Tiagabine (tye AG a been) has been approved by the FDA as adjunctive therapy in the treatment of focal seizures in both adults and children over the age of 12.

Your epilepsy treatment should always be discussed with your healthcare provider before use. Based on their judgment and knowledge, a drug may be prescribed for other epilepsy types not included in the indications. For more information, please see the prescribing information.

How can you take tiagabine? (Available formulations)

Tiagabine is available as an oral tablet taken with food.

Who should not take tiagabine?

If you are allergic to tiagabine or any of the inactive ingredients, then you should not take it.

Other considerations may influence whether you should take tiagabine. Tell your healthcare provider if you:

  • have or have had depression, mood problems, or suicidal thoughts or behavior.
  • have liver problems.
  • have a history of seizures that do not stop (status epilepticus).
  • are pregnant or plan to become pregnant.
  • are breastfeeding or plan to breastfeed.

What is important to know about taking tiagabine?

Do not stop taking tiagabine suddenly unless directed to do so by your healthcare provider.

As with all antiseizure medications, tiagabine should be withdrawn gradually to minimize the risk of causing or worsening seizures or status epilepticus. You should not stop using tiagabine suddenly unless your healthcare provider tells you to stop the medicine because of a serious side effect.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Taking tiagabine with certain other medicines may cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider. Especially tell your healthcare provider if you take: drugs that cause sleepiness or dizziness, St. John’s wort.

Women or those who are/plan to become pregnant
Use in pregnancy

At this time, there is not enough evidence regarding developmental risks associated with the use of tiagabine in pregnant people. In animal studies, there were instances of developmental issues at clinically relevant doses. However, having a seizure during pregnancy could harm both the pregnant individual and the baby. Tell your healthcare provider right away if you become pregnant. Do not start or stop taking seizure medication during pregnancy without your healthcare provider’s advice.

If you become pregnant while taking tiagabine, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this registry is to collect information about the safety of antiseizure medicine during pregnancy. You can enroll in this registry by calling 1-888-233-2334.

Use during breastfeeding

There are no data on the presence of tiagabine in human milk, the effects on the breastfed child, or the effects of the drug on milk production. Talk to your healthcare provider about the risks. Your healthcare provider will consider the developmental and health benefits of breastfeeding along with your need for tiagabine and the potential effect on the infant from tiagabine or from your epilepsy.

What are the side effects of tiagabine?

Tiagabine is approved by the FDA because it is safe and effective for the majority of people who take it. However, there are risks associated with all medicines. Some side effects caused by tiagabine can be very serious, and even life-threatening. It is important to be informed about these serious reactions and to be aware of their symptoms.

Common side effects

The most common side effects that were reported in studies of tiagabine are dizziness/light-headedness, asthenia/lack of energy, somnolence, nausea, nervousness/irritability, tremor, abdominal pain, and thinking abnormal/difficulty with concentration or attention.

Rare, but serious side effects
Other serious reactions, including serious blood or liver problems

Rare but life-threatening reactions involving the immune system or multi-organ hypersensitivity, which can cause serious blood or liver problems have been reported with tiagabine use. You may or may not have a rash with these types of reactions. Call your healthcare provider right away if you experience fever, frequent infections, severe muscle pain, swelling of your face, eyes, lips, or tongue, swollen lymph glands, unusual bruising or bleeding, weakness, fatigue, yellowing of your skin, or the white part of your eyes, trouble walking or seeing, seizures happening more often, or pain/tenderness in the area toward the top of your stomach (enlarged liver/spleen).

Suicidal thoughts or behaviors

Studies have found that people who take antiseizure medications including tiagabine may have suicidal thoughts or behaviors, which occur in approximately 1 in 500 patients. If you experience any thoughts or impulses to hurt yourself, you should contact your healthcare provider immediately.

Cognitive/neuropsychiatric reactions

Patients with a history of spike and wave discharges on electroencephalogram (EEG, a tool that measures brain activity) have been reported to have exacerbations of their EEG abnormalities associated with these cognitive/neuropsychiatric events. This raises the possibility that these clinical events may, in some cases, be a manifestation of underlying seizure activity. In the documented cases of spike and wave discharges on EEG with cognitive/neuropsychiatric events, patients usually continued tiagabine, but required dosage adjustment.

Status epilepticus

A critical risk factor for status epilepticus was the presence of a previous history; 33% of patients with a history of status epilepticus had recurrence during tiagabine treatment. Because adequate information about the incidence of status epilepticus in a similar population of patients with epilepsy who have not received treatment with tiagabine is not available, it is impossible to state whether or not treatment with tiagabine is associated with a higher or lower rate of status epilepticus than would be expected to occur in a similar population not treated with tiagabine.

Sudden unexpected death in epilepsy (SUDEP)

There have been as many as 10 cases of sudden unexpected deaths during the clinical development of tiagabine among 2531 patients with epilepsy (3831 patient-years of exposure). This represents an estimated incidence of 0.0026 deaths per patient year. This rate is within the range of estimates for the incidence of sudden and unexpected deaths in patients with epilepsy not receiving tiagabine. The estimated SUDEP rates in patients receiving tiagabine are also similar to those observed in patients receiving other antiseizure medications, chemically unrelated to tiagabine, that underwent clinical testing in similar populations at about the same time. This evidence suggests that the SUDEP rates reflect population rates, not a drug effect.