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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.

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

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 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

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

Dermatologic

Very common (10% or more): Common (1% to 10%): Rash, pruritus
Uncommon (0.1% to 1%): Dermatitis bullous dermatitis, bruising
Frequency not reported: Vesiculobullous rash, exfoliative dermatitis[Ref]

Cardiovascular

Common (1% to 10%): Vasodilation[Ref]

Gastrointestinal

Very common (10% or more): Nausea (11%)
Common (1% to 10%): Abdominal pain, diarrhea, vomiting, increased appetite, mouth ulceration[Ref]

Hepatic

Very rare (less than 0.01%): Abnormal hepatic function (elevated SGPT, GGT)[Ref]

Musculoskeletal

Common (1% to 10%): Myasthenia, muscle twitching[Ref]

Immunologic

Very common (10% or more): Infection (15%)
Common (1% to 10%): Influenza syndrome[Ref]

Nervous system

Very common (10% or more): Dizziness (27%), asthenia (20%), somnolence (18%), nervousness (10%), tremor
Common (1% to 10%): Ataxia, paresthesia, abnormal gait, nystagmus, speech disorder
Uncommon (0.1% to 1%): Nonconvulsive status epilepticus
Frequency not reported: Encephalopathy[Ref]

Ocular

Very common (10% or more): Blurred vision, visual field defects
Common (1% to 10%): Amblyopia, diplopia[Ref]

Respiratory

Common (1% to 10%): Pharyngitis, cough, rhinitis[Ref]

Psychiatric

Common (1% to 10%): Difficulty with concentration/attention, insomnia, confusion, memory loss, depressed mood, emotional liability, hostility/aggression, agitation
Uncommon (0.1% to 1%): Depression, psychosis
Rare (0.01% to 0.1%): Hallucinations, delusion[Ref]

Other

Very common (10% or more): Accidental injury (17%)
Common (1% to 10%): Pain (unspecified), fatigue[Ref]

References

1. "Product Information. Tiagabine Hydrochloride (tiaGABine (tiagabine))." Teva Pharmaceuticals USA, North Wales, PA.

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. Cerner Multum, Inc. "Australian Product Information." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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