914-2023
Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing
Tiagabine Hydrochloride Tablets, 2 mg, 30-count bottle, Distributed by Sun Pharmaceutical Industries. Inc. Cranbury NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Halol-Baroda Highway, Halol-389 350, Gu — SUN PHARMACEUTICAL INDUSTRIES INC
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 1299903, 1299909, 1299911, 1299917 |
|---|---|
| SPL set ID of the quoted label | 953ef3cc-e3cb-480f-b9ea-256520fd62b8 |
| FDA labels (SPL) | 3 |
| FDA applications | NDA020646, 2 ANDA |
| Active ingredients (FDA) | TIAGABINE |
Next steps
- Find a pharmacy near youAsk which price applies to you and whether your product is affected by a recall
- Latest FDA drug recallsAll medicines, newest first
- Novadoz Pharmaceuticals LLCMaker or distributor
- Teva Pharmaceuticals USA, Inc.Maker or distributor
- Sun Pharmaceutical Industries, Inc.Maker or distributor
- All prescription drugs A to ZSearch by generic, brand or Spanish name
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Tiagabine Hydrochloride, Teva Pharmaceuticals USA, Inc., effective September 30, 2021; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →