Gabitril Side Effects

Generic name: tiagabine

Note: This document contains side effect information about tiagabine. Some of the dosage forms listed on this page may not apply to the brand name Gabitril.

Some side effects of Gabitril may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to tiagabine: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking tiagabine (the active ingredient contained in Gabitril) hives; fever; swollen glands; painful sores in or around your eyes or mouth; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have any of these serious side effects:

• new or worsened seizures;

• confusion, hallucination;

• problems with speech or vision;

• severe blistering, peeling, and red skin rash;

• tremor;

• fever, chills, body aches, flu symptoms; or

• chest pain, fast heart rate.

Less serious side effects of tiagabine may include:

• dizziness, drowsiness, weakness, tired feeling;

• feeling restless, irritable, or depressed;

• nausea, vomiting, stomach pain, diarrhea;

• trouble concentrating;

• sleep problems (insomnia);

• lack of coordination;

• cough, sore throat; or

• weight changes.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

For Healthcare Professionals

Applies to tiagabine: oral tablet

Nervous system

Nervous system side effects including dizziness (28% to 31%), asthenia (18% to 23%), tremor (14% to 21%), somnolence (19% to 21%), nervousness (11% to 14%), difficulty with concentration/attention (7% to 14%), ataxia (6% to 9%), depression (1% to 7%), insomnia (5% to 6%), abnormal gait (5%), and hostility (5%) have been reported. From the launch of tiagabine (the active ingredient contained in Gabitril) in 1997 through the end of 2004, fifty-nine postmarketing reports of seizures in patients without a history of epilepsy have been reported. A case of transient athetosis induced by tiagabine has also been reported.

General

In patients experiencing incapacitating generalized weakness, the weakness resolved in all cases after either discontinuation or a reduction in tiagabine (the active ingredient contained in Gabitril) dosage.

General side effects including accidental injury (15% to 21%), infection (10% to 19%), flu syndrome (6% to 9%), pain (2% to 7%), and abdominal pain (5% to 7%) have been reported. Moderately severe to incapacitating generalized weakness (1%) has also been reported.

Gastrointestinal

Gastrointestinal side effects including diarrhea (2% to 10%), nausea, vomiting, and mouth ulceration have been reported.

Ocular

Studies have reported that when dogs received a single dose of radiolabeled tiagabine (the active ingredient contained in Gabitril) residual binding in the retina and uvea was present after 3 weeks. While no specific recommendations for periodic ophthalmic monitoring are recommended, prescribers should be aware of the possibility of long term ophthalmic effects.

Ocular side effects including amblyopia (4% to 9% ) have been reported.

Respiratory

Respiratory side effects including pharyngitis (7% to 8%) have been reported.

Hematologic

Hematologic side effects including ecchymosis have been reported in up to 6% of patients receiving tiagabine (the active ingredient contained in Gabitril) therapy. A case of thrombocytopenia suspected of being secondary to tiagabine has also been reported.

Musculoskeletal

Musculoskeletal side effects including myalgia (2% to 5%) have been reported. Three cases of transient dystonias have also been reported.

Genitourinary

Genitourinary side effects including urinary tract infection have been reported in up to 5% of patients on tiagabine (the active ingredient contained in Gabitril) therapy.

Dermatologic

A definite correlation between tiagabine (the active ingredient contained in Gabitril) and any of the rashes was not made.

Dermatologic side effects including four cases of serious rashes have been reported. Two of the rashes were maculopapular, one case was vesiculobullous, and the last was diagnosed as Stevens-Johnson Syndrome.

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