Applies to tiagabine: oral tablet.

Serious side effects of Tiagabine

Along with its needed effects, tiagabine 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

Other side effects of Tiagabine

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

• 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.

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 lability, 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]