Gabitril Side Effects

Generic Name: tiagabine

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

Not all side effects for Gabitril may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to tiagabine: oral capsule, oral tablet

In addition to its needed effects, some unwanted effects may be caused by tiagabine (the active ingredient contained in Gabitril). In the event that any of these side effects do occur, they may require medical attention.

If any of the following side effects occur while taking tiagabine, check with your doctor or nurse as soon as possible:

More common
  • Blue or purple spots on skin
  • difficulty in concentrating or paying attention
Less common
  • Burning, numbness, or tingling sensations
  • clumsiness or unsteadiness
  • confusion
  • itching
  • mental depression
  • speech or language problems
Rare
  • Agitation
  • bloody or cloudy urine
  • burning, pain, or difficulty in urinating
  • frequent urge to urinate
  • generalized weakness
  • hostility
  • memory problems
  • quick to react or overreact emotionally
  • rash
  • uncontrolled back-and-forth and/or rolling eye movements
  • walking in unusual manner
Symptoms of overdose
  • Agitation (severe)
  • clumsiness or unsteadiness (severe)
  • coma
  • confusion (severe)
  • drowsiness (severe)
  • increase in seizures
  • mental depression
  • severe muscle twitching or jerking
  • sluggishness
  • speech problems (severe)
  • weakness

Some of the side effects that can occur with tiagabine may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Chills
  • diarrhea
  • dizziness
  • drowsiness
  • fever
  • headache
  • muscle aches or pain
  • nervousness
  • sore throat
  • tremor
  • unusual tiredness or weakness
  • vomiting
Less common
  • Abdominal pain
  • flushing
  • impaired vision
  • increased appetite
  • increased cough
  • mouth ulcers
  • muscle weakness
  • nausea
  • pain
  • trouble in sleeping

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.[Ref]

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.[Ref]

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.[Ref]

Gastrointestinal

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

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.[Ref]

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

Respiratory

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

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.[Ref]

Musculoskeletal

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

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.[Ref]

Dermatologic

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

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.[Ref]

References

1. Tombini M, Pacifici L, Passarelli F, Rossini PM "Transient athetosis induced by tiagabine." Epilepsia 47 (2006): 799-800

2. "Product Information. Gabitril (tiagabine)." Abbott Pharmaceutical, Abbott Park, IL.

3. Willert C, Englisch S, Schlesinger S, Runge U "Possible drug-induced thrombocytopenia secondary to tiagabine." Neurology 52 (1999): 889

4. Wolanczyk T, Grabowska-Grzyb A "Transient dystonias in three patients treated with tiagabine." Epilepsia 42 (2001): 944-6

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