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 capsule, oral tablet
Along with its needed effects, tiagabine (the active ingredient contained in Gabitril) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor as soon as possible if any of the following side effects occur while taking tiagabine:More common
- Blue or purple spots on skin
- difficulty in concentrating or paying attention
- Burning, numbness, or tingling sensations
- clumsiness or unsteadiness
- mental depression
- speech or language problems
- bloody or cloudy urine
- burning, pain, or difficulty in urinating
- frequent urge to urinate
- generalized weakness
- memory problems
- quick to react or overreact emotionally
- uncontrolled back-and-forth and/or rolling eye movements
- walking in unusual manner
- Agitation (severe)
- clumsiness or unsteadiness (severe)
- confusion (severe)
- drowsiness (severe)
- increase in seizures
- mental depression
- severe muscle twitching or jerking
- speech problems (severe)
Some side effects of tiagabine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:More common
- muscle aches or pain
- sore throat
- unusual tiredness or weakness
- Abdominal pain
- impaired vision
- increased appetite
- increased cough
- mouth ulcers
- muscle weakness
- trouble in sleeping
For Healthcare Professionals
Applies to tiagabine: oral tablet
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.
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 side effects including diarrhea (2% to 10%), nausea, vomiting, and mouth ulceration have been reported.
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 side effects including pharyngitis (7% to 8%) have been reported.
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 side effects including myalgia (2% to 5%) have been reported. Three cases of transient dystonias have also been reported.
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.
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.
More about Gabitril (tiagabine)
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