Tiagabine Side Effects

Brand Names: Gabitril

Please note - some side effects for Tiagabine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Tiagabine - for the Consumer

Tiagabine

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Tiagabine:

Abnormal skin sensations; diarrhea; dizziness; drowsiness; flushing; increased appetite; increased cough; irritability; lack of energy; lightheadedness; nausea; nervousness; pain; shakiness; sleeplessness; sore throat; stomach pain; vomiting; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal thinking; abnormal walking; blurred vision or other vision problems; burning, tingling, or numbness sensation; chest pain; confusion; difficulty with concentration or attention; fainting; incoordination; itching; jerky eye movements; memory problems; mental or mood changes (eg, agitation, depression, hostility, mood swings); seizures; severe or persistent headache or dizziness; severe weakness; speech or language problems; suicidal thoughts or actions; urination problems or difficult or painful urination.

Side Effects by Body System

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 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 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, 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 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 therapy.

Dermatologic

A definite correlation between tiagabine 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.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.